Biotech's Latest Failed Trials, Missed Targets

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Includes: AMGN, ANSV, FRX, HLUKY, JNJ, MIPI, PFE
by: The Burrill Report

The U.S. Food and Drug Administration said it would review the anemia drugs sold by Amgen (NASDAQ:AMGN) and Johnson & Johnson (NYSE:JNJ) as a new clinical study renews safety concerns about their use in patients with chronic kidney disease. The study found high doses of one of the drugs might cause strokes. The FDA plans to have an outside advisory committee evaluate the use of the drugs and consider ways to control their dose. The drugs include Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit.

Pfizer (NYSE:PFE) said that the U.S. Food and Drug Administration had not yet completed its review of its application for approval to market Prevnar 13, the company’s candidate 13-valent pneumococcal conjugate vaccine. As a result, the review will continue beyond the December 30, 2009 date by which the FDA had said it expected to act on the application. In May 2009, Prevnar 13 was designated for priority review, which is given to products that, if approved by the FDA’s Center for Biologics Evaluation & Research, would be a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. In August 2009, the FDA extended its review by 90 days from the original action date of September 30, 2009, to December 30, 2009, based on the submission of additional manufacturing data requested by the FDA.

Anesiva (ANSV) said that it was unable to satisfy the closing conditions set forth in its merger agreement with Arcion Therapeutics and will immediately cease operations and file for bankruptcy. The South San Francisco-based company was focused on developing drugs for pain management. Its lead drug candidate was adlea, a small molecule formulation of capsaicin that was in development for acute pain following orthopedic surgeries.

A U.S. Food and Drug Administration staff memo to an advisory panel says that based on a preliminary analysis of Forest Laboratories (NYSE:FRX) hypertension drug Bystolic, it should not be approved for people with heart failure, the Associated Press reported. The memo said that “the totality of evidence is not convincing to support a claim for treatment of heart failure,” the AP reported. Forest launched Bystolic in 2008 for treating high blood pressure.

The European Commission notified Lundbeck (OTC:HLUKY) that it has opened proceedings against the Danish drug group. The investigation seeks to determine whether the company misused its dominant position or has been involved in anticompetitive agreements to hinder the entry of generic competition for antidepressant Citalopram. Lundbeck said it is cooperating fully with the European Commission and is confident that the group has complied with all relevant national and EU competition legislation.

Molecular Insight Pharmaceuticals (MIPI) said it will eliminate nine positions in a strategic alignment to support the development of its oncology product candidates and to reduce operating costs. The Cambridge, Massachusetts-based company said it will take a one-time charge of about $200,000 in the first quarter and expects to save $1 million annually in operating expenses as a result of the reduction. The company has 61 employees.