Omthera Pharmaceuticals, Inc.
) recently submitted a new drug application (NDA) for its
cholesterol management candidate, Epanova. Omthera is seeking US
Food and Drug Administration (FDA) approval of Epanova for the
treatment of patients with severe hypertriglyceridemia.
The NDA was based on encouraging efficacy data from two phase
III studies (EVOLVE and ESPRIT), conducted under the FDA's
Special Protocol Assessment (SPA) program in 2012.
We note that in May 2013,
had announced its intention to purchase Omthera for approximately
$323 million or $12.70 per share. Moreover, Omthera shareholders
will get contingent value rights of up to approximately $120
million, subject to the achievement of Epanova milestones.
The transaction is expected to close by the third quarter of
2013 subject to regulatory approvals. AstraZeneca expects to file
a supplemental NDA for Epanova for mixed dyslipidemia as soon as
possible. AstraZeneca also intends to get Epanova approved as a
fixed dose combination with its cardiovascular drug, Crestor, for
mixed dyslipidemia patients with high risk of cardiovascular
events. Moreover, AstraZeneca is planning to conduct a large
scale cardiovascular outcomes trial to assess Epanova in
combination with statins.
We note that on Nov 13, 2009, Omthera entered into an
exclusive license agreement with Chrysalis Pharma under which it
acquired an exclusive global license for the development,
manufacture, and commercialization of Epanova.
Omthera carries a Zacks Rank #2 (Buy). Currently companies
Lannett Company, Inc.
) look more attractive in the pharma space with a Zacks Rank #1
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