Glucomed/Flexove approved by EU
(Lysaker, Norway, 14 December 2006) The EU Commission has issued final approval of Navamedic ASA’s Glucomed/Flexove product for symptom relief in osteoarthritis.
The EU Committee for Medicinal Products for Human Use (CHMP) in September recommended approval of the product across the 25 EU/EAA countries included in the procedure. This recommendation has now been finally decided by the EU Commission
-This is a great day for Navamedic. We are glad to see that our product reached the final EU approval, which is the final milestone on EU level. We look forward to introducing Glucomed/Flexove in new markets, and believe our safe and effective product will attract significant interest among doctors and in the large and growing group of patients suffering from osteoarthritis, says CEO Øyvind Brekke in Navamedic ASA.
Next step for Navamedic is to obtain national marketing authorisations (MA) in the individual countries, concerning product packaging and information leaflets in local languages, etc. According to EU timelines, Navamedic should receive the MAs during the first quarter of 2007, and the company prepares for product launches in new markets from the second quarter of 2007. In the relevant markets, the company and its partners are also working to secure reimbursement procedures for Glucomed/Flexove prior to product launch.
The active substance in Glucomed/Flexove is glucosamine HCl, which is derived from chitin from shrimp shells. Navamedic is establishing a position throughout the value chain, with own chitin production and a proprietary and cost-efficient method for refinement into glucosamine HCl. The company has already entered into marketing and distribution agreements with 12 partners covering 22 countries in and outside of the EU/EAA region, and will continue to widen the geographical coverage. Glucomed/Flexove is already on the market in Sweden and Iceland.
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 25 countries in the EU/EAA region. The product has been launched in Sweden and Iceland and Navamedic prepares product launches in further countries during 2007. For more information, please see www.navamedic.com
- Contact Information
- Bernt-Olav Røttingsnes
- Navamedic ASA
- Contact via E-mail
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