PRINCETON, NJ, USA I July 9, 2013 I Omthera Pharmaceuticals, Inc. (OMTH), an emerging specialty pharmaceutical company, today announced that it has submitted a New Drug Application (NDA) to the U.S. 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 program, specifically positive results from two Phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, 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 Food and Drug Administration.
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.
About Omthera Pharmaceuticals, Inc.
Omthera Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development and commercialization of new therapies for dyslipidemia and the treatment of cardiovascular disease. Epanova, currently the Company‘s sole product candidate, is a late-stage, novel, omega-3 free fatty acid composition that meaningfully reduces triglycerides, improves other key lipid parameters and is expected to increase patient convenience with 2-gram once-a-day dosing with or without meals. Epanova™ is a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils, including multiple long-chain omega-3 and omega-6 fatty acids, with EPA, DHA, and docosapentaenoic acid being the most abundant forms of omega-3 fatty acids. The Company has completed pharmacokinetic and Phase III clinical studies to investigate the safety and efficacy profile of Epanova™. In 2012 the Company reported positive results from its Phase III EVOLVE and ESPRIT trials, both of which were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration. Omthera holds worldwide rights to Epanova™ under a license from Chrysalis Pharma AG, a privately held Swiss company that is the owner of the product. For more information, please visit http://www.omthera.com.
SOURCE: Omthera Pharmaceuticals
Post Views: 194
PRINCETON, NJ, USA I July 9, 2013 I Omthera Pharmaceuticals, Inc. (OMTH), an emerging specialty pharmaceutical company, today announced that it has submitted a New Drug Application (NDA) to the U.S. 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 program, specifically positive results from two Phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, 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 Food and Drug Administration.
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.
About Omthera Pharmaceuticals, Inc.
Omthera Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development and commercialization of new therapies for dyslipidemia and the treatment of cardiovascular disease. Epanova, currently the Company‘s sole product candidate, is a late-stage, novel, omega-3 free fatty acid composition that meaningfully reduces triglycerides, improves other key lipid parameters and is expected to increase patient convenience with 2-gram once-a-day dosing with or without meals. Epanova™ is a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils, including multiple long-chain omega-3 and omega-6 fatty acids, with EPA, DHA, and docosapentaenoic acid being the most abundant forms of omega-3 fatty acids. The Company has completed pharmacokinetic and Phase III clinical studies to investigate the safety and efficacy profile of Epanova™. In 2012 the Company reported positive results from its Phase III EVOLVE and ESPRIT trials, both of which were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration. Omthera holds worldwide rights to Epanova™ under a license from Chrysalis Pharma AG, a privately held Swiss company that is the owner of the product. For more information, please visit http://www.omthera.com.
SOURCE: Omthera Pharmaceuticals
Post Views: 194
