Amarin Builds Global Supply Network for AMR101

Amarin Corp. has expanded its supply network for AMR101 through the addition of two API suppliers and two encapsulators. Equateq Ltd. and Chemport Inc. have agreed to provide Amarin with API, while Catalent Pharma Solutions and Banner Pharmacaps Europe will provide soft-gel encapsulation services. These agreements expand Amarin’s entire supply chain and provide the company with significantly greater global capacity and diversification in preparation for the commercial launch of AMR101.

AMR101 is a prescription-grade omega-3 fatty acid that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels.

Joseph Zakrzewski, Amarin’s executive chairman and chief executive officer, stated, “A primary 2011 goal for Amarin is to expand our global supply chain to support expected product demand, diversify our supply base and ensure cost-efficient supply. Positive clinical trial results heightened the timing and urgency of achieving that goal. We believe that the addition of these suppliers position us, subject to regulatory approval, for an aggressive launch of AMR101.”

Equateq, based in Scotland, and Chemport, based in South Korea, are companies with substantial expertise in manufacturing polyunsaturated fatty acids for use in both pharmaceutical and nutraceutical products. Amarin has used Banner for encapsulation services for many years, including encapsulation for all of AMR101’s clinical trials.

Amarin’s current plan, subject to 3Q11 submission and subsequent approval of an NDA, is to launch AMR101 based on product produced by its existing API supplier. The company has created a protocol, with feedback from regulatory authorities, for the qualification of additional API suppliers. The company’s aim is for Equateq and Chemport to complete all necessary qualification steps needed to facilitate the submission of a supplemental NDA promptly upon any approval of the NDA.

As part of the API agreements, Amarin is obligated to make minimum annual purchases from Equateq ranging from approximately $10 to $20 million. In addition, Amarin has agreed payEquateq a one-time commitment payment of $1.0, development fees up as much as $0.5 million, as payment as high as $5.0 million for purchasing initial raw materials to be credited against future API purchases. The company is obligated to make minimum annual purchases from Chemport ranging from approximately $7.5 to $15 million. Amarin agreed to make a minority share equity investment in Chemport of up to $3.3 million.

No lump-sum or minimum dollar amount payments are required in the terms with which the company has agreed with Catalent and Banner.