Medivation, Pfizer Disappointed Over Drug Failure - Biotech's Latest Mishaps

by: The Burrill Report

Pfizer (NYSE:PFE) and Medivation (NASDAQ:MDVN) said dimebon, their experimental drug to treat Alzheimer’s disease, failed in two late-stage clinical trials. Medivation’s stock, which had been trading at an all time high of $40.49 right before the news, tumbled nearly 70 percent to $13.04. In one trial, dimebon did not show statistical significance compared to placebo in measures of cognition and global function – the primary endpoints for the study. The results were surprising because early studies had produced promising results of the drug as a treatment for the neurodegenerative disease. A separate phase 3 safety and tolerability study found dimebon was well tolerated when given alone or in combination with a variety of other Alzheimer’s disease medicines, including cholinesterase inhibitors, memantine, or both. Previous studies have confirmed the tolerability of dimebon alone. Pfizer said it is evaluating the data from the trials and will determine appropriate next steps regarding the dimebon program when that process is completed.

AstraZeneca (NYSE:AZN) said it would slash 1,800 R&D jobs as part of a previously announced reorganization, Associated Press reported. About 550 of those job cuts will occur at the company’s U.S. headquarters in Delaware. As part of the reorganization, the company is ceasing work on developing drugs for thrombosis, acid reflux disease, ovarian and bladder cancers, systemic scleroderma, schizophrenia, bipolar disorder, depression, anxiety, and hepatitis C. It is also eliminating vaccine research other than for influenza and respiratory syncytial virus, AP reported. The company is closing research sites in the United Kingdom and Sweden.
PTC Therapeutics and Genzyme (GENZ) said their experimental drug ataluren failed to show statistical significance compared to placebo in a mid-stage trail in patients with nonsense mutation Duchenne/Becker Muscular Dystrophy. The primary endpoint of change in 6-minute walk distance did not reach statistical significance within the 48-week duration of the study. Study results showed that ataluren was well tolerated and no clinical trial patients discontinued treatment due to an adverse event. Additional efficacy analyses are underway in patient subgroups. PTC’s Chief Medical Officer Langdon Miller, however, said the results demonstrate ataluren’s safety profile and support continued development of the drug. “Importantly, this trial does provide a wealth of valuable data about ataluren and DBMD, he said. “Additional analyses will guide the overall clinical and regulatory path forward.”
Ranbaxy Laboratories (OTC:RBXLF) said it would not be able to launch a generic urinary drug as scheduled because it failed to win necessary approval from the U.S. Food and Drug Adminstration, Reuters reported. The India generics maker said it expected to launch a cheaper version of Astellas Pharma’s (OTCPK:ALPMF) Flomax in the United States this month. One analyst expected sales of the generic Flomax to generate $93 million in sales during the 180-day exclusive marketing period. But Ranbaxy now stands to lose the market advantage to other generic drugmakers launching their own generic versions ahead of the company.
Gentium (GENT) announced a reorganization including management changes in an effort to consolidate its resources and operations. The move follows a license agreement with Sigma-Tau that provides Gentium with up to $15 million in non-dilutive funding. Gentium will close its New York office and consolidate corporate activities and the executive management team within its headquarters in Italy. Gary Gemignani, executive vice-president and CFO since 2006, will be leaving the company March 31, but will provide transitional services through a consulting agreement. Khalid Islam, currently Gentium's chairman and interim CEO, will assume the role of CEO on a full-time basis. In addition, Salvatore Calabrese, Gentium's current vice president of finance, has been promoted to senior vice president of finance. The closure of the New York office is expected to result in one-time payments of approximately $1.5 million and is anticipated to yield annual cost savings of approximately $1.3 million.