Omthera Pharmaceuticals is touting a new batch of Phase III data on its cardiovascular drug for patients with very high triglycerides. And the Princeton, NJ-based developer says its omega-3 drug, Epanova, has shown comparable efficacy to rival therapies in a lower 2-gram dose in two late-stage studies.
The privately held company, founded in 2008, aims to file for FDA approval of its industrial-grade fish oil drug in the first half of 2013, Jerry Wisler, Omthera's CEO, told FierceBiotech in an interview. The company is seeking approval for use of its drug to treat the same category of patients with high blood fat levels as Amarin ($AMRN) did with its approved therapy Vascepa, which is expected to hit the market in the first quarter of 2013 with some blockbuster expectations.
The developer nailed the primary and secondary endpoints of its Phase III "ESPRIT" trial and its late-stage "EVOLVE" study, for which the company revealed positive top-line results in April. In the 647-patient ESPRIT study, the company tested Epanova as an add-on therapy to statins in patients with very high triglycerides and risk of heart disease, and the study showed that patients on the omega-3 drug showed statistically significant lowering of non-HDL cholesterol from baseline to 6 weeks, achieving the main goal of the study.
Both Omthera's and Amarin's therapies have shown efficacy in late-stage studies as the companies aim to elbow in on GlaxoSmithKline's ($GSK) marketed drug, Lovaza. Omthera argues that its highly concentrated, free fatty acid formulation for Epanova has shown better bioavailablity than Lovaza, and the company has presented data showing comparable effects of its 2-g dose compared to the 4-g dose of GSK's drug. The recent approval of Vascepa and Omthera's data set the stage for heated competition in what Wisler described as a $2 billion global market.
"I think there's always room for multiple competitors," Wisler said in an interview. "I think Lovaza will maintain share, I think Vescepa will capture share, I think we'll capture share as well. … [Physicians] do tend to use multiple drugs. Even in the statin world, you didn't see somebody using 100% Lipitor, a 100% Crestor or a 100% Zocor."
"The next question is going to be who is going to be the market leader," he added, "and that all comes down to who has the best profile. We clearly think that we have the best profile because we positively affect all the key lipid parameters, we lower triglycerides, we lower non-HDL cholesterol, we raise HDL [cholesterol]. … But importantly, we do it with a lower and much more convenient dose."
- here's the company's release