The Burrill Report


Shares of Transcept Pharmaceuticals tumbled more than 40 percent after the U.S. Food and Drug Administration notified the company it would not approve Intermezzo, its experimental insomnia drug because of safety concerns. The drug, a low-dose form of zolpidem, is intended for people who have trouble going back to sleep after they wake in the middle of the night. It is the second time that the FDA has declined approving the drug without further data. In October 2009, the agency told the company that it needed an additional study to show that Intermezzo would not unacceptably impair driving in the morning following its use. The agency is not concerned about the efficacy of the drug, but wants to see additional data showing that it does not provide an unacceptable level of impairment the day after its use for patient subpopulations. Some demographic groups had higher blood levels of the drug the day following its use, but the company says it did not correlate with an increase in residual effects. Transcept, which is developing the drug with Purdue Pharmaceutical Products, said it will meet with the FDA to discuss potential paths forward.

Shares of Medicis Pharmaceuticals fell following reports that the girlfriend of the company’s CEO Jonah Shacknai was found dead at the executive’s beachside mansion in Coranado, California, Bloomberg reported. Rebecca Nalepa, 32, was found naked, with her hands and feet bound. Shacknai’s brother Adam, who was visiting his brother, told the Sheriff’s Department he discovered her hanging over a balcony and cut her down, officials said in a press briefing. The sheriff’s department hasn’t ruled the death a homicide, but is investigating the matter. Jonah Shacknai was not at the home when his brother found the body.

The National Institute for Health and Clinical Excellence, the United Kingdom’s healthcare advisory body that rules on what drugs can be paid for through the National Health Service, said the eye drug Lucentis is not an effective treatment for diabetic macular edema, a cause of blindness in diabetic patients. It said Lucentis was less cost-effective than laser therapy to seal ocular blood vessels. Novartis markets Lucentis in the United Kingdom. NICE already recommends Lucentis for wet age-related macular degeneration. The health authority has not yet issued final guidance to the NHS and Novartis has as opportunity to appeal its draft decision.

The U.S. Food and Drug Administration said dapagliflozin, a first-in-class experimental diabetes drug being developed by Bristol-Myers Squibb and AstraZeneca, lowered blood sugar levels, but had unexpected safety issues, Dow Jones reported. An FDA advisory panel is scheduled to review the drug next week. The agency said safety issues include an imbalance in breast and bladder cancer as well as a possible case of liver injury that might be related to use of the drug. The agency also wants the panel to look at reduced efficacy of the drug in patients with kidney impairment. The drug has not been associated with excess cardiovascular risk associated with some other diabetes drugs such as Avandia.

Oral Cancer Prevention International is seeking at least $90 million in a suit against Johnson & Johnson over allegations the drug giant interfered with a sales agreement for its oral cancer prevention product to protect sales of its mouthwash Listerine, Reuters reported. At issue is a 2010 contract between Oral Cancer Prevention and the former J&J unit OraPharma, which distributed Oral Cancer’s diagnostic to detect precancerous cells in the mouth. The company charges J&J was worried about an Australian study that linked the use of mouthwashes with high alcohol to cancer and that J&J did not want to “lend credence to the link between Listerine and oral cancer” by selling both its mouthwash and OralCDx. A J&J spokesman told Reuters the company engaged in proper business practices and looks forward to the opportunity to resolve the matter through the legal system.




July 15, 2011
http://www.burrillreport.com/article-fda_delivers_blow_to_transcept_over_insomnia_drug.html