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Scores updated at the end of each quarter. Winner
The stock price of Amarin Corp. plc, a biotech firm with research headquarters in Groton, plunged more than 20 percent Friday after the company announced it is hiring its own sales force to launch the newly approved heart drug Vascepa.
Analysts have been concerned that a go-it-alone strategy would reduce the potential market for Amarin's fish-oil drug and had been hoping the company would launch Vascepa in conjunction with a major pharmaceutical marketer. But Joseph Zakrzewski, Amarin's chief executive, said in a conference call after stock-market trading Thursday that negotiations to find a marketing partner were taking longer than expected and the company wanted to move forward with a launch in the first quarter of next year.
"At some point you just have to move on with it," Zakrzewski said. "The discussions are still quite active. Hopefully it will get somewhere - who knows?"
To help finance the launch, Amarin announced that an investment fund managed by Pharmakon Advisors has agreed to kick in $100 million in non-equity financing.
Zakrzewski said Amarin, an Irish company with U.S. headquarters in Bedminster, N.J., will be hiring between 250 and 300 sales representatives and targeting about 30,000 clinicians who are considered top prescribers for heart patients.
Vascepa, approved by the U.S. Food and Drug Administration in June, lowers a type of fat in the blood known as triglycerides. The ultra-pure prescription fish oil targets a market similar to GlaxoSmithKline's drug Lovaza, but might be able to be used in an expanded population in the next year or so if tests on people with slightly elevated triglycerides show a benefit in clinical studies expected to be completed in February.
Amarin is still awaiting an FDA determination on whether Vascepa will be granted new chemical entity (NCE) status, which would offer at least two extra years of patent protection, but Zakrzewski said the lack of a decision was not a factor in negotiations to find a Big Pharma partner.
"We still believe the NCE piece is an overhang and much ado about nothing," he said.
Zakrzewski said Amarin is continuing its partnering talks while also considering a sale of the company or continued self-launch of Vascepa, perhaps with third-party support. He said a marketing partner would be in place if Amarin receives FDA approval to market Vascepa to an expanded population of 40 million U.S. adults with high levels of triglycerides, which is about 10 times the number currently targeted with the agency's initial decision to OK the drug for people with very high levels of fat in their blood.
Zakrzewski said investors should be focused on Amarin patents, which have been winning approvals from the U.S. Patent and Trademark Office at an increasing rate in the past few months. The company currently has about 10 patents approved, he said, with key patents targeting patients with less severe levels of triglycerides still awaiting final decisions.
Amarin's so-called ANCHOR trial involving patients with high levels of triglycerides is expected to be completed in February.
A favorable ANCHOR outcome "can clearly only help in whatever discussions are going forward," Zakrzewski said.