Amarin (NASDAQ:AMRN) spiked nearly 8% on Tuesday before falling to earth and landing essentially flat over Monday's close. The day's moves followed a seemingly encouraging development for the only drug the company has on the market.
Amarin announced that the regulatory approval process for Vascepa has started in China and Hong Kong.
On the mainland, the Chinese National Medical Products Administration has accepted a new drug application for the medicine. The Hong Kong Department of Health is separately evaluating it based on current approvals in the U.S. and Canada. Amarin's partner Edding has filed both submissions.
Amarin expects a decision near the end of this year from authorities in both mainland China and Hong Kong.
It feels that decision will be in its favor. In Amarin's press release heralding the news, Edding Chief Medical Officer James He said, "Prevention and treatment of cardiovascular disease (CVD) is one of the major initiatives promoted by Health China 2030." Health China 2030 is a broad program to improve the massive Asian country's overall healthcare.
"However, few new [cardiovascular disease] medications other than statins were launched in the market during the past several decades," He added.
Perhaps the initial enthusiasm over this news was tempered by the sobering realization that Amarin's current fortunes depend heavily on Vascepa. I don't think investors should be discouraged. The drug is still a potential global blockbuster despite recent legal setbacks in the U.S.