Will Patent Protection Derail Amarin's Miracle Fish Pill?

Shares in Amarin Corporation recently fell 10%, due to a decision by the US Patent and Trademark Office to issue a non-final rejection of a patent linked to AMR101, a lipid reduction drug that helps to treat high levels of triglycerides in patients. The company had previously announced that the drug was highly effective in reducing levels of triglycerides in a pair of Phase 3 trials, and is considered to have blockbuster potential, with some analysts projecting sales up to $2 billion a year, as nearly 75 million people in the US are affected by high TG levels. Amarin has submitted multiple method-of-use patent applications with the hopes of extending its 5 years of exclusivity for AMR101, as well as fending off generic competitors. However, multiple patent rejection letters, as well as comments from CEO Joe Zakrzewski that the small company may choose to market the drug itself has dealt swift blows to the stock price, as it now trades near 52-week lows, well off highs of $19.87. AMR101 is composed of a purified, omega-3 fat acid compound and demonstrated strong safety and efficacy in a pair of Phase 3 trials in its ability to lower triglycerides in patients with high levels. In its initial MARINE study, AMR101 showed a decrease in TG levels of 45% for patients given a 4 gram dose, and 33% for patients given a 2 gram dose. The clinical benefit is crucial, as similar drugs such as GlaxoSmithKline's Lovaza have not been able to demonstrate the same result. AMR101's primary advantage against Lovaza stems from its superior cholesterol profile. Unlike Lovaza, AMR101 does not have the side effect of raising LDLs, or bad cholesterol. Lovaza has this side effect, which potentially requires patients to undergo additional treatments. AMR101 also demonstrated that it could reduce AMR markers, resulting in a reduction of total cholesterol levels. In August, Amarin announced that it had reached a Special Protocol Assessment on how to potentially run an outcome study. The SPA meant that the FDA had examined the trial and was comfortable with its parameters and how it would be run. SPAs typically give drugs greater odds of approval, given that the FDA has already agreed upon the design of the respective trial. Amarin's trial is particularly important, as its success would give the company permission to market AMR101 to reduce cardiovascular events such as heart attacks and strokes, in addition to treating high triglyceride levels. Unfortunately, the trial figures to last 6 years and enroll nearly 8,000 patients. Amarin announced in September that it had submitted an NDA for potential AMR101 approval. The submission is based on the entire AMR101 data package, and highlights positive safety and efficacy data from the MARINE and ANCHOR Phase 3 trials. "The submission of this NDA moves AMR101 one step closer to commercial launch. If AMR101 is approved, we believe it can play a significant role in cardiovascular health management," said CEO Zakrzewski.