AMRN to deliver Phase 3 study results by end of 2010 Print E-mail
By Patrick Crutcher   
Wednesday, 17 November 2010 00:07

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Amarin Corp.(NASDAQ: AMRN) sure does have a way of surprising investors by delivering results ahead of schedule. We want to highlight the recent news from their 3rd quarter update.

In particular, we want to address the new CEO, shelf registration and new guidance for top-line results. All three of these events are important for the future of AMRN and AMR101. The recent momentum is indicative of the positive developments that are shaping Amarin.

Last week, we learned that their current CEO, Colin Stewart, was stepping down. The big news was that Joseph S. Zakrzewski was appointed as the new CEO. While CEO of Reliant Pharmaceutical, Mr. Zakrzewski was instrumental in the successful development of Omacor®/Lovaza® for reducing very high triglyceride levels. In 2007, Mr. Zakrzewski brokered a deal with GlaxoSmithKline to acquire Reliant for $1.65 billion. GSK recently reported strong sales of Lovaza, noting a 20 percent boost in sales on $213M in US sales for 3Q. His future role at Amarin is a strategic move to land the best partnership deal they can get, since AMR101 could be a great potential source of revenue. Ideally, AMR101 would compete directly with Lovaza, with presumably a better clinical profile.

In addition to the management change, Amarin filed a $150M mixed shelf. Amarin's cash balance as of September 30, 2010 was approximately $31.4 million. They have stated they expect current cash/resources to be sufficient through the filing of the NDA pending positive clinical results. As the ANCHOR and MARINE study wrap up over the next few months, AMRN will be spending less cash. The shelf needs to be considered in connection with the upcoming results from these pivotal studies. Amarin has stated their desire to find a commercial partner for AMR101; they even state they want Phase 3b trials to be funded by partner for several expanded label opportunities. With Zakrzewski at the helm, we have a little more confidence in this goal being achieved. This shelf could be used to raise cash in order to further attract a partner or allow for a large capital investment.

To briefly review,  AMR101(ethyl icosapentate) is a purified, prescription-grade omega-3 fatty acid compound that is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels(MARINE) and the other for the treatment of patients with high triglycerides with mixed dyslipidemia(ANCHOR). Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. We feel these are low safety risk trials and the years of research behind AMR101 demonstrate that results from the MARINE study are likely to be very positive. See the Investor Presentation below for a great overview of these trials or our initial coverage.

The most important news was an update on the MARINE trial. Previous guidance suggested that results would be known sometime in Q1 2011, but investors were greeted with a surprise.  They now expect to report top-line results from the MARINE trial before the end of 2010. To quote their CEO directly, "With less than two months remaining before we expect to learn the results of the MARINE trial, it is a very exciting time at Amarin," commented Joseph Zakrzewski, Chairman and CEO. Amarin sounds like have been really pushing the AMR101 development program. The results of the MARINE study are vital to the future of AMR101, since this study will test AMR101 in the same indication as Lovaza.

In a recent interview, Dr. Declan Doogan, chief medical officer at AMRN, had some very optimistic things to say about AMR101. First, he stated that, “AMR101 is cleaner in that when you combine AMR101 and a statin, you should not get this LDL change. We believe it will be an easier drug for doctors to prescribe than Lovaza.” This is an important point since Amarin believes the lack of DHA in AMR101 will offer a unique advantage in lowering lower high triglycerides.

He also notes the incredible amount of data backing AMR101 and it use in conjunction with statins. “If you’re using this drug as a treatment for vascular disease and cardiovascular complications, we have data to show in 19,000 patients if you add AMR101 or 96% EPA to a statin, compared with a statin alone you will get an additional 19% reduction in coronary events. You turbo-charge the statin when you give AMR101. That’s saying that pure EPA alone will do the business.” As the article states, AMR101 has demonstrated its efficacy in half the dose of Lovaza.

Amarin has been very transparent throughout the development of AMR101. They have delivered results on-time and now top-line results are ahead of schedule. The recent management change is a net positive for Amarin; Mr. Zakrzewski's past could very well be an indicator for future success. Based on statements from management at AMRN and the historical success of this type of treatment, we feel confident the top-line results should be good enough to support their NDA submission.

Disclosure: Long AMRN
Our initial coverage - http://biomedreports.com/2010102558802/potential-blockbuster-in-the-making-for-amarin.html

AMRN 3Q 2010 update - http://bit.ly/9YrcD0
AMRN appoints new CEO - http://bit.ly/aef5yX
AMRN files $150M shelf - http://bit.ly/dxoel0
AMRN 3Q conference call - http://bit.ly/ayIbBh
Investor Presentation November 12, 2010(large PDF)- http://bit.ly/bRSJKY
Recent AMRN CMO interview @ Nutraceuticals World - http://bit.ly/dfzpss




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