Capital markets day: presentation material and CEO introduction
(Thomson Reuters ONE) - Pronova BioPharma's capital markets day is held at Kalundborg,Denmark, today. Thepresentation material is enclosed, and can also be downloaded fromthe company's website www.pronova.com. The key elements of Chiefexecutive Morten Jurs' introductory presentation are as follows:The growth strategy continuesSubstantial investments in new production capacity have been madeduring the last years, driven by the growth in demandThe new plant in Kalundborg, Denmark is close to completion, andPronova BioPharma is well positioned to grow further and meet thecurrent demandThe completion of this major project creates a room to manoeuvre,which enables the company to further strengthen its focus onactivities to increase the future market potential. This impliesfurther focus on growth in existing markets, successful launches innew markets, development of new indications, new formulations, andnew productsLetter of intent signed for the VITAL studyPending a final agreement, Pronova BioPharma has signed a letter ofintent, where Pronova BioPharma will supply the trial with Omacor asstudy drugThe study is one of the largest primary prevention trials, studyingthe effect of Omega-3 FA/ Vitamin D, in a population of 20 000 trialsubjects (men >= 60 years, women >= 65 years) with no history ofcancer or cardiovascular disease (CVD)The trial period is 5 yearsPrimary endpoint for the trial is the composite of myocardialinfarction, stroke and cancerSecondary endpoint (Omacor® arms) is a) the composite of primaryendpoint + revascularization, and b) individually, myocardialinfarction, stroke, revascularization, cancer mortalityQualified person statement received for initiating production atKalundborgThe QP statement implies that the new plant has obtained legaladmission to produce for commercial purposesThe timeframe for GMP certification and regulatory approval remainsunchanged, and the first commercial shipments are expected to takeplace in Q1 2010.Frost & Sullivan Excellence award grantedPronova BioPharma was recently awarded the 2009 Frost & SullivanExcellence in Financial & Risk Management Award in the Global HeartHealth Ingredients market for its lead product Omacor®/LovazaTMThe Frost & Sullivan Excellence in Financial & Risk Management Awardsare presented annually to companies that demonstrate outstandingmanagement of current market conditions, besides preparing for thefuture, above others within their respective industriesIntellectual property updatePronova filed lawsuits in Q2 against Teva Pharmaceuticals USA , Inc.,PAR Pharmaceutical, Inc. USA and Apotex Inc. at the States DistrictCourt for the District of DelawareA scheduling conference was held on 11 August 2009. No documentationfrom the hearing has been made available yetA preliminary process for discovery is initiatedPronova BioPharma continues to have strong confidence in its USpatentsFor further information, please contact:Hilde H. Steineger, Vice president IR and communications, +47 48 0042 40Morten Jurs, President and CEO, +47 22 53 49 10http://hugin.info/137506/R/1340376/320292.pdfhttp://hugin.info/137506/R/1340376/320293.pdfhttp://hugin.info/137506/R/1340376/320297.pdfhttp://hugin.info/137506/R/1340376/320298.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Bereitgestellt von Benutzer: hugin
Datum: 09.09.2009 - 10:30 Uhr
Sprache: Deutsch
News-ID 5626
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