NEJM Editorial Raises Questions About Dendreon’s Cancer Vaccine Study: Biotech's Latest Mishaps

Includes: DNDN, LLY, SNY
by: The Burrill Report

A New England Journal of Medicine editorial is raising questions about a pivotal study of Dendreon’s (NASDAQ:DNDN) prostate cancer vaccine Provenge. The study found that the vaccine extended survival by 4.1 months compared to placebo in men with prostate cancer that had spread who do not respond to hormone therapy. What’s raised questions about the Provenge study is that it showed no measurable effect on tumors. An editorial that ran with the study called that “surprising” and said "it is hard to understand how the natural history of a cancer can be affected without some apparent measurable change in the tumor.” It went on to suggest that the lack of tumor effect could indicate that “the results could have been influenced by an unmeasured prognostic variable that was accidentally imbalanced in study-group assignments.

The U.S. Court of Appeals for the Federal Circuit has upheld a prior ruling by the U.S. District Court for the Eastern District of Michigan that found Eli Lilly’s (NYSE:LLY) method-of-use patent on its cancer drug Gemzar was invalid. The patent wasn’t set to expire until mid-2013. Lilly said it strongly disagrees with the ruling and is considering legal options. Lilly said in light of the ruling it expects to maintain market exclusivity for Gemzar until November 15, 2010, but the decision will force it to modify its current 2010 financial guidance. Global sales of Gemzar were nearly $1.4 billion in 2009.

A U.S. District Court Judge set an August 17 hearing date in a lawsuit filed by Sanofi-Aventis (NYSE:SNY) to prevent Sandoz from selling a generic version of its blood thinner Lovenox, but failed to comply with the French pharmaceuticals’ request for a preliminary injunction. At the status conference, the court did not place any restrictions on the sale of the generic version of the drug.

The U.S. Food and Drug Administration has notified Sanofi Pasteur that during an inspection of its Marcy l’Etoile, France facility it found “significant deviations from current good manufacturing practice.” The plant manufactures licensed biological products and bulk drug substances. Among the issues noted in the letter was a failure to investigate unexplained discrepancy of products to meet specifications, failure to report deviations in biological products, and failure to inform the agency about chances in the production process in the company’s approved license application.

The U.S. Food and Drug Administration is notifying patients and healthcare professionals that use of the intravenous antibiotic Cubicin could lead to the development eosinophilic pneumonia. Cubicin was first approved in September 2003 to treat serious skin infections. In 2006, it was approved to treat bloodstream infections. Eosinophilic pneumonia is a rare, but serious condition where a type of white blood cell fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing. The agency said healthcare professionals should closely monitor patients being treated with Cubicin for eosinophilic pneumonia. Patients receiving Cubicin should immediately contact their healthcare professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing.