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news.Amarin has chosen Equateq and Chemport as active pharmaceutical ingredient (API) suppliers and Catalent Pharma Solution and Banner Pharmacaps Europe as soft-gel encapsulation service providers, to enhance AMR101 supplying.
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AMR101 is a prescription-grade omega-3 fatty acid indicated 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.
Amarin expects to launch AMR101 following the filing of a new drug application (NDA) and receiving of approval based on product produced by its existing API supplier.
Amarin also believes that Equateq and Chemport have the capabilities to scale-up and qualify their facilities to meet the requirements of Amarin and regulatory authorities.
The company has selected Catalent Pharma Solution and Banner as encapsulators based on their technical abilities, quality standards and cost.
Under the terms of the agreement, Amarin has agreed pay Equateq a one-time commitment payment of $1m, development fees up to a maximum of $0.5m as well as up to $5m payments for purchasing initial raw materials to be credited against future API purchases.
Additionally, Amarin has decided to make a minority share equity investment in Chemport of up to $3.3m.
Amarin executive chairman and CEO Joseph Zakrzewski said a primary 2011 goal for Amarin is to expand global supply chain to support expected product demand, diversify supply base and ensure cost-efficient supply.
"We believe that the addition of these suppliers position them, subject to regulatory approval, for an aggressive launch of AMR101," Zakrzewski said.