) and partner
Bristol-Myers Squibb Company
) recently announced that the US Food and Drug Administration
(FDA) has accepted the Biologics License Application (BLA) for
their pipeline candidate, metreleptin.
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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
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
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
) look more attractive with a Zacks Rank #1 (Strong Buy).