AstraZeneca (AZN) and partner Bristol-Myers Squibb Company (BMY) recently announced that the US Food and Drug Administration (:FDA) has accepted the Biologics License Application (:BLA) for their pipeline candidate, metreleptin.
The FDA has granted priority review designation to the candidate. We note that the US regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within eight months of submission as against the usual twelve months.
The companies are looking to get metreleptin approved for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy. We note that the candidate enjoys orphan drug designation in both the US and Europe for the above indication.
Lipodystrophy is characterized by loss of fat tissue and can lead to several serious complications including diabetes.
The BLA for metreleptin includes data from an ongoing, open-label National Institutes of Health (:NIH) study in patients suffering from inherited or acquired lipodystrophy. Last month, encouraging results from a 12-month sub-group analysis from the study was presented.
We remind investors that Bristol-Myers Squibb and AstraZeneca have been collaborating since Jan 2007 for the development and commercialization of candidates for type II diabetes. In Aug 2012, Bristol-Myers purchased Amylin Pharmaceuticals, Inc. for $31.00 per share or approximately $5.3 billion in cash. Following the deal, Bristol-Myers expanded its partnership with AstraZeneca for developing and marketing the erstwhile Amylin's diabetes candidates/drugs including metreleptin.
Both AstraZeneca and Bristol-Myers carry a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. (SNTS) and Salix Pharmaceuticals (SLXP) look more attractive with a Zacks Rank #1 (Strong Buy).
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