Marketing and distribution agreement in France
The agreement is dependent on granting of Marketing Authorisation and reimbursement in France, following a positive outcome of the ongoing arbitration procedure.
Navamedic's glucosamine HCl product was approved in 20 countries in the EU/EAA region in January but France was among five countries which rejected approval. Navamedic's application was thus referred to arbitration in the EU Committee for Medicinal Products for Human Use (CHMP) in March. The outcome of the arbitration procedure will at the earliest be ready during September 2006, and, depending on the outcome and potential appeals, a final decision by the EU Commission may still be 9-12 months away. The final decision will be valid for all 25 EU/EAA countries concerned with Navamedic's application.
-Although both product approval and reimbursement need to be obtained before this marketing and distribution agreement will take effect, we are very glad and proud to secure this major player as a partner. This shows that one of the leading pharmaceutical companies in the important French market shares our confidence in Glucomed as safe and effective in the treatment of osteoarthritis symptoms, says CEO Øyvind W. Brekke in Navamedic ASA. Our partner is a leading company with a demonstrated track record on the French market for rheumatology treatment, and we believe it is the best partner we could have for the marketing of our product in France.
Our partner holds a significant share of the French EUR 200+ million market for rheumatology treatment, and aims to position Glucomed as a new and important product in this market.
Navamedic will receive an up-front payment of EUR 100,000 and an additional EUR 100,000 when both approval and reimbursement has been granted. Navamedic has a repayment obligation if the product should not be approved.
Including the new agreement for France, Navamedic has established a network of 10 marketing and distribution partners, covering 14 countries of which four are outside of the EU/EAA region.
Navamedic launched its glucosamine HCl product in Sweden in December 2005, and additional launches are dependent on the timeline for the granting of national marketing authorisations. Navamedic is currently in the process of applying for Marketing Authorisations in all the countries that have approved the product, and the first Marketing Authorisation has already been obtained. The company will return with a more detailed status report on this process in connection with the presentation of the interim financial report for the second quarter 2006 on 23 August.
For further information, please contact:
Øyvind W. Brekke, CEO
E-mail: oyvind.brekke@navamedic.com
Office: +47 67 11 25 40
Mobile: +47 91 19 81 64
Jon W. Ringvold, CFO/IRO
E-mail: jon.ringvold@navamedic.com
Office: +47 67 11 25 44
Mobile: +47 99 15 85 34
About Navamedic ASA:
Navamedic is a Norwegian speciality pharmaceutical company focusing on the development and production of glucosamine HCl (hydrochloride) based medicines. Glucosamine is a generic active ingredient which relieves pain and improves function in patients with mild to moderate osteoarthritis. The product has a favourable safety profile. Osteoarthritis is a chronic disease which affects a large and growing share of the world`s population. Navamedic aims to become a leading company in the glucosamine industry, with a competitive advantage in proprietary production technology. The company`s products will be sold through a network of sales, marketing and distribution partners. Navamedic`s product Glucomed has been approved as a medicine against osteoarthritis in 20 European countries. The product was launched in Sweden in December 2005, and Navamedic prepares product launches in further European countries in 2006. For more information, please see www.navamedic.com