Celgene decided to pull its European application to expand use of its blood-cancer drug Revlimid after regulators asked for more “mature” data before evaluating the drug. The company also said it would reevaluate its plans to request a label expansion from the U.S. Food and Drug Administration for Revlimid and will instead likely file next year. Analysts were quick to reassess the company’s near-term prospects for growth. Celgene shares slipped more than 12 percent on the day of its announcement.
The U.S. Food and Drug Administration has blocked Pozen’s application for approval of its combo aspirin drug. Three months after Pozen offered positive top-line date from a late stage trial of its omeprazole-aspirin combination, designed to prevent ulcers, the FDA has identified issues with the company’s early-stage bioequivalence study. The agency advised Pozen that, “for the development of a combination product with 81 mg aspirin, an in vivo bioequivalence study will be necessary unless a biowaiver can be justified.” Shares of the Pozen plummeted 16 percent on the news.
Pfizer said in a securities filing that it has paid $896 million to resolve nearly 60 percent of the cases alleging that its menopause drugs, Prempro, caused cancer in women. The filing with the U.S. Securities Exchange Commission states that Pfizer has now settled 6,000 lawsuits and notes that the company has set aside another $330 million to resolve the remaining 4,000 suits. Pfizer originally acquired Prempro and other hormone-replacement drugs from its purchase of Wyeth and its Pharmacia & Upjohn units. As of May 10, Pfizer has paid an average of $150,000 per case, according to the company.
A U.S. Food and Drug Administration advisory panel declined to support Sanofi’s injection meant to prevent blood clots in cancer patients on chemotherapy. The panel voted 14-1 against recommending approval of the semuloparin injection for cancer patients, with one abstention. Many of the panel members said the company has not done a good enough job of defining exactly which patients would benefit most from the drug, especially as those taking the medicine were also at higher risk of bleeding. Sanofi has said that cancer patients getting chemotherapy have a 6.5 times higher risk of getting blood clots than patients without cancer, and no other medicines are currently approved specifically to prevent the clots in patients on chemotherapy.
AstraZeneca has had to halt an early-stage trial of the experimental obesity drug AZD2820 following an adverse event. The man affected is believed to have had an allergic reaction to the first shot of the drug. AstraZeneca’s co-developer on the drug, Palatin, issued a statement that said the man was treated and recovered from a serious adverse reaction to the shot. “We are pleased that the subject has fully recovered from the unfortunate adverse event, and we will work closely with our partner AstraZeneca to investigate the cause of this incident and the overall plans for the AZD2820 program,” said Carl Spana, Palatin’s CEO.
June 22, 2012
http://www.burrillreport.com/article-celgene_withdraws_eu_application_for_revlimid.html