The Burrill Report


Pfizer has recalled an opioid painkiller that it obtained through its recently completed $3.6 billion acquisition of King Pharmaceuticals because of formulation problems, Reuters reported. The company said the drug could remain unavailable for many months. Embeda, an abuse resistant painkiller, contains pellets of morphine surrounded by a chemical that blocks its effects if it is crushed or chewed. Routine testing found problems with the stability of the extended-release product.

The U.S. Food and Drug Administration notified RegeneRx Biopharmaceuticals that it has placed on hold its mid-stage trial of the company’s injectable therapy for acute myocardial infarction because its contract manufacturer failure to comply with current Good Manufacturing Practice regulations. The company said it is currently unable to estimate the length of time that the trial will be on clinical hold. RegeneRx was scheduled to begin enrolling patients in the trial in the coming weeks. The Company will provide additional information as it becomes available.

Amylin Pharmaceuticals and Takeda Pharmaceutical said that they have suspended clinical activities in an ongoing mid-stage clinical trial examining the safety and effectiveness of an experimental combination therapy pramlintide/metreleptin for the treatment of obesity. The company voluntarily halted the study to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity. Metreleptin is an analog of human leptin, a neurohormone secreted by fat cells that plays a fundamental role in the regulation of energy metabolism and body weight. Amylin said the development does not affect Amylin's lipodystrophy development program investigating the use of metreleptin to treat diabetes and/or high levels of triglycerides in the bloodstream.

The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a negative opinion for Amgen's application to extend the marketing authorization in Europe for Amgen’s Vectibix to include combination with chemotherapy for the treatment of patients with wild-type KRAS metastatic colorectal cancer. Amgen said it will review the opinion and consider appropriate next steps. Amgen said it remains committed to patients with this aggressive disease, for whom there are limited treatment options.

The European Medicines Agency notified Belgian drugmaker UCB that it would not recommend Xyrem as a treatment for fibromyalgia, PharmaTimes reported. UCB in-licensed Xyrem from Jazz Pharmaceuticals, which currently markets the drug as a treatment for narcolepsy with cataplexy.

The U.S. Food and Drug Administration notified Eli Lilly and Avid Radiopharmaceuticals that it would not approve Amyvid, an imaging agent under investigation for the detection of Alzheimer’s disease. The agent is used to detect beta-amyloid plaque in the brains of living patients. The FDA expressed concerns about a training program to ensure accuracy and consistency of interpretations of Amyvid scans. Lilly and Avid said they have been working to address these questions and will continue to do so in an ongoing dialogue with the FDA.

Actelion has hired Goldman Sachs and the New York law firm of Wachtell, Lipton, Rosen & Katz to help defeat the effort by hedge fund Elliott Advisors to unseat several board members, Bloomberg reported. Bloomberg attributed the report to a source that wanted to remain unidentified because the matter is confidential. A spokesman for Actelion declined to comment. Elliott has been pushing the board to consider a sale of the company.

Pfizer recalled several lots of its injectable anti-impotence drug Caverject because of potentially defective needles, Dow Jones reported. The U.K. Medicines and Healthcare products Regulatory Agency said that Pfizer had recalled certain batches of the product because a few of the needles had blockages that could lead to bending or breaking when used.












March 18, 2011
http://www.burrillreport.com/article-pfizer_recalls_pain_drug_acquired_through_king_deal.html