Pronova BioPharma announces Strategic Supply Agreement for a Fixed Dose Combination Product with Omacor and Simvastatin
Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) (“Pronova BioPharma” or the “company”) today announces that its subsidiary Pronova BioPharma Norge AS has entered into a strategic supply agreement with Defiante Farmacêutica SA, a subsidiary of the Italian sigma-tau group, for the exclusive supply of the active pharmaceutical ingredient (API) for a fixed dose combination product with Omacor and simvastatin in Spain, France and Portugal, with a possibility to add other countries upon prior written agreement.
Clinical trials of the fixed dose combination product have been completed. Initial discussions with regulatory authorities in Europe have taken place. The fixed dose combination product could come to the market in 2011, contingent upon regulatory approvals and collaboration with Pronova BioPharma’s existing pharmaceutical partner network in said European countries.
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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) (USA), 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 USA.
Omacor/Lovaza 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 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$650 million, and the Company estimates that approximately 750,000 patients are currently on a prescription for Omacor/Lovaza.
Pronova BioPharma had revenues of NOK 1,014 million and EBITDA of NOK 503 million in 2007. The company is listed at Oslo Børs.
See www.pronova.com for more information.
About DEFIANTE Farmacêutica
DEFIANTE Farmacêutica, the Portuguese subsidiary of the Italian Group Sigma-Tau based in Funchal, has been active since 1999 in developing new compounds in the oncology and cardiovascular fields while continuing to invest in mature branded products. At the moment, Defiante owns the marketing rights of several medicines in many markets all over the world, especially in Europe and Africa.
For further information see Defiante web site.: www.defiante.com
sigma-tau is a leading, all Italian capital, international pharmaceutical group that invests in the research, development and marketing of innovative and effective treatments to improve patient well-being and quality of life.
sigma-tau Group has headquarters in Pomezia (Rome, Italy), and subsidiaries in France, Switzerland, the Netherlands, Portugal, Germany, the UK and the USA, as well as in Spain and Sudan where the Group operates two production facilities. It has over 2500 employees and an extensive network of licensees worldwide.
sigma-tau was founded in Italy in 1957 and achieved a global turnover of € 665 million (US$ 920 million) in 2007.
sigma-tau SpA constantly invests 16 per cent of its annual turnover in R&D. sigma-tau’s 400 R&D staff are currently running 43 R&D projects. A total of 14 NCEs and 12 known molecular entities in 30 different indications are at various stages of development.
Therapeutic areas in which the company’s research and development are focused include metabolism, neurology, cardiovascular, oncology and immunology.
sigma-tau website: www.sigma-tau.it
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