Pfizer, Adolor End Collaboration to Develop Pain Meds: Biotech's Latest Troubles

by: The Burrill Report

Adolor (ADLR) and Pfizer (NYSE:PFE) will end their alliance to develop two of Adolor’s experimental pain drugs, the Philadelphia Business Journal reported. The two companies since December 2007 have been developing ADL-5859 and ADL-5747, which are delta opioid receptor agonist compounds. The agreement between the two companies called for Pfizer to pay Adolor $30 million in upfront fees and up to $232.5 million in milestones if the development of the compounds was successful. Adolor said clinical evaluations in multiple indications failed to provide compelling evidence for continuing development of the drugs.

AstraZeneca (NYSE:AZN) said it will take a $445 million charge as it will discontinue further development of the experimental monoclonal antibody motavizumab use to prevent RSV disease. The company notified the U.S. Food and Drug Administration that it is withdrawing its application to being marketing the drug for that indication. The company said the charge will not affect core earnings per share for 2010. AstraZeneca has $445 million in intangible assets relating to motavizumab. The company’s biologics unit Medimmune originally filed for approval of motavizumab in the indication in January 2008. The FDA twice notified the company that it could not approve the drug with the data provided. MedImmune has decided to discontinue certain motavizumab development paths, but motavizumab remains in development for other RSV treatments.

Cyclacel Pharmaceuticals (NASDAQ:CYCC) said topline results from a mid-stage clinical study showed oral seliciclib as a third or more line treatment in patients with non-small cell lung cancer did no better than a placebo in terms of progression free survival. The company, though, said it was encouraged that the seliciclib arm did better than the placebo arm in overall survival. The company said it will analyze available biopsy samples to see if there is a biological explanation for the results. The trial's primary efficacy endpoint was progression free survival. Secondary endpoints include overall survival, response rate, response duration, safety and tolerability.

The French Health Ministry is investigating why the type 2 diabetes drug Mediator, which may be linked to the deaths of as many as 2,000 people who may have died from resulting heart valve problems, remained on the market so long, Bloomberg reported. Mediator became available in France in 1976, but wasn’t pulled from the market until 2009. Privately-held Servier, France’s second largest drugmaker, produced the drug.

Shareholders in Johnson & Johnson (NYSE:JNJ) are suing the company alleging that directors and top executives should have seen warning signs of a series of manufacturing and other problems and are seeking damages for mismanagement, Bloomberg reported. The company recalled a wide range of medicines this year because of contamination and incorrect labeling. A Congressional investigation began following the recall of batches of children’s Tylenol that forced J&J to suspend operations at a plant in Pennsylvania. The investigation found rather than recalling defective bottles of its Motrin pain medication, the company used contractors to buy it from stores. J&J also faces government investigations into whether it illegally marketed drugs and devices for uses not approved by the U.S. Food and Drug Administration.

The U. S. Food and Drug Administration notified Cumberland Pharmaceuticals (NASDAQ:CPIX) that it would not approve the company’s supplemental new drug application to expand indications for Acetadote Injection to include the treatment of patients with non-acetaminophen induced acute liver failure. The FDA noted that there was not sufficient evidence of efficacy for the proposed indication of increasing survival in all patients with acute liver failure. Cumberland said it will request a meeting with the FDA to resolve the outstanding issues related to this application.