AMARIN, THE Dublin-based clinical stage drug development company, has announced plans to significantly expand manufacturing capacity for its lead drug subject to regulatory approval.
The Dublin-based company has recently reported stronger-than-expected trial results for its purified Omega 3 fish oil product AMR101 as a therapy for patients with high triglycerides – fats in the blood that are implicated in coronary heart disease.
Amarin’s trials also showed the drug acted without increasing the level of low density lipoprotein (“bad cholesterol”), giving it an advantage over the only rival drug in the market, GlaxoSmithKline’s Lovaza.
Amarin has signed agreements with Scottish group Equateq and South Korean-based Chemport to manufacture active pharmaceutical ingredient for its product. The company already has one supplier and is considering signing up a fourth one.
“We believe the addition of these suppliers positions us, subject to regulatory approval, for an aggressive launch of AMR101,” chief executive Joseph Zakrzewski said.
Amarin is committed to taking a minimum of $17.5 million of ingredient from the two firms annually and a maximum of $30 million. Both suppliers will have to expand their operations.
Amarin has made upfront payments of $9.8 million, $3.3 million of it to take a minority stake in Chemport. The company has also signed up two softgel capsule manufacturers.