At the time of the release of this report, there has not been a rul­ing in the US litigation and none of the defendants have received tentative marketing approval from the FDA, 43 months after the assumed date of Abbreviated New Drug Application (ANDA) sub­missions. The Company believe that a ruling is imminent.

Furthermore, as previously communicated on 20 April 2012, Teva UK Limited has obtained authorisation to market a generic version of a 1 gram soft capsule omega-3 acid ethyl esther in the United Kingdom. The composition patent covering Omacor® in most Euro­pean territories expired in August 2009, and this is the first known marketing authorisation of a generic pharmaceutical product based on Pronova BioPharma's active pharmaceutical ingredient (API). Pronova BioPharma is not aware of any generic launch in Europe. The Group has been preparing for the possibility of losing exclusivity since patent expiry, and will continue to monitor the situation as it evolves. Together with the company's commercial partners, Pronova BioPharma will continue to prepare to reposi­tion in a new competitive landscape. 

In the first quarter of 2012, Pronova BioPharma prepared for an expected second quarter launch in Brazil, Argentina and India. These markets possess strong demographic and healthcare growth trends, and represent attractive longer term opportunities for the Group.

In addition, Pronova BioPharma has made significant progress towards developing its consumer healthcare business for the fast-growing omega-3 consumer healthcare market with first orders expected in May and official launch in November. Pronova BioPharma's superior innovation power, based on its pharma­ceutical product expertise, and pure quality, producing high concentration omega-3s with patented environmental pollutant-stripping techniques, will help to differentiate the Company's products. 

Pronova BioPharma has also made significant progress in devel­oping its clinical nutrition business. The Group has identified two clinical research projects in clinical nutrition with top academic institutions in the United States. Furthermore, in order to help define and position the offering for the clinical nutrition markets, Pronova BioPharma has established an advisory board of global key opinion leaders in the sector. The Company is also in commercial dis­cussions with potential key clinical nutrition partners.

Phase I clinical trials of the Group's leading research and develop­ment candidate, PRC-4016, have demonstrated that the product has a high degree of tolerability; there has been no toxicity at the dose levels tested. Pronova BioPharma is therefore conducting fur­ther tests to evaluate PRC-4016 at higher doses. Once these tests are completed, in Q4 2012, the Group expects to move the product into Phase II clinical trials. 

Pronova BioPharma continues to extend its manufacturing advan­tages. During the period the Group made further progress towards achieving its 2014 target of increasing manufacturing yields by 50 percent compared to 2009 levels, and is on track to meet that goal. The Group has also made a number of technological advancements in order to produce different omega-3 concentrates.

Pronova BioPharma maintains its outlook for 2012 with revenue and EBITDA growth. The main risk to the outlook is loss of market exclusivity.

Pronova BioPharma's Chief Executive Officer Morten Jurs com­mented, "We achieved strong financial results in the first quarter of 2012. Furthermore, since the start of the year we have again made significant progress towards our strategic objectives of strengthening and diversifying the business. For our pharmaceu­tical product, we are preparing launches in developing markets and have extended our manufacturing advantages. We also con­tinue to make strong progress towards diversification, having further developed our consumer healthcare and clinical nutrition businesses, and seen encouraging safety signals in our R&D trials."

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

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