Partly positive outcome of generic substitution case
Pfizer launched a complaint against the recommendation, based on claimed difference in tablet size between Glucomed/Glucosine, and due to significant differences in product composition between Artrox and Glucosine. Länsrätten did not find that it was sufficiently demonstrated that these differences are important enough to prevent generic substitution.
In desember 2006, Länsrätten rejected Navamedic's similar complaint regarding substitution of Recip's Glucosine. Navamedic has appealed this decision to Kammarrätten. If the outcome in the two substitution cases will remain in force, all three products will bee on the same generic substitution list.
-We are satisfied that Länsrätten have maintained the decision of Läkemedelsverket's that Glucomed is subject to substitution with Artrox, but we continue to believe that Glucosine is not identical to Glucomed and Artrox. The company will now evaluate the best way to address the Swedish market if the outcome of the cases remain in force, says CEO Øyvind W. Brekke.
The decision applies only to Sweden, and has no effect on other markets.
The EU Commission in December 2006 approved Navamedic's product Glucomed/Flexove for symptomatic treatment of osteoarthritis. The approval is valid in all 25 EU/EAA countries involved in the application. Navamedic has built a sales, marketing and distribution network with 12 partners covering 23 countries inside and outside Europe.
For further information, please contact:
CEO Øyvind W. Brekke, Navamedic
E-mail: oyvind.brekke@navamedic.com
Office: +47 67 11 25 40, Mobile: +47 91 19 81 64
CFO Bernt-Olav Røttingsens, Navamedic
E-mail: bor@navamedic.com
Office: +47 67 11 25 44 Mobile: +47 913 47 021
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. Navamedic`s product Glucomed®/Flexove(TM) has been approved across 25 EU/EEA states by European Medicines Agency (EMEA), as the first and only glucosamine based medicine against osteoarthritis. The company`s products will be sold through a network of sales, marketing and distribution partners.