FMC Corporation and Pronova BioPharma Sign Alginate Agreement
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.
17/12/07 FMC Corporation and Pronova BioPharma ASA have announced the companies have entered into a worldwide license and development agreement to develop products using a novel capsule technology developed by FMC. The 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 Pronova BioPharma's current active pharmaceutical ingredient, 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 expected in 2010-2011.
FMC's novel 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, reducing the size of the capsule by approximately 25 percent. The enteric release profile and smaller capsule size are expected to result in increased patient compliance.
Commenting on the announcement, Tomas Settevik, Chief Executive Officer of Pronova BioPharma, said: "The new alginate capsule technology has the potential to deliver significant benefits for patients, as well as creating important patent life-extensions for Omacor/Lovaza and other products under development in our pipeline. We look forward to working with FMC in bringing the new capsule technology to market, which we anticipate taking place by 2010-2011."
Ted Butz, Vice President and General Manager, FMC Specialty Chemicals Group said: "We are delighted to partner with Pronova BioPharma to combine our leading edge oral dose technology with such an important pharmaceutical product franchise."
