Capital markets day: presentation material and CEO introduction

Pronova BioPharma's capital markets day is held at Kalundborg, Denmark, today. The
presentation material is enclosed, and can also be downloaded from the company's website www.pronova.com. The key elements of Chief executive Morten Jurs' introductory presentation are as follows:

 

The growth strategy continues
Substantial investments in new production capacity have been made during the last years, driven by the growth in demand
The new plant in Kalundborg, Denmark is close to completion, and Pronova BioPharma is well positioned to grow further and meet the current demand
The completion of this major project creates a room to manoeuvre, which enables the company to further strengthen its focus on activities to increase the future market potential. This implies further focus on growth in existing markets, successful launches in new markets, development of new indications, new formulations, and new products

Letter of intent signed for the VITAL study 
Pending a final agreement, Pronova BioPharma has signed a letter of intent, where Pronova BioPharma will supply the trial with Omacor as study drug
The study is one of the largest primary prevention trials, studying the effect of Omega-3 FA/ Vitamin D, in a population of 20 000 trial subjects (men >= 60 years, women >= 65 years) with  no  history of cancer or cardiovascular disease (CVD) 
The trial period is 5 years
Primary endpoint for the trial is the composite of myocardial infarction, stroke and cancer
Secondary endpoint (Omacor® arms)  is  a) the composite of primary endpoint + revascularization, and b) individually,  myocardial infarction, stroke, revascularization, cancer mortality

 

Qualified person statement received for initiating production at Kalundborg
The QP statement implies that the new plant has obtained legal admission to produce for commercial purposes
The timeframe for GMP certification and regulatory approval remains unchanged, and the first commercial shipments are expected to take place in Q1 2010.

 

Frost & Sullivan Excellence award granted
Pronova BioPharma was recently awarded the 2009 Frost & Sullivan Excellence in Financial & Risk Management Award in the Global Heart Health Ingredients market for its lead product Omacor®/LovazaTM
The Frost & Sullivan Excellence in Financial & Risk Management Awards are presented annually to companies that demonstrate outstanding management of current market conditions, besides preparing for the future, above others within their respective industries

 

Intellectual property update
Pronova filed lawsuits in Q2 against Teva Pharmaceuticals USA , Inc., PAR Pharmaceutical, Inc. USA and Apotex Inc. at the States District Court for the District of Delaware
A scheduling conference was held on 11 August 2009. No documentation from the hearing has been made available yet
A preliminary process for discovery is initiated
Pronova BioPharma continues to have strong confidence in its US patents

For further information, please contact:
Hilde H. Steineger, Vice president IR and communications, +47 48 00 42 40
Morten Jurs, President and CEO,  +47 22 53 49 10