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.

New Study Shows Hospital-Based Out-of-Home Advertising Delivers Above Average ROI

Posted on July 13, 2010 Written by Editor

SOURCE: Interactivation Health Networks

Proves ‘Fourth Screen’ Value of Interactivation Health Networks’ Channels

NEW YORK, NY–(Marketwire – July 13, 2010) – The Patient Channel, a 24/7 in-hospital television network from Interactivation Health Networks, has conducted a study for one if its pharmaceutical advertisers that demonstrates above average ROI — a 5:1 ROI after six months and 8:1 ROI after a 12 month targeted advertising campaign — further evidence of the immense value of Digital Out-of-Home advertising, particularly as it relates to hospitals as a “fourth screen” location.

“The reason why advertising is so effective at hospital bedside, and why the Patient Channel and Newborn Channel work is simple — we provide marketers with a unique and differentiated platform that offers compelling and essential health content delivered at the precise moment it is needed most,” said Suzanne Fleming, SVP of Sales at Interactivation Health Networks. “Our channels provide the ideal branding environment where consumers are highly attentive, highly motivated and ready to act. Connecting brands with our hyper-focused audience is an opportunity that is hard to replicate with traditional television advertising.”

Interactivation Health Networks engaged IMS Consulting to perform a quantitative ROI study based upon dispensed prescribing tied to participating physicians exposed to a specified pharmaceutical company’s program. The study found that when comparing post-exposure prescribing to a similar control group of physicians, identified by IMS, the pharmaceutical company saw a +2.1% incremental increase in prescribing, representing a positive return on the pharmaceutical company’s investment with Interactivation Health Networks.

Results from the IMS study corroborate findings from studies conducted by Nielsen* and Razorfish** that project the continued rise of Out-Of-Home advertising due to the unchallenged ability to pinpoint a targeted, and often captive, audience with relevant messaging. For brands within the health and wellness field, the Interactivation Health Networks are a documented means of successfully activating these consumers.

Advertisers who use The Patient and Newborn Channels will have the added opportunity of further engaging with their target audience via Interactivation’s propriety interactive technology. This would allow viewers of ads to directly and immediately interact with the brand with their mobile device to receive more information or coupons on the advertised product. For example, consumers can locate a nearby retailer by texting their zip code to the Interactivation-owned short code promoted in their on-air commercial.

About Interactivation Health Networks
The Patient Channel and The Newborn Channel are the most comprehensive in-hospital TV networks. Delivered directly to patient rooms and waiting areas, the Channels provide viewers with original, award-winning health programs and advertisers with the unique ability to integrate brand messaging with content that is compelling and endorsed by healthcare professionals. The Newborn Channel broadcasts baby care and postpartum programming for new parents, reaching 60% of new moms. The Patient Channel features both condition-specific and preventative health programming to empower and inform patients. The channels are currently available in over 2,700 hospitals nationwide.

IMS Health Consulting conducted the study with one of the Patient Channel’s long-standing advertisers.

*Nielsen Inaugural Fourth Screen Report – April 12, 2010
**Razorfish Outlook Report 2010

Scientific Leaders Urge Type 2 Diabetes Patients to Remain on Their Prescribed Medications Unless Instructed Otherwise by Their Health Care Provider

Posted on July 13, 2010 Written by Editor

SOURCE: American Diabetes Association

American Association of Clinical Endocrinologists, American Diabetes Association and The Endocrine Society Issue Joint Statement in Response to Reports of Potential Cardiovascular Risks Associated With Rosiglitazone

ALEXANDRIA, VA–(Marketwire – July 12, 2010) – Over the past several weeks reports have again surfaced regarding the cardiovascular safety of the diabetes drug rosiglitazone. While some analyses have suggested an increased cardiovascular risk with use of rosiglitazone, others have not provided any evidence of such an association. To help patients and physicians make informed decisions regarding use of rosiglitazone, the American Association of Clinical Endocrinologists (AACE), the American Diabetes Association and The Endocrine Society issued a joint statement with recommendations:
http://www.diabetes.org/for-media/2010/ada_aace_endo.html

The statement recommends that patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider. Stopping diabetes medications can result in higher levels of blood glucose that may cause serious short term health problems and could increase the risk of diabetes-related complications in the long term.

The joint statement also informs patients that regardless of the opinion and decisions on rosiglitazone, there are numerous drugs available to maintain glucose control in people with type 2 diabetes. Patients should discuss these options with their health care providers.

In the next few days (July 13-14) the U.S. Food and Drug Administration (FDA) is expected to complete the Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. This committee was convened to evaluate the scientific research available on the safety of rosiglitazone and then issue its decision on how the drug should or should not be used. The joint statement recommends that until further clarification is provided by the FDA, the decision whether or not to use any medication must remain that of the treating provider in direct discussion with the individual patient.

Following any decision from the FDA, AACE, the American Diabetes Association and The Endocrine Society will provide detailed information interpreting FDA action for both health care professionals and patients with diabetes.

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 a professional medical organization with more than 6,000 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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Pharma Benefits Executive Michael Darkoch Joins CNS Response

Posted on July 12, 2010 Written by Editor

SOURCE: CNS Response

Darkoch to Lead Marketing and Commercialization Activities

ALISO VIEJO, CA–(Marketwire – July 12, 2010) – CNS Response (OTCBB: CNSO) announces the appointment of Michael E. Darkoch as Executive Vice President and Chief Marketing Officer. In this role, Darkoch will assume all responsibility for the launch and commercialization of the Company’s flagship product, Referenced-EEG, including all marketing, business development and patient advocacy activities.

“Mike is a known quantity,” said CNS Response CEO George Carpenter. “In the world of pharmaceutical benefits, he understands what drives consumers, what payers pay for, and how to scale services around them. His industry expertise and payer relationships will be incredibly valuable as we introduce Referenced-EEG to a broader market. I’ve worked with Mike in three companies and his experience, skills and performance record will be crucial to our future success.”

Darkoch joins CNS Response with extensive executive experience at healthcare companies including Baxter International, CORE, Inc, and pharmaceutical benefits management firm Caremark Rx, where he grew sales from $100 million to $2.1 billion within five years, while achieving an industry record of 98 percent client retention for a two-year period.

Prior to joining CNS Response, Darkoch held senior management positions with MedImpact Health Systems, a prescription benefit management firm in San Diego, where he successfully managed product development and increased new sales revenues 15 percent, market segment revenues by 40 percent and specialty products’ revenues by 35 percent.

Darkoch commented, “One of the greatest challenges in the pharmaceutical arena is to understand how medications will impact patients differently, and mental disorders represent one of the largest opportunities where numerous medications have individualized outcomes.

“I believe Referenced-EEG may offer an important answer, helping physicians improve clinical outcomes for patients, and economic outcomes for us all. My goal is to establish the CNS Response brand and reputation quickly in this emerging area of personalized medicine.”

Darkoch holds a Bachelor of Science of Industrial Engineering from Lehigh University and Master of Science in Business from Southern Methodist University. He started his engineering and management career with Texas Instruments and Mobil Chemical Company, before moving into the healthcare and pharmaceutical sectors.

About CNS Response
Today, most physicians are able to base treatment on objective test data, such as EKGs, MRIs, blood tests, etc. Broadly speaking, such advances have not yet come to those physicians practicing psychiatry.

Referenced-EEG was developed by physicians to provide objective, personalized, statistical data on patient neurophysiology. In clinical trials, physicians using rEEG data have consistently achieved superior clinical results compared to physicians using trial and error pharmacotherapy.

The Company announced publication last week of results from its most recent clinical trial in The Journal of Psychiatric Research, in which physicians using Referenced-EEG (rEEG^®₎ had success rates reaching 65 percent for patients with treatment-resistant depression.

To read more about the benefits this patented technology provides physicians, patients and insurers, please visit the CNS Response website, www.cnsresponse.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements involve risks and uncertainties as set forth in the Company’s filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.

Investors:
Marty Tullio
Managing Partner
McCloud Communications, LLC
949.553.9748
Email Contact

Media:
Chris Stern
Washington Media Group
202.628.1280
Email Contact

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DiaMedica Initiates Type 1 Diabetes Study; Announces Preliminary Results

Posted on July 8, 2010 Written by Editor

WINNIPEG, MANITOBA–(Marketwire – July 8, 2010) – DiaMedica Inc., (TSX VENTURE:DMA) today announces that it has initiated a Type 1 diabetes program. The recently announced Sanomune acquisition allows DiaMedica to expand into Type 1 diabetes. The initiation of this program is based on encouraging preclinical results with DM-99, a naturally occurring protein that the company has previously shown to have clinical efficacy for Type 2 diabetes.

In the study, animals were injected with streptozotocin, a naturally occurring compound known to be toxic to beta cells, to mimic the disease. A week after this streptozotocin treatment, animals were injected twice daily with DM-99 for a period of 21 days at which time fasting blood glucose measurements were taken. Animals treated with DM-99 had a statistically significant 68% (p=0.05) reduction in fasting blood glucose compared to untreated animals. Furthermore, the DM-99 treatment resulted in a positive reduction in total glucose as measured by an oral glucose tolerance test.

“Initial results from this study show that DM-99 was able to reduce fasting blood glucose, an indication that new beta cells may be created or that existing beta cells are being protected from the streptozotocin insult,” stated Rick Pauls, President and CEO of DiaMedica. “The final results and analysis of DM-99 on the direct effects upon the pancreas (insulin production and beta cell proliferation) is expected during the summer of 2010.”

About Type 1 Diabetes

According to the Juvenile Diabetes Research Foundation, as many as 3 million Americans may have Type 1diabetes, an autoimmune disease that strikes children and adults suddenly and can be fatal. In Type 1 diabetes, the host’s own immune system destroys beta cells in the pancreas that normally control blood sugar level by producing insulin. Currently, patients with Type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times each day, or use a pump daily to control blood sugar levels. Even with intensive care, insulin is not a cure for diabetes, nor does it completely prevent the eventual and devastating complications of diabetes, which may include kidney failure, blindness, heart disease, stroke, and amputation.

About DiaMedica

DiaMedica is a biopharmaceutical company focused on developing novel treatments for diabetes and neurological disorders. The Company’s Type 2 diabetes program is based on a critical liver nerve signaling mechanism involved in enhancing insulin sensitivity after meal consumption. Two of DiaMedica’s products have previously demonstrated human efficacy in lowering blood sugar levels in people diagnosed with Type 2 diabetes based on this novel nerve signaling mechanism.

DiaMedica has expanded its DM-199 recombinant protein program into neurological and autoimmune disorders. The Company has demonstrated that DM-99, the naturally occurring form of DM-199, confers neural protection (protects brain cells) and triggers neural stem cell proliferation (creates brain cells) for the treatment of numerous neurological disorders including Alzheimer’s disease. DiaMedica is listed on the TSX Venture Exchange under the trading symbol “DMA”.

For further information please visit www.diamedica.com.

Caution Regarding Forward-Looking Information

Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, the “forward-looking statements“). These forward-looking statements relate to, among other things, DiaMedica’s objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, and can, in some cases, be identified by the use of words such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “will,” “may” and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Specifically, this press release contains forward-looking statements regarding matters such as, but not limited to, the anticipated use of proceeds from the Offering, management’s assessment of DiaMedica’s future plans, information with respect to the advancement of DiaMedica’s research and development programs, and DiaMedica’s other estimates and expectations. These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: uncertainties and risks related to our research and development programs, the availability of additional financing, risks and uncertainties relating to the anticipated use of proceeds, changes in debt and equity markets, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition, potential product liability, additional financing requirements and access to capital, unproven markets, the cost and supply of raw materials, management of growth, effects of insurers’ willingness to pay for products, risks related to regulatory matters and risks related to intellectual property matters. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release, as well as under the heading “Risk Factors” contained in DiaMedica’s 2009 annual information form. DiaMedica cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on DiaMedica’s forward-looking statements to make decisions with respect to DiaMedica, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Such forward-looking statements are based on a number of estimates and assumptions, which may prove to be incorrect, including, but not limited to, assumptions regarding the availability of additional financing for research and development companies, and general business and economic conditions.These risks and uncertainties should be considered carefully and investors and others should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, DiaMedica cannot provide assurance that actual results will be consistent with these forward-looking statements. DiaMedica undertakes no obligation to update or revise any forward-looking statement. Additional risk factors, factors which could cause actual results to differ materially from expectations, and assumptions relating specifically to our acquisition of Sanomune may be found in our press releases dated February 18, 2010 and April 20, 2010.

Advantages Of Buying Drugs From An Internet-based Canadian Pharmacy

Posted on July 8, 2010 Written by Editor

The addition of the prescription plan to the Medicare changes by the Obama administration only worsened a bad situation. These supposed advantages do not go well with lots of people and have left numerous Americans upset and confused because they now need to deal using the lack of medication as the system is being looked into. The only safe thing now is to get drugs from somewhere else, and Canada is the people’s first option. The Canadian pharmaceutical industry is a really valuable asset towards the American individuals more than ever.

The very first group of individuals to realize the value and also the relief that the Canadian drugs brings are the senior citizens who were among the very first to purchase drugs from a Canadian pharmacy. Many people have now discovered the advantages of purchasing medicines from Canada than persevering using the higher costs of nearby medicines and medications. [Read more…]

Bio Island Bouncing Back

Posted on July 7, 2010 Written by Editor

SOURCE: PRIDCO

Puerto Rico Attracts New Blu Pharmaceuticals and Pioneer Hi-Bred Facilities

SAN JUAN, PR–(Marketwire – July 7, 2010) – After a lull brought on by the global recession, Puerto Rico appears to be bouncing back as one of the world’s top destinations for life science companies. Two U.S. companies — Blu Pharmaceuticals and a DuPont business, Pioneer Hi-Bred — announced new manufacturing and R&D facilities on the island during the past several months.

With Amgen, Eli Lilly and Abbott Laboratories investing $4 billion in the island over the past seven years, Puerto Rico rapidly became the world’s third largest biotech manufacturer, earning it the nickname “Bio Island.” Puerto Rico also has one of the largest concentrations of pharmaceutical manufacturing operations in the world and produces 13 of the top 20 blockbuster drugs sold in the United States.

Most recently, Pioneer Hi-Bred announced a new state-of-the-art research and development facility in Salinas on the southern coast of Puerto Rico to complement its existing trial seed production facility. The $6 million facility is expected to employ 100 scientists, agronomists and others.

“Puerto Rico was a smart choice for many reasons,” said John Soper, Pioneer Vice President of Crop Genetics Research and Development. He noted that the island has the same regulatory framework as the mainland United States, a longer growing season suitable for planting crops year-round and a steady stream of quality talent coming out of the University of Puerto Rico.

Pioneer also worked closely with the Puerto Rico Industrial Development Company (PRIDCO), a governmental economic development agency, to take advantage of aggressive new economic incentives.

“The new Pioneer laboratory is exactly the kind of investment the Government of Puerto Rico has been working to foster to help move our island into R&D and other aspects of an innovation economy,” said PRIDCO’s Executive Director Javier Vázquez Morales.

Kentucky-based Blu Pharmaceuticals also opened a new generic drug manufacturing facility in Dorado in March. The company is expected to invest $60 million in the facility during the next three years and employ nearly 250 people as it manufactures seven different medicines it will supply to the U.S. government.

“The stars aligned for us in Puerto Rico,” said Bill Luster, President of Blu Pharmaceuticals. “We were able to acquire a state-of-the-art manufacturing facility for pennies on the dollar of what it would have cost for us to build an operation from the ground-up, plus we were able to tap into a highly talented workforce.”

For more information, visit www.pridco.com.

For free broadcast quality downloads of b-roll and other videos and additional press materials, visit newsinfusion.com.

Contact:
Sandy Gutierrez
Chief Officer, Marketing and Communications
Puerto Rico Industrial Development Company
Cell: 787-438-1388
[email protected]

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Carilion Clinic Announces SampleMD as New Patient Sample & Support System

Posted on July 7, 2010 Written by Editor

SOURCE: OPTIMIZERx Corp

ROCHESTER, MI–(Marketwire – July 7, 2010) – OPTIMIZERx Corporation (OTCBB: OPRX) announced today that it has signed an agreement with Carilion Clinic to implement its SampleMD™ solution to allow its doctors and staff a more efficient way to search, select and distribute sample vouchers, prescription co-pay coupons and other support information right from their desktops.

Carilion Clinic is a healthcare organization with more than 600 physicians in a multi-specialty group practice and eight not-for-profit hospitals that specializes in patient-centered care, medical education and clinical research, with a goal of providing the best possible health outcome and healthcare experience for each patient.

“Our providers are very sensitive to the costs involved when prescribing brand name medications. The SampleMD platform allows our practitioners a better way to provide sample vouchers to make sure they can tolerate any new medications prescribed or co-pay coupons to help them continue to stay on their medication,” said Howard B. Graman, MD, Carilion Clinic Chair, Primary Care and Regional Medicine.

“We are excited to launch this important initiative with Carilion Clinic to provide an integrated electronic platform that reduces workflow interruption while providing more support to more patients,” said David Harrell, Chairman and Founder of SampleMD. “It is right in line with the Carilion Clinic’s mission to provide the highest quality health care for the individuals, families, and communities they serve.”

For more information on SampleMD, go to www.samplemd.com.

About OPTIMIZERx Corporation

OPTIMIZERx provides unique platforms to help patients better afford and comply to their medicines and healthcare products, while offering pharmaceutical and healthcare companies effective ways to expand patient access and adherence to their products.

About Carilion Clinic

Carilion Clinic is a multi-specialty healthcare organization with more than 600 doctors and eight hospitals, based in Roanoke, Va. Led by physicians, Carilion Clinic is committed to clinical excellence, education and research. Carilion Clinic is dedicated to providing care that is centered on the patient’s needs, supported by an ongoing commitment to quality and service. With nationally recognized specialists, award-winning nurses, the latest technology and state-of-the-art facilities, Carilion Clinic is bringing tomorrow’s healthcare into focus today. For more information, please visit www.CarilionClinic.org.

‘SAFE HARBOR’

This press release contains forward-looking statements within the definition of Section 27A of the Securities Act of 1933, as amended and such section 21E of the Securities Act of 1934, amended. These forward-looking statements should not be used to make an investment decision. The words ‘estimate,’ ‘possible’ and ‘seeking’ and similar expressions identify forward-looking statements, which speak only as to the date the statement was made. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted, or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

Contact:
David Lester
248-651-6568

Statement From the American Academy of Ophthalmology Regarding the Circle Lenses

Posted on July 7, 2010 Written by Editor

SOURCE: American Academy of Ophthalmology

SAN FRANCISCO, CA–(Marketwire – July 6, 2010) – New decorative contact lenses called circle lenses are an emerging and potentially dangerous trend among teenagers and young adults. In response to this, the American Academy of Ophthalmology (Academy) would like to alert consumers to the hazards of buying any decorative lenses, including circle lenses, without a prescription. Any type of contact lens is a medical device that requires a prescription, proper fitting by an eye care professional and a commitment to proper care by the consumer.

Inflammation and pain can occur from improperly fitted, over-the-counter lenses and lead to more serious problems including corneal abrasions and blinding infections.

Although over-the-counter sales of nonprescription “plano” cosmetic lenses have been illegal in the United States since 2005, they are still widely available without prescription in retail stores and on the Internet. In 2005, an Academy-backed federal law classified all contact lenses as medical devices and restricted their distribution to licensed eye care professionals.

To protect your eyes, all contact lenses must be fitted by an eye care professional. If you have any pain, burning, redness, tearing or sensitivity to light while wearing any type of contact lenses, see your ophthalmologist, an Eye M.D. For more information about contact lenses, go to www.geteyesmart.org.

Media: Spokespeople are available to comment.

About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons — Eye M.D.s — with more than 29,000 members worldwide. Eye health care is provided by the three “O’s” — opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy’s Web site at www.aao.org.

Contact:
Media Relations
(415) 561-8534
[email protected]

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American Diabetes Association Statement on Blood Glucose Lowering Drugs

Posted on June 30, 2010 Written by Editor

SOURCE: American Diabetes Association

ALEXANDRIA, VA–(Marketwire – June 30, 2010) – The American Diabetes Association does not have official position favoring or recommending against specific drugs that are approved by the FDA to lower glucose. The 2009 consensus statement on medical management of hyperglycemia in type 2 diabetes does not reflect official position of the ADA but rather the expert opinion of the authors of the paper.

Recently, additional information regarding the cardiovascular safety of rosiglitazone was reported, with some analyses suggesting a possible increase in risk and others supporting the drug’s safety. This information as well as past reports of a potential increase in the risk of CVD is being reviewed by the FDA. The Association’s staff and volunteer leadership are also reviewing the information in the public domain and await further information from the FDA. Until further information is provided, patients and health care professionals should continue to recognize that multiple classes of drugs, often with more than one agent per class, are available to maintain glucose control in type 2 diabetes.

The decision whether or not to use any medication must remain that of the treating physician in direct discussion with their patients. As additional information becomes available, the Association will provide detailed updates for both health care professionals and patients with diabetes. Patients should continue taking all currently prescribed medications unless otherwise informed by their health care team.

The American Diabetes Association is leading the fight against the deadly consequences of diabetes 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.

Contact:
Colleen Fogarty
703-549-1500, ext. 2146

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CNS Response to Receive Fourth U.S. Patent

Posted on June 30, 2010 Written by Editor

SOURCE: CNS Response

Patented Methodology for Determining Drug Effects Using Quantitative EEG

ALISO VIEJO, CA–(Marketwire – June 30, 2010) – CNS Response, Inc. (OTCBB: CNSO) today announced that the U.S. Patent and Trademark Office has allowed patent number 77,54,190, Method for Determining Drug Effects Using Quantitative EEG, which extends application of the Company’s Referenced-EEG^® technology platform to improve the performance and efficacy of clinical trials conducted by pharmaceutical companies. The patent will be published July 13, 2010.

“As the costs of discovering and testing new drugs have soared, particularly those in the central nervous system (CNS) class, Referenced-EEG presents new opportunities for the pharmaceutical industry,” said CNS Response CEO George Carpenter. “Our patented methodology can assist pharmaceutical companies in drug discovery, program evaluation, and clinical trial design.”

The contribution of Referenced-EEG has been successfully demonstrated in numerous clinical studies, including the multi-site Depression Efficacy Study completed in 2009. CNS Response submitted a 510(k) for review by the FDA in April 2010.

Referenced-EEG was developed by physicians to provide objective, statistical data on patient neurophysiology. In clinical trials, physicians using Referenced-EEG data have consistently achieved superior clinical results compared to physicians using trial and error pharmacotherapy.

To read more about this patented technology, please visit the CNS Response website, www.cnsresponse.com.

Investor and Media Relations:
Marty Tullio, Managing Partner
McCloud Communications, LLC
949.553.9748
Email Contact

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AXcess News: Neostem Cleared for China Manufacturing, Stock Upgraded

Posted on June 29, 2010 Written by Editor

SOURCE: AXcess News

NEW YORK, NY–(Marketwire – June 29, 2010) – Neostem (NYSE Amex: NBS) was cleared for manufacturing penicillin and cephalosporin powder for injection at its new manufacturing facility by China’s State Food and Drug Administration. The news helped convince WBB Securities to upgrade the company from ‘sell’ to ‘hold’.

WBB Securities initially extended coverage on Neostem on June 3, 2010 with a ‘sell’ recommendation, however, it should be noted that the investment banking firm began touting four other stem cell companies in late April. The fact that Neostem raised $5 million in cash through a placement in late June had no bearing on the investment banker’s outlook, however, after the Chinese State Food and Drug Administration cleared the way to begin selling drugs manufactured at Neostem’s new, state-of-the-art facility in China, WBB Securities analysts had second thoughts and upgraded the company’s shares.

Neostem announced Tuesday morning that two of its manufacturing lines were up and running at its China pharmaceutical manufacturing unit which would increase production capacity by more than 50%. With that country’s State FDA giving the green light to manufacture penicillin and cephalosporin powder for injection, sales forecasts are expected to show substantial gains.

Based on sales results for 2009 and the new manufacturing plant’s increased capacity, sales could increase by more than $20 million.

Neostem founder and CEO, Dr. Robin Smith, noted that Eyre was one step closer to becoming “one of the largest antibiotic producers in Eastern China.”

Note to Editors: “News Features” are stories provided to publishers copyright-free for print or online display at no charge. All we ask is that publishers include our byline (AXcess News) as the source, or if online, link to our Web Site: http://www.axcessnews.com. If you are interested in displaying our news on a regular basis, please contact our editorial department at: 775-461-0362 or by email at: [email protected].

Contact:
AXcess News
Email Contact
775-461-0362

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HHS Secretary Sebelius to Join Leaders From NIH, FDA and Academia to Discuss New Roles in Drug Discovery and Development

Posted on June 29, 2010 Written by Editor

SOURCE: Ewing Marion Kauffman Foundation

KANSAS CITY, MO–(Marketwire – June 29, 2010) – U.S. Secretary of Health and Human Services Kathleen Sebelius and other national leaders are coming together on July 6, 2010 for a first-of-its-kind town hall-style meeting with the goal of accelerating the discovery and development of new cancer drugs.

The event will bring together other senior government officials and thought leaders from industry, venture capital, academia, venture philanthropy and non-profit sectors to spur innovation and move discoveries more quickly from the laboratory to the clinic, where they can benefit patients battling cancer. Francis Collins, director of the National Institutes of Health, Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, and Richard Gephardt, former U.S. House Majority Leader and Chairman of the Council for American Medical Innovation, are among those who will participate.

Reflecting the growing shift away from the model of large pharmaceutical companies developing drugs internally from start to finish, the town hall is titled, “The New Role of Academia in Drug Discovery and Development.” It is being sponsored by Friends of Cancer Research and the University of Kansas Cancer Center, with support from the Kansas Bioscience Authority, Ewing Marion Kauffman Foundation and Council for American Medical Innovation.

Where: The Kauffman Foundation Conference Center, 4801 Rockhill Road, Kansas City, Mo., 64110

When: July 6, 2010, 7:45 a.m. – 3:45 p.m. CDT

Many key participants and organizational leadership will be available for press prior to the conference.

Press Contacts:
Friends of Cancer Research: Ryan Hohman, [email protected] or 717-333-6248

The University of Kansas Cancer Center: Marci Nielsen, [email protected], 913-961-0759 or Stephanie Sharp, [email protected], 913-579-4376

Kansas Bioscience Authority: Chad Bettes, [email protected] or 913-397-8300

Kauffman Foundation: Barb Pruitt, [email protected] or 816-932-1288

Council for American Medical Innovation: Sean Donahue, [email protected] or 202-347-7947

About Friends of Cancer Research

Friends of Cancer Research (Friends) is a cancer research think tank based in the Washington, D.C. area. Working with the entire cancer research and advocacy community, Friends pioneers innovative public-private partnerships, organizes critical policy forums, educates the public, and brings together key stakeholders to overcome the barriers standing between patients and the most promising cancer treatments.

About The University of Kansas Cancer Center

At The University of Kansas Cancer Center, we are more than an academic cancer center; we are a unique community-based cancer research and care partnership focused on one mission: eliminating the burden of cancer. The University of Kansas Cancer Center is transforming cancer research and clinical care by linking our innovative approach to drug discovery, delivery and development to our nationally accredited patient care program.

About the Ewing Marion Kauffman Foundation

The Ewing Marion Kauffman Foundation is a private nonpartisan foundation that works to harness the power of entrepreneurship and innovation to grow economies and improve human welfare.

About the Council for American Medical Innovation

The United States faces serious challenges to maintaining its leadership position in innovation. The Council for American Medical Innovation is bringing together leaders in research, medicine, public health, academia, education, labor, investment, and business, who are working in partnership toward a national policy agenda aimed at preserving U.S. leadership in medical innovation. American medical innovators create millions of high-paying jobs, and their discoveries are integral in the fight to cure cancer and other illnesses. The Council for American Medical Innovation views leadership in medical innovation as a key part of America’s economic recovery, future prosperity and health.

About the Kansas Bioscience Authority

The KBA is a $581 million initiative that is advancing Kansas’ national bioscience leadership by building world-class research capacity; fostering the formation and growth of bioscience startups; supporting expansion of the state’s bioscience clusters; and facilitating industrial expansion and attraction.

Press Contacts:
Friends of Cancer Research:
Ryan Hohman
[email protected]
717-333-6248

The University of Kansas Cancer Center:
Marci Nielse
[email protected]
913-961-0759

Stephanie Sharp
[email protected]
913-579-4376

Kansas Bioscience Authority:
Chad Bettes
[email protected]
913-397-8300

Kauffman Foundation:
Barb Pruitt
[email protected]
816-932-1288

Council for American Medical Innovation:
Sean Donahue
[email protected]
202-347-7947

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Fake Prescriptions Still an Issue; Corey Haim Death Highlights Problem

Posted on March 13, 2010 Written by Editor

With the recent untimely death of actor Cory Haim this week, the public is learning about an industry-wide problem that continues to plague the health insurance industry, fake prescriptions.

Corey Ian Haim (December 23, 1971 – March 10, 2010) was a Canadian actor, best for his 1980s Hollywood career as a teen idol. Mr. Haim starred or co-starred in a number of movies like Lucas, Murphy’s Romance, The Lost Boys, License to Drive, and Dream a Little Dream. Corey Haim appeard many times alongside his friend Corey Feldman. The two later starred in the hit A&E reality television show called The Two Coreys.

Corey Haim died an untimely death on March 10, 2010.

According to the Examiner, “A state investigation turned up an unauthorized prescription in Corey Haim’s name. According to People.com, the illegal prescription was noticed when investigators ordered drug pads from a San Diego vendor. The prescriptions were filled out by using the stolen identity of doctors. Authorities have described this prescription drug ring as “massive”.

California Attorney General Jerry Brown said that the illegal prescription made out to Corey Haim was for the pain killer OxyContin. The prescription was located through the California computer database that tracks all prescriptions that are filled in the state.”

The Associated Press is also reporting that “California Attorney General Jerry Brown said records of the prescription in the name of the former teen heartthrob were found during an investigation of the ring that illegally obtained prescription pads and used the stolen identities of doctors to fill them out.”

The public is learning of the problem of fake drug prescriptions because of this celebrity’s untimely death and the fact that one of the prescriptions that was part of illegally obtained prescription pads and the stolen identities of physicians. There continues to be calls for changes in the way prescriptions are written that will make it more difficult for fake prescriptions to be obtained by the public.

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TriCipher myOneLogin SignatureBook Offers Digital Signatures On-Demand

Posted on February 28, 2010 Written by Editor

TriCipher, a leading provider of Internet identity services, today announced a hosted, on-demand version of its powerful digital signature solution. myOneLogin SignatureBook is an on-demand service that accelerates and streamlines business processes requiring non-repudiable signatures across different groups, organizations or geographic locations. It supports a number of different online credentials, including a clientless credential and the SAFE-BioPharma digital signature widely adopted in healthcare and pharmaceutical industries.

“The SAFE-BioPharma® signature standard provides a high level of trust assurance for digital identities, and is instrumental to speeding processes and reducing costs in the healthcare and pharmaceutical industries,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association. “The Tricipher myOneLogin SignatureBook service offers SAFE-BioPharma members a means of improving business process and simplifying the signing process. This service will be especially attractive to the growing body of smaller companies which have joined SAFE-BioPharma as a step toward improving their workflows and converting to paperless operations.”

myOneLogin SignatureBook collects digital signatures on an electronic document, automatically applying signature policies and streamlining processes of collecting and validating signatures. It creates an original, signed version of a final document as well as a flattened PDF without active signature blocks, suitable for distribution. As an on-demand service, myOneLogin SignatureBook is easy to deploy, and is particularly useful for organizations with many business processes requiring signatures by multiple parties. The service offers several different signature methods, including a TriCipher clientless credential and with credentials compliant with the SAFEBioPharma digital signature standard. myOneLogin SignatureBook is the in-the-cloud, hosted version of the on-premise TriCipher mySignatureBook digital signing solution.

“Digital signatures are a natural extension of the Internet identity services that we provide at TriCipher, making it easier and more secure to do business on the web,” said John De Santis, chairman and CEO at TriCipher. “The on-premise TriCipher mySignatureBook solution is already adopted in large pharmaceutical organizations. By offering these capabilities as an on-demand service, we deliver on the promise of digital signatures for a wider range of businesses.”

For more information, please visit www.myOneLogin.com.

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FDA Extends Marketing Exclusivity for LEVAQUIN

Posted on March 14, 2007 Written by Editor

The U.S. Food and Drug Administration (FDA) has granted LEVAQUIN(R) (levofloxacin) an additional six months of marketing exclusivity, known as “pediatric exclusivity.” The action attaches to the U.S. patent covering LEVAQUIN, extending exclusivity from December 2010 to June 2011. This decision was based on five, company-sponsored pediatric studies conducted at the request of the FDA.

The studies included trials to determine the pharmacokinetic profile and the efficacy and safety of LEVAQUIN in children with community-acquired pneumonia (CAP) and recurrent and/or persistent acute otitis media. The studies were conducted in close collaboration with leaders in the pediatric and infectious disease communities and in consultation with the FDA. LEVAQUIN is not indicated for use in children and adolescents (under 18 years of age).

Since its U.S. introduction in 1996, LEVAQUIN has gained widespread use in the treatment of adults for a variety of bacterial infections caused by specific pathogens(1), including: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections (mild to moderate), chronic bacterial prostatitis, complicated and uncomplicated urinary tract infections (mild to moderate) and acute pyelonephritis (mild to moderate).

LEVAQUIN is available in 250 mg, 500 mg and 750 mg doses in both oral and I.V. formulations. The safety profile of LEVAQUIN is similar across doses. LEVAQUIN is marketed to healthcare providers by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil, Inc.

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Access Pharmaceuticals to Acquire Somanta Pharmaceuticals

Posted on February 21, 2007 Written by Editor

Access Pharmaceuticals, Inc. (BULLETIN BOARD: ACCP) and Somanta Pharmaceuticals, Inc. (BULLETIN BOARD: SMPM) have signed a letter of intent for Access to acquire Somanta. Somanta is an Irvine, California based biotechnology company with four novel anti-cancer compounds in development, one of which is currently in Phase 2 clinical trials.

Each of Somanta’s drug candidates acts by a unique mechanism of action, and has the potential to target a wide range of different cancer types. In addition to its significant product pipeline, Somanta brings an experienced team of clinical development and regulatory professionals who have an established track record of guiding compounds through the FDA and EMEA approval processes.

Upon consummation of the acquisition, Somanta’s preferred and common shareholders will receive an aggregate of 1.5 million shares of Access common shares which would represent approximately 13% of the combined company assuming the conversion of Access’ existing convertible debt under existing terms of conversion. The letter of intent is non-binding. The acquisition is expected to close in the second quarter.

“The proposed acquisition of Somanta is very exciting for Access from a number of perspectives,” stated Stephen R. Seiler, Access’ President and CEO. “Somanta comes with four very interesting anti-cancer compounds, one of which is already in Phase 2 clinical trials. Each compound acts by a novel mode of action, and one represents a novel platform technology. As a result, the combined Access and Somanta will have a broad cancer-focused portfolio which will include one approved product, two drug candidates in Phase 2 trials and three novel and exciting pre-clinical products. Our goal has always been to make Access a leader in the oncology space and this acquisition fills out our product pipeline extremely well.”

“In addition, the Somanta clinical development team fits well with our current management group,” continued Mr. Seiler. “I look forward to leveraging their expertise to assist in accelerating and broadening the clinical program for Access’ ProLindac which is in Phase 2 trials in the EU and in the U.S. as well as on our oral insulin program.”

“The proposed combination of Somanta with Access is highly synergistic,” added Agamemnon Epenetos, M.D., Ph.D., Somanta’s CEO. “Each company is at a position where the combination makes strategic sense, and the product pipelines and management teams come together very well, with little overlap. I believe the combined product and technology pipeline is extremely exciting, and I look forward to working closely with the Access team to advance both companies’ products through the development and regulatory process.”

About Somanta
Somanta Pharmaceuticals is a company focused on the development of novel oncology compounds and anti-cancer agents. Somanta’s lead clinical product Sodium Phenylbutyrate (PB) is currently in Phase 2 development. In National Institute of Health sponsored trials, PB has demonstrated the greatest activity in CNS cancers, several of which are “orphan” indications such as Glioblastoma Multiforme. Moreover, promising data has also emerged which suggests PB may be an effective therapy for certain blood cancers and other solid tumors. PB has been well tolerated; its safety profile has generally been established due to its many years of clinical use in pediatrics for inherited urea cycle disorders.

Somanta’s other drug candidates include Alchemix, Prodrax and Angiolix. Alchemix is pan-target inhibitor that is effective in tumor cells resistant to conventional chemotherapy by targeting and irreversibly binding to DNA. Prodrax, a technology platform, is a novel family of prodrugs that enables compounds to remain inert until they reach the hypoxic region of tumors where they become toxic, thus targeting tumor cells which are typically difficult to kill. Somanta believes Alchemix and Prodrax have the ability to overcome many different pathways of drug resistance, and will be studied in a broad range of cancers including lung, colon, ovarian and renal. Proof-of-principle pre- clinical studies have been completed in both of these compounds, and Phase 1 dose escalation trials are being planned. Additionally, Somanta is developing a humanized monoclonal antibody, Angiolix, which appears to induce cell death selectively to tumor blood vessels using a different mode of action than VEGF- oriented therapies. Somanta has prepared clinical development plans for all preclinical projects. For additional information on Somanta Pharmaceuticals, please visit http://www.somanta.com/ .

About Access
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access’ products include ProLindac(TM), currently in Phase II clinical testing of patients with ovarian cancer and MuGard(TM) for the management of patients with mucositis. The Company also has other advanced drug delivery technologies including Cobalamin(TM)-mediated targeted delivery and oral drug delivery. For additional information on Access Pharmaceuticals, please visit our website at http://www.accesspharma.com/ .

About ProLindac(TM)
Access’ lead compound, ProLindac(TM), is a novel DACH platinum prodrug which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials. The Company believes that ProLindac’s unique molecular design potentially could eliminate some of the toxic neurological side effects seen in currently marketed DACH platinums. The Company is currently enrolling patients in two Phase II clinical trials, one in ovarian cancer and one in head and neck cancer, and plans to initiate one or more additional Phase II trials, including one in colorectal cancer in 2007.

About MuGard(TM)
Access has received 510(k) clearance from the FDA to market MuGard(TM) in the United States. MuGard(TM) is Access’ proprietary oral rinse product for the management of oral mucositis, the debilitating side-effect which afflicts more than 40% of cancer patients undergoing radiation and chemotherapy. There is currently no well-accepted treatment for mucositis. Access is actively seeking marketing partners in Europe and the US.

About Cobalamin(TM)
The Company is actively pursuing development of its novel Cobalamin(TM) drug delivery technology, particularly as it pertains to the oral delivery of large molecule drugs that are only currently deliverable by injection or subcutaneous administration. Pre-clinical animal studies utilizing Access’ Cobalamin(TM) technology have demonstrated the ability to deliver insulin by oral administration in therapeutic levels.

The conclusion of the acquisition of Somanta by Access as anticipated in the Letter of Intent is subject to a number of conditions, including, without limitation negotiation of a definitive acquisition agreement which will contain standard and customary provisions, completion of due diligence to the full satisfaction of each party, approval by the respective Boards of Directors and by Somanta shareholders, completion of all government filings and receipt of all necessary government approvals and all required third party consents.

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New Rogaine Foam Features VersaFoam

Posted on September 5, 2006 Written by Editor

Connetics Corporation (Nasdaq:CNCT), a specialty pharmaceutical company that develops and commercializes dermatology products, today announces the use of its proprietary VersaFoam(R) technology in Pfizer Consumer Healthcare’s new Men’s Rogaine(R) Foam, now available wherever Rogaine is sold. In January 2006, Pfizer received FDA approval for Men’s Rogaine(R) Foam (minoxidil, 5%) developed under a license from Connetics’ VersaFoam technology.

“Rogaine is the most popular topical treatment for hair loss. A Rogaine formulation utilizing Connetics’ VersaFoam technology offers patients suffering from hair loss a convenient therapy that absorbs rapidly upon contact with the scalp leaving minimal residue,” said Thomas G. Wiggans, Chief Executive Officer of Connetics. “Connetics’ innovative skin delivery vehicles have created strong customer acceptance and leading brands in the prescription topical steroid and antibiotic markets. We believe the elegance of our VersaFoam delivery system also holds potential to increase patient compliance and to expand the current market for Rogaine.”

“We are very happy to be partnering with Connetics, a leader in foam technology, to provide this novel formulation for the hair loss patient,” says Dr. Bruce Kohut, Senior Director of Dermatology at Pfizer Consumer Healthcare. “We expect that patients will find the new Rogaine Foam easy to use and an enjoyable experience.”

About VersaFoam Technology
As a leader in novel topical delivery systems, Connetics owns worldwide rights to a number of unique topical delivery systems and has branded its proprietary foam drug delivery vehicle, VersaFoam. This unique, versatile topical drug delivery vehicle quickly absorbs into the skin when applied and has versatility for application on multiple body sites. The formulation is thermolabile, which melts at skin temperature and evaporates quickly. In addition, it is easy to apply, non-dripping, stain-free and leaves minimal to no residue. It is also preservative-free. The VersaFoam system has important cosmetic and functional benefits compared with conventional delivery vehicles including creams, ointments, gels and lotions. Connetics’ VersaFoam-based products are OLUX(R) for scalp dermatoses and non-scalp psoriasis, Luxiq(R) Foam for scalp dermatoses and Evoclin(R) Foam for the treatment of acne. These formulations have earned wide acceptance by physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information on VersaFoam, please visit www.VersaFoam.com.

About Connetics
Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. Connetics’ innovative approach to product development includes the exploration of new ways to optimize drug delivery at targeted treatment sites on the skin, and the assessment of novel formulation and delivery technologies. The Company’s marketed products are OLUX (clobetasol propionate) Foam, 0.05%; Luxiq (betamethasone valerate) Foam, 0.12%; Soriatane(R) (acitretin) capsules; and Evoclin (clindamycin) Foam, 1%. Connetics is developing Desilux(TM) (desonide) Foam, 0.05%, a low-potency topical steroid formulated to treat atopic dermatitis; Primolux(TM) (clobetasol propionate) Foam, 0.05%, a super high-potency topical steroid formulation to treat atopic dermatitis and plaque psoriasis; Extina(R) (ketoconazole) Foam, 2%, to treat seborrheic dermatitis; and Velac(R) (a combination of 1% clindamycin and 0.025% tretinoin) Gel, to treat acne. Connetics’ product formulations are designed to improve the management of dermatological diseases and provide significant product differentiation. For more information about Connetics and its products, please visit www.connetics.com.

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