Amarin gets boost from AstraZeneca and Acasti's study failures

Posted on January 13, 2020 by Medtech[y] Staff

After fake news attacks, and constant attacks by short sellers, Amarin investors finally woke up to some great news on Monday morning as AstraZeneca and Acasti Pharma both announced surprisingly disappointing study results for their fish oil products, effectively removing both as future competitors to Amarin's Vascepa.

AstraZeneca decided to close the Phase III STRENGTH trial for Epanova after receiving the recommendation from an independent Data Monitoring Committee. The committee believed there would be a low likelihood in demonstrating a benefit to patients with mixed dyslipidaemia (MDL) who are at increased risk of cardiovascular (CV) disease.

Eponova is a fish oil-derived mixture of free fatty acids mostly composed of EPA and DHA. It is approved in the US and indicated as an adjunct to diet to reduce triglyceride levels in adults with severely high hypertriglyceridaemia. This indication is not impacted by the data from the STRENGTH trial.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “It was important to assess the potential benefit of Epanova in mixed dyslipidaemia. We are disappointed by these results, but we remain committed to addressing the needs of patients in the cardiovascular space where we have an extensive pipeline.”

The news of Acasti Pharma's Phase III TRILOGY 1 Trial failure was equally surprising to many investors as CaPre (omega-3 phospholipid), which is meant to treat severe hypertriglyceridemia, failed to reach statistical significance and had a abnormally large placebo response. While the data showed a 30.5% median reduction in triglyceride levels compared to 27.5% in the placebo group at 12 weeks, and a 42.2% decrease in patients on background statins compared to 31.5%, the data was met with a nasty response from investors, driving the stock price down over 70% to a low of .51.

Dariush Mozaffarian, M.D., Dr.P.H., principal investigator for the study, commented, “Compared with baseline, triglyceride levels in subjects receiving CaPre were substantially lower at 12 and 26 weeks in the CaPre arm, with 30.5% and 37.5% lower levels, respectively. However, these reductions were accompanied by larger than expected declines in triglyceride levels in the placebo group, which remain unexplained and highly unusual. Initial analyses suggest no protocol deviations in treatment allocation, capsule contents, laboratory quality control, or mismatched randomization that could explain these highly unusual placebo results. We are continuing to evaluate the data in detail to assess possible explanations. I am also hopeful that TRILOGY 2 topline data, expected in late January 2020, may provide more insight into this unprecedented placebo response seen in TRILOGY 1.”

What is next for Acasti Pharma?

Jan D’Alvise, president and CEO of Acasti Pharma, stated, “First, we wish to thank the physicians, study professionals, and of course the 242 patients who dedicated their time to participate in this trial. While we are encouraged by the magnitude of reduction in triglyceride levels seen among patients receiving CaPre, the large placebo effect was completely unexpected, and was about double what was seen in all other therapeutic OM3 hypertriglyceridemia trials. Several hypotheses are being investigated now by our clinical team, and by our CRO and Dr. Mozaffarian. These avenues of investigation are being carefully and rigorously pursued, and we are moving as quickly as possible to try to gain understanding and insight into the large and unexpected placebo response seen in TRILOGY 1. The Company will continue to provide updates on this investigation, as well as topline results for TRILOGY 2 as we get them, to be followed by all secondary and exploratory endpoints for TRILOGY 1 and 2 once the TRILOGY 2 study is completed and fully analyzed.”

Amarin investors have been rewarded so far today as the company's stock is up ~7% on the news and it does appear that the only remaining overhang for Amarin is their patent infringement case, which started today and is expected to last three weeks unless a settlement is reached first.

As Amarin will not face competition from AstraZeneca, and with the patent overhang likely being resolved this quarter, the next question is whether the company will take a "go at it alone" strategy or if they will go the partnership or buyout route.

The ability to maximize revenue, both domestically and internationally, with a "go at it alone" strategy is limited in so many ways. From not having enough sales reps in front of the right customers on a regular basis, to less leverage in working with payers, it would be wise for Amarin to consider any partnership or buyout options if their goal is to maximize returns for not only investors, but also the patients who will benefit from the opportunity to take Vascepa.

The next three to six months will answer a number of these questions and will be fun to see. What's certain though, is that Amarin is finally in the driver's seat and is close to being able to control their own future. That's never been the case in the past.