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PRC-4016 to begin clinical trials for mixed dyslipidemia

June 16, 2011 - London

Lysaker, Norway, 16 June 2011: Pronova BioPharma will today announce pre-clinical results of PRC-4016, a new chemical entity for the treatment of mixed dyslipidemia, and the Company is preparing to initiate clinical trials.


Mixed dyslipidemia is one of three main types of dyslipidemia, which is caused by 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. Mixed dyslipidemia is characterized by elevated triglycerides (TG) and low high-density lipoprotein-cholesterol (HDL-C) with or without raised LDL cholesterol. The prevalence of dyslipidemia across the seven major pharmaceutical markets is estimated at approximately 270 million people with diagnosis rates of approximately 35-40 percent.


Pronova BioPharma is preparing to submit a CTA (Clinical Trial Application) for PRC-4016 in Europe, with the first patients expected to be dosed in September 2011. The Phase I trial will involve 80-120 subjects and be conducted in the UK. PRC-4016 will be tested in single and multiple escalating doses.  Phase II studies are expected to begin in H1 2012.


PRC-4016 is a structurally enhanced omega-3 fatty acid with potent triglyceride and cholesterol lowering effects.


Results of pre-clinical studies of PRC-4016 will be announced today at Pronova BioPharma's Capital Markets Day in Oslo, Norway. PRC-4016 was shown to be more potent than fenofibrate in lowering both triglycerides and LDL cholesterol. PRC-4016 also increased HDL cholesterol more than the corresponding dose of fenofibrate in mouse models. Fenofibrate is currently the most commonly used treatment for mixed dyslipidemia.


PRC-4016 is the first of a number of new chemical entities to emerge from Pronova BioPharma's research into derivatives of omega-3 fatty acids. More than 500 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. A substantial number of the derivatives identified are more potent than traditional omega-3 fatty acids.


Commenting on the announcement, Morten Jurs, CEO of Pronova BioPharma, said, "There is a significant need for new approaches to the treatment of mixed dyslipidemia that can reduce triglyceride and non-HDL cholesterol levels in the blood while raising levels of HDL cholesterol. Current approaches do not achieve all of these goals and are further hampered by a narrow therapeutic window and unwanted side effects. We are optimistic that PRC-4016 has an optimal profile to set new standards in the treatment of dyslipidemia. This is a significant milestone for Pronova BioPharma and we look forward to the clinical development phase."



About Pronova BioPharma
Pronova BioPharma is a global leader in research, development and manufacture of lipid therapies derived from nature.


Omacor®, also known as Lovaza(TM) in the US market, and Zodin®, Seacor®, Esapent®, and Eskim® elsewhere, is the first commercialised product developed from Pronova BioPharma's active pharmaceutical ingredient (API).


It is also the first and only EU and U.S. FDA-approved Omega 3-derived prescription drug. Pronova BioPharma estimates that 1.4 million cardiovascular patients, with high elevated levels of triglycerides and/or having suffered a Heart attack, are currently on a prescription for one of the branded products containing its API. 


Marketing and distribution of Pronova BioPharma's key product is currently licensed to both local and global pharmaceutical companies. In 2009, the product reached blockbuster status with sales over USD 1 billion in the current 8 major markets and in 2010 it grew a further 19 percent to USD 1 260 million in 2010, according to IMS Health. It is currently marketed in 56 countries with potential launch in a further 30 countries.


Pronova BioPharma is developing several new, patentable lipid derivatives. The most advanced Lipid Derived Pharmaceutical programme is in the area of dyslipidemia, the abnormal concen­tration of lipids or lipoproteins in the blood.


Pronova BioPharma's headquarters are located at Lysaker in Norway, while production takes place in manufacturing facilities at Sandefjord in Norway and in Kalundborg, Denmark. The company's shares are listed on Oslo Børs with the ticker code PRON.



For further information contact:
Hamed Brodersen, VP Investor Relations and Communications           Tel: +47 40 46 81 10
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)

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

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the
information contained therein.

Source: Pronova BioPharma ASA via Thomson Reuters ONE



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