Omthera Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the marketing and sale of Epanova for the treatment for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).
The submission is based on the entire data set from Omthera's clinical development programme, specifically positive results from two phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerid es, and in reducing non-HDL cholesterol in combination with a statin for patients with high triglycerides.
Both trials were conducted under a Special Protocol Assessment with the US FDA.
Omthera announced on May 28, 2013 that it had entered into a definitive merger agreement with an affiliate of AstraZeneca PLC pursuant to which such affiliate of AstraZeneca will acquire all of the outstanding shares of common stock of Omthera for $12.70 per share, or approximately $323 million. In addition to the cash payment, each Omthera stockholder will receive one Contingent Value Right (CVR) of up to approximately $4.70 for each share of common stock that they own, equating to approximately $120 million, if specified milestones related to Epanova are achieved, or if a milestone related to global net sales is achieved. This will bring the total potential acquisition value to approximately $443 million.
Omthera Pharmaceuticals, Inc. is focused on the development and commercialization of new therapies for dyslipidemia and the treatment of cardiovascular disease.