Mannkind (MNKD) said it is eliminating 41 percent of its staff, 179 employees, following notification from the U.S. Food and Drug Administration that it would not approve the company’s experimental inhaled insulin Afrezza without two additional clinical trials, The Los Angeles Times reported. The company in a call with analysts said it plans to focus on winning regulatory approval for Afrezza. After the layoffs, Mannkind will have 257 employees.
Orexigen Therapeutics (OREX) said that it has cut about 40 percent of its staff or 23 employees as part of a reorganization following its inability to win U.S. Food and Drug Administration approval for its experimental obesity drug Contrave. At the end of January, the FDA said it would not approve Contrave without an additional clinical trial to better establish its safety. “We continue to believe in the potential of Contrave and look forward to discussions with the FDA,” says Mike Narachi, CEO of Orexigen. “Unfortunately, given the near term uncertainty of Contrave approval, we felt it prudent to consolidate and focus our resources. We are deeply grateful for the dedication and tremendous effort provided by all of our colleagues who are impacted by this realignment.” The company said it expects to take a $2.6 million restructuring charge in the first quarter of 2011. It expects to save about $5 million a year because of the job cuts.
Pfizer (PFE) will pay $330 million to settle claims relating to its menopause drug Premrpo, Bloomberg reported. The settlement will resolve more than 2,200 lawsuits, which alleged that Wyeth, which Pfizer acquired, had hidden the cancer risks associated with use of the drug. Bloomberg attributed its report to two people familiar with the agreement who were not authorized to speak to the press. A Pfizer spokesman told Bloomberg that the report was not accurate and that the firm does not comment on its litigation strategy.
A.P. Pharma (APPA) said it is awaiting a decision from the Nasdaq Listing and Qualifications Panel on its eligibility for continued listing following a recent meeting with the exchange to discuss efforts to bring the company into compliance with listing requirements. In November, the company received a second letter from Nasdaq notifying it that its stock price was below $1.00, making it subject to delisting. The company said it is actively seeking debt or equity financing to fund its operations. It also said it will meet later this quarter with the U.S. Food and Drug Administration about how it could move forward on APF530, its experimental drug to prevent and control nausea and vomiting in patients undergoing cancer treatment. In March 2010, the FDA notified the company it would not approve its application to begin marketing the drug based on current information provided to the agency.
The World Health Organization called for additional research into a possible link between GlaxoSmithKline’s (GSK) H1N1 flu vaccine Pandemrix and the sleeping disorder narcolepsy, Reuters reported. A WHO advisory panel issued a statement after a study from Finland suggested children given the vaccines were nine times more likely to suffer from narcolepsy, which causes a person to fall asleep suddenly without warning. WHO continues to keeps Pademrix on a list of prequalified vaccines and has made no change to its recommendations on it or other flu vaccines as a result of the study.