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Omthera Seeks FDA Approval for Epanova - Analyst Blog
Omthera Pharmaceuticals, Inc. ( OMTH ) 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, AstraZeneca ( AZN ) 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.
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