Amarin shares soar after drug trial

THE most advanced in-trial drug of Dublin-headquartered bio-pharmaceutical company, Amarin is being tipped for “blockbuster” status, following successful Phase-3 trials.

The Nasdaq-listed company’s share price rose by 74%, yesterday, its highest in more than seven years.

Latest pre-marketing trials of the AMR101 cardiovascular treatment — aimed at proving its effectiveness in reducing triglyceride levels in patients with high triglycerides, without increasing “bad cholesterol” levels — proved successful, with its safety profile also impressing.

In the US, alone, around 40 million people have high triglyceride (the chemical form of fats in food and the body) levels. In addition to that, more than 100 million people across the world’s seven largest pharmaceutical markets have mixed dyslipidemia, or an abnormal amount of lipids in their blood.

According to Dr Manus Rogan, managing partner with Fountain Healthcare Partners — which led 2009’s €70m investment round enabling the latest Phase-3 trials for Amarin — the latest results indicate big things for Amarin’s lead drug.

“The successful pivotal clinical trial results clearly position Amarin’s lead drug as a highly differentiated, effective and safe therapy for patients with at-risk lipid profiles. The product is now firmly on track to become a multi-billion dollar, blockbuster on a scale similar to statin-based lipid management drugs,” he said.

The next step for Amarin, on AMR101, is to submit a novel drug application with the US regulator (the FDA), after whose review the drug is expected to be made commercially available sometime next year.

Amarin’s management yesterday said that it was delighted with the test results, adding they “clearly differentiate AMR101 from other triglyceride lowering therapies and positions it to be both first-in-class and best overall therapy for treating the high triglyceride population.”