Granted national marketing authorisation
30 May 2006
Lysaker, Norway, - Navamedic ASA has been granted national marketing authorisation in the first of 19 EU/EAA countries which in January approved the company’s glucosamine HCl product for treatment of osteoarthritis symptoms. By the end of the summer, Navamedic expects to have filed for national marketing authorisation in all 19 countries.
Navamedic’s glucosamine HCl product Glucomed was last year approved in Sweden, which acted as reference member state in an application to 24 other EU/EAA countries under a so-called mutual recognition procedure (MRP) in October 2005. 19 countries approved the product in January this year, but as five countries did not approve the application it was referred to arbitration in the EU Committee for Medicinal Products for Human Use (CHMP) in the end of March.
Navamedic has since referral to arbitration been free to apply for national marketing authorisations in the 19 countries which already have approved the product in addition to Sweden, and has begun with the countries where it already has established distribution partnerships. The marketing authorisation includes approvals of product information leaflets as well as the packaging in the local language. Where applicable, Navamedic and its distribution partners will in addition also need to negotiate price and reimbursement terms with the medical authorities prior to product launch.
-We are glad to have received the first national marketing authorisation in addition to Sweden. We have already filed in several other countries and expect to have filed in all 19 countries by the end of the summer. We expect to revert with a more detailed status report on this process in connection with the release of our second quarter figures on 23 August, says CEO Øyvind Brekke in Navamedic.
Brekke underlines that each of the 19 countries may issue Marketing Authorisation following the submission of the texts in local language, or decide to wait for the outcome of the MRP arbitration, as the final decision by the EU Commission will be valid for all 24 MRP countries. The CHMP recommendation will at the earliest be ready by the end of September 2006. Depending on the need for additional information and, in the event of a negative outcome, a re-examination of the case, the recommendation from the CHMP and the final decision by the EU Commission may still be 10-13 months away.
For further information, please contact:
Øyvind W. Brekke, CEO
Office: +47 67 11 25 40
Mobile: +47 91 19 81 64
Jon W. Ringvold, CFO/IRO
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.
- Contact Information
- Øyvind W. Brekke
- Navamedic ASA
- Contact via E-mail
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