Marketing authorization in Mexico increases Pronova BioPharma’s growth potential
Lysaker: Pronova BioPharma ASA’s (OSE: PRON.OL) Spanish partner, Gruppo Ferrer has received marketing authorization from the Mexican health authorities.
The sales and marketing license in Mexico covers both the treatment of elevated levels of triglycerides in humans, hypertriglyceridemia (HTG), and the secondary prevention of post-myocardial infarction (post-MI).
Mexico has a population of about 113 million people and is the world’s fourteenth largest pharmaceutical market, according to IMS.
“Mexico is one of a long list of new markets where we expect Omacor®/Lovaza(TM) to be approved in the coming years. This is part of our strategy to maximize the potential of our first commercialized product,” says president and CEO Morten Jurs in Pronova BioPharma.
Gruppo Ferrer is Pronova BioPharma’s licensing and distribution partner for Spain, Portugal, Germany, Greece, Central and South America and South East Asia. The territory served includes such major pending markets as Brazil.
About Pronova BioPharma
Pronova BioPharma is a global leader in the research, development and manufacture of marine-originated omega-3 derived pharmaceutical products. Pronova is the first and only company with an EU and FDA approved Omega-3 derived prescription drug. 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, using a unique and complex process, at the Company’s plants in Sandefjord, Norway and Kalundborg, Denmark.
Omacor®/LovazaTMis 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®/LovazaTM 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®/LovazaTM 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 (USA), Takeda Pharmaceutical (Japan), Prospa (Italy) and Abbott (UK, Germany and others). The combined sales force from this network, focused on the sale of Omacor®/LovazaTM, is approximately 2,650 sales representatives.
Omacor®/LovazaTM was launched in 2005 in the USA and in major European markets, such as France and Spain. IMS Health reports that global end-user sales of the product have increased from USD144 million in 2005 to USD 1.1 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.
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 information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)
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