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TRIALS AND TRIBULATIONS

Amylin’s Bydureon Fails in Head-to-Head Match with Victoza

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

The Burrill Report

Amylin Pharmaceuticals, Eli Lilly, and Alkermes said its experimental type 2 diabetes drug Bydureon failed to meet the endpoints of a head-to-head clinical study that compared it to Novo Nordisk’s Victoza. The news sent Amylin’s shares down about 25 percent. Both drugs are members of the class of type 2 diabetes drugs known as glucagon-like peptide-1 receptor agonists. Further evaluation of this data set is underway and, when complete, the companies plan to submit the full study results for publication.

Targacept said that GlaxoSmithKline is terminating its strategic alliance with the company focused on discovering and marketing drugs that target specific neuronal nicotinic receptors in five therapeutic areas including pain, smoking cessation, addiction, obesity, and Parkinson’s disease. The termination follows GSK’s decision to make significant strategic changes in the neurosciences area. Targacept will have full rights to its programs subject to the alliance, including compounds discovered or advanced as part of the alliance. Since the start of the agreement in July 2007, Targacept has received $45 million from GlaxoSmithKline, which included a $15 million equity investment. As a result of the termination of the agreement, Targacept plans to recognize into revenue in the first quarter of 2011 an incremental $17.6 million of amounts received under the agreement and recorded initially as deferred revenue. Burrill & Company, the publisher of The Burrill Report, is an investor in Targacept.

Renovo Group said that a late-stage trial of Juvista in scar revision surgery failed to meet its primary or secondary endpoints. The company said the findings are surprising in view of the results of the earlier studies of Juvista, which were conducted in more restricted, controlled populations. Shire, Renovo’s commercialization partner for Juvista, is terminating the licensing agreement and returning the rights to Renovo in the United States, Canada and Mexico. Renovo said it is discontinuing further development of Juvista and will initiate immediate and significant reductions in expenditures including cutting staff by more than 100 people.

The U.S. Food and Drug Administration said it plans to remove from the market hundreds of unapproved prescription medicines intended to relieve cough, cold, and allergy symptoms. These products have not been evaluated by the agency to assure that they are safe, effective, and of good quality. FDA officials have numerous concerns about these products, which include potentially risky combinations of ingredients, while others—marketed as “timed-release”—may release active ingredients too slowly, too quickly, or inconsistently. FDA has also received reports that some of the products have names that look or sound similar to other products—a problem that could contribute to medication errors. In addition, FDA health experts are concerned that some of the products are inappropriately labeled for use by infants and young children. FDA says most manufacturers affected by today’s action must stop making the products within 90 days and stop shipping them within 180 days. Some of the prescription medicines being removed have been marketed for many years. Over the past century, the laws outlining the requirements for drug approval have changed.

GlaxoSmithKline CEO Andrew Witty saw his compensation cut by nearly 25 percent because the drugmaker failed to hit profit targets, Dow Jones Newswires reported. Witty received total compensation of $3.7 million in 2010, down from $4.9 million. The company blamed competition from generic drugs and the dramatic drop in sales from its diabetes drug Avandia following regulators’ concerns about the drug’s safety. GSK also pointed to U.S. healthcare reforms and litigation costs. Witty’s base salary of $1.6 million was unchanged, but his bonus was cut 41 percent to $2 million.

The U.S. Food and Drug Administration told EMD Serono, an affiliate of Merck KGaA, that it would not approve its experimental oral drug from multiple sclerosis Cladribine with out additional analysis or an additional study to show the overall benefits of the drug justifies its risks. EMD Serono said it intends to request an end-of-review meeting with the FDA to clarify next steps and to identify whether data from completed and ongoing clinical studies can address the agency's questions.



March 03, 2011
http://www.burrillreport.com/article-amylin%e2%80%99s_bydureon_fails_in_head_to_head_match_with_victoza.html

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