Amarin Blows Up After Negative Adcom Vote for ANCHOR Print E-mail
By Brian Wilson - Lead Contributor   
Thursday, 17 October 2013 09:41
Yesterday was the advisory committee meeting for the ANCHOR supplementary new drug application (sNDA) submitted for the drug Vascepa (icosapent ethyl) as a treatment for patients with TG >200 mg/dL and <500 mg/dL with mixed dyslipidemia. Amarin Corporation (NASDAQ: AMRN)’s meeting turned out to be quite the disaster, and it appears that almost all investors are giving up on the company. A final vote of 2-9 was given to the sNDA , which virtually guarantees that Amarin will receive a complete response letter (CRL) on the PDUFA date of December 20th. The stock opened about 60% lower this morning as beaten investors continue to sell the ticker in full force. Amarin, at about $2.00 per share, is now down 76% for the year.

Since the stock has returned into penny stock territory, it seems that institutional support for Amarin will be quite limited going forward due to purchasing restrictions. The stock’s direction will be largely left up to individual investors who are willing to trade a stock with this kind of volatility.

The advisory committee meeting itself focused heavily on the safety profile of Vascepa in the first hours, which was generally not expected by biotech investors. It was generally agreed that Vascepa had demonstrated sufficient safety in both MARINE and ANCHOR indications, which was also supplemented by the fact that the drug has already been on the market for about nine months. However, the efficacy of the drug in lipid reduction was less clear and remained a hot topic throughout the adcom - as expected.

The panel agreed that the drug had shown promise as a triglyceride-lowering agent, although there was concern that the drug could not reduce cardiovascular risk. To establish this, Vascepa apparently needs to be put through the entirety of the REDUCE-IT trial. While this is not the final decision, it is likely that the FDA will reject the sNDA in its current form and request at least interim data from the REDUCE-IT trial.

The problem is that the trial is not scheduled to be completed until 2016, which leaves the cash-strapped company with few options going forward. Unless Amarin arranges a partnership agreement with big pharmaceutical company, it is unlikely that they will be able to fund the trial until completion. Because of this financial situation, investors have begun to panic and are now wondering whether Amarin will cut into its MARINE indication sales force.

It’s not certain what will happen to the company at this point, although the damage to the company has reached the point where a big pharma acquisition carries little risk due to the drug’s currently approved indication and reputation amongst certain pools of physicians. Even if it cannot be put under a cardiovascular risk label, the drug still has the potential to take a large portion of Lovaza’s $1 BB/year market with proper marketing.

 




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