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TRIALS AND TRIBULATIONS

Alzheimer’s Drug Bapineuzumab Fails in Second Trial

The weekly round-up of failed trials, missed targets, and other business mishaps.

The Burrill Report

Johnson & Johnson, Pfizer, and Elan Pharmaceuticals have put an end to their closely watched late-stage trial of the experimental Alzheimer’s drug, bapineuzumab. Just two weeks after data from the trial showed the drug failed to meet two primary endpoints, another related study proved similarly disappointing. The results from the related study in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 genotype showed that bapineuzumab failed to meet the co-primary endpoints of a change in cognitive and functional performance compared to a placebo. The results forced J&J, Pfizer, and Elan to pull the plug on all ongoing late-stage trials of bapineuzumab. A Pfizer spokeswoman said there is “no path forward” for the intravenous version of bapineuzumab in patients with mild-to-moderate Alzheimer’s disease.

Amgen has decided to scrap a late-stage trial of ganitumab, its experimental drug for the treatment of pancreatic cancer, after it showed weak signs of improving survival of patients with aggressive forms of the disease. Amgen had decided to continue the development of ganitumab even after independent data monitors suggested the company halt trials due to weak interim data. Amgen also halted a mid-stage trial of ganitumab in patients with locally advanced pancreatic cancer.

The experimental antibody drug CytoFab, developed by AstraZeneca and BTG to treat severe sepsis, failed to help patients in a mid-stage trial, pushing the companies to discontinue further development of the drug. Sepsis occurs when the body’s immune system over-reacts to an infection, often damaging vital organs. Although a potential drug to treat sepsis could be very lucrative, the development of such a drug has proved to be very risky. BTG says it expects to take a charge of approximately $43.8 million (£28 million) in the current year due to the failure.

Agennix suffered a major setback when its experimental lung cancer drug, talactoferrin, failed to hit its target endpoints in a late-stage clinical trial. Agennix shares plunged more than 80 percent following the announcement, raising major doubts about the company’s future. The company’s chief financial officer, Torsten Hombeck, said the company would take “immediate steps” to conserve cash while it evaluates potential business options.

The U.S. Securities and Exchange Commission has charged Pfizer with violating the Foreign Corrupt Practices Act after finding that several Pfizer subsidiaries bribed doctors and healthcare professionals in order to win business. The SEC found that Pfizer employees in Bulgaria, China, Croatia, Czech Republic, Italy, Kazakhstan, Russia, and Serbia made improper payments to foreign officials in order to obtain regulatory approvals and increase prescriptions for its medicines. The SEC also separately charged Wyeth, acquired by Pfizer three years ago, with separate FCPA violations. Pfizer and Wyeth agreed to pay $45 million combined to settle the charges. Pfizer will pay an additional $15 million to settle a parallel action from the U.S. Department of Justice.


August 09, 2012
http://www.burrillreport.com/article-alzheimer%e2%80%99s_drug_bapineuzumab_fails_in_second_trial_.html

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