Omthera Pharmaceuticals is heading to Wall Street in search of $75 million of IPO cash to support a prospective launch of an omega-3 drug, soon after the biotech reported positive Phase III data and laid out plans to file for an approval within months.
The Princeton, NJ-based biotech is pinning its IPO and entire future on Epanova, an omega-3 therapy that demonstrated its ability to lower non-HDL cholesterol from baseline in 6 months over the course of the Phase III study. If successful at the FDA, Omthera will be poised to take on GlaxoSmithKline's ($GSK) Lovaza as well as Vascepa, which Amarin has been struggling to launch.
At the end of January, Amarin elected to launch Vascepa on its own as a treatment for high triglycerides. But while GSK has earned hundreds of millions of dollars on its sales of Lovaza, Amarin's go-it-alone approach, after waiting fruitlessly for an FDA decision on NCE status needed to lock down an extended period of patent protection, is expected to proceed slowly. The lingering shadow over Vascepa could influence Omthera's fate on the Street, which is likely to wonder how a biotech would do marketing to primary-care docs and specialists.
Omthera reported in its S-1 this week that it expects "to submit a New Drug Application, or NDA, with the FDA in mid-2013 to commercialize Epanova in the United States for the treatment of patients with triglyceride levels greater than or equal to 500 mg/dL, or severe hypertriglyceridemia. We expect to build a U.S.-based sales and marketing infrastructure to support a launch of Epanova in patients with severe hypertriglyceridemia and anticipate initially targeting specialists, cardiologists and primary care physicians who are the top prescribers of lipid-regulating therapies."
Omthera says only that "it may also be eligible" for NCE status.
- here's the S-1