Norwegian pharmaceutical company opens new Danish plant
(Thomson Reuters ONE) - 30 September 2009, Lysaker, Norway: Pronova BioPharma will doublecapacity for its Omacor® pharmaceutical product based on omega-3 whenits new factory opens at Kalundborg in Denmark tomorrow.Production of the company's active pharmaceutical ingredient isalready well under way at this plant when the official opening takesplace. The first commercial deliveries are due in the first quarterof 2010.The factory was certified earlier this week to good manufacturingpractice. All that now remains are final approvals from the EuropeanUnion and the USA, which are expected to be secured in the first andsecond halves of next year respectively.Until these approvals are in place, the Kalundborg facility willdeliver intermediate products to Pronova BioPharma's existing factoryat Sandefjord south of Oslo.The new plant has cost some NOK 1.9 billion, and its completion marksthe start of a new phase in the development of the fast-growingpharmaceutical company."This is an important milestone for us," says chief executive MortenJurs at Pronova BioPharma. "Our new Kalundborg plant puts us in agood position to handle rapidly expanding demand for Omacor®."That gives us opportunities to make a further commitment to boostingthe growth potential - including new markets, indications andpharmaceuticals based on marine omega-3 fatty acids."All the company's production has so far taken place at the Sandefjordfactory, which has been expanded several times in line with risingdemand.It currently has about 152 employees and an annual productioncapacity of roughly 1 200 tonnes. The Kalundborg plant will have asimilar capacity but with only 108 personnel.Several locations were assessed for the new factory. When Kalundborgwas ultimately chosen, weight was given in part to goodinfrastructure, technical services and willingness from the localauthority, and good availability of personnel, contractors andsuppliers with pharmaceutical expertise.Technology in the new facility copies the Sandefjord factory, and itsDanish workforce has received extensive training in Norway. Thatmeans they are qualified to operate the new plant from day one."Construction of the technically advanced production plant has beencompleted ahead of the deadline set when work began in the autumn of2007," says Mr Jurs. "Our project team has done a fantastic job."Omacor® is the first and only prescription pharmaceutical derivedfrom omega 3 to have secured approvals both in the EU and from the USFood and Drugs Administration.It is prescribed as a supplement to dietary changes for treatingenhanced levels of triglyceride fats in the blood(hypertriglyceridemia), associated with a number of cardiovascularconditions.Omacor® is also approved in most of the major EU countries andcertain Asian markets as a supplement to the standard treatment forpatients who have suffered a heart attack.Documented as an effective and safe pharmaceutical, Omacor® acts as acomplement to other lipid-reducing products such as statins. It isprotected by a number of patents covering product, process, use(specific indications) and formulation.Further information from:Hilde H Steineger, vice president investor relations and corporatecommunications, Pronova BioPharma ASA, +47 48 00 42 40Kjetil Olsen, president, Pronova BioPharma Danmark A/S +47 90 61 4366Pronova BioPharma in briefPronova BioPharma is a world leader for research into and thedevelopment and production of pharmaceuticals derived from marineomega-3 fatty acids.Its first commercial product is sold under the Omacor® brand in anumber of European and Asian countries, and as Lovaza(TM) in the USA.Omacor®/Lovaza(TM) is made by a complex production process at thecompany's factory in Sandefjord, Norway. A second plant built atKalundborg in Denmark is expected to become operational in the firstquarter of 2010.The product is the first and only prescription pharmaceutical derivedfrom omega-3 to have secured approvals both in the EU and from the USFood and Drugs Administration (FDA).It is prescribed as a supplement to dietary changes for treatinghypertriglyceridemia (HTG) - enhanced triglyceride fats in the blood.Very high levels of such fats can be associated with a number ofcardiovascular conditions.Omacor® is also approved in most of the major EU countries andcertain Asian markets as a supplement to the standard treatment forpatients who have suffered a heart attack.Documented as an effective and safe pharmaceutical, Omacor® acts as acomplement to other lipid-reducing products such as statins. It isprotected by a number of patents covering product, process, use(specific indications) and formulation.Pronova BioPharma's global network of licensed distribution partnersincludes GlaxoSmithKline PLC (USA), Takeda Pharmaceutical (Japan),Prospa (Italy) and Solvay (UK, Germany and others). This networkembraces a dedicated corps of roughly 2 650 salesreps.Omacor®/Lovaza(TM) was launched in the USA and major European marketssuch as France and Spain in 2005. Analyst IMS Health reports thatglobal end-user sales of the product rose from USD 144 million in2005 to USD 778 million in 2008.Annual ongoing end-user sales were estimated in June to total USD 1.2billion, and the company estimates that more than 1.28 millionpatients are now being treated with Omacor®/Lovaza(TM).Pronova BioPharma had operating revenues of NOK 1 302 million and anoperating profit (EBITDA) of NOK 603 million in 2008. It is listed onthe Oslo Stock Exchange.See www.pronova.com for further information.This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 30.09.2009 - 15:50 Uhr
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