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New lipid-derived programme to enter clinical phase I trial


August 12, 2011 - London

12 August 2011, Lysaker, Norway: Pronova BioPharma announced second quarter and first half year results for 2011 with revenues of NOK 380.7 million, down 14.2 per cent, and NOK 832.2 million, down 7.4 per cent respectively, and compared to the same period last year. EBITDA reached NOK 150.8 million in the quarter, down 15 per cent year-on-year, and NOK 328.2 million in the first half, down 9.5 per cent. End-user demand in Pronova BioPharma's current eight largest markets, as measured by IMS, grew 12 per cent, pushing the moving annual total volume to 1 267 tonnes. This represents USD 1 350.9 billion in drug sales, consolidating the blockbuster status of Pronova BioPharma's phar­maceutical product. The robust end-user demand and higher prices helped to partly offset a previously announced decision by US mar­keting partner GSK to bring inventory levels of Lovaza(TM) in line with end-user demand, resulting in lower shipments to GSK. 2011 supply prices were higher than in 2010, with the revenue-to-shipment ratio increasing to 1.15 in the second quarter of 2011 compared to 1.00 in the same period last year. Pronova BioPharma maintains its out­look for 2011, with volume off-take in line with underlying end-user demand, tempered by inventory adjustments in the US market. Sup­ply prices are expected to increase by 10-20 per cent, from 2010 to 2011.

Numerous new derivatives of omega-3 fatty acids have been synthesised by Pronova BioPharma's scientists and run through extensive tests to identify candidates with the most promising profile. The lead candidate, PRC-4016, is the first of a number of new chemical entities to emerge from Pronova BioPharma's research into omega-3 fatty acid derivatives. A Clinical Trial Appli­cation (CTA) has been submitted to the UK authorities (Medicines and Healthcare products Regulatory Agency and the ethics com­mittee) to enter PRC-4016 into a Phase I trial. Pronova BioPharma expects the first subject to be dosed in Q3 2011, and the results are expected by Q1 2012.

The drug is a structurally modified omega-3 fatty acid. Studies in ani­mal models have shown potent triglyceride and cholesterol lowering effects. The clinical profile targets the treatment of cardiovascular and metabolic diseases, in particular mixed dyslipidemia. Mixed dys­lipidemia is one of three main types of dyslipidemia (an imbalance in the level of blood lipids). Mixed dyslipidemia is characterised by ele­vated triglycerides (TG) and low high-density lipoprotein-cholesterol (HDL-C), with or without raised low-density lipoprotein-cholesterol (LDL-C). Dyslipidemia has been shown to play an important role in the development of cardiovascular diseases. The prevalence of dyslipidemia across the seven largest pharmaceutical markets is estimated at approximately 270 million people with diagnosis rates of approximately 35-40 per cent.

Pronova BioPharma also continued its geographical expansion into new markets. The company has launched Omacor®/Lovaza(TM) in 56 markets and has, together with commercial partners, identified a further 30 countries for potential future launches. Launch in the world's second largest pharmaceutical market, Japan, is expected in 2013. Demographic developments coupled with westernisation of lifestyles, wide acceptance of omega-3 pharmaceuticals, excel­lent phase III trial results, a strong commercial partner (Takeda) and eight years of market exclusivity makes Japan a very impor­tant geographical expansion prospect. In addition to this, Pronova BioPharma expects regulatory approval and launch in a number of fast-growing emerging markets. During the quarter, regulatory approval was received in Argentina and Macedonia and market launch in Venezuela is planned for Q3 2011.

Pronova BioPharma continues to defend its intellectual property rights in the US through lawsuits against Teva and Par regarding infringement of the company's patents relating to Lovaza(TM). A ruling is expected, at the earliest, in Q4 2011. 24 months post patent expiry in most European markets, no generic entry has been identified.

Pronova BioPharma's Chief Executive Officer Morten Jurs com­mented, "Our strategic objectives are to defend our intellectual property, expand our manufacturing advantages, increase the growth potential of Omacor® and invest in R&D to secure future growth. During the quarter, we made further progress in terms of geographical expansion and development of a new pharmaceutical product pipeline. We look forward to entering a number of impor­tant new growth markets over the next three years and to starting the clinical phase with our lead pipeline candidate, PRC-4016, which has been designed to have an optimal profile in the treat­ment of dyslipidemia."

The complete second quarter and first half year report is available at www.newsweb.no and at www.pronova.com. The company will present the results today at 08:30AM CET/07:30 GMT. The presentation will be webcast live and can be accessed at www.pronova.com. (Internet explorer web browser needed). Webcast attendees may send questions electronically during the session.

                                 -- Ends --

 

For further information, please contact:
Hamed Brodersen, Vice President IR and Communications
+ 47 40 46 81 10

 

Synne H. Røine, CFO
+ 47 99 22 98 92  

 

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)

 

Pronova BioPharma Q2 2011



This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

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information contained therein.

Source: Pronova BioPharma ASA via Thomson Reuters ONE

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