FDA Concerned About Forest Labs Drug: Biotech's Latest Missed Targets, Mishaps

by: The Burrill Report

Reviewers with the U.S. Food and Drug Administration questioned both the safety and efficacy of Forest Laboratories’ (NYSE:FRX) and Nycomed’s once-daily pill Daxas for the treatment of chronic obstructive pulmonary disease, Reuters reported. The reviewers in FDA documents characterized improvements in lung function from use of the drug as "quite modest.” Among the safety concerns, which included a slightly higher rate of cancers, were three suicides and two attempted suicides. The success of Daxas is seen as important to Forest as its antidepressant Lexapro will go off patent in 2012.

Generex Biotechnology (OTCPK:GNBT) said that it has filed a $250 million libel suit against TheStreet.com (TSCM) and its senior columnist Adam Feuerstein in the Supreme Court of the State of New York. The suit is in response to two articles authored by Feuerstein and published on TheStreet.com website on March 19 and March 26, 2010. Generex contends that the articles contain defamatory statements about the company, its management, and its flagship product Generex Oral-lyn. It charges the articles put forward several ostensible statements of fact that are, in truth, misleading or outright misstatements made with malicious intent or with a reckless disregard for the truth [see story]. Feuerstein called Generex “a total bust” and questioned the soundness of Oral-lyn’s clinical testing and the underpinning of its claimed foreign commercial success in India. The company was vocal about Oral-lyn's approval by the Drugs Controller General India, the Indian equivalent of the FDA, but said nothing in SEC filings or public announcements about an apparent revocation of that approval in March, writes Feuerstein.
The U.S. Food and Drug Administration informed Cell Therapeutics (NASDAQ:CTIC) that it would not approve the company’s Pixuvri for relapsed or refractory aggressive non-Hodgkin's lymphoma without additional data. An Oncologic Drugs Advisory Committee on March 22 recommended Cell Therapeutics conduct an additional trial to demonstrate the safety and effectiveness of its product. Cell Therapeutics said it plans to request a meeting with the FDA on both the design of the follow-on study as well as expanded access program for patients who are not participating in the Company's clinical trial. The company is preparing to submit its Marketing Authorization Application to the European Medicines Agency for review. Based on feedback and guidance from its clinical expert, the company expects to submit the application in the third quarter of 2010.
Neovacs, a French biotech, cut the hoped for amount to be raised through an IPO nearly in half to $14.8 million from $26.9 million, Reuters reported. An analyst told the news agency that Neovacs' decision reflects a lack of appetite among investors. The company, a a spin-off from Pierre & Marie Curie University in Paris, develops immunotherapy technology.
Basilea Pharmaceutica (OTC:BPMUF) said it will discontinue the sale of the antibiotic ceftobiprole (Zeftera) in Canada. The Switzerland-based pharmaceutical company said that Janssen-Ortho, a Johnson & Johnson (NYSE:JNJ) company, has in consultation with Health Canada decided to discontinue sale of ceftobiprole for the treatment of complicated skin and skin structure infections in Canada. Janssen-Ortho, the holder of the Market Authorization in Canada, is discontinuing sale of the drug effective April 16. The move comes following discussions with Health Canada in response to recent regulatory recommendations in the United States and European Union to not approve Zetera for complicated skin and skin structure infections due to concerns regarding the conduct of clinical trials. Zetera was authorized in Canada in June 2008 for the treatment of cSSSI. The company said there have been no safety observations that would be in conflict with the approved label of Zetera in Canada. The decision to discontinue sale of the product in the Canadian market does not preclude the submission of a new application for market authorization in the future, it said.