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Pronova BioPharma ASA (OSL:PRON) 11 November, 2008, Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) ("Pronova BioPharma" or the "company") today announces that a study to be presented at the American Heart Association Scientific Sessions in New Orleans, USA, shows that Lovaza/Omacor co-administered with atorvastatin significantly improves non-HDL cholesterol and triglycerides compared with atorvastatin alone. An abstract of the study was published on the AHA's conference website http://www.abstractsonline.com/plan/start.aspx?mkey=%7BD78A4520%2D4797%2D409B%2DBF84%2D2F89D1773D57%7D .
Results of the OM9L-study will be presented by Dr. Harold Bays of the Louisville Metabolic and Atherosclerosis Research Centre, principal investigator of the trial. In addition to a significant reduction in non-HDL-C levels and improvement in secondary endpoints with atorvastatin 10 mg/day, concomitant Lovaza/Omacor also significantly improved non-HDL-C and other efficacy parameters when co-administered with atorvastatin 20 and 40 mg. The study revealed no serious drug-related adverse experiences.
OM9L was a randomized, double blind, placebo-controlled study in patients with mixed dyslipidemia. The study, sponsored by the company's licensee GlaxoSmithKline plc, was designed to investigate the efficacy and safety of Lovaza/Omacor concomitant therapy with atorvastatin, also marketed as Lipitor. The primary endpoint was percentage change in non-HDL cholesterol. The major secondary endpoints consisted of percentage change in triglycerides and other lipid parameters, as well as a safety assessment.
Patients included in the study had high triglycerides and elevated LDL-cholesterol (<= 20% above the target stated by the National Cholesterol Education Program Adult Treatment Panel III guidelines). After a four-week diet run-in phase, patients were randomized to receive Omacor/Lovaza 4 g/day or placebo for 16 weeks. All patients were concomitantly treated with atorvastatin as follows; week 1-8 with atorvastatin 10 mg, weeks 9-12 with atorvastatin 20 mg, and weeks 13-16 with atorvastatin 40 mg.
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For further information, please contact:
Hilde Steineger, Head of IR +47 48 00 42 40 Jonathan Birt, Financial Dynamics +44 207 269 7205
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/SPA (Switzerland/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 RELEASE HAS BEEN PREPARED BY PRONOVA BIOPHARMA ASA (THE "COMPANY") EXCLUSIVELY FOR INFORMATION PURPOSES. THIS PRESENTATION HAS NOT BEEN REVIEWED OR REGISTERED WITH ANY PUBLIC AUTHORITY OR STOCK EXCHANGE. THE DISTRIBUTION OF THIS PRESENTATION AND ANY OFFERING, SUBSCRIPTION, PURCHASE OR SALE OF SECURITIES ISSUED BY THE COMPANY IN CERTAIN JURISDICTIONS IS RESTRICTED BY LAW. POTENTIAL INVESTORS ARE REQUIRED BY THE COMPANY TO INFORM THEMSELVES ABOUT AND TO COMPLY WITH ALL APPLICABLE LAWS AND REGULATIONS IN FORCE IN ANY JURISDICTION IN WHICH IT INVESTS AND MUST OBTAIN ANY CONSENT, APPROVAL OR PERMISSION REQUIRED UNDER THE LAWS AND REGULATIONS IN FORCE IN SUCH JURISDICTION. THE COMPANY SHALL NOT HAVE ANY RESPONSIBILITY OR LIABILITY FOR THESE OBLIGATIONS. THIS PRESENTATION DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY ANY SECURITIES IN ANY JURISDICTION TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH AN OFFER OR SOLICITATION IN SUCH JURISDICTION
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