Global growthDemand for omega-3 derived pharmaceutical products is growing on a global basis. Record-high end-user sales of Omacor®/Lovaza™ in 2009 lead to blockbuster status of Pronova BioPharma’s active pharmaceutical ingredient (API). Omacor®/Lovaza™ is approved in the USA as well as key European and certain Asian markets as an adjunct to diet for the treatment of elevated levels of triglycerides, and has also been approved in certain European and Asian markets for the secondary prevention of post-myocardial infarction in the period following the initial survival of a heart attack. High triglycerides (HTG) and post-myocardial infarction (Post-mi) therefore represent the group’s two target segments based on indications. Pronova BioPharma’s eight major geographical market segments comprise the USA, Italy, the UK, France, Greece, Spain, Germany, and Korea. Omacor® and Lovaza™ are distributed in 46 countries through our network of strong, regional distribution partners. Post-MI marketEach year, around 3.7 million patients in the major pharmaceutical markets suffer an MI. Around 1.1 million of these cases occur in the five major European markets, and the prevalence of MI is expected to increase (source: Business Insights). HTG-marketDyslipidemia is a disorder of lipid metabolism which refers to an imbalance in the level of blood lipids. Lipids, or fat molecules, include both cholesterol and triglycerides, and dyslipidemia has been shown to play an important role in the development of cardiovascular diseases. The main types of dyslipidemia are:
The prevalence of dyslipidemia across the seven major pharmaceutical markets in 2005 was roughly 267 million people (source: Datamonitor 2005). In addition, it is estimated that some 103 million of the individuals with dyslipidemia are actually diagnosed, with diagnosis rates ranging from 35 to 42 per cent in the major pharmaceutical markets. Pronova BioPharma believes that the market will experience further expansion as more patients are diagnosed and combination therapies are implemented. Our API has been documented to be highly complementary to other lipid-lowering agents, such as statins. New indications and formulation developmentsWe are involved in phase III of clinical trials for several cardiovascular diseases. Selective programs are ongoing with external partners to develop new capsule technology and a fixed-dose combination with a statin. Blockbuste statusThe market for Omacor®/Lovaza™ continued to grow in 2009, with total end-user sales in the eight major markets totalling roughly USD 1,063 million (source: IMS Health). More than one million patients worldwide were estimated to be on a prescription for either Omacor® or Lovaza™ at the end of 2009. The USA is by far the largest market segment, accounting for around 63 per cent of total end-user sales in 2009, with a growth of 67 per cent from 2007. This market growth is expected to continue, and GlaxoSmithKline is actively promoting Lovaza™ in the USA to increase market penetration.
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