Pronova BioPharma and FMC Corporation to develop new alginate-based capsule production
Pronova BioPharma ASA announced that it has entered into a worldwide licence and development agreement with FMC Corporation to develop products using a novel capsule technology.
The proprietary alginate-based capsule technology is expected to significantly strengthen the product life-cycle management of Pronova BioPharma`s products and has the potential for use both with the Company`s current active pharmaceutical ingredient (`API`), marketed as Omacor in Europe and Lovaza in the United States, as well as in future products under development.
Under the terms of the agreement, FMC will apply its technology to Pronova BioPharma`s products while Pronova BioPharma will be responsible for the clinical development and for securing regulatory approval. Pronova BioPharma plans to initiate clinical trials in early 2009 and launch of the new capsule is anticipated in 2010/2011
FMC`s proprietary capsule technology uses alginate, a marine plant-derived biopolymer, as the main component in the capsule shell. Alginate is gastro-resistant, providing an enteric release profile that delays release of the drug until passage from the stomach into the intestine. The technology also has the benefit of producing a seamless capsule with a significantly thinner shell wall, thus reducing the size of the capsule by approximately 25%. The enteric release profile and smaller size of capsule are expected to result in increased patient compliance.
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