20 April 2010, Lysaker: Pronova BioPharma ASA (OSE: PRON.OL) has received approval from the US FDA for its new manufacturing plant in Kalundborg, Denmark, ahead of schedule. The manufacturing plant in Kalundborg has design capacity of 1,200 tonnes, with the possibility for a modular expansion of additional 1,200 tonnes.
"FDA approval of the Kalundborg facility is the final milestone in the construction of our second manufacturing plant, doubling our current capacity. The state-of-the art manufacturing plant in Kalundborg is now recognised by both the US and Europe as an approved manufacturer of our active pharmaceutical ingredient. I am very pleased that this complex project has now been successfully completed," says CEO Morten Jurs.
_____ ends ________
For further information, please contact:
Morten Jurs, CEO +47 22 53 49 10
Hilde H. Steineger, Vice president of IR and communications +47 48 00 42 40
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 United States. The product is manufactured at the company's plant in Sandefjord, Norway using a unique and complex process. A new manufacturing plant in Kalundborg, Denmark opened on 1 October 200.
Omacor®/Lovaza(TM) 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(TM) 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. In addition, Pronova BioPharma is involved in various projects to develop Omacor®/Lovaza(TM) 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: GlaxoSmithKline PLC (US), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK, Germany and others). The combined sales force from this network focused on the sale of Omacor®/Lovaza(TM) is approximately 2,650 sales representatives.
Omacor®/Lovaza(TM) 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 US1.1 billion in 2009.
Pronova BioPharma had revenues of NOK 1,790 million and EBITDA of NOK 823 million in 2009. 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.