PRONOVA BIOPHARMA GRANTED GMP CERTIFICATION IN DENMARK
(Thomson Reuters ONE) - 29 September 2009, Lysaker, Norway: Pronova BioPharma ASA (OSE:PRON.OL) announces today that the Danish Medicines Agency(Lægemiddelstyrelsen) has recently inspected new manufacturingfacility in Kalundborg, Denmark and granted the company a GMP (goodmanufacturing practice) certificate.The GMP certificate from the Danish Medicines Agency verifiescompliance with the GMP guidelines. The GMP guidelines are intendedto ensure that the active pharmaceutical substance manufactured hasthe quality and purity it is represented to possess. The Agency will,at Pronova BioPharma's request, conduct periodic inspections at thefacility to ensure continued compliance."The GMP certificate marks another important milestone for thecompany's new manufacturing plant in Kalundborg. The remainingregulatory approvals are expected to be achieved early in 2010, inorder for the first commercial shipments to take place in Q1" saidKjetil Olsen, senior vice president supply chain.-- Ends --For further information, please contact:Hilde H. Steineger, vice president investor +47 48 00 42 40relations (IR) and communicationsKjetil Olsen, senior vice president supply chain +47 90 61 43 66About Pronova BioPharmaPronova BioPharma is a global leader in the research, development andmanufacture of marine-originated omega-3 derived pharmaceuticalproducts. Pronova BioPharma's first commercialized product isbranded as Omacor® in a number of countries throughout Europe andAsia and as LovazaTM in the United States. The product ismanufactured at the Company's plant in Sandefjord, Norway using aunique and complex process. An additional manufacturing plant isunder construction in Kalundborg, Denmark and is expected to beoperational in first quarter 2010.Omacor/Lovaza is the first and only EU- and FDA-approved omega-3derived prescription drug. The drug is prescribed as an adjunct todiet for the treatment of elevated levels of triglycerides in humans,a condition known as hypertriglyceridemia (HTG), a form ofdyslipidemia (or disorder of lipid metabolism). Very hightriglycerides have been linked to a number of cardiovasculardiseases. Omacor is also approved in key European and certain Asianmarkets for the secondary prevention of post-myocardial infarction,or Post-MI, the period following the initial survival of a heartattack.Omacor/Lovaza has been demonstrated in a number of clinical trials tobe a potent triglyceride-lowering agent as a monotherapy. It hasbeen documented to be efficacious, safe, and highly complementary toother lipid-lowering agents, such as statins. In addition, PronovaBioPharma is involved in various projects to develop Omacor/Lovaza ina number of cardiovascular indications, including as a combinationtherapy with statins for mixed dyslipidemia which management believerepresents a major market opportunity for the Company.Pronova BioPharma's global network of license and distributionpartners includes: GlaxoSmithKline PLC (US), Takeda Pharmaceutical(Japan), Prospa (Italy) and Solvay (UK, Germany and others). Thecombined sales force from this network focused on the sale ofOmacor/Lovaza is approximately 2,650 sales representatives.Omacor/Lovaza was launched in 2005 in the US and in major Europeanmarkets, such as France and Spain. IMS Health reports that globalend-user sales of the product have increased from US$144 million in2005 to US$778 million in 2008. The current annual run rate forend-user sales is estimated at US$953 million (as of December 2008),and the Company estimates that approximately 750,000 patients arecurrently on a prescription for Omacor/Lovaza.Pronova BioPharma had revenues of NOK 1,302 million and EBITDA of NOK603 million in 2008. The company is listed at Oslo Børs. Seewww.pronova.com for more information.DisclaimerCertain statements in this release concerning our future growthprospects are "forward-looking statements", which involve a number ofrisks, and uncertainties that could cause actual results to differmaterially from those in such forward-looking statements. The risksand uncertainties relating to these statements include, but are notlimited to, risks and uncertainties regarding fluctuations inearnings, our ability to manage growth, intense competition in thepharmaceutical industry including those factors which may affect ourability to manufacture our products, our ability to attract andretain highly skilled professionals, the regulatory environment inwhich we operate and unauthorized use of our intellectual propertyand general economic conditions affecting our industry. We do notundertake to update any forward-looking statement that may be madefrom 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.
Datum: 29.09.2009 - 10:37 Uhr
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