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Pronova BioPharma ASA (OSL:PRON) 6 January 2009, Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) ("Pronova BioPharma" or the "Company") today announces that it has filed a Terminal Disclaimer in US patent No. 5,656,667 ('667 Patent) with the U.S. Patent & Trademark Office. The '667 Patent is listed in the FDA's Orange Book with respect to Lovaza(TM). A Terminal Disclaimer was filed by Pronova BioPharma to disclaim the terminal part of the statutory term under 35 U.S.C. § 154 of the '667 patent which would extend beyond the expiration date of the full statutory term of U.S. Patent No. 5,502,077 ('077 Patent), also listed in the Orange Book with respect to Lovaza(TM). With patent term extension under 35 U.S.C. § 156, the '677 patent will now expire on April 10, 2017.
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For further information, please contact:
Hilde Steineger, Head of Investor Relations +47 48 00 42 40 Solveig Hellebust, Vice President HR and Communications +47 90 14 96 33
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 LovazaTM in the USA. The product is manufactured at the company's plant in Sandefjord, Norway using a unique and complex process. An additional manufacturing plant is under construction in Kalundborg, Denmark and is expected to be operational in first quarter 2010.
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 management believe represents a major market opportunity for the Company.
Pronova BioPharma's global network of license and distribution partners includes: Reliant Pharmaceuticals (owned by GlaxoSmithKline PLC) (US), Takeda Pharmaceutical (Japan), Prospa (Italy), Pierre Fabre (France), Grupo Ferrer (Spain, and others) and Solvay (UK, Germany and others). The combined sales force from this network focused on the sale of Omacor/Lovaza is approximately 2,650 sales representatives, of which about 1,500 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 and US$511 million in 2007. The current annual run rate for end-user sales is estimated at US$650 million, and the Company estimates that approximately 750,000 patients are currently on a prescription for Omacor/Lovaza.
Pronova BioPharma had revenues of NOK 1,014 million and EBITDA of NOK 503 million in 2007. The company is listed at Oslo Børs. See www.pronova.com for more information.
Disclaimer
Certain statements in this release concerning our future growth prospects are "forward-looking statements", which involve a number of risks, and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding fluctuations in earnings, our ability to manage growth, intense competition in the pharmaceutical industry including those factors which may affect our ability to manufacture our products, our ability to attract and retain highly skilled professionals, the regulatory environment in which we operate and unauthorized use of our intellectual property and general economic conditions affecting our industry. We do not undertake to update any forward-looking statement that may be made from time to time by us or on our behalf.
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.