Pronova BioPharma Norge AS files lawsuit against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. relating to Lovaza(TM).
Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) (“Pronova BioPharma”) today announces that Pronova BioPharma Norge AS has filed a lawsuit against Teva Pharmaceuticals USA, Inc. (“Teva USA”) and Teva Pharmaceutical Industries Ltd. in the United States District Court for the District of Delaware asserting infringement of Pronova BioPharma’s U.S. Patents Nos. 5,502,077 and 5,656,667 relating to omega-3-acid ethyl ester compositions and methods of using omega-3-acid ethyl esters. These patents are listed in the U.S. Food and Drug Administration’s (FDA’s) Orange Book and expire in 2013 and 2017, respectively. The lawsuit is in response to Teva USA’s Paragraph IV Certification Notice to Pronova BioPharma advising that Teva USA has submitted an Abbreviated New Drug Application to the FDA seeking approval to engage in the commercial manufacture, use, or sale of generic versions of Pronova Bio Pharma’s omega-3-acid ethyl esters capsules which are marketed in the U.S. as Lovaza(TM).
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. 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. 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: 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 is approximately 2,650 sales representatives.
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$778 million in 2008. The current annual run rate for end-user sales is estimated at US$953 million (as of December 2008), and the Company estimates that approximately 750,000 patients are currently on a prescription for Omacor/Lovaza.
Pronova BioPharma had revenues of NOK 1,302 million and EBITDA of NOK 603 million in 2008. The company is listed at Oslo Børs. See www.pronova.com for more information.
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.
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