Industry News and Innnovations

JDRF Praises President for Executive Order Lifting Restrictions on Stem Cell Research
The Juvenile Diabetes Research Foundation (JDRF) praised President Barack Obama for the Executive Order officially repealing the existing policy limiting federal research funding for embryonic stem cell research to cell lines established prior to August 9, 2001.

"We're very grateful to President Obama for setting in place a policy to fully explore this promising field of science," said new JDRF President and CEO, Alan J. Lewis, PhD. "President Obama's Executive Order is a strong signal to patients, scientists, and the nation that we have his full support to pursue science that may accelerate progress to new treatments and possible cures for diabetes."

Type 1 diabetes affects as many as 3 million people in the United States, causing the immune system to attack insulin-producing cells in the pancreas so that the body no longer uses sugar to create energy. There is no cure for type 1 diabetes. Research into human embryonic stem cells could speed the development of a cure for diabetes by helping researchers better understand how the disease occurs and eventually derive insulin-producing cells that are safe to use for transplantation. These discoveries are years away, but federal guidance and funding from the National Institutes of Health (NIH) will help speed scientific progress.

"This is an exciting day for children and adults living with type 1 diabetes, their families, and everyone with a connection to diabetes who have worked for years to remove restrictions to this research," said Dr. Lewis. "Now researchers, physicians, and ethicists at NIH can make decisions on ethical research based purely on sound science."

For more information, please visit www.jdrf.org.

Takeda Receives New Information on Alogliptin (SYR-322) NDA
Takeda Pharmaceutical Company Limited announced that Takeda Global Research and Development Center, Inc., a wholly-owned US subsidiary, was informed as part of regular discussions about the alogliptin new drug application (NDA) with the US Food and Drug Administration (FDA), that although the alogliptin NDA was filed prior to issuance of the FDA's December 2008 guidance on new type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.

Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance, according to the Takeda news release. The agency is open to discussions regarding the design of additional cardiovascular studies with alogliptin. Alogliptin's Prescription Drug User Fee date—June 26, 2009—remains unchanged. For more information, please visit www.takeda.com.

FDA Accepts Complete Submission to NDA for Nebido
Endo Pharmaceuticals and its majority-owned subsidiary Indevus Pharmaceuticals, Inc. announced that the FDA has accepted for review the complete response submission to the NDA for Nebido (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. The FDA is targeting September 2, 2009, as the action date for a decision on this application.

Nebido is a novel, long-acting injectable testosterone preparation for the treatment of male hypogonadism, according to a company news release. The agent was licensed by BayerSchering Pharma AG to Indevus Pharmaceuticals, a majority interest in which Endo Pharmaceuticals acquired earlier this year. If approved, Nebido is expected to be the first long-acting testosterone preparation available in the United States in the growing market for testosterone replacement therapies. Nebido is currently marketed by BayerSchering and its partners in Europe and other territories.

Thumbs Down For New Testosterone Patch To Boost Women's Sex Drive
A new testosterone patch, designed to increase a woman's diminshing sex drive after uterus and ovary removal, may not work, and its long-term safety is not proven, according to the Drug and Therapeutics Bulletin (DTB).

Intrinsa (Proctor & Gamble) was recently licensed in the United Kingdom for the treatment of women who have gone through the menopause as a result of uterus and ovary removal and are subsequently experiencing a drop in sex drive. The condition is referred to as hypoactive sexual desire disorder (HSDD). There is some evidence to suggest that a fall in sex drive after the menopause might be linked to low levels of circulating testosterone.

Intrinsa is prescribed for women with HSDD who are receiving estrogen-replacement therapy. It delivers a daily dose of testosterone from a patch replaced twice weekly and worn continuously on the lower abdomen. The key trials on testosterone patches have involved highly selective groups of women—excluding, for example, those with various mental or physical conditions that could affect sex drive, according to DTB. In some trials, a diagnosis of HSDD was made on the basis of short, unvalidated questionnaires.

There was also a large placebo response in the studies, with significant numbers of women not treated with the patch reporting improved sex drive, which indicates that low hormone levels might not have been the problem, according to DTB.

Furthermore, the improvements were small. And the fact that some of the women were already having sex twice or three times a month before they entered the trials raises questions about whether they really had a poor sex drive in the first place. The two key trials reported side-effect rates of around 75%, mostly attributable to skin reactions at the sites where the patches had been applied. Other common unwanted side effects, occurring in up to one in 10 women, were acne, hirsutism, alopecia, breast pain, weight gain, insomnia, voice deepening, and migraine. Some of these may persist.

As the trials for Intrinsa lasted a maximum of 6 months, the long -term safety of the patch is not clear, according to DTB. For more information, please visit dtb.bmj.com.

Merck and Schering-Plough to Merge
Merck & Co., Inc. and Schering-Plough Corporation announced that their Boards of Directors have unanimously approved a definitive merger agreement under which Merck and Schering-Plough will combine, under the name Merck, in a stock and cash transaction. Under the terms of the agreement, Schering-Plough shareholders will receive 0.5767 shares and $10.50 in cash for each share of Schering-Plough, according to the company news release. Each Merck share will automatically become a share of the combined company. Merck Chairman, President and CEO Richard T. Clark will lead the combined company.

Based on the closing price of Merck stock on March 6, 2009, the consideration to be received by Schering-Plough shareholders is valued at $23.61 per share, or $41.1 billion in the aggregate. This price represents a premium to Schering-Plough shareholders of approximately 34% based on the closing price of Schering-Plough stock on March 6, 2009. The consideration also represents a premium of approximately 44% based on the average closing price of the two stocks over the last 30 trading days.

Upon closing of the transaction, Merck shareholders are expected to own approximately 68% of the combined company, and Schering-Plough shareholders are expected to own approximately 32%. Merck anticipates that the transaction will be modestly accretive to non-GAAP EPS1 in the first full year following completion and significantly accretive thereafter.

Gilead Agrees to Acquire CV Therapeutics
Gilead Sciences, Inc. and CV Therapeutics, Inc. announced the signing of a definitive agreement pursuant to which Gilead will acquire CV Therapeutics for $20.00 per share in cash through a tender offer and second step merger. CV Therapeutics' Board of Directors has unanimously approved the transaction and has agreed to recommend to its stockholders that they tender their shares pursuant to the tender offer, according to a news release from the companies. CV Therapeutics will become a wholly-owned subsidiary of Gilead. The transaction is valued at approximately $1.4 billion and is expected to be dilutive to Gilead's earnings in 2009, neutral to accretive in 2010, and accretive in 2011 and beyond.

CV Therapeutics focuses on the development of small molecule drugs for the treatment of cardiovascular diseases. In 2008, its two marketed products, Ranexa (ranolazine extended-release tablets), indicated for the treatment of chronic angina, and Lexiscan (regadenoson) injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress, contributed to total revenues of $154.5 million. CV Therapeutics' pipeline includes multiple product candidates currently being evaluated for the treatment of atrial fibrillation, pulmonary diseases and diabetes.

For more information on Gilead Sciences, please visit the company's Web site at www.gilead.com.

Roche to Acquire Outstanding Shares of Genentech
Roche and Genentech announced that they signed a merger agreement under which Roche will acquire the outstanding publicly held interest in Genentech for $95.00 per share in cash, or a total payment of approximately $46.8 billion to equity holders of Genentech other than Roche.

Arthur D. Levinson, PhD, chairman and chief executive of Genentech, said: "We have had a highly successful partnership with Roche for more than 18 years, and we intend to pursue our shared goal of discovering medications for serious and life-threatening conditions. We look forward to working with our partners at Roche to ensure a smooth transition once the transaction is complete and to continue our mission of serving patients." For more information, please visit www.roche.com.