5 Pharma Setbacks This Week

by: The Burrill Report

Infinity Pharmaceuticals (NASDAQ:INFI) lost 40 percent of its value after it voluntary stopped a mid-stage clinical trial of its investigational cancer therapeutic saridegib due to disappointing results. Preliminary analysis of interim data comparing saridegib in combination with gemcitabine to a placebo plus gemcitabine in 122 patients with previously untreated metastatic pancreatic cancer showed a difference in survival favoring the placebo plus gemcitabine arm. There was a higher rate of progressive disease in the saridegib plus gemcitabine arm. The adverse events observed in both arms were consistent with the known safety profile of each agent, with no unexpected toxicities. The company expects to present the final data after the analyses are complete. “While the outcome of this study is disappointing, we continue to believe in the therapeutic potential of Hedgehog pathway inhibition. As the Hedgehog pathway plays distinctly different biological roles in myelofibrosis and chondrosarcoma, our phase 2 trials in these disease settings are ongoing,” said Julian Adams, president of research and development at Infinity.

Shares of Columbia Laboratories (CBRX) plunged almost 60 percent to 65 cents after a U.S. Food and Drug Administration panel recommended against approval of its progesterone vaginal gel for the reduction of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy. The panel said that data from two late-stage studies was not sufficient to recommend approval. “We will work with the FDA to address the advisory committee's comments as the agency finalizes its review of our NDA,” said Frank Condella, president and CEO of Columbia Laboratories. “We hope the agency's final decision will acknowledge the clear unmet medical need in this patient population.” Columbia’s gel has a February 26 PDUFA date. Columbia is partnered with Watson Pharmaceuticals on the development of the drug.

Abbott Laboratories (NYSE:ABT) laid off about 700 workers, primarily in manufacturing operations, and plans to eliminate several hundred additional positions over the course of the year, according to Dow Jones Newswire. Some of the layoffs have been attributed to an impending expiration of a contract to supply the artery-opening stent Promus to Boston Scientific in mid-2012. Boston Scientific is switching to a new version of the stent that it will manufacture itself. But layoffs are also expected to affect some employees in Abbott's diagnostics and pharmaceutical manufacturing operations, according to Dow Jones. Abbott employs about 91,000 people worldwide.

Novartis (NYSE:NVS) has resolved a class action suit brought by more than 7,000 sales representatives who claimed they should be eligible for overtime pay when on the road. Novartis had claimed that they were not outside employees and therefore were ineligible for overtime. After winding its way through the courts since 2006, Novartis has come to an agreement with plaintiffs’ lawyers to a one-time payment of up to $99 million to eligible class members to settle all claims brought in the 2006 suit as well as additional wage and hour claims covering a more recent time period. “We are pleased to have secured a $99 million dollar settlement wherein Novartis compensates its sales representatives for years of overtime pay,” says David Sanford, lead counsel for the plaintiffs. “While we remain confident that the United States Supreme Court later this year will uphold the Department of Labor's interpretation of wage and hour law, the risks of further litigation are great. We are proud that over seven thousand current and former Novartis sales representatives will be able to participate in this settlement. It is a fair and equitable result and can serve as an exemplar for companies around the United States that face wage and hour litigation.” The agreement remains subject to final court approval, which may take several months.

Indian generic drugmaker Ranbaxy (RBXZF.PK may never be able to sell its drugs in the United States. The U.S. Department of Justice filed a consent decree for a permanent injunction against the company at the request of the U.S. Food and Drug Administration. Government investigators uncovered numerous problems with Ranbaxy's drug manufacturing and testing in India and at facilities owned by its U.S. subsidiary, Ranbaxy Inc., including failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date. The government also found that Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed. All of these actions constituted violations of the federal Food, Drug and Cosmetic Act, making many of Ranbaxy's drugs adulterated, potentially unsafe and illegal to sell in the United States. The Justice Department called the consent decree “unprecedented in scope.”