(openPR) - (Lysaker, Norway, 21 September 2006) Navamedic has received notice that its glucosamine HCl product Glucomed®/Flexove(TM) has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP). A formal approval is expected from a Standing Committee of the EU Commission in the next three months. The approval will be valid for all 25 EU/EEA countries in Navamedic´s application, and Navamedic is preparing for product launches in several new markets during 2007.
The case was decided by majority vote in a regular meeting in the CHMP 18-21 September. A considerable majority of the CHMP members voted in favor of the approval.
-This is a major breakthrough for us. We have been confident throughout this approval process that the European Medical Community, represented here by the CHMP, would recognize our glucosamine HCl product Glucomed®/Flexove(TM) as an important treatment option for osteoarthritis patients. With this CHMP decision our product Glucomed®/Flexove(TM) is approved in 25 EU/EEA countries. We have spent significant resources demonstrating the efficacy and safety of Glucomed®/Flexove(TM). The decision concludes the discussion regarding the efficacy of Glucomed®/Flexove(TM), confirming that our product has a positive risk/benefit ratio, which means that it is effective and safe in symptom relief in osteoarthritis. We are excited and eager to make our glucosamine HCl product Glucomed®/Flexove(TM) available for osteoarthritis patients throughout the EU/EEA region, says CEO Øyvind W. Brekke in Navamedic ASA.
Navamedic´s glucosamine HCl product Glucomed®/Flexove(TM) for symptom relief in patients with osteoarthritis was approved in Sweden last August. Using Sweden as a reference member state, Navamedic applied for approval in further 24 EU/EAA countries in October 2005, under the rules of Mutual Recognition Procedure (MRP). In January, 19 countries approved the product but due to negative reviews from five countries the application was further referred to arbitration in the Committee for Medicinal Products for Human Use (CHMP), which is a sub-committee of the European Medicines Agency. This disagreement has now been settled through the CHMP decision.
The Opinion from the CHMP will be submitted to a Standing Committee of the EU Commission, which is expected to issue the formal approval within the coming three months. Only in exceptional cases will this differ from the Opinion of the CHMP. National Marketing Authorisations (including approval of product information and packaging in local languages) should be obtained within Q1 2007.
-The product has already been launched in Sweden and Iceland. We have already requested national Marketing Authorisations in the countries which approved the product in January and will file in the rest of the countries as soon as possible. All in all we expect to get going with further launches from the second quarter 2007, says Brekke.
The countries covered by the decision are Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Portugal, Poland, Slovakia, Spain, Sweden and United Kingdom.
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.
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