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Home Archives for Prescription Drugs and Pharmacy

Prescription Drugs and Pharmacy News

Prescription drug costs are one of the fastest-moving parts of health care spending, and they are shaped by decisions made far from the pharmacy counter. Drug manufacturers set list prices. Pharmacy benefit managers (PBMs), the companies that administer drug benefits for health plans and employers, negotiate rebates and build formularies, the lists of drugs a plan covers. The U.S. Food and Drug Administration (FDA) approves new drugs, generics and biosimilars. Health plans then decide what members pay at the pharmacy.

What We Cover

This section covers drug pricing and coverage decisions, FDA approvals and recalls, PBM practices and reform, formulary changes, pharmacy industry news, and the self-pay and direct-to-consumer programs that manufacturers have launched for high-demand drugs such as GLP-1 medications for diabetes and weight loss. We also report on insulin pricing, specialty drugs, and the vaccines and therapies that health plans add to coverage.

For Medicare beneficiaries, Part D rules and the annual out-of-pocket cap determine what they pay for prescriptions; that coverage appears in our Medicare section. Legislative and regulatory action on drug pricing and PBMs is covered in Healthcare Policy and Law, and carrier pharmacy partnerships appear in Health Insurance Companies and Blue Cross Blue Shield. Clinical research and public health findings about medications are covered in Public Health and Research.

The latest prescription drug and pharmacy news appears below, newest first.

First China Pharma Increases Market Share With Announcement of New Distribution Agreement at 3 Regional Hospitals in China

Posted on October 19, 2010 Written by Editor

SOURCE: First China Pharmaceutical Group, Inc.

HONG KONG–(Marketwire – October 19, 2010) –  First China Pharmaceutical Group, Inc. (OTCBB: FCPG) (“First China” or the “Company”) is pleased to announce it has recently signed agreements to distribute medicinal and pharmaceutical products to three district hospitals in Yunnan Province, thereby dramatically increasing its regional market share.

The agreement comes, in part, as a result of a proposal put forward in 2009 by the Ministry of Health during the National Health Conference that public hospitals should gradually phase out the existing 15% medicines and pharmaceutical products “cost plus” pricing system within 3 years. The government also advised that medical institutions should centralize their procurement and distribution of drug and pharmacare products.

These new guidelines identified that the previous system maintained high prices and commissions which have been deemed unsustainable and that these institutions should move towards agreements with large scale pharmaceutical distributors. This new methodology has been welcomed and is increasingly becoming popular as many leading hospitals and clinics move to this new system of procurement.

This news has been welcomed at First China and the results are just now coming to fruition with these new contracts now in place with the Yunnan No. 1 Peoples Hospital as well as the Kunming Yanan and Lin Cang Peoples Hospitals. The Company is perfectly positioned to take advantage of this Government approved purchasing directive and stands ready to be catapulted into the forefront of this rapidly growing market segment.

First China’s combination of bulk purchasing, low prices and growing variety of product lines (both Chinese and Western) complements its high capacity supply chain and B2B operating system all of which fully utilizes and exploits the benefits of their exclusive government issued internet ordering and distribution license. As a result, the Company is daily increasing its differentiation from the rest of the competition in this region of over 45 million inhabitants. 

Currently any hospital or clinic in Yunnan Province can easily sign up to procure the medicines they need from First China, enjoying instant response, rapid fulfillment and secure services combined with excellent price points, allowing those institutions to recover increased margins while offering lower retail pricing in many instances.

First China Pharmaceutical Group plans to continue the growth of the company from its current position as a provider of approximately 5,000 drugs to more than 4,700 pharmacies, hospitals and clinics in China’s Yunnan Province. The Company anticipates its business model will change to leverage the efficiencies of internet ordering and fulfillment and intends to rapidly expand its capacity to approximately 30,000 products. It is estimated that a broader product line will ensure customers will be able to order 80% to 90% of their product needs directly from the Company.

The Definitive Agreement contains customary representation and warranties, covenants and indemnification provisions and conditions. Details of the company’s business, finances, appointments and agreements can be found as part of the Company’s continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission’s (“SEC”) EDGAR database.

About First China Pharmaceutical Group, Inc. (OTCBB: FCPG)
First China Pharmaceutical Group, Inc. aims to develop a high growth pharmaceutical distribution company generating significant revenue from the sale of healthcare products in China. As part of its business strategy, the Company has acquired the assets of Kun Ming Xin Yuan Tang Pharmacies Co. Ltd. (XYT), which includes a strategic advantage over its competitors as it is the only pharmaceutical distribution company in Yunnan Province that has obtained government approval to fulfill orders over the internet. First China Pharmaceutical Group plans to continue the rapid growth of the company from its current position as a provider of approximately 5,000 drugs to more than 4,700 pharmacies, hospitals and clinics in China’s Yunnan Province. For more information visit: www.firstchinapharma.com

Notice Regarding Forward-Looking Statements
This news release contains “forward-looking statements” as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, regulatory incentives, the development of new business opportunities, and projected costs, revenue, profits and results operations. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

ON BEHALF OF THE BOARD
First China Pharmaceutical Group, Inc.
————————————————-
Zhen Jiang Wang
Chairman and CEO

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Filed Under: Hospitals and Health Systems, Prescription Drugs and Pharmacy

Radient Pharmaceuticals and Gaur Diagno Launch Cancer Education and Screening Program in India

Posted on October 19, 2010 Written by Editor

SOURCE: Radient Pharmaceuticals Corporation

TUSTIN, CA–(Marketwire – October 19, 2010) –  Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) and its exclusive India-based distribution partner Jaiva Technologies, Inc. (JTI) and Jaiva’s Indian subsidiary Gaur Diagno, Pvt Ltd (GDL) announced today the launch of a cancer education and screening program in India — a key international market where GDL is actively commercializing RPC’s Onko-Sure® in vitro diagnostic (IVD) cancer test. The goal of the program is to drive public education; raise market awareness; and offer Onko-Sure® as a commercialized cancer screening test that can potentially help stem the rising cancer epidemic in India.

According to the Cancer Foundation of India, cancer impacts up to 2.5 million people in India annually and the fight against cancer — in both the public and private healthcare sectors — is largely restricted to improving diagnostic and treatment facilities throughout the country. Because of this, it has become increasingly vital to enhance activities and programs that support cancer education and offer treatment options to potential and existing cancer patients. 

With the launch of its cancer education and screening program on behalf of RPC, GDL is taking an aggressive leadership role in India with two distinct launch strategies. The first comprises a widespread deployment of GDL’s mobile cancer screening laboratory units where Indian-based physicians and other medical staff travel to local towns to provide counseling and education, along with patient screening using RPC’s Onko-Sure® IVD cancer test. The second program is focused on Company collaboration with Indian government agencies to establish GDL-sponsored cancer screening and testing facilities directly on-site in government hospitals. Physician-referred general cancer screening will also be conducted at these hospitals and it is anticipated that RPC’s Onko-Sure® IVD cancer tests will be administered to patients contacted through the program. The goal of both strategies is to reduce the incidence of cancer in India, and through each program, patients will be provided with registered health cards that will track a patient’s health records for future reference and statistical analysis.

RPC’s projected Onko-Sure® IVD test kit purchase plan is focused primarily on the ramp-up of the government sponsored cancer testing program. RPC estimates test kit purchases to be approximately US$2 million in FY2011, and US$3 million in FY2012. These estimates are subject to change based on results of the 64-point questionnaire and these figures have the potential to increase if GDL’s results show more than 50% of the patients at high-risk when screened through the 64-point questionnaire.

According to Mr. Douglas MacLellan, Executive Chairman and CEO of RPC, “The introduction of GDL’s new cancer education and screening program in India is the next most important and major milestone in the commercialization of Onko-Sure® in India. GDL is taking a leadership role in providing a market with 2.5 million cancer patients with not only educational resources and support through this program, but also the potential of early disease detection and on-going monitoring though our USFDA approved Onko-Sure® IVD cancer test.”

According to Dr. Umesh Bhatia, CEO of JTI and GDL, “This government screening program is a breakthrough project and we believe a continuous and aggressive approach is necessary if we are to reduce the incidence of cancer in India. We anticipate this is just the beginning of additional large-scale screening programs we employ. GDL is committed to continuing all efforts to work with Indian government agencies with the ultimate goal of reducing cancer rates in this country.”

RPC’s Onko-Sure® IVD cancer test is a simple, non-invasive, patent-pending and regulatory-approved in vitro diagnostic (IVD) test used for the detection, screening, and monitoring of various types of cancer. The test enables physicians and healthcare professionals to effectively monitor and/or detect certain types of cancers by measuring the accumulation of Fibrin and Fibrinogen Degradation Products (FDP) in the blood. FDP levels rise dramatically with the progression of cancer. Onko-Sure® is approved by the US FDA for the monitoring of colorectal cancer and by Health Canada as a lung cancer detection and monitoring test. For more information visit www.onko-sure.com.

For additional information on Radient Pharmaceuticals, ADI and its portfolio of products visit the Company’s corporate website at www.Radient-Pharma.com. For Investor Relations information contact Kristine Szarkowitz at [email protected] or 1.206.310.5323.

About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals is dedicated to saving lives and money for patients and global healthcare systems through the deployment of its Onko-Sure® In Vitro Diagnostic cancer test. The company’s focus is on the discovery, development and commercialization of unique high-value diagnostic tests that help physicians answer important clinical questions related to early disease detection; treatment strategy; and the monitoring of disease progression, prognosis, and diagnosis to ultimately improve patient outcomes. Radient Pharmaceutical’s current Onko-Sure® cancer test is used to guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, perform additional testing, or assist in the selection of therapy. To learn more about our company, people and potentially life-saving cancer test, visit www.Radient-Pharma.com.

About Jaiva Technologies and Gaur Diagno:
Jaiva Technologies, headquartered in Houston, TX, and subsidiary Gaur Diagno, headquartered in New Delhi, India, are working to develop and license novel products for life-threatening diseases. Through science and innovation the company aims to develop novel therapies that will significantly impact and extend the quality of life for patients. Part of the company’s effort is large-scale screening of populations that result in meaningful and epidemiological slow-down of life threatening diseases, such as cancer. For further information visit www.gaurdiagno.com.

Forward Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company’s operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.

Radient Pharma Contact:
Kristine Szarkowitz
Director-Investor Relations
Email Contact
Tel: 206.310.5323

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Filed Under: Prescription Drugs and Pharmacy, Public Health and Research

Omni Bio Announces First Infusion in Phase I/II Clinical Trial of Alpha-1 Antitrypsin in Recently Diagnosed Diabetic Patients

Posted on October 18, 2010 Written by Editor

SOURCE: Omni Bio Pharmaceutical, Inc.

Treatment Commences at Barbara Davis Center for Childhood Diabetes at University of Colorado Denver Anschutz Medical Campus

DENVER, CO–(Marketwire – October 18, 2010) –  Omni Bio Pharmaceutical, Inc. (“Omni Bio”) (OTCBB: OMBP) today announced that the first patient has been infused in its FDA-cleared Phase I/II human clinical trial of Alpha-1 antitrypsin (“AAT”) in recently diagnosed Type 1 diabetics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver Anschutz Medical Campus.

The Phase I/II clinical trial is evaluating the potential of AAT to halt or reduce the deterioration of islet beta cells that causes Type 1 diabetes. While Type 1 diabetics will experience islet beta cell destruction, the trial evaluates whether AAT treatment may help stop the course of disease in newly diagnosed diabetics who may have remaining islet beta cells.

AAT is an FDA-approved, off-patent drug with an almost 20-year safety track record as an approved treatment in the approximately $400 million market for emphysema in AAT deficient patients. Omni Bio believes that the market opportunity for the use of AAT in treating Type 1 diabetes may exceed the current market.

Dr. Charles A. Dinarello, Acting Chief Executive Officer of Omni Bio, stated, “Following promising preclinical evidence of AAT in Type 1 diabetes, we filed with the FDA to move right into a Phase I/II clinical trial in newly diagnosed Type 1 diabetic patients. We are encouraged by the agency’s clearance to advance from the preclinical stage into actual patients, and the initial patient infusion is a major milestone for Omni Bio. If AAT is effective in disrupting the deterioration of the islet beta cells, we believe that we may be able to expedite our time to market in Type 1 diabetes, given the significance of the unmet medical need and the supportive safety track record of AAT in its currently approved indication.”

Dr. Dinarello continued, “Type 1 diabetes is a large and attractive market for Omni Bio, and we believe that our method of use patent applications surrounding AAT further position us to capitalize on this opportunity to deliver shareholder value while improving treatment for up to 20,000 Type 1 diabetics diagnosed in the U.S. each year.”

About the Phase I/II Trial
The FDA-cleared Phase I/II human clinical trial of AAT in recently diagnosed Type 1 diabetics is underway at the Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver Anschutz Medical Campus. Patients will receive an eight-week treatment course of AAT infusions, followed by two years of monitoring. Targeted enrollment is initially 15 patients, and may be expanded to up to 50 patients pending positive data in critical measurements.

About AAT in Type 1 Diabetes
Type 1 diabetes is an autoimmune disease in which the immune system attacks insulin-producing beta cells in the pancreas, which are necessary for the body to maintain proper blood glucose levels. Not all beta cells are typically destroyed at the time of diagnosis, and between 15-40% remain healthy and able to produce insulin. Preserving these remaining beta cells is the goal of AAT therapy in Type 1 diabetics, as their ability to naturally produce even small amounts of insulin can improve blood sugar control, simplify daily management of diabetes, and reduce the risk of long term complications.

About Omni Bio Pharmaceutical, Inc.
Omni Bio Pharmaceutical, Inc. (www.omnibiopharma.com) is an emerging biopharmaceutical company formed to acquire, license, and develop existing therapies for indications with substantial commercialization potential. Omni Bio’s core technology and pipeline are based on issued and pending patents licensed from the University of Colorado Denver (“UCD”) and a privately held corporation surrounding the broader therapeutic potential of currently marketed therapies. One of Omni Bio’s lead development programs is evaluating an FDA-approved, off-patent drug, AAT, for the treatment of Type 1 diabetes. Novel discoveries made at UCD indicate that AAT has the potential to address a variety of indications in the areas of bacterial and viral disorders, biohazards, diabetes and transplant rejection.

Omni Bio is led by Acting CEO Dr. Charles Dinarello, Professor of Medicine in the Division of Infectious Diseases at UCD. Dr. Dinarello is considered a founding father of cytokine biology. For additional information, please visit www.omnibiopharma.com.

Forward-Looking Statements
Some of the statements made in this press release are forward-looking statements that reflect management’s current views and expectations with respect to future events, including the clinical trial. These forward-looking statements are not a guarantee of future events and are subject to a number of risks and uncertainties, many of which are outside our control, which could cause actual events to differ materially from those expressed or implied by the statements. These risks and uncertainties are based on a number of factors, including but not limited to the business risks disclosed in our SEC filings, especially the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended March 31, 2010. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Edward C. Larkin
Chief Operating Officer
Omni Bio Pharmaceutical, Inc.
720-488-4708

Sara Pellegrino
The Ruth Group
646-536-7002
[email protected]

Ashleigh Barreto (investors)
The Ruth Group
646-536-7028
[email protected]

Filed Under: Hospitals and Health Systems, Prescription Drugs and Pharmacy

Depomed to Present at the NewsMakers in the Biotech Industry Conference and the Oppenheimer 21st Annual Healthcare Conference

Posted on October 18, 2010 Written by Editor

SOURCE: Depomed, Inc.

MENLO PARK, CA–(Marketwire – October 18, 2010) –  Depomed, Inc. (NASDAQ: DEPO) announced today that its president and chief executive officer, Carl A. Pelzel will be presenting at the 17th Annual Meeting of NewsMakers in the Biotech Industry Conference on Friday, October 22, 2010 at 9:30 am EST, and at the Oppenheimer 21st Annual Healthcare Conference on Wednesday, November 3, 2010 at 2:45 pm EST, both in New York City.

The company will be webcasting its presentation and interested parties can access the live or archived presentation for up to 90 days on the company’s website at www.depomed.com.

About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one product candidate through Phase 3 clinical development, another in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 has completed Phase 3 clinical development and has been licensed to Abbott Products Inc. A New Drug Application for DM-1796 was accepted by the FDA in the second quarter of 2010. Product candidate Serada® is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Additional information about Depomed may be found on its website, http://www.depomed.com.

CONTACT:
Sheilah Serradell
Depomed, Inc.
650-462-5900
[email protected]

Filed Under: Prescription Drugs and Pharmacy

Radient Pharmaceuticals and Provista Life Sciences Announce New Blood Test for Lung Cancer

Posted on October 13, 2010 Written by Editor

SOURCE: Radient Pharmaceuticals Corporation

TUSTIN, CA–(Marketwire – October 13, 2010) – Provista Life Sciences and Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today the validation study results of a blood test for early detection of lung cancer and Provista’s plans to broadly introduce this new test to market.

The study completed the requisite analyses and data evaluation needed to validate Provista’s test, based on Radient Pharmaceutical Corporation’s antigens for fibrinogen degradation products (FDP), successfully detects lung cancer with a high degree of accuracy. The study included men and women between 20-76 years of age. The data generated in this final study proved consistent with previous findings and produced positive clinical performance marks of 87% sensitivity; 95% specificity; and an ROC Accuracy of 0.97. By industry standards the study proved very successful and will serve as the cornerstone to Provista’s efforts to introduce a new lung cancer detection assay branded LC Sentinel™ to market. Provista intends to introduce LC Sentinel™ as a CLIA Laboratory Developed Test (LDT) for use in high-risk lung cancer patient populations in the U.S. by the end of the fourth quarter 2010 through its standard clinical channels that include physicians, medical clinics and hospitals. The company expects to seek FDA registration for LC Sentinel™ in 2011.

According to Provista CEO William Gartner, “We are exceptionally pleased at the test results and will aggressively market and commercialize this important and potentially life-saving lung cancer test beginning in the fourth quarter 2010.” Gartner also expressed high praise for the quality of the RPC’s manufacturing facilities and chemicals indicating the Company is pleased to be an exclusive partner of RPC in the development of the test. In conjunction with today’s announcement, RPC and Provista also announced the two Companies will execute an exclusive lab partnership agreement where Provista Life Sciences will purchase RPC reagents exclusively for the development of LC Sentinel™.

The American Cancer Society’s estimates of the impact of lung cancer in the U.S. during 2009 include approximately 219,000 new cases (both non-small cell and small cell) and 159,000 deaths resulting from the disease, accounting for 28 percent of all cancer deaths. Lung cancer is the leading cause of cancer death among both men and women — 62% of those diagnosed in late stages die within 5 years. Provista estimates there are approximately 18 million high-risk patients who stand to benefit from the test’s US introduction. 

According to Mr. Douglas MacLellan, Executive Chairman and CEO of RPC, “The detection benefit observed in this study represents a meaningful additional to tests available today. We are very encouraged by the potential benefit of this test to patients who are facing the deadly threat of lung cancer. As previously announced, RPC is actively engaged in acquisition negotiations with Provista and with the success of the deal; we expect to combine both companies to achieve a leadership presence in the global cancer diagnostics market.”

On September 27, 2010 RPC signed an extension of its original agreement dated July 13, 2010 to merge with Provista Diagnostics Inc., making the agreement between Provista Diagnostics and Radient Pharmaceuticals effective through December 31, 2010. Both Companies have confirmed continued interest in the merger and to pursue completion of the deal within a timeframe that suits the needs of both Companies and shareholders.

For additional information on Radient Pharmaceuticals, ADI and its portfolio of products visit the Company’s corporate website at www.Radient-Pharma.com. For Investor Relations information contact Kristine Szarkowitz at [email protected] or 1.206.310.5323.

For additional information on Provista Diagnostics Inc and its diagnostic portfolio, visit the company’s website at www.ProvistaLS.com. For additional information contact Donald Weber, COO, or William Gartner, CEO, at 602.224.5500.

About Provista Life Sciences:
Provista Life Sciences is a biotechnology diagnostics development and Commercialization Company located in Phoenix, AZ, the Company provides the scientific and operating management resources to rapidly advance the development and introduction of novel diagnostics technologies into the domestic and global marketplace. For more information, visit the company’s Web site at www.ProvistaLS.com or call 1.602.224.5500.

About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals is dedicated to saving lives and money for patients and global healthcare systems through the deployment of its Onko-Sure® In Vitro Diagnostic cancer test. The company’s focus is on the discovery, development and commercialization of unique high-value diagnostic tests that help physicians answer important clinical questions related to early disease detection; treatment strategy; and the monitoring of disease progression, prognosis, and diagnosis to ultimately improve patient outcomes. Radient Pharmaceutical’s current Onko-Sure® cancer testis used to guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, perform additional testing, or assist in the selection of therapy. To learn more about our company, people and potentially life-saving cancer test, visit.

Forward Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company’s operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.

Radient Pharma Contact:
Kristine Szarkowitz
Director-Investor Relations
Email Contact
Tel: 206.310.5323

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Filed Under: Prescription Drugs and Pharmacy, Public Health and Research

Biotech Distributor BDI Pharma, Inc. Launches New Animal Health Division, 4legPharma

Posted on October 11, 2010 Written by Editor

SOURCE: BDI Pharma, Inc.

COLUMBIA, SC–(Marketwire – October 11, 2010) – BDI Pharma, Inc. (BDI), the nation’s fastest growing national distributor of biotech therapies, announced the continuing expansion of the company’s specialty pharmaceutical portfolio with the launch of a new Animal Health Division, 4legPharma. This latest BDI Pharma expansion, focused on the biopharmaceutical needs of the veterinary specialist, is supported by the launch of its own website, www.4legpharma.com, as well as a staff of highly trained representatives dedicated to service this unique marketplace.

“As the Animal Health Division of BDI Pharma, 4legPharma is backed by over 15 years of experience in handling urgent need, critical care pharmaceutical products. We are uniquely positioned to offer veterinary specialists the best of both animal drugs as well as human therapies for extralabel use to treat pets suffering from the same chronic, life-threatening conditions that affect humans. Our customers appreciate that we deliver the safety of a secure product distribution channel and a level of personal service that is unrivaled in the veterinary medical community,” said Angela Phillips, Director of Animal Health.

The US Bureau of Labor Statistics states that the number of veterinary jobs is expected to increase thirty-three percent (33%) by 2018 as a whole, and reports published by the AVMA indicate an average annual increase of eleven percent (11%) in the number of veterinarians seeking board-certification to specialize in the areas of internal medicine, anesthesiology, dermatology, and seventeen other recognized specialties.

“At BDI Pharma, it is our commitment to bring definable value and uncompromising service to our customers and trade partners that sets us apart from others,” stated Edward Stiefel, Jr., Co-President of BDI Pharma. “Our Animal Health Division is a testament to the capabilities and resources we are willing to dedicate to service the specific nature of a growing marketplace.”

About BDI Pharma, Inc.

Since 1995, BDI Pharma has defined its customer-centric approach to serving the nation’s healthcare community through innovative inventory supply solutions, unparalleled customer service, extensive product knowledge, 24/7 emergency availability and urgent need delivery. An open-access resource for reference material, educational literature, market data and online ordering, www.bdipharma.com has become an industry renowned point of reference. Proprietary programs for product consignment (www.consignadvantage.com), flu vaccine pre-booking (www.securiflu.com), vaccine ordering (www.securivax.com) and purchasing/reward programs (www.qoreprogram.com and www.securigam.com) round out a family of solutions tailored to the needs of the healthcare community at large.

BDI Pharma’s portfolio includes branded and generic specialty pharmaceuticals, chemotherapy products, vaccines, albumin, IVIG, coagulation factors, high-titer or “hyper” immune globulins, and other specialty injectables. BDI Pharma is recognized as an “ADR,” or Authorized Distributor of Record, for all of the manufacturers it represents.

Contact:
Brad Davis
Assistant Vice President, Marketing
(800)948-9834

Filed Under: Prescription Drugs and Pharmacy

Continuous Glucose Monitoring a Testing Area to Watch, Says Kalorama

Posted on October 7, 2010 Written by Editor

SOURCE: Kalorama Information

NEW YORK, NY–(Marketwire – October 7, 2010) – For insulin dependent diabetics it has been the ultimate treatment goal: a pump and monitor combination that would not only read glucose levels but also determine how much insulin to deliver, and administer it. In recent years, such products have become available and given the growing patient population, this should be a high-growth area in the IVD market, according to healthcare market research publisher Kalorama Information, in its latest report on the IVD industry, “Worldwide Market for In Vitro Diagnostic Tests, 7th Edition.”

Kalorama estimates that in 2009, continuous blood glucose systems by three companies, Medtronic, Dexcom and Insulet, generated product sales of close to $200 million, as compared to approximately $100 million in 2008. This is high revenue growth for testing markets, and growth could increase in the future given an expanding patient population and increasing acceptance in healthcare, according to Kalorama Information.

“This is a hot and very competitive area and companies are demonstrating well above average growth for IVD products,” said Shara Rosen, lead diagnostic analyst for Kalorama Information and author of the report. “Most importantly, it’s an underserved market.”

Fewer than 30% of U.S. type 1 diabetes patients using insulin pumps and less than 1% of type 2 diabetes patients who use insulin pumps are currently using continuous monitors. CMS assigned unique codes and reimbursement rates for continuous glucose monitoring. 

According to Rosen, the unmet demand for this type of system is best illustrated by DexCom’s revenue track record. Since starting at just $2 million in 2006, sales have virtually doubled each of the past three years.

Kalorama’s report lists at least 10 devices that are already available and at least as many more in development. According to the report, not all of these developed products will be able to succeed. Smiths Medical’s (St. Paul, MN) recent exit from the market indicates just how competitive this segment has become, even when partnered with IVD veteran Abbott Diabetes Care. Smiths Medical (formerly Deltec, Inc.) was one of the first companies to commercialize a continuous BGM system. In June 2004, the company received FDA clearance to market the CozMore Insulin Technology System and in spite of continued improvements, the product failed to gain significant market share. 

Point-of-Care, or POC diagnostic tests are just one area covered in Kalorama Information’s extensive review of the in vitro diagnostic testing industry, “Worldwide Market for In Vitro Diagnostic Tests, 7th Edition.” The report can be found at:
http://www.kaloramainformation.com/redirect.asp?progid=79735&productid=2613362.

About Kalorama Information
Kalorama Information supplies the latest in independent market research in the life sciences, as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter (http://www.twitter.com/KaloramaInfo) and LinkedIn (http://www.linkedin.com/groups?gid=2177845&trk=hb_side_g).

Filed Under: Prescription Drugs and Pharmacy

Global Healthcare Network Launched for Healthcare Professionals

Posted on October 6, 2010 Written by Editor

DUBAI, UNITED ARAB EMIRATES–(Marketwire – Oct. 6, 2010) – The recent re-launch of a global networking web-site has attracted thousands of healthcare industry affiliated professionals keen to share information on-line. The website, www.GlobalHealthcareNetwork.com was revamped last month to help facilitate (showcase/broadcast) research, provide business & networking opportunities and act as an easily accessible forum for healthcare issues and challenges (around the world to be discussed) The site is also proving popular as an informal tool that allows members to socialise with their healthcare peers in other countries.

“This is the age of social networking and a great deal of information is now being traded (exchanged) on-line using this method,” said Dr. Prem Jagyasi, renowned global healthcare consultant and founder of the Global Healthcare Network. “There are many general purpose social networking sites with millions of users, but we were encouraged by healthcare professionals across the world to create a site designed especially with the sector in mind,” he added.

The www.GlobalHealthcareNetwork.com is unique in that it has customised settings so that healthcare professionals can participate in specific activities. Healthcare professionals using the site can join various special interest groups in the sector; such as Healthcare Management, Healthcare Marketing, Healthcare Insurance, Pharmaceutical, Medical Equipment, Healthcare Finance, Healthcare Journalist and, Medical Tourism (Health Tourism / Healthcare Travel / Medical Travel), amongst others.

The site also aggregates the latest news from around the world to provide easy access of vital healthcare information at one place, as well as offering all the standard networking benefits that include connections, blogging, forum discussions, media uploads and event updates. The network is integrated with Facebook and Twitter so members can post to other networking sites from Global Healthcare Network. The Global Healthcare Network also has group/fan pages on LinkedIn, Facebook and Twitter, with more than 1750 members actively communicating.

Dr. Jagyasi believes that the advantage of the Global Healthcare Network is that it allows for health professionals to share information easily, which in turn breaks down barriers and improves cooperation between healthcare providers. “Even the small links that are established through purely social interaction can develop into bigger links over time, as channels of communication become progressively embedded,” he said. “We can see from the buzz and chatter happening on the site that connections are being made that should lead to the forging of relationships that can only benefit healthcare in the future. I believe that this site will act as an important adjunct to the continued growth of the sector worldwide,” he added. 

The site provides us with updated information about all upcoming healthcare events worldwide at one place.

Dr Prem Jagyasi, recently presented the topic ‘ Social Media Marketing’ at the World Medical Tourism and Global Healthcare Association 2010 in Los Angeles, USA. The presentation provided a prescriptive roadmap for Online Media and Social Media Success while discussing best practices and answering the biggest questions faced by health care marketers in the field of Social Media Marketing. His presentation is also available to view on www.slideshare.net/jagprem or www.GlobalHealthcareNetwork.com or www.DrPrem.com.

Anyone, health professional or otherwise, can access the Global Healthcare Network by logging on to http://www.globalhealthcarenetwork.com and creating a user account. They will then be able to connect to health workers from around the world.

Below are quick links:

Global Healthcare Network Site: www.GlobalHealthcareNetwork.com

Members: http://www.globalhealthcarenetwork.com/profiles/members/

Notes & News http://www.globalhealthcarenetwork.com/notes/index/allNotes

Forums http://www.globalhealthcarenetwork.com/forum

Blogs http://www.globalhealthcarenetwork.com/profiles/blog/list

Facebook Page http://www.facebook.com/pages/Global-Healthcare-Medical-Tourism-Health-Tourism/105868006128124

LinkedIn http://www.linkedin.com/groups?mostPopular=&gid=2997546

Twitter http://twitter.com/Globalhcn

About Global Healthcare Network

Global Healthcare Network is a unique social networking platform for Healthcare Professionals. Join the group now to Network, share & learn. There is a total of 1750+ Network members across all Global Healthcare Networking sites/pages including facebook & linkedin.

The network allows you to create blog, start discussion, join various healthcare groups, promote your services.

About Dr Prem Jagyasi

A successful entrepreneur and experienced strategic professional, Dr Prem Jagyasi is a renowned Chartered Management, Healthcare Marketing and Medical Tourism Consultant. Providing high-profile consultancy services to Government authorities and private healthcare organizations, Dr. Prem Jagyasi is a noticeably leading Global Healthcare and medical tourism consultant in the world.

Apart from running a successful healthcare solution firm and consultancy business, he has initiated several innovative healthcare awareness projects such as Family Health Festival, No Tobacco Campaign, Summer Health Festival, Ahlan Ramadan and Diabetes Events. His initiatives are endorsed and recognized by the country’s ministry of health and other government authorities. On a global front, he is also working on Medical Tourism Guide, Educational Events, Global Health Directory, and workshops on quality practice for international patients. etc.

Currently, Dr Prem Jagyasi is MD & CEO of ExHealth, a Dubai HealthCare City based firm engaged in offering multi-dimensional healthcare solutions in international domain. He also serves the Medical Tourism Association (also known as Global Healthcare Association) —a Non Profit organization based in USA as Honorary Chief Strategy Officer. He is also the Chief Editor of UAE’s leading health magazine – HealthFirst, published in association with one of the leading English dailies of the region.

Filed Under: Prescription Drugs and Pharmacy

Pharma Sales & Marketing New Market Trends and Strategies Covered at iiBIG’s Baltimore Forum in November

Posted on September 28, 2010 Written by Editor

SOURCE: iiBIG

NEW YORK, NY–(Marketwire – September 28, 2010) –  iiBIG presents the Next Generation Pharma Sales & Marketing Summit, scheduled for November 16-17, 2010 at the Baltimore Marriott Inner Harbor at Camden Yards in Baltimore, MD. The pharmaceutical sales and marketing landscape has changed dramatically over the past few years with an expectation of global sales of pharmaceuticals to grow at a rate of 5%-8% annually over the next five years. At the center of this highly regulated industry emerges an increase of communications, digital marketing efforts, social media and sales force success strategies. Today’s pharmaceutical executives continue to create and implement influential campaigns with the goal of ultimately improving health outcomes by exploring new and dynamic selling techniques. At the same time, pharmaceutical sales representatives face increasing difficulty due to falling physician accessibility, stronger regulation in the industry, and changing operational models surrounding healthcare delivery.

This event will address the value of both sales and marketing operations within large, mid-size, and specialty pharmaceutical companies. It will feature keynote presentations from industry leaders, panel debates, relevant case studies, and high-level networking. This is an essential opportunity for any executive striving to make the most out of cutting-edge and alternative sales and marketing innovation best-practices.

The executive speaking faculty includes: A.T. Kearney; Acorda Therapeutics; Amarin Corporation; Astellas Pharma; AstraZeneca; Baxter; Biomet Microfixation; Bristol-Myers Squibb; comScore, Inc.; Covidien; Daiichi Sankyo, Inc.; Digitas Health; Epocrates; Genentech; Genzyme Genetics; GSW Worldwide; Harris Interactive; HighPoint Solutions; King Pharmaceuticals; Klick Pharma; Lundbeck Inc.; M2 Worldwide; MedImmune; NicOx; NuPathe; OSI Pharmaceuticals; Pacific Bridge Medical ; Pfizer; Physicians Interactive; PricewaterhouseCoopers ; Saint Joseph’s University; Sequella; Shire Pharmaceuticals; SymCare Personalized Health Solutions, Inc. (a Johnson & Johnson Company); Symphogen, Inc.; Teva Pharmaceuticals; UCB, Inc.; and WellDoc Communications, Inc.

For conference details: http://www.iibig.com/P1005

ABOUT iiBIG
iiBIG (International Institute for Business Information & Growth) is an unbiased, independent company dedicated to organizing business-to-business conferences and seminars for senior-level business executives. We provide learning and networking settings for some of the business community’s BIGgest thinkers – those who occupy the highest levels in their companies and organizations. Our events focus on the most pressing and timely issues facing decision-makers in today’s global economy. For more information, visit: http://www.iibig.com.

Filed Under: Prescription Drugs and Pharmacy

Radient Pharmaceuticals Signs 5-Year Exclusive Distribution Agreement for Its Onko-Sure Cancer Test in Vietnam, Cambodia, and Laos

Posted on September 28, 2010 Written by Editor

SOURCE: Radient Pharmaceuticals Corporation

TUSTIN, CA–(Marketwire – September 28, 2010) –  Through its subsidiary AMDL Diagnostics Inc., Radient Pharmaceuticals Corporation (NYSE Amex: RPC), a US-based company specializing in the research, development, and international commercialization of In Vitro Diagnostic (IVD) cancer tests, announced today it has entered into an exclusive 5-year full-service distribution agreement with Phu Gia Trading Co. Ltd. to expand the Company’s Onko-Sure™ IVD cancer test into the Vietnam, Laos, and Cambodia healthcare markets.

Phu Gia has committed to purchase a minimum of 2,425 Onko-Sure™ kits over the duration of the agreement.  Phu Gia Trading Co. Ltd. will represent RPC while obtaining regulatory clearances and providing marketing, sales, and distribution services for Onko-Sure in diagnostic centers and clinical labs throughout the designated territory. Marketing, sales and distribution services include developing product localization strategies; representing Radient Pharmaceuticals and its Onko-Sure IVD cancer test at relevant healthcare conferences and events; and ensuring all relevant product marketing materials are available in local languages. The Phu Gia customer service team will also be responsible for responding to customer inquiries and technical questions. Phu Gia will work directly with the Vietnam Ministry of Health and other government officials to secure approvals and regulatory clearances.   

“Our full-service distribution partnership with Radient allows us to work closely with top diagnostic centers and clinical labs in Vietnam, and reach healthcare professionals across the designated territories of Vietnam, Cambodia and Laos. Cancer continues to be one of our gravest healthcare challenges and Onko-Sure offers a valuable new tool for cancer detection and cancer treatment monitoring,” commented Jack Nguyen, President, Phu Gia. “We plan to commit extensive outreach resources to oncology thought leaders along with automating the Onko-Sure test at top labs — including the Ho Chi Minh Diagnostic Centre, to increase cancer testing across our region.”

“With a significant cancer challenge, Asia continues to show an increased demand for cancer diagnostic products like Onko-Sure,” commented Mr. Douglas MacLellan, Executive Chairman and CEO of RPC. “Phu Gia becomes our third distribution partner for Onko-Sure in the rapidly expanding Asia healthcare market, and we feel confident in our ability to gain strong market share throughout the region as we establish long-term agreements with well positioned partners like Phu Gia.”

Onko?Sure is a simple, non?invasive, patent?pending and regulatory?approved in vitro diagnostic test that enables physicians and their patients to effectively monitor and/or detect certain types of cancers by measuring the accumulation of specific breakdown products in the blood called Fibrin and Fibrinogen Degradation Products (FDP). FDP levels rise dramatically with the progression of cancer. Onko?Sure is approved by the US FDA for the monitoring of colorectal cancer and by Health Canada for lung cancer detection and treatment monitoring. 

RPC Contact Information:
For additional information on Radient Pharmaceuticals, ADI and its portfolio of products visit the Company’s corporate website at www.radient-pharma.com. For Investor Relations information contact Kristine Szarkowitz at [email protected] or 1.206.310.5323.

About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals is dedicated to saving lives and money for patients and global healthcare systems through the deployment of our Onko Sure™ In Vitro Diagnostic cancer test. Our focus is on the discovery, development and commercialization of unique high-value diagnostic tests that help physicians answer important clinical questions related to early disease detection; treatment strategy; and the monitoring of disease progression, prognosis, and diagnosis to ultimately improve outcomes for patients. Radient Pharmaceutical’s current Onko-Sure™ cancer test is used to guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, perform additional testing, or assist in the selection of therapy. To learn more about our company, people and potentially life-saving cancer test, visit www.radient-pharma.com. 

Forward Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company’s operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.

Contact:
Kristine Szarkowitz
Director-Investor Relations
Email Contact
(Tel : ) 206.310.5323

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Filed Under: Prescription Drugs and Pharmacy, Public Health and Research

MMRGlobal Prevails in Biotech Assets Case With Lymphoma Research Foundation

Posted on September 24, 2010 Written by Editor

SOURCE: MMRGlobal, Inc.

LOS ANGELES, CA–(Marketwire – September 24, 2010) –  MMRGlobal, Inc. (OTCBB: MMRF) (MMR) announced today that it has successfully opposed a Summary Judgment Motion brought by the Lymphoma Research Foundation (LRF) as part of its efforts to protect a portion of the Company’s intellectual property, which it previously disclosed on May 3, 2010.

The Company acquired the biotech assets from its reverse merger with Favrille, Inc., a San Diego biotech company, in January 2009. Over the past year, MMR identified a collection of these biotech assets, which include biotech samples that were in the possession of the Lymphoma Research Foundation. They do not include other pre-merger biotech assets, including the Company’s anti-CD20 monoclonal antibodies, results of clinical trials data, patents and other intellectual property.

According to declarations filed on behalf of MMR, the Company understands that the biotech samples could have a value as high as $1.376 million. However, based on other information currently maintained by the Company, the samples could have a far greater value, depending on the extent and depth of the clinical data collected at trial initiation, the extent and depth of the clinical data collected during patient follow-up, whether follow-up tissue samples are available, and whether accompanying whole blood or serum is available from patients from trial enrollment or during trial progression.

Robert H. Lorsch, Chairman and CEO of MMRGlobal, said, “We are pleased by this early ruling. When combined with clinical data from the Company’s vaccine research into the causes and potential treatment of B-Cell Non-Hodgkin’s Lymphoma, including data from patient follow-ups which the Company has, the value could be significant.”

The Company understands its intellectual properties may also be of value in a possible reinterpretation of the pre-merger Favrille vaccine trials and that the IP may also unlock ways to create other “custom-made” cancer vaccines and be valuable in discovering additional opportunities in cancer research. The Company hopes to enter into licensing agreements with biopharmaceutical companies, academic institutions, research organizations and others regarding the use of its assets.

About MMRGlobal, Inc.
MMR Global, Inc., through its wholly-owned operating subsidiary, MyMedicalRecords, Inc. (“MMR”), provides secure and easy-to-use online Personal Health Records (“PHRs”) and electronic safe deposit box storage solutions, serving consumers, healthcare professionals, employers, insurance companies, financial institutions, and professional organizations and affinity groups. MyMedicalRecords enables individuals and families to access their medical records and other important documents, such as birth certificates, passports, insurance policies and wills, anytime from anywhere using the Internet. The MyMedicalRecords Personal Health Record is built on proprietary, patented technologies to allow documents, images and voicemail messages to be transmitted and stored in the system using a variety of methods, including fax, phone, or file upload without relying on any specific electronic medical record platform to populate a user’s account. The Company’s professional offering, MMRPro, is designed to give physicians’ offices an easy and cost-effective solution to digitizing paper-based medical records and sharing them with patients in real time through an integrated patient portal. MMR is an Independent Software Vendor Partner with Kodak to deliver an integrated turnkey EMR solution for healthcare professionals. MMR is also an integrated service provider on Google Health. To learn more about MMR Global, Inc. and its products, visit www.mmrglobal.com.

Forward-Looking Statements
Statements in this press release that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, statements regarding MMRGlobal, Inc.’s assets including but not limited to its primary Health IT businesses, samples and data from vaccine and clinical trials, and anti-CD20 antibody assets. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the development and approval of biotechnology/biopharmaceutical product candidates and Health IT products and additional risks discussed in the Company’s filings with the Securities and Exchange Commission. All subsequent written and oral forward-looking statements attributable to the Company (or any person acting on the Company’s behalf) are qualified by the cautionary statements in this notice. MMRGlobal, Inc. is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information.

CONTACT:

Michael Selsman
Public Communications Co.
(310) 553-5732
[email protected]

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Filed Under: Prescription Drugs and Pharmacy, Public Health and Research

FDA Announces It Will Significantly Restrict Access to the Diabetes Drug Avandia

Posted on September 23, 2010 Written by Editor

SOURCE: American Diabetes Association

The American Diabetes Association, the Endocrine Society and the American Association of Clinical Endocrinologists Joint Statement in Response to the FDA Decision to Restrict the Use of Avandia (rosiglitazone) in the U.S.

ALEXANDRIA, VA–(Marketwire – September 23, 2010) –   Today, the Food and Drug Administration (FDA) announced that it will significantly restrict the use of the diabetes drug Avandia and other drugs containing rosiglitazone to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

The FDA, in its announcement, noted that it will require GlaxoSmithKline (GSK) to develop a restricted access program for Avandia under a risk evaluation and mitigation strategy (REMS). Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

The European Medicines Agency (EMA) has suspended the marketing authorization for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). These medicines will no longer be available in Europe within the next few months.

The American Diabetes Association, The Endocrine Society and the American Association of Clinical Endocrinologists urge patients who are currently taking Avandia or any combination pill that includes Avandia to contact their diabetes care provider’s office for instructions about treatment options. Patients should be aware that stopping a diabetes medication without consulting a doctor can result in higher levels of blood glucose that may cause serious short term health problems and could increase the risk of long term diabetes-related complications.

Patients and health care professionals should also be aware that multiple classes of drugs, often with more than one agent per class, are available to achieve and maintain glucose control in type 2 diabetes. In order to limit the risk of long-term complications, optimal glucose control, along with control of other risk factors, such as high blood pressure and cholesterol, is critically important for patients with type 2 diabetes. A number of other medications can be used to control diabetes and should be discussed with a patient’s health care team. For more information on the different classes of available medications drugs: http://www.diabetes.org/living-with-diabetes/treatment-and-care/medication/oral-medications/what-are-my-options.html.

The American Diabetes Association, The Endocrine Society, and American Association of Clinical Endocrinologists continue to support the FDA in its role as the regulatory agency that makes decisions regarding drug safety and efficacy.

The American Diabetes Association is leading the fight to stop diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information from both these sources is available in English and Spanish.

Founded in 1916, The Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society and the field of endocrinology, visit our site at www.endo-society.org.

AACE is the world’s largest professional medical organization of clinical endocrinologists with more than 6,500 members in the United States and 91 other countries. AACE members are physicians who specialize in endocrinology, diabetes, and metabolism. For more information about AACE, visit our Web site at www.aace.com, become a fan on Facebook at www.facebook.com/theaace or follow us on Twitter at www.twitter.com/theaace. 

Contacts:
American Diabetes Association
Colleen Fogarty
(703) 549-1500, ext. 2146

The Endocrine Society
Aaron Lohr
(240) 482-1380

American Association of Clinical Endocrinologists
Bryan Campbell
(904) 353-7878, ext.122

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Filed Under: Prescription Drugs and Pharmacy

Portola Pharmaceuticals Appoints Jean-Jacques Bienaime to Board of Directors

Posted on September 23, 2010 Written by Editor

SOURCE: Portola Pharmaceuticals

SOUTH SAN FRANCISCO, CA–(Marketwire – September 23, 2010) – Portola Pharmaceuticals, Inc. today announced the appointment of Jean-Jacques Bienaimé to the company’s board of directors. Mr. Bienaimé currently serves as chief executive officer of BioMarin Pharmaceutical Inc. He is chairman of the board of NeurogesX, Inc., a member of the board of BIO and a member of the advisory board of Bellevue Asset Management’s BioVentures II fund.

“Jean-Jacques Bienaimé is a biotechnology and pharmaceutical industry veteran with more than 25 years of experience,” said William Lis, chief executive officer of Portola. “His experience as a CEO managing and building fully integrated biotechnology companies and his expertise commercializing anti-thrombotic products will be invaluable to Portola as we advance our two lead partnered product candidates, elinogrel and betrixaban, and our pipeline of proprietary products in cardiovascular disease and inflammation through clinical development and into commercialization.”

Mr. Bienaimé joined BioMarin, which develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions, in May 2005 as chief executive officer and member of the board of directors. Prior to joining BioMarin, he served as chairman, chief executive officer and president of Genencor, a biotechnology company focused on industrial bioproducts and targeted cancer biotherapeutics. Before that, he served as chairman, chief executive officer and president of Sangstat Medical Corporation, an immunology-focused biotechnology company that he guided to profitability prior to its acquisition by Genzyme Corporation. Earlier in his career, Mr. Bienaimé held several senior management positions at Rhone-Poulenc Rorer Pharmaceuticals (now sanofi-aventis) culminating in the position of senior vice president of worldwide marketing and business development responsible for, among other things, the launch of Lovenox® (for the prevention of pulmonary embolism and treatment of unstable angina) in the United States. He also worked at Genentech, Inc. where he was involved in the launch of tissue plasminogen activator (t-PA) for the treatment of heart attacks.

He received an M.B.A. from the Wharton School at the University of Pennsylvania and an undergraduate degree in economics from the École Supérieure de Commerce de Paris.

About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals develops innovative therapeutics based on targets with established proofs of concept that are designed to provide significant advances over current treatments for cardiovascular disease and inflammation. The company has global development and commercialization agreements with two of the world’s leading pharmaceutical companies collectively valued at about $1 billion in upfront and milestone payments plus double-digit royalties on future sales. Betrixaban, its oral direct Factor Xa inhibitor, is licensed to Merck & Co., Inc., and elinogrel, its competitive, reversible P2Y12 ADP receptor antagonist, is licensed to Novartis Pharma AG. Both are Phase 2 product candidates that have features to address the global multi-billion dollar hospital, specialty and chronic care anticoagulant and antiplatelet markets, respectively.

Portola’s proprietary pipeline programs are focused on the discovery and development of PRT061103, a thromboxane receptor antagonist, which is targeted to address a significant unmet need as a potential aspirin alternative for patients intolerant to aspirin; PRT064445, a Factor Xa inhibitor antidote to help manage or reverse the bleeding complications in the tens of millions of patients expected to be treated with Factor Xa inhibitors or low-molecular weight heparin worldwide in the next decade; and PRT062607, a novel, oral Syk-specific kinase inhibitor to treat chronic inflammatory diseases, including rheumatoid arthritis, and certain cancers, including non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. For additional information, visit www.portola.com.

Contacts:

Mardi Dier
CFO
Portola Pharmaceuticals
(650) 246-7236
Email Contact

Joey Fleury
Invigorate
(415) 946-1090
Email Contact

Filed Under: Healthcare Business, Prescription Drugs and Pharmacy

Active Lung Cancer Vaccine Market in Next Five Years: Kalorama Reports

Posted on September 20, 2010 Written by Editor

SOURCE: Kalorama Information

NEW YORK, NY–(Marketwire – September 20, 2010) – There could be as many as three vaccine treatments for lung cancer by 2015, according to a market research report from Kalorama Information. The report, “Emerging Cancer Vaccines: Forecasts, Developments and Pipeline Analysis, 4th Edition,” notes that one product will see an approval in three years and two more products could join shortly thereafter, setting the stage for healthy competition. The healthcare market research publisher recently forecasted a market exceeding $7 billion for vaccines treating all cancers in the next five years. Lung, cervical and prostate cancers are among the most viable areas, according to the report.

Lung cancer continues to be deadly despite a decrease in smoking in many developed countries. Worldwide, more than 1.2 million people are diagnosed with lung cancer annually, while 1.1 million people lose their battle against the disease each year. The American Cancer Society reports that the 5 year survival rate for lung cancer patients in all stages is only 15%.

“Although lung cancer continues to show steadily increasing incidence and mortality rates and is the number one cancer in terms of new cases worldwide, it is still an underserved area of therapeutic options,” said Melissa Elder, analyst for Kalorama Information. “Therapeutic vaccines are a big step in providing life-saving options for these patients.”

According to the report, one of the most promising products in development is Stimuvax, co-developed by Oncothyreon and Merck. The approval of Stimuvax, which Kalorama Information expects to occur in 2013, could slow the number of long-term treatment cases of lung cancer each year, offering huge health and economic benefits to the United States and other approved areas.

Kalorama Information also anticipates the approval of NovaRx Corporation’s Lucanix at the end of 2013, and GlaxoSmithKline’s MAGE-A3 vaccine sometime after 2015 — both products are currently in Phase III development. If approved these products would compete directly with Merck/Oncothyreon’s vaccine, increasing the competitive landscape in the lung cancer treatment segment.

More information on lung cancer vaccine developments can be found in Kalorama Information’s report, “Emerging Cancer Vaccines: Forecasts, Developments and Pipeline Analysis, 4th Edition,” which also includes markets for and developments in other cancer areas along with forecasts, issues and company profiles. The report can be found at: http://www.kaloramainformation.com/redirect.asp?progid=79625&productid=2794580.

About Kalorama Information
Kalorama Information supplies the latest in independent market research in the life sciences, as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter (http://www.twitter.com/KaloramaInfo) and LinkedIn (http://www.linkedin.com/groups?gid=2177845&trk=hb_side_g).

Filed Under: Prescription Drugs and Pharmacy, Public Health and Research

Center for Technology and Aging Report Examines Technologies That Help Improve Transitions From Hospital to Home and Reduce Readmissions

Posted on September 16, 2010 Written by Editor

SOURCE: Center for Technology and Aging

OAKLAND, CA–(Marketwire – September 16, 2010) –  Every day thousands of patients are readmitted to hospitals because they did not get adequate follow-up care following their previous hospitalization. In fact, 18% of patients are readmitted to a hospital within 30 days of discharge — and as many as 76% of these readmissions are preventable. The most recent national figures on health care expenditures indicate that unplanned hospital readmissions cost Medicare $17.4 billion in a single year. In its latest report, “Technologies for Improving Post-Acute Care Transitions,” the Center for Technology and Aging examines how the use of a variety of existing technologies could dramatically reduce readmissions.

“Several technologies are widely available and have potential to support post-acute care transitions, but they are underutilized,” said David Lindeman, Ph.D., Director of the Center for Technology and Aging. “Home-use technologies help decrease readmissions in a variety of ways, including engaging patients and caregivers in ways that promote better communication, medication adherence, and monitoring of chronic conditions.”

The complete report is available for download at www.techandaging.org.

The report covers four post-acute care transition (PACT) technology focus areas. Included is information such as technology definitions, how they are used in the home, their impact on readmissions, and charts that compare basic features of various technologies.

  • Medication adherence technologies
    • Non-adherence is responsible for 33% to 69% of medication related hospital readmissions.
    • Four categories are described in a chart that lists sample technologies, pros/cons of each, market stage, economics, and what function each fills in the medication adherence spectrum.
  • Medication reconciliation technologies
    • “Med-rec” seeks to reduce adverse drug events. Twenty percent of discharged patients experience an adverse event and 2/3 of those are medication related.
    • A chart lists seven tools that help patients maintain an accurate list of medications, a description of each tool, and the organizations sponsoring them.

(More on medication optimization technologies is available in the Center’s report, “Technologies for Optimizing Medication Use in Older Adults.”)

  • Remote patient monitoring (RPM) technologies
    • A chart shows RPM capabilities and applications.
    • A discussion of the VHA’s use of and research on Health Buddy.
    • A chart describing seven popular remote patient monitoring devices: Health Buddy, Telestation, Genesis DM, Intel’s Health Guide, LifeView, Ideal LIFE Pod, and Healthanywhere.

(More information is available in the Center’s report, “Technologies for Remote Patient Monitoring in Older Adults.”)

  • Health information and communication technologies (ICT)
    • Personal health records and information — includes a description of the Stepping Stones Project of Whatcom County.
    • Web-based social networking — including a description of Tyze, www.tyze.org, which provides secure, online personal support networks.
    • Remote training and supervision technologies — includes a description of Rest Assured, and a Visiting Nurse Service of New York demonstration project.

According to the report, ICT enables timely access to vital health information. It points out that when ICT is used in conjunction with devices that monitor health parameters in the home, care becomes continuous rather than episodic. And, according to Dr. Lindeman, “care becomes patient-centered, rather than facility-centered.”

The report includes a description of four well-known care transition models with varying use of home-based technologies. The models are: the Care Transitions Intervention (www.caretransitions.org), Guided Care (www.guidedcare.org), the Transitional Care Model (www.innovativecaremodels.com/care_models/21/overview), and Geriatric Resources for Assessment and Care of Elders (www.medicine.iupui.edu/iucar/research/grace.asp).

The Center for Technology and Aging (www.techandaging.org) supports more rapid adoption and diffusion of technologies that enhance independence and improve home and community-based care for older adults. Through grants, research, public policy involvement and development of practical tools and best practice guidelines, the Center serves as an independent, non-profit resource for improving the quality and cost-effectiveness of long-term care services. The Center was established with funding from The SCAN Foundation (www.thescanfoundation.org) and is affiliated with the Public Health Institute (www.phi.org) in Oakland, CA.

FOR MORE INFORMATION:
Daniel Danzig
925-254-6078
Email Contact

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Filed Under: Prescription Drugs and Pharmacy, Senior Care

Media Advisory: Dr. David Blumenthal, Sen. Sheldon Whitehouse Join Surescripts to Headline 5th Annual Safe-Rx Awards Luncheon Sept. 21

Posted on September 15, 2010 Written by Editor

SOURCE: Surescripts

Annual Release of 1-50 State Rankings Based on E-prescribing Use

WASHINGTON, DC–(Marketwire – September 15, 2010) –

About Surescripts
Surescripts operates the nation’s largest e-prescription network and supports the most comprehensive ecosystem of health care organizations nationwide. Surescripts was founded on the principles of neutrality, transparency, interoperability, efficiency, collaboration and quality. Surescripts connects prescribers in all 50 states through their choice of e-prescribing software to the nation’s leading payers, chain pharmacies and independent pharmacies. The Nation’s E-Prescription Network is available every day to healthcare providers in need of low-cost, electronic access to prescription and health information. By securely and reliably providing that information during emergencies and routine care, Surescripts is committed to saving lives, improving efficiency and reducing the cost of health care for all. For more information, go to www.surescripts.com and follow us at twitter.com/surescripts.

Press Contact:
Rob Cronin
917-414-5289
[email protected]

Filed Under: Prescription Drugs and Pharmacy

Davis B. Nguyen, MD to Reveal Results of FDA Clinical Trials With Fibrin Glue to The International Society of Aesthetic Plastic Surgeons

Posted on September 14, 2010 Written by Editor

SOURCE: Davis B. Nguyen, MD

“An Advancement in Plastic Surgery That Really Sticks,” Says Dr. Nguyen

BEVERLY HILLS, CA–(Marketwire – September 14, 2010) –  Plastic Surgeon Davis B. Nguyen, MD is pleased to announce that he will be speaking at The International Society of Aesthetic Plastic Surgery conference in San Francisco on September 18, 2010. ISAPS members are nationally certified plastic surgeons in 91 countries who are dedicated to educating members in the latest procedures. Only one of two speakers chosen to address the international audience of his peers, Dr. Nguyen will be revealing his findings from the FDA clinical trials he recently completed examining the effects of Fibrin Glue in facelifts.

Dr. Nguyen, one of seven renowned plastic surgeons who conducted the Phase 3 Clinical Trials (efficacy testing) says of his findings, “Every now and then, an innovation in plastic surgery comes along that sticks. The recently completed clinical trials confirm that Fibrin Glue is a groundbreaking product that makes facelift surgery much more comfortable for patients.” Fibrin Glue is applied internally before the external skin is closed and stitched.

The clinical trials tracked 75 patients who received Fibrin Glue on half their face. The other side of the lift was closed in the traditional manner. The results showed the side sealed by Fibrin Glue swelled and bruised dramatically less. “Recovery is faster and more comfortable because drains, normally left in the face for 48 hours after surgery, are eliminated. Patients heal nearly twice as fast,” states Dr. Nguyen. Overall, patients experienced substantially less discomfort.

The innovative plastic surgeon is also one of the pioneers in using the miracle glue in browlift procedures. “The results are remarkable,” notes Dr. Nguyen. “A major benefit of using Fibrin Glue in the browlift is that the traditional ‘raccoon eyes’ resulting from bruising and swelling, are eliminated. This allows patients to get back to work and a normal life much more quickly.” 

Dr. Nguyen has been in the forefront of research on the benefits of Fibrin Glue as he published an independent study on the subject in 2007 with his mentor, renowned plastic surgeon, Dr. Frank Kamer of the famed Lasky Clinic. The study was so well received, it helped to propel the recently concluded FDA clinical trials, which validate the previous findings of Drs. Nguyen and Kamer. 

Dr. Nguyen is dedicated to providing his patients with maximum comfort and aesthetic beauty. “The use of Fibrin Glue has had a major impact on my practice. My patients benefit from shorter recovery periods, fewer complications and greater post-operative comfort,” states Dr. Nguyen.

Dr. Nguyen is dual Board Certified in Facial Plastic Surgery and Otolaryngology-Head and Neck Surgery. For more information about Davis B. Nguyen, MD, please visit www.drdavisnguyen.com or call 310-550-0288. Dr. Nguyen is located at 9735 Wilshire Blvd., Suite 216, Beverly Hills, CA 90212

Contact:
Helaine Ross
310-246-1872
Email Contact

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Filed Under: Hospitals and Health Systems, Prescription Drugs and Pharmacy

FDAAdvisoryCommittee.com to Webcast Hearings on New Weight Loss Drugs MERIDIA and LORQESS

Posted on September 13, 2010 Written by Editor

SOURCE: TalkPoint

Two-Day Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Will Be Streamed Live and Archived for Six Months

NEW YORK, NY–(Marketwire – September 13, 2010) –  FDAAdvisoryCommittee.com (FDAAC.com), a provider of live video webcasts of Food and Drug Administration (FDA) Advisory Committee meetings, today announced that it will webcast the Endocrinologic and Metabolic Drugs Advisory Committee’s discussions on the cardiovascular implications for Meridia® as well as the safety and efficacy of Lorqess®. The Meridia meeting is scheduled for September 15, 2010 from 8:00 a.m. ET to 5:00 p.m. ET. The Lorqess meeting will be held on September 16, 2010 from 8:00 a.m. ET to 5:00 pm. ET. 

On September 15, Abbott Laboratories’ new weight loss drug Meridia comes under review as experts discuss the results of clinical trials that evaluated the potential benefits of weight loss with the drug on major cardiovascular adverse events. Meridia acts as an appetite suppressant in combination with a diet and exercise regimen.

The Committee will review the safety and efficacy of Lorqess, Arena Pharmaceuticals’ new diet pill, on September 16. The drug acts as an appetite suppressant and works in conjunction with diet and exercise for obese patients as determined by body mass index (BMI).

Audience members, including biotech equity analysts, pharmaceutical employees, and journalists will be able to watch from anywhere in the world as the Committee reviews Meridia and Lorqess. FDAAC.com will webcast the meeting live and on location from the Inn and Conference Center at the University of Maryland University College.

FDAAC.com is committed to delivering the highest quality of video and experience. By utilizing h.264 encoding in conjunction with Flash Media, FDAAC.com’s webcasts deliver a near instantaneous stream. These high-quality streams can be accessed from anywhere around the globe and are archived for six months after the live event for unlimited review.

FDAAC.com‘s webcasts are powered by TalkPoint, a provider of Web-based audio and video Webcasting solutions and services. With over a decade of experience, TalkPoint has developed the most robust, scalable, interactive webcasting platform in the industry. TalkPoint’s easy-to-use applications incorporate audio, video, slides, and other interactive elements to deliver high-impact webcasts cost-effectively.

To join the webcasts on September 15 and 16 at 8 a.m. ET register at http://fdaac.com

About FDAAdvisoryCommittee.com
FDAAC.com provides live video webcasts of FDA Advisory Committee meetings captured on location. These meetings cover an array of topics related to medicinal health including OTC, prescription and treatment devices. Very often meetings will result in rulings on clinical trials, final approval and bans of medications and treatment options. TalkPoint is the exclusive webcast provider for FDAAdvisoryCommitte.com.

For more information on FDAAC.com, go to www.fdaac.com.

Media Contacts:
Richard Taber
FDAAdvisoryCommittee.com
Tel: (800) 627-8171
Email Contact

Susan Kiddy
LVA Communications
Tel: (860) 739-5598
Email: Email Contact

Filed Under: Prescription Drugs and Pharmacy

Stellar Biotechnologies Announces Achievement of Milestone in Cooperation With Bayer Innovation

Posted on September 13, 2010 Written by Editor

SOURCE: Stellar Biotechnologies, Inc.

PORT HUENEME, CA–(Marketwire – September 13, 2010) –  (TSX-V: KLH) (PINKSHEETS: SBOTF) — Stellar Biotechnologies, Inc. is collaborating with Bayer Innovation GmbH (BIG) in the development of biopharmaceuticals. Bayer’s personalized idiotype vaccine for the treatment of Non-Hodgkin’s-Lymphoma (NHL) is currently in Phase I clinical trials, and the cooperation is related to the development of a personalized Non-Hodgkin’s-Lymphoma vaccine. The vaccine antigen is produced in tobacco plants based on Bayer’s proprietary magnICON® technology. Bayer Innovation GmbH is a wholly-owned subsidiary of Bayer AG (PINKSHEETS: BAYRY) (XETRA: BAYGN) (LSE: BYRB).

A critical project feasibility milestone in the “Joint Development Agreement” has been achieved. Under terms of the agreement, Stellar Biotechnologies supplies Keyhole Limpet Hemocyanin (KLH) which is coupled to the idiotype protein produced in tobacco plants. KLH is a highly potent immuno-stimulatory protein, which stimulates the lymphocytes to recognize even familiar proteins attached to it as foreign. During the immune response that ensues, the lymphocytes mainly focus on the peptide sequence of the attached tumor idiotype. This so-called immunogenic carrier molecule comes solely from the rare keyhole limpet, and Stellar has technology for the maintenance of the animal, the non-lethal extraction of the critical molecule and a profitable refinement process of KLH.

By consent of both parties, Stellar will receive a milestone payment from BIG, and the co-development agreement is being expanded and continued to achieve important new endpoints that may prove critical to Bayer’s interest in therapeutic vaccines based on its plant-based protein expression system, the magnICON® technology.

Dr. John Butler, Global Project Leader of Plant Made Pharmaceuticals (PMP) for Bayer, said, “We are happy to have achieved this important milestone, and appreciate working with Stellar’s talented scientific team, led by Professor Daniel Morse. Together with Bayer’s scientists and engineers, we believe we have made a significant impact on the potential cost structure as well as efficiency and sustainability of our vaccine production. Securing a long-term sustainable KLH supply is a key element in our efforts to enable a new therapy that could significantly benefit disease outcomes and quality of life of NHL patients.”

Frank Oakes, CEO of Stellar, said, “Stellar has been honored by the opportunity to partner with the cutting-edge team at Bayer Innovation, and now, to grow this new relationship to the next level. Bayer Innovation is among the highest regarded participants in the PMP field, and we believe the credibility that comes from working with an internationally recognized biotechnology, materials science, and pharmaceutical powerhouse is incalculable. We are excited by the opportunity for growth in this relationship, and the potential for exploring future business development opportunities with Bayer Innovation.”

About Bayer Innovation GmbH (BIG — http://www.bayer-innovation.com/en/homepage.aspx) is part of Bayer’s innovation strategy and complements the innovation activities of the different subgroups in the fields of health care, nutrition and high-quality materials. Its objective is to identify and develop new growth opportunities, preparing entry into new and expanding markets. Currently the focus is on medical technology and the production of plant-made pharmaceuticals.

About Stellar Biotechnologies, Inc. (TSX-V: KLH) (PINKSHEETS: SBOTF) (www.StellarBiotechnologies.com) is a world leader in sustainable manufacturing of pharmaceutical grade immune carrier proteins (ICP), particularly with regard to the present most important pharmaceutical protein in this class, KLH (Keyhole Limpet Hemocyanin). This ancient evolutionary protein has a highly complex structure that makes it ideal for use in human and animal vaccines and diagnostic products. With partners and customers, its flagship Stellar KLH products are in the clinic, and on the way to being established as the only sustainable, long-term pharmaceutical source.

Statements in this press release other than purely historical factual information, including statements relating to revenues or profits, or the Company’s future plans and objectives, or expected sales, cash flows, and capital expenditures constitute forward-looking statements. Forward-looking statements are based on numerous assumptions and are subject to all of the risks and uncertainties inherent in the Company’s business, including risks inherent in the technology history. There can be no assurance that such forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on such statements. Except in accordance with applicable securities laws, the Company expressly disclaims any obligation to update any forward-looking statements or forward-looking statements that are incorporated by reference herein. This news release does not constitute an offer to sell, or a solicitation of an offer to buy any of the Company’s securities set out herein in the United States, or to, or for the benefit or account of, a U.S. person or person in the United States. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact:
Darrell Brookstein
Executive VP, Business Development & Finance
[email protected]

Filed Under: Prescription Drugs and Pharmacy

UPDATE: Stellar Biotechnologies Files Key Patent for Company

Posted on September 10, 2010 Written by Editor

SOURCE: Stellar Biotechnologies, Inc.

PT. HUENEME, CA–(Marketwire – September 10, 2010) – Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) announces filing for patent protection of inventions related to its native Immunogenic (IMG) KLH technology platform and immune status monitoring product portfolio. KLH (keyhole limpet hemocyanin) is presently the most pharmaceutically important ICP (immune carrier protein) and IMG KLH is the most effective immune stimulant for use in cancer, viral and parasite vaccines; animal vaccines; and diagnostic products. Patent claims include pharmaceutical grade compositions of matter, processes for manufacture and methods of use in a wide range of therapies.

John Sundsmo, Ph.D., VP Research and Intellectual Property, said, “With filing of this patent application Stellar has achieved an important milestone on the road to becoming the preeminent world leader in development and manufacture of pharmaceutical grade immune carrier proteins. We are very pleased with the progress achieved by our scientists and what this patent application tangibly demonstrates.”

Corporate Website: www.StellarBiotechnologies.com
Stellar News at Marketwire: http://www.marketwire.com/mw/search.do?params=&grpSearch=C&companyid=70788

About Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) – (www.StellarBiotechnologies.com): is a world leader in sustainable manufacturing of pharmaceutical grade immune carrier proteins (ICP), particularly with regard to the present most important pharmaceutical protein in this class, KLH (Keyhole Limpet Hemocyanin). This ancient evolutionary protein has a highly complex structure that makes it ideal for use in human and animal vaccines and diagnostic products. With partners and customers, its flagship Stellar KLH products are in the clinic, and on the way to being established as the only sustainable, long-term pharmaceutical source.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy any of the Company’s securities set out herein in the United States, or to, or for the benefit or account of, a U.S. Person or person in the United States. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact:
Darrell Brookstein
Executive VP, Business Development & Finance
[email protected]

Filed Under: Prescription Drugs and Pharmacy

Stellar Biotechnologies Files Key Patent for Company

Posted on September 9, 2010 Written by Editor

SOURCE: Stellar Biotechnologies, Inc.

PT. HUENEME, CA–(Marketwire – September 9, 2010) –  Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) announces filing for patent protection of inventions related to its native Immunogenic (IMG) KLH technology platform and immune status monitoring product portfolio. KLH (keyhole limpet hemocyanin) is presently the most pharmaceutically important ICP (immune carrier protein) and IMG KLH is the most effective immune stimulant for use in cancer, viral and parasite vaccines; animal vaccines; and diagnostic products. Patent claims include pharmaceutical grade compositions of matter, processes for manufacture and methods of use in a wide range of therapies.

John Sundsmo, Ph.D., VP Research and Intellectual Property, said, “With filing of this patent application Stellar has achieved an important milestone on the road to becoming the preeminent world leader in development and manufacture of pharmaceutical grade immune carrier proteins. We are very pleased with the progress achieved by our scientists and what this patent application tangibly demonstrates.”

Corporate Website: www.StellarBiotechnologies.com
Stellar News at Marketwire: http://www.marketwire.com/mw/search.do?params=&grpSearch=C&companyid=70788

About Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) – (www.StellarBiotechnologies.com): is a world leader in sustainable manufacturing of pharmaceutical grade immune carrier proteins (ICP), particularly with regard to the present most important pharmaceutical protein in this class, KLH (Keyhole Limpet Hemocyanin). This ancient evolutionary protein has a highly complex structure that makes it ideal for use in human and animal vaccines and diagnostic products. With partners and customers, its flagship Stellar KLH products are in the clinic, and on the way to being established as the only sustainable, long-term pharmaceutical source.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy any of the Company’s securities set out herein in the United States, or to, or for the benefit or account of, a U.S. Person or person in the United States. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact:
Darrell Brookstein
Executive VP, Business Development & Finance
[email protected]

Filed Under: Prescription Drugs and Pharmacy

InoLife Technologies, Inc. Announces Immediate Availability of the Cytochrome P450 2C1 Plavix Metabolizing Test to the Medical Industry

Posted on September 8, 2010 Written by Editor

SOURCE: InoLife Technologies Inc.

RALEIGH, NC–(Marketwire – September 8, 2010) –  InoLife Technologies, Inc. (OTCBB: INOL), a service based healthcare products development, integration and marketing Company, is extremely pleased that their recently presented Cytochrome P450 2C1 test to determine a person’s ability to metabolize Plavix is immediately available to the medical industry which includes physicians, hospitals, medical clinics, and pharmacies. Physicians are currently placing orders on a daily basis and are incorporating the Cytochrome P450 2C1 Plavix Metabolizing test into their patients health programs. 

InoLife’s Cytochrome P450 2C1 test is currently being used to identify how a patient’s genetics may affect the body’s response to Plavix (Clopidogrel). The test is available through the medical community only including physicians, hospitals, and medical clinics. This test is not available for sale to the general public.

According to the FDA in a press release dated March 12th, 2010 it is estimated that 2 percent to 14 percent of the U.S. population are poor metabolizers of certain medications. In 2009 the Federal Drug Administration approved wording on the drug label encouraging genetic testing for DNA variants based on specific risks. It is important to note that this drug metabolism test is not all-inclusive and is for the physician’s guidance only.

InoLife has incorporated the EasiCollect™ System, which combines an optimized foam collection surface with an FTA card for collection of buccal cells and preservation of DNA. InoLife prides itself in providing the EasiCollect™ System that adheres to the strict guidelines of the Clinical Laboratory Improvement Amendments (CLIA) that monitors approximately 200,000 laboratory entities. The Center for Medicare & Medicaid Services regulates all laboratory testing (except research) performed on humans in the U.S. through CLIA.

About InoLife Technologies, Inc.
InoLife is poised to become one of the premier U.S. marketers of state-of-the-art DNA-based test products. Positioned for growth and success in a burgeoning market, InoLife Technologies, www.inolifetech.com, is primarily focused on products, services and solutions that will enable state-of-the-art healthcare for today and the future for a diverse base of customers and end users. The Company’s mission is to identify, develop, integrate and bring to market innovative healthcare-based products and services that provide timely and practical solutions. The primary products and services that InoLife is currently addressing focuses upon those specific products and services that provide key solutions through the innovative use of specific DNA testing and Genetic analysis systems.

The principal customers of InoLife’s products and services are healthcare providers, physicians, practitioners, hospitals and outpatient facilities. InoLife will be marketing and distributing its products through traditional distribution channels. Additionally InoLife has developed certain products that can be sold directly to consumers and has created specific programs to reach those customers including e-commerce, direct sales, healthcare providers, pharmacies, distributors, retail sellers and specialty retailers.

(Plavix is a trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.)

Forward-Looking Statements
Safe Harbor Statement under the Private securities Litigation Reform Act of 1995: The statements contained herein, which are not historical, are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements including, but not limited to, certain delays beyond the Company’s control with respect to market acceptance of new technologies, products and services, delays in testing and evaluation of products and services, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission.

Filed Under: Hospitals and Health Systems, Prescription Drugs and Pharmacy

ALDA Pharmaceuticals Closes Private Placement for Gross Proceeds of $327,500

Posted on September 8, 2010 Written by Editor

VANCOUVER, BRITISH COLUMBIA–(Marketwire – Sept. 8, 2010) – ALDA Pharmaceuticals Corp. (TSX VENTURE:APH)(OTCQB:APCSF) (the “Company”) is pleased to announce that it has closed the private placement announced July 27th, 2010. A total of 3,275,000 Units of the Company were issued at a price of $0.10 per Unit for gross proceeds of $327,500. All securities issued with respect to the private placement will be subject to a hold period expiring on January 8, 2011 in accordance with the policies of the TSX Venture Exchange and applicable Canadian securities laws. 

Each Unit consists of one common share of ALDA and one non-transferable share purchase warrant entitling the holder to acquire one additional common share of ALDA at a price of $0.20 per common share for a period of two (2) years from the date of the issuance of the purchase warrant with a forced exercise provision attached to each warrant commencing on the day following the expiry of any applicable hold period on the underlying Common Share, stating that if, for ten consecutive trading days, the closing price of the listed shares of the Company exceeds $0.40 then the exercise period of the warrants will be reduced to a period of 10 days following such trading days. Net proceeds from the offering will be used for working capital.

The Company paid finders’ fees of $2,250 (5% of the gross proceeds of $45,000) to certain registrants with respect to the offering.

Insiders of ALDA subscribed for 677,500 Units on the same terms as arm’s length investors, constituting a related party transaction pursuant to Multilateral Instrument 61-101 and TSX Venture Exchange Policy 5.9. Such Insider participation was exempt from the requirement to obtain an independent valuation pursuant to Section 5.5(b) of MI 61-101 and the requirement to obtain minority shareholder approval pursuant to Section 5.7(1)(b) of MI 61-101.

About ALDA Pharmaceuticals Corp.

ALDA is focused on the development of infection-control therapeutics derived from its patented T36® technology. The company trades on the TSX Venture Exchange under the symbol APH and on the OTCQB under the symbol APCSF. The Company was the Official Supplier to the Vancouver 2010 Olympic Winter Games and the Vancouver 2010 Paralympic Winter Games and is the Official Supplier to the Canadian Olympic Committee, the 2010 Canadian Olympic Team and the 2012 Canadian Olympic Team for antiseptic hand sanitizer, disinfectant and disinfectant cleaning products. The Company was also selected as one of the TSX Venture 50 companies in the Technology and Life Sciences sector for 2010.

Terrance G. Owen, Ph.D., MBA
President & CEO
ALDA Pharmaceuticals Corp.
www.aldacorp.com

The Units, common shares, warrants and the common shares issuable upon exercise of the warrants have not been registered under the United States Securities Act of 1933 (the “Act”) and may not be offered or sold absent registration under the Act or an applicable exemption from the registration requirements thereof. This news release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction or an exemption therefrom.

Cautionary Note Regarding Forward-looking Statements: Information in this press release that involves ALDA’s expectations, plans, intentions or strategies regarding the future are forward-looking statements that are not facts and involve a number of risks and uncertainties. ALDA generally uses words such as “outlook”, “will”, “could”, “would”, “might”, “remains”, “to be”, “plans”, “believes”, “may”, “expects”, “intends”, “anticipates”, “estimate”, “future”, “plan”, “positioned”, “potential”, “project”, “remain”, “scheduled”, “set to”, “subject to”, “upcoming”, and similar expressions to help identify forward-looking statements. The forward-looking statements in this release are based upon information available to ALDA as of the date of this release, and ALDA assumes no obligation to update any such forward-looking statements. Forward-looking statements believed to be true when made may ultimately prove to be incorrect. These statements are not guarantees of the future performance of ALDA and are subject to risks, uncertainties and other factors, some of which are beyond its control and may cause actual results to differ materially from current expectations.

Filed Under: Prescription Drugs and Pharmacy

Virtual Pharma Rep(TM) Partners With digitalDVM(TM) to Launch virtualVetRep(TM) for the Animal Health Industry

Posted on September 2, 2010 Written by Editor

SOURCE: Virtual Pharma Rep

Virtual Pharma RepTM E-Detailing Platform Brings a New Virtual Sales Approach to the Animal Health Industry

OAK BROOK, IL–(Marketwire – September 2, 2010) –  Virtual Pharma Rep™, a leader in e-detailing marketing strategies, announced today that the company has entered into an agreement to provide their patent-pending e-detailing platform for use as the foundation for a new progressive communication program, in partnership with digitalDVM™, a sales and marketing solutions provider for the animal health industry.

Virtual Pharma Rep™ facilitates a paradigm shift in the traditional sales process, and revolutionizes expensive sales models with a fresh, value-added approach that supplements existing field reps and provides a new voice in the sales process. The partnership between Virtual Pharma Rep™ and digitalDVM™ brings together key components that supplement and enhance existing sales and marketing strategies for the animal health industry. Timely, relevant product and support information will be provided to busy veterinarians in an appealing format that meets the needs of the growing number of practices who prefer online resources that can be accessed at their convenience. 

“Virtual Pharma Rep™ has had significant success in the pharmaceutical industry,” said Jim Rediehs, CEO of Virtual Pharma Rep™. “The versatility of our e-detailing platform allows us to branch into new markets like Animal Health. It shares many similarities with the pharmaceutical market, and VPR provides a tool we know will prove useful for sales reps and veterinarians to maximize time, enhance education and therefore better serve their clients within the animal health industry.”

“More than 80% of physicians participate in e-detailing from pharmaceutical companies, and with the explosive growth of internet use among veterinary professionals, now is the time to make this service available to those in the animal health industry,” said Daryl Schraad, president of digitalDVM™. “virtualVetRep™ complements existing sales and marketing efforts by adding increased voice to top veterinary targets, and provides a cost-effective alternative to increasing field representatives in remote geographical regions.”

digitalDVM™’s virtualVetRep™ offers customized one-on-one virtual sales calls that include streaming video messages, live chat and sample or literature requests. In addition, the service connects veterinarians directly with their field sales representative, which helps optimize field sales call cycles and clinic staff’s time.

The virtualVetRep™ service is available to animal health product manufacturers and distributors worldwide.

About Virtual Pharma Rep™

Virtual Pharma Rep™ is revolutionizing the pharmaceutical industry by leading the paradigm shift to virtual sales support and service models that enhance or replace existing and expensive pharmaceutical marketing strategies. Led by a team that is highly experienced in the creation of future sales and growth strategies in pharmaceuticals, Virtual Pharma Rep™‘s patent pending sales platform shares a cost reduction within the pharmaceutical industry by streamlining existing sales and marketing strategies. In addition, thanks to VPR’s disease awareness, management and compliance processes, VPR assists with overall long-term healthcare cost reductions in the form of fewer doctor’s office visits and hospitalizations. For more information please visit www.virtualpharmarep.com.

About digitalDVM™
With a growing portfolio of advanced technology and innovative marketing platforms, digitalDVM™ enables animal health companies to gain more effective, immediate access to progressive veterinarians. Best-in-class capabilities include virtualVetRep™, an exclusive e-detailing platform for product and service information, groupDVM™ ecommerce solutions, and virtualRepCoach™, the digital alternative for sales representative training and development. Based in Denver with a worldwide clientele, the company works directly with product manufacturers and distributors throughout the animal health industry. More information is available at www.digitaldvm.com.

Media Contact:
Ann Norman
+1-310-927-5158
Email Contact

Filed Under: Healthcare Business, Prescription Drugs and Pharmacy

Aegis’ ProTek(R) Excipients Prevent Aggregation and Eliminate Unwanted beta-Interferon Immunogenicity

Posted on September 1, 2010 Written by Editor

SOURCE: Aegis Therapeutics LLC

SAN DIEGO, CA–(Marketwire – September 1, 2010) –  Recombinant human beta-interferon reduces the frequency of multiple sclerosis (MS) exacerbations and improves MS outcome measures. Unfortunately, current beta-interferon drug products form aggregates that provoke a neutralizing antibody response in MS patients, significantly reducing the effectiveness of the drug.

In a Journal article titled: “n-Dodecyl-?-D-Maltoside Inhibits Aggregation of Human Interferon-?-1b and Reduces Its Immunogenicity” which appeared in the Journal of Neuroimmune Pharmacology, published online on June 7, 2010 scientists from a leading US University Medical School report that addition of a patented ProTek® excipient, a pharmaceutical grade of dodecyl maltoside developed by Aegis, inhibits aggregation and prevents development of antibodies in vivo suggesting a route to greatly improved beta interferon formulations. The abstract of the scientific report may be viewed online at: http://www.springerlink.com/content/v46614510n311211/.

According to Dr. Edward T. Maggio, CEO of Aegis Therapeutics, “Aggregation-induced immunogenicity is a problem for many protein therapeutics, reducing drug effectiveness and in extreme instances, causing life-threatening adverse reactions as with erythropoietin and Factor VIII. And because protein aggregation also adversely affects manufacturing process yields and drug potency it has become a major concern for pharmaceutical formulators worldwide.”

ProTek® excipients are being used to prevent aggregation of monoclonal antibodies, human growth hormone, parathyroid hormone, and insulin, as well as a number of undisclosed proprietary peptide or protein therapeutics now in development.

About Aegis Therapeutics
Aegis Therapeutics commercializes its patented drug delivery and drug formulation technologies through product specific licenses. Our Intravail® technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide macromolecular therapeutics that can currently only be administered by injection with exceptionally high and unmatched bioavailability. Our ProTek® technology provides proprietary, easily manufacturable, aqueous dosage forms that are stable at elevated temperature and that reduce unwanted immunogenicity of many protein and peptide therapeutics.

Contact Information:

Ralph Barry
Chief Business Officer
Aegis Therapeutics LLC
1-858-618-1400 Ext. 102
Email: Email Contact

Edward T. Maggio, PhD
CEO
Aegis Therapeutics LLC
1-858-618-1400 Ext. 101
Email: Email Contact

Filed Under: Prescription Drugs and Pharmacy

Micro Identification Technologies (MIT): Independent Testing, Manufacturing, Sales and Financing Goals Converge

Posted on August 31, 2010 Written by Editor

SOURCE: Micro Imaging Technology, Inc.

SAN CLEMENTE, CA–(Marketwire – August 31, 2010) –  Micro Identification Technologies, Inc. (OTCBB: MMTC) is a California-based public company that has developed, patented and produces a rapid microbial identification (ID) System that revolutionizes the bacteria ID process and can annually save thousands of lives and tens of millions of healthcare dollars. The MIT 1000 System identifies bacteria in minutes, not days, and at significant cost per test savings when compared to any conventional method — it is not reliant on chemical or biological agents, conventional processing, fluorescent tags, gas chromatography or DNA analysis — requiring only clean water and a sample of the unknown bacteria. Revenues for all rapid testing methods exceed $5 billion annually — with food safety accounting for over $3 billion — having expanded at a rate of 9.2 percent annually since 1998. Current growth projections are at 10.2 percent annually reaching $6.2 billion by 2013 and driven by major health, safety and homeland security issues.

MIT, to meet this growing demand, announces today that it has made significant manufacturing progress since its initiation of a manufacturing alliance with OSI Optoelectronics (OSIO), a subsidiary of OSI Systems, to produce the MIT 1000 System. OSIO has manufacturing facilities in California, Malaysia and India. “We are pleased to work with MIT as we feel their innovative product will become a valuable tool to help prevent widespread bacterial contamination in the future,” stated Manoocher Mansouri, OSIO’s President.

“All of OSIO’s world class facilities are ISO 9001:2000 certified, FDA registered and GMP compliant making them the perfect company to fabricate MIT’s systems for food safety applications as well as planned pharmaceutical and clinical diagnostic applications,” stated John Ricardi, MIT’s Executive Vice President and Chief Operating Officer. Mr. Ricardi further added that “While we are predicting quantity deliveries of the MIT 1000 System by the end of this year, initially the systems will be built in OSIO’s California facility, as volume increases, fabrication will move to one of their lower cost overseas facilities enabling MIT to improve future profit margins.” For more information on OSI Systems, visit the company’s website at www.osi-systems.com

The MIT 1000 Systems, in limited production during this last year, have had several distinguished users, including the U.S. Department of Agriculture, Japanese Ministry of Food Safety, University Putra Malaysia and several local contract bioscience testing laboratories. MIT’s Chairman Michael Brennan stated, “We have a small and growing backlog, are in discussions with several potential customers and are on track with this year’s goal to begin quantity deliveries by year’s end, and in turn need to increase our system support and microbiological research capabilities in conjunction with helping improve the food industry’s safety capabilities.”

To fund these activities, MIT has entered into a three-year $5,000,000 equity agreement with the Boston-based private equity firm, Dutchess Capital — the underlying S-1 Registration Statement was recently approved by the Securities Exchange Commission (SEC). MIT’s Chief Executive Officer, Michael Brennan, stated, “We have been very pleased working with Dutchess which has an excellent track record in the investment banking industry and has been a leading provider of private equity for over 10 years. Their successful background was the primary reason we selected them to be one of our partners.”

Chris Quin, Dutchess Vice President of business development stated, “We are excited to work with MIT as they continue to execute their business plan, develop further applications and increase market penetration of their laser-based, rapid microbial identification technology.” For more information on Dutchess Capital, visit the firm’s website at www.dutchesscapital.com

About Micro Identification Technologies:

The MIT 1000 System can identify bacteria in less than five minutes after culturing at a cost of less than 10 cents per test and is a certified AOAC Research Institute (RI) test method of Listeria, one of three bacteria (the others are Salmonella and E.coli) that are responsible for most of the worldwide food contamination events. The Company is in the process of preparing the MIT 1000 System to become AOAC RI certified later this year for the presence of all “three” bacteria with a single mouse click. The AOAC RI Report and Certification are available from the Company. www.aoac.org 

Further, MIT has demonstrated the ability to detect and identify, within several minutes, the microbes Escherichia coli, Listeria, Salmonella, Staphylococcus aureus, MRSA and other pathogenic bacteria. MIT recently performed over 300 tests for the identification of these contaminants and scored over 95 percent in accuracy. The System’s database currently enables the identification of over twenty species of bacteria and is easily expandable. This identification process has also been verified by North American Science Associates, Inc. (NAMSA), an independent, internationally recognized bioscience testing laboratory. The NAMSA Test Report is available from the Company and, in MIT’s opinion, documents the accuracy, speed and cost effectiveness of the MIT System over conventional processes. www.namsa.com

Please visit our website: www.micro-identification.com

This release contains statements that are forward-looking in nature. Statements that are predictive in nature, that depend upon or refer to future events or conditions or that include words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions are forward-looking statements. These statements are made based upon information available to the Company as of the date of this release, and we assume no obligation to update any such forward-looking statements. These statements are not guarantees of future performance and actual results could differ materially from our current expectations. Factors that could cause or contribute to such differences include, but are not limited to dependence on suppliers; short product life cycles and reductions in unit selling prices; delays in development or shipment of new products; lack of market acceptance of our new products or services; inability to continue to develop competitive new products and services on a timely basis; introduction of new products or services by major competitors; our ability to attract and retain qualified employees; inability to expand our operations to support increased growth; and declining economic conditions, including a recession. These and other factors and risks associated with our business are discussed from time to time within our filings with the Securities and Exchange Commission, referencing: “MMTC”

CONTACT:
Michael Brennan
Chairman
Email: Email Contact
Telephone: (805) 557-0614

Filed Under: Prescription Drugs and Pharmacy

Radient Pharmaceuticals Resumes Collaboration to Advance Its Onko-Sure(R) In Vitro Diagnostic Cancer Test in the USA

Posted on August 31, 2010 Written by Editor

SOURCE: Radient Pharmaceuticals Corporation

TUSTIN, CA–(Marketwire – August 31, 2010) –  Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today it has resumed collaborations with Mayo Collaborative Services, Inc. to conduct a clinical study for the validation of RPC’s US FDA-approved Onko-Sure® in vitro diagnostic (IVD) cancer test as a useful tool in colorectal cancer (CRC) recurrence and treatment monitoring.

Over 1,000 colorectal patient samples with various disease stages will be tested in parallel by RPC and Mayo Clinic to directly compare the results of the Onko-Sure® test with the Carcinoembryonic Antigen (CEA) test. The primary goal of the study is to determine whether Onko-Sure® is more effective than CEA at detecting early stage colorectal cancers. CEA has been reported to misdiagnose a disproportionate number of early stage cancers. Detecting cancer in earlier stages can lead to improved accuracy in the treatment, monitoring and recurrence monitoring of the disease in cancer patients. This head-to-head study is scheduled to be completed in the fourth quarter FY2010 and data generated will be provided to Mayo physicians and investigators for publication in medical journals.

“We are very excited to resume collaboration with Mayo’s Validation Support Services team. This marks a critical and potentially market changing milestone for Radient Pharmaceuticals and for our Onko-Sure® IVD cancer test,” commented Douglas MacLellan, Chairman and CEO of RPC. “Through this work, we expect to validate the efficacy of RPC’s Onko-Sure® test as a critical tool for treatment, monitoring, and/or recurrence monitoring of colorectal cancer suffers.”

RPC’s Onko-Sure® IVD cancer test is a simple, non-invasive, patent-pending and regulatory-approved in vitro diagnostic (IVD) test used for the detection and monitoring of the treatment and/or recurrence of various types of cancer. The test enables physicians and healthcare professionals to effectively detect and/or monitor certain types of cancers by measuring the accumulation of Fibrin and Fibrinogen Degradation Products (FDP) in the blood. FDP levels rise dramatically with the progression of cancer. Onko-Sure® is cleared by the US FDA for detection during colorectal cancer treatment and/or for recurrence monitoring in colorectal cancer patients and by Health Canada for the detection, treatment and/or recurrence monitoring of lung cancer. For more information visit www.onko-sure.com.

RPC Contact Information:
For additional information on Radient Pharmaceuticals, ADI and its portfolio of products visit the Company’s corporate website at www.Radient-Pharma.com. For Investor Relations information contact Kristine Szarkowitz at [email protected] or 1.206.310.5323.

About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals is dedicated to saving lives and money for patients and global healthcare systems through the deployment of its Onko-Sure® In Vitro Diagnostic cancer test. The company’s focus is on the discovery, development and commercialization of unique high-value diagnostic tests that help physicians answer important clinical questions related to early disease detection; treatment strategy; and the monitoring of disease progression, prognosis, and diagnosis to ultimately improve patient outcomes. Radient Pharmaceutical’s current Onko-Sure® cancer test is used to guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, perform additional testing, or assist in the selection of therapy. To learn more about our company, people and potentially life-saving cancer test, visit www.radient-pharma.com.

About Mayo Validation Support Services:
Mayo Validation Support Services, an affiliate of Mayo Clinic, based in Rochester, Minnesota and assists pharmaceutical, biotechnology and diagnostic companies in validating the clinical significance of emerging biomarkers and technologies. Mayo’s contribution of well-annotated biospecimens and clinical follow-up data support the development of individualized medicine, one of Mayo’s strategic initiatives.

Forward Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company’s operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.

Radient Pharma Contact:
Kristine Szarkowitz
Director-Investor Relations
Email Contact
Tel: 206.310.5323

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Filed Under: Prescription Drugs and Pharmacy, Public Health and Research

Neurotech Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial for AAD-2004, a Potent Spin Trapping Molecule and Microsomal Prostaglandin E…

Posted on August 30, 2010 Written by Editor

SOURCE: Neurotech Pharmaceuticals Co., Ltd.

SUWON, SOUTH KOREA–(Marketwire – August 30, 2010) – Neurotech Pharmaceuticals Co., Ltd. has begun dosing in the Phase 1 clinical testing of AAD-2004. AAD-2004 was developed as a dual function drug to remove free radicals and PGE2, the key mediators of nerve injury in Alzheimer’s disease (AD), Parkinson’s disease (PD), and amyotrophic lateral sclerosis (ALS). The Phase 1 clinical trial was initiated to evaluate the safety, tolerability, and pharmacokinetics of AAD-2004 in healthy volunteers in April, 2010. The first two cohorts of the clinical study have been successfully completed without serious adverse events.

About FREE RADICALS AND PGE2 IN NEURODEGENERTIVE DISEASES
Free radicals and PGE2-mediated inflammation are expected to play a central role in the neurodegenerative process occurring in neurodegenerative diseases including AD, PD, and ALS. However, no drugs have been developed to prevent free radicals in the brain of AD, PD, and ALS due to poor blood-brain barrier permeability and adverse effects. Long-term use of conventional nonsteroidal anti-inflammatory drugs (NSAIDs) has been limited by the risk of cardiovascular infarction and thrombosis as well as gastrointestinal complications. Currently there are no FDA-approved drugs to protect nerve cells against toxic free radicals and inflammation evolving in the nervous system of patients with AD, PD, and ALS.

About AAD-2004
The scientific founders of Neurotech Pharmaceuticals discovered a novel chemical library on the premise that a single agent combining the anti-inflammatory attributes of aspirin with powerful anti-oxidant efficacy would constitute effective disease modifying therapeutics for nerve protection in neurodegenerative diseases, based on the additive/synergistic neuroprotective effects via compromising free radicals and inflammation. With leading supports via 21C Frontier R&D Program in Neuroscience from Ministry of Education, Science, and Technology, a National Drug Discovery Program from Ministry of Health and Welfare, and Ajou University in South Korea, Neurotech Pharmaceuticals launched an Anti-Alzheimer’s Drug discovery program. AAD-2004 was selected as a final drug candidate based upon safety and efficacy study in animal models of AD that improved cognitive function far better than antioxidants or NSAIDs as well as memantine, an FDA approved drug for the symptomatic treatment of AD. The therapeutic potential of AAD-2004 has been verified in animal models of ALS, PD, and major depression. Unlike conventional NSAIDs causing gastric damage, however, AAD-2004 did not produce gastric damage even at a dose 400-fold higher than maximally effective doses in animal models.

“While NASIDs cause gastric and cardiovascular risks by preventing production of prostaglandins PGI2 as well as PGE2 by inhibiting cyclooxygenases, AAD-2004 selectively prevents PGE2 production as an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), the terminal isomerase catalyzing conversion of PGH2 to PGE2, at nanomolar concentrations, which explains why AAD-2004 is safer than NSAIDs. In addition, the potent spin trapping property of AAD-2004 provides additional efficacy and safety,” said Byoung J. Gwag, Ph.D., CEO of Neurotech Pharmaceuticals and Professor at Department of Pharmacology of Ajou University School of Medicine. “The marked safety and efficacy in preclinical studies make AAD-2004 a promising drug candidate to advance into clinical trials. We are so pleased to see safety profile of AAD-2004 in human healthy volunteers exposed to doses higher than maximally effective doses in preclinical studies.”

About Neurotech Pharmaceuticals
Neurotech Pharmaceuticals was founded to develop drugs for the treatment of neurological diseases on the basis of the close collaboration of basic and clinical academic teams in 1998. In addition to AAD-2004, Neu2000, a moderate NMDA receptor NR2B-selective antagonist and potent antioxidant, has been developed as a drug candidate for stroke, spinal cord injury, acute myocardial infarction, and burn injury. Nonclincial and human phase I studies in the United States demonstrate that Neu2000 is safe (therapeutic index = 35 – 800 depending on types and severity of diseases) and thus can be advanced into human phase II study. ND-07 has been developed to treat inflammatory diseases including pancreatitis, inflammatory bowel disease, rheumatoid arthritis, and pain and is near the end of preclinical study.

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Filed Under: Prescription Drugs and Pharmacy

CLSI and APHL Announce New Teleconference on Point-of-Care Glucose Devices

Posted on August 30, 2010 Written by Editor

SOURCE: Clinical and Laboratory Standards Institute

WAYNE, PA–(Marketwire – August 30, 2010) –  The Clinical and Laboratory Standards Institute (CLSI) and Association of Public Health Laboratories (APHL) are offering a teleconference to the health care community to learn more about the different considerations surrounding acceptance criteria on point-of-care (POC) glucose devices. The teleconference on September 30 is titled “POC Glucose Devices: Perspectives From the Hospital, Government, and Vendor.”

The US Food and Drug Administration (FDA) recently held a public forum on glucose meter devices to gather wide perspectives on the clinical requirements for blood glucose meter accuracy and precision. Using the CLSI consensus process in gathering balanced viewpoints from industry, professional societies, and government bodies, this educational program will provide an overview of different perspectives surrounding the glucose device acceptance criteria for both self-testing and professional use, and possibly expand the presentations at the most recent FDA public meeting.

“This teleconference will not only highlight the need for glucose meter accuracy and precision, but also discuss the studies that have been performed and what is to come from the many organizations and associations looking into guidelines around this issue,” said Marcy Anderson, MS, MT(ASCP), Director of Development and Education, CLSI.

The teleconference will help participants to describe differences in the use of glucose meters in self-testing vs hospital or professional settings. They will also understand the differences between the perspectives of the government agency, professional expert, and POC glucose vendor representative. There will be an opportunity to ask questions at the end of the program.

Speakers include:

  • Alan Cariski, MD, JD
    VP, Worldwide Medical Affairs, LifeScan Inc., Milpitas, California

  • Courtney Harper, PhD
    Director, FDA Division of Chemistry and Toxicology Devices, Silver Spring, Maryland

  • Mitch Scott, PhD
    Director, Division of Laboratory Medicine at Washington University Hospital, St. Louis, Missouri

Upcoming point-of-care teleconferences:

  • Deciding Factor: Selection Criteria for Point-of-Care Testing Devices (588-614-10)
    September 16 • 1:00-2:00 PM Eastern (US) Time

  • POC Glucose Devices: Perspectives From the Hospital, Government, and Vendor (588-623-10)
    September 30 • 1:00-2:30 PM Eastern (US) Time (1.5 contact hours)

  • Getting It Right: Approaches to Reducing Errors at the Point of Care (588-616-10)
    October 7 • 1:00-2:00 PM Eastern (US) Time

Register for the upcoming teleconferences at www.aphl.org/clsi. Discounts are offered for conference series registration.

APHL is approved as a provider of continuing education programs in the clinical laboratory sciences by the American Society for Clinical Laboratory Science (ASCLS) P.A.C.E.® Program. Participants will be awarded contact hours for each program they successfully complete. P.A.C.E.® is accepted by all licensure states except Florida. Florida continuing education credit will also be offered.

CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information on CLSI, visit the CLSI website at www.clsi.org or call 610.688.0100.

Contact:
Amanda Holm
Senior Marketing Manager
Phone: 610.688.0100 ext. 129
E-mail: Email Contact

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Filed Under: Hospitals and Health Systems, Prescription Drugs and Pharmacy

Radient Pharmaceuticals Provides Domestic and International Target Market Details for Its Onko-Sure(R) IVD Cancer Diagnostic Test

Posted on August 26, 2010 Written by Editor

SOURCE: Radient Pharmaceuticals Corporation

TUSTIN, CA–(Marketwire – August 26, 2010) – Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today target market details for the domestic and international commercialization of its Onko-Sure® in vitro diagnostic (IVD) cancer test. 

RPC received USFDA for its Onko-Sure® IVD cancer test approximately 24 months ago, which marked the point at which RPC could begin commercialization. Since that time a considerable amount of work has gone into creating a domestic & international distribution network, plus the highly effort of validating RPC’s USFDA approved Onko-Sure® test kits with oncologists, gastroenterologist and lab directors. RPC has added various needed validation tools that include the first edition of RPC’s 2010 Onko-Sure® Reference Guide for physicians, oncologists, clinicians, consumers and patients, (“ODR”) designed to significantly gain sales traction for Onko-Sure® in North America and other international markets. The Company is also working on additional clinical trials and inclusion in industry publications to determine the standard of care for cancer diagnosis and targeting additional validation tools, which are anticipated to be in place by year-end. The Company is now in a position to begin making significant headway in commercializing Onko-Sure® in target market.

According to Mr. Douglas MacLellan, Chairman and CEO of RPC, “RPC has focused 18 months of dedicated, diligent work related to product validation, and we expect the Company will demonstrate significantly improved sales results during the second half of FY2010. Given the timing of our US FDA approval and commercialization work, we are akin to a start-up Company. That said, we expect meaningful sales to begin over the next two quarters. We understand there is tremendous market pressure and encourage the investing community to look to the long-term success of RPC, especially given the current economic environment and the very competitive and sophisticated market we are operating in.”

FY2010/ FY2011 Onko-Sure® Commercialization Plan
As RPC executes its domestic and international Onko-Sure® sales plan, the Company is focusing on 4 key target markets, that include:

  • US FDA approved use and sales of Onko-Sure® as a CRC Monitoring Test in the U.S. & eventually Canada;
  • US FDA approved use and sales of Onko-Sure® as a CRC Monitoring Test in various international markets;
  • Use and sales of Onko-Sure® as a general cancer screening test (predominately outside the US, currently in Taiwan and Korea); and,
  • Health Canada approved use and sales of Onko-Sure® as a lung cancer screening and monitoring test.

Target Market Segment Details:

  • US FDA approved use as a CRC Monitoring Test Market in the US & Canada: This market represents a US$200 million per year market at the wholesale level, and is growing at a 10% annual growth rate. The competing test for Onko-Sure® is the Carcinoembryonic Antigen (CEA) — a test that typically only identifies cancer its latest stages when the probability of treating the disease is lowest. Onko-Sure® has been clinically shown to identify cancer in its earliest stages, and these studies also indicate Onko-Sure® to be a superior test to CEA. To capitalize on this, we are implementing an aggressive commercialization strategy in the US specifically targeted towards physicians, oncologists, clinicians, consumers, patients and reference labs that show demand for the test.

  • US FDA Approved use as a CRC Monitoring Test in International Markets: This market represents a US$250 million per year market at the wholesale level, and is also growing at a 10% annual growth rate. We expect sales of Onko-Sure® in North America will create new market share in the International CRC monitoring market by FY2011.

  • Government-backed General Cancer Screening Test (predominately outside the US): Government backed general cancer screening represents a potential US$1 billion per year market that is currently in its infancy. International recognition and demand for government-backed general cancer screening has only just begun. U.S. adoption of government back general cancer screening for high risk populations is expected to be commonplace by 2015. Based on RPC market analysis, we anticipate driving solid adoption and sales of Onko-Sure® in high risk populations specifically in India and Colombia by the fourth quarter 2010, and Brazil by the second quarter of 2011. We are actively targeting other countries and expect sales to ramp as RPC’s initial commercialization program in the above markets demonstrates results. Additionally, through our US-based CLIA lab partner, we have initiated product sales for Onko-Sure® that is being used as a general cancer screen in the US and Canada and we are selling Onko-Sure® as a general cancer screen in Korea and Taiwan. In order for RPC to gain up to US$1 billion in Onko-Sure sales from government-backed general cancer screening initiatives (“GCSI”), which would be focused on “patients with a high risk of developing cancer,” RPC will need to sell approximately 1,488,095 kits annually.

  • Health Canada Approved use as a Lung Cancer Screening & Monitoring Test: This represents a US$50 million per year market, also currently in an infancy stage. More Canadians are diagnosed with lung cancer than any other cancer type, with mortality from lung cancer higher than breast, colorectal and prostate cancer combined. In 2010 alone, 1 in 12 Canadians are expected to develop lung cancer. Smoking causes most lung cancers. That said, approximately 50% of patients diagnosed have never smoked (15%) or are former smokers (35%). Most lung cancers are diagnosed in late stages, due in part to lack of effective screening procedures, this is a primary factor that leads us to believe Onko-Sure® will become an important and high demand test for cancer screening. Lung cancer patients and their family members are often stigmatized by a widespread prejudice about smoking, and many feel isolated and hesitant to tell others about their diagnosis. Lung cancer receives little public or media attention. This is due, in part, to a small community of survivors to bring a voice and attention to lung cancer issues. We are seeking Canadian government support for a lung cancer screening program to high risk segments of the population.

Global Cancer Statistics & Onko-Sure®
The latest World Health Organization (“WHO”) statistics indicate there are approximately 7.4 million cancer deaths worldwide annually. RPC’s goal is to test approximately 70 million “high risk factor” patients per year with the goal of identifying cancer in approximately 10% of this high risk factor population. According to the WHO, the annual global cost for cancer is approximately US$1 Trillion. By implementing GCSI, and catching early stage cancer, the savings with a low cost test such as Onko-Sure™ could be at least 30% or approximately US$330 billion per year, to government health agencies.

For additional information on RPC and its portfolio of cancer products visit the Company’s corporate website at www.Radient-Pharma.com. For Investor Relations information contact Kristine Szarkowitz at [email protected] or 1.206.310.5323.

About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals Corporation is an integrated pharmaceutical company devoted to the research, development, manufacturing, and marketing of in-vitro diagnostic products.

Forward Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company’s operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.

References:

  • Lung Cancer Canada, lungcancercanada.ca.
  • World Health Organization (WHO) Cancer Fact Sheet No. 297, February 2009
  • “Cancer costs the world nearly $1 trillion”, By Aaron Smith, CNNMoney.com staff writer, August 17, 2010.

Radient Pharma Contact:
Kristine Szarkowitz
Director-Investor Relations
Email Contact
Tel: 206.310.5323

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Filed Under: Prescription Drugs and Pharmacy

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