Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that it has raised $33.9 million in a Series B funding round, led by new investor, New Enterprise Associates ("NEA"), one of the world's leading venture capital firms. Existing investor, Sofinnova Partners, also participated in the financing. The capital raised will be used to fund the Phase 3 clinical development of Omthera's novel Omega-3 fatty acid compound, Epanova™, and for general corporate purposes. With this latest round, Omthera has raised approximately $40.4 million in venture capital since commencement of operations in 2009.
In a separate press release issued today, Omthera announced that the Company has initiated its pivotal Phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial for Epanova, for the treatment of patients with very high triglycerides (greater than or equal to 500 mg/dL). In January 2011, the Company announced data from its ECLIPSE (Epanova Compared to Lovaza In a Pharmacokinetic Single-dose Evaluation) trial, designed to evaluate the bioavailability of Epanova in comparison to Lovaza®, the leading prescription Omega-3. Data from the trial showed that the bioavailability of Epanova was dramatically superior to Lovaza.
"Omthera continues to generate very positive data indicating that Epanova has the potential to become the best-in-class therapy in the nearly $2 billion worldwide Rx Omega-3 market and an important treatment for the millions of patients suffering from high triglycerides," stated Jerry Wisler, President, Chief Executive Officer and co-founder of Omthera. "As such, we are delighted to gain the support of a venture capital firm of the stature of NEA to lead this substantial new funding."
David M. Mott, formerly the Chief Executive Officer of MedImmune, and now a General Partner at NEA, has joined Omthera's Board of Directors, bringing the Board to four members. Mr. Wisler added, "We appreciate the continued strong support of Sofinnova Partners and welcome our newest Board member, David Mott, who brings a wealth of experience to our growing Company. The participation of Sofinnova Partners, together with David and NEA, reflects the market's confidence in the potential of Epanova. The funds raised in this latest round will enable Omthera to progress its clinical program with Epanova in patients with very high triglyceride levels and mixed dyslipidemia through to a New Drug Application filing, which is anticipated to occur in 2012."
Mr. Mott noted, "I am very pleased to join the Omthera team and believe strongly in the Company's value proposition. Management's significant expertise and proven track record have allowed the Company to move rapidly since inception to bring the clinical development of Epanova to this important inflection point." He continued, "There is a distinct market need for a more effective and convenient prescription-strength Omega-3 treatment option for patients suffering from very high triglycerides who need to maintain a low-fat diet. Data generated to date indicates that Epanova has solid promise in this area, with the potential to deliver improved and more predictable bioavailability than currently available ethyl ester based formulations of Omega-3s. Epanova has the potential to capture significant market share and eclipse currently available therapies to become the drug of choice."
Mr. Mott, with more than 20 years of experience in the life sciences industry, including his 16 year tenure at MedImmune, focuses on biopharmaceutical investments at NEA. He is currently Chairman of 3-V Biosciences and Zyngenia, and is a director of Ardelyx, Epizyme, and TESARO.