TRIALS AND TRIBULATIONS

Gilead Falls on News of Additional Hep C Patients Relapsing

The weekly round-up of failed trials, missed targets, and other business mishaps.

The Burrill Report


Gilead said that two more patients in a small segment of a mid-stage trial testing its experimental hepatitis C drug, acquired through the company’s $11 billion purchase of Pharmasset, had the virus return within four weeks of completing treatment. The latest results from the 10-patient mini-trial, brings to eight the number of patients who have relapsed after completing a 12-week treatment regimen. The trial segment involves patients infected with genotype 1 of the hepatitis C virus, the most common and most difficult to treat segment of the disease. Last month Gilead reported that six of the patients had seen the virus return after completing treatment. Gilead’s shares have plummeted more than 18 percent since initial results were announced.

Merck was handed a significant setback when the U.S. Food and Drug Administration rejected the company’s new combination cholesterol drug. In the complete response letter, the FDA requested more data on the therapy. Merck has been attempting to create a more potent cholesterol pill by combining the active ingredient in Lipitor, atorvastatin, with an active ingredient in its own cholesterol drug Vytorin, ezetimibe. “Merck plans to discuss next steps with the agency in the near future, including new data that are expected to be available later this year, which may address the FDA’s comments,” the company said in a press release.

The FDA rejected AstraZeneca’s attempt to delay the entry of any generic versions of its anti-psychotic blockbuster drug Seroquel in the United States. In September 2011, AstraZeneca filed Citizen Petition with the FDA for Seroquel and Seroquel XR requesting that U.S. regulators withhold approving any generic version of its drug that had labels that didn’t include the same warnings as its branded version. AstraZeneca said it is reviewing the agency’s decision.

NeurogesX announced that it has decided to follow through on a restructuring of its operations after it received a complete response letter from the FDA regarding Qutenza, its pain management patch for HIV patients. As part of the restructuring, aimed to minimize cash burn and preserve cash resources, NeurogesX will be slashing 43 jobs, or a 57 percent of the company’s workforce. The company anticipates that the cuts will decrease 2012 operating expenses by 32 percent and intends to reduce the 2012 cash burn rate to between $5.5 million to $6.5 million per quarter.

Argos Therapeutics will have to find other ways to finance its late-stage clinical trials for its experimental kidney cancer treatment after it decided to pull back on its plans for an initial public offering. In a letter filed with the U.S. Securities and Exchange Commission, the company simply stated that it would be withdrawing its registration statement “due to market conditions.” Argos was hoping to raise around $65 million to finance the development of its kidney cancer immunotherapy along with drug candidates being developed for the treatment of lupus and inflammatory conditions.













March 09, 2012
http://www.burrillreport.com/article-gilead_falls_on_news_of_additional_hep_c_patients_relapsing.html