SOURCE: Pronova BioPharma ASA

December 14, 2007 02:27 ET

PRONOVA BIOPHARMA AND FMC CORPORATION TO DEVELOP NEW ALGINATE-BASED CAPSULE PRODUCTION

LYSAKER, NORWAY--(Marketwire - December 14, 2007) -



Pronova BioPharma ASA (OSE: PRON) ("Pronova BioPharma" or the "Company") today announces that it has entered into a worldwide licence and development agreement with FMC Corporation (NYSE: FMC) ("FMC") 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 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, 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.

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."

For further information, please contact:

Pronova BioPharma:
Tomas Settevik, CEO +47 22 53 48 61
Solveig Hellebust, Vice President HR &
Communications +47 22 53 48 94
Hilde Steineger, Head of IR +47 48 00 42 40

Financial Dynamics:
David Yates / Lara Mott +44 207 269 7182

About Pronova BioPharma

Pronova BioPharma is a global leader in the research, development and manufacture of marine-originated omega-3 derived pharmaceutical products. Pronova BioPharma's first commercialized product is branded as Omacor in a number of countries throughout Europe and Asia and as Lovaza in the United States. The product is manufactured at the Company's plant in Sandefjord, Norway using a unique and complex process. Omacor/Lovaza is the first and only EU- and FDA-approved omega-3 derived prescription drug. The drug is prescribed as an adjunct to diet for the treatment of elevated levels of triglycerides in humans, a condition known ashypertriglyceridemia (HTG), a form of dyslipidemia (or disorder of lipid metabolism). Very high triglycerides have been linked to a number of cardiovascular diseases. Omacor is also approved in key European and certain Asian markets for the secondary prevention of post-myocardial infarction, or Post-MI, the period following the initial survival of a heart attack.

Omacor/Lovaza has been demonstrated in a number of clinical trials to be a potent triglyceride-lowering agent as a monotherapy. It has been documented to be efficacious, safe, and highly complementary to other lipid-lowering agents, such as statins, and can be used in concomitant treatment for mixed dyslipidemia. In addition, Pronova BioPharma is involved in various projects to develop Omacor/Lovaza in a number of cardiovascular indications, including as a combination therapy with statins for mixed dyslipidemia which management believe represents a major market opportunity for the Company.

Pronova BioPharma's global network of license and distribution partners includes: Reliant Pharmaceuticals (US), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK, Germany and others). The combined sales force from this network focused on the sale of Omacor/Lovaza is over 1,750 sales representatives, of which approximately 600 are employed by Reliant Pharmaceuticals in the US.

Omacor/Lovaza was launched in 2005 in the US and in major European markets, such as France and Spain. IMS Health reports that global end-user sales of the product have increased from US$144 million in 2005 to US$306 million in 2006. The current annual run rate for end-user sales is estimated at US$500 million, and the Company estimates that approximately 600,000 patients are currently on a prescription for Omacor/Lovaza.

Pronova BioPharma is listed at Oslo Børs. See www.pronova.com for more information.

About FMC Corporation

FMC Corporation is a diversified chemical company serving agricultural, industrial and consumer markets globally for more than a century with innovative solutions, applications and quality products. The company operates its businesses in three segments: Agricultural Products, Specialty Chemicals and Industrial Chemicals.

FMC BioPolymer, a division of FMC Specialty Chemicals Group, is the world's leading producer of alginate, carrageenan and microcrystalline cellulose. For more than half a century, manufacturers around the world have turned to FMC BioPolymer for the uncompromising performance and quality of these products. Through FMC BioPolymer's Healthcare Ventures, the company focuses on the development of improved oral dose systems for pharmaceuticals and nutraceuticals including new technology platforms and materials derived from FMC's core expertise in marine-derived biopolymers. For more information, go to www.fmcbiopolymer.com.





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