Regulatory approval in EU achieved for the Kalundborg manufacturing
plant
(Thomson Reuters ONE) - 25 November 2009, Lysaker: Pronova BioPharma ASA (OSE: PRON.OL) hasreceived approval from EU regulatory authorities for its newmanufacturing plant in Kalundborg, Denmark, enabling the plant tostart commercial deliveries in the first quarter of 2010, as planned.The timeline for the approval from the US Food and DrugAdministration remains unchanged and is expected to be received inthe second half of 2010. "This approval marks one of the last major milestones for theimportant and prestigious investment project in Kalundborg. Our newplant is now recognised by the EU as an approved manufacturer of ouractive pharmaceutical ingredient, and we look forward to start thecommercial deliveries to our European partners early in the firstquarter of 2010," says CEO Morten Jurs._____ ends ________For further information, please contact:Morten Jurs, CEO +47 99 16 79 22Hilde H. Steineger, Vice president of IR and +47 48 00 42 40communicationsAbout 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. A new manufacturing plant in Kalundborg,Denmark opened on 1 October 2009, which is expected to startcommercial deliveries in the first quarter of 2010.Omacor®/Lovaza(TM) 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(TM) has been demonstrated in a number of clinicaltrials to be a potent triglyceride-lowering agent as a monotherapy. It has been documented to be efficacious, safe, and highlycomplementary to other lipid-lowering agents, such as statins. Inaddition, Pronova BioPharma is involved in various projects todevelop Omacor®/Lovaza(TM) in a number of cardiovascular indications,including as a combination therapy with statins for mixeddyslipidemia which management believe represents a major marketopportunity 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(TM) is approximately 2,650 sales representatives.Omacor®/Lovaza(TM) was launched in 2005 in the US and in majorEuropean markets, such as France and Spain. IMS Health reports thatglobal end-user sales of the product have increased from US$144million in 2005 to US$778 million in 2008. The current annual runrate for end-user sales is estimated at US$953 million (as ofDecember 2008), and the Company estimates that approximately 750,000patients are currently 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: 25.11.2009 - 15:06 Uhr
Sprache: Deutsch
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