PHILADELPHIA, Dec. 14 /PRNewswire-FirstCall/ -- FMC Corporation and Pronova BioPharma ASA today 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.”
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.
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 Pronova BioPharma’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 as hypertriglyceridemia (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 the management of Pronova BioPharma believes represents a major market opportunity for the company.
Pronova BioPharma’s global network of license and distribution partners includes: Reliant Pharmaceuticals (U.S.), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (U.K., 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 United States.
Omacor/Lovaza was launched in 2005 in the United States 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 Pronova BioPharma estimates that approximately 600,000 patients are currently on a prescription for Omacor/Lovaza.
Pronova BioPharma is listed at Oslo Bors. See www.pronova.com for more information.
Safe Harbor Statement under the Private Securities Act of 1995: Statements in this news release that are forward-looking statements are subject to various risks and uncertainties concerning specific factors described in FMC Corporation’s 2006 Form 10-K and other SEC filings. Such information contained herein represents management’s best judgment as of the date hereof based on information currently available. FMC Corporation does not intend to update this information and disclaims any legal obligation to the contrary. Historical information is not necessarily indicative of future performance.
CONTACT: Media, Jim Fitzwater, +1-215-299-6633, or Investors, Brennen
Arndt, +1-215-299-6266, both of FMC Corporation
Web site: http://www.fmcbiopolymer.com/
http://www.pronova.com/
