BEDMINSTER, NJ ( TheStreet) -- Another month of FDA Orange Book updates, another non-decision on the New Chemical Entity (NCE) market exclusivity for Amarin's (AMRN) prescription fish-oil pill Vascepa.
The disclosure of another NCE delay Friday (this is number four since FDA approved Vascepa in July) moves Amarin closer to its own fiscal cliff -- the forced launch of the drug without a Big Pharma partner.
Amarin spokespersons did not return phone calls seeking comment. Amarin shares closed Friday down 4% to $10.84.
On its last conference call, Amarin said a decision to hire a Vascepa sales force would be made in the second half of November. Amarin was clearly waiting and hoping for an affirmative decision Friday from FDA that Vascepa is chemically distinct from GlaxoSmithKline's (GSK - Get Report) Lovaza. The five years of market exclusivity that comes with NCE status might have helped Amarin land a Big Pharma marketing partner for Vascepa and avoid the need to launch the drug on its own."Regarding opportunities with large pharma companies, the uncertainty around our pending regulatory exclusivity request has presented a challenge in our discussions," said Amarin CEO Joe Zakrzewski on an investor conference call Nov. 8. But with Friday's non-decision on Vascepa in hand and the Thanksgiving holiday coming up next week, Amarin must start hiring its own sales reps soon or risk delaying the drug's launch expected in the first quarter 2013. Launching Vascepa on its own is the most expensive and riskiest of three commercial options being pursued by Amarin. The company's stock price has already fallen by 30% since Vascepa's approval on July 26. The disclosure of a solo launch is likely to send Amarin's stock price even lower. Amarin's CEO Zakrzewski knows his stock price will fall if he fails to land a marketing partner or a suitor for the company. He tried to prep investors for the bad news on the Nov. 8 conference call: "I don't think anyone should think that once you build the sales force and you're launching yourself that you've eliminated the two other options," he said. Plenty of unsubstantiated rumors have been aired linking Amarin with potential suitors, including AstraZeneca (AZN - Get Report) and Teva (TEVA - Get Report), most recently. But right now, Amarin is alone, and by the company's own admission, the lack of a Vascepa NCE decision makes any deal unlikely. Amarin ended the September quarter with $215 million but quarterly operating losses of $34 million will only grow larger as the company staffs up to sell Vascepa. Amarin will have to raise more money to launch the drug effectively, if it can do that at all against a deep-pocketed competitor like GlaxoSmithKline. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein