Arbitration next step in product approval process
(Lysaker, Norway, 31 March 2006) Navamedic on 31 March received notice that the application for approval of its glucosamine product for medicinal use as expected will be referred to arbitration in the EU Committee for Medicinal Products for Human Use (CHMP). The company in January announced that the product was approved in 20 countries under the European Mutual Recognition Procedures (MRP) including Sweden as Reference Member State. Five countries have not yet approved the application.
Due to the negative review in five countries, the application has since January been discussed in a coordination group (CMD) consisting of one member from each of the 25 concerned member states in the European Economic Area. The CMD operates on a consensus basis and each member ultimately has ’veto’ power. As expected, the CMD was thus unable to resolve the disagreements with regards to approval of the application. The case will therefore be referred to arbitration at the CHMP, which is a part of the European Medicines Agency (EMEA).
Under the MRP, a member state can only reject approval on the basis of “potential serious risk to public health” with regards to the quality, efficacy and/or safety of the product, and the referral of the case to the CHMP is due to persisting disagreements on the clinical efficacy of glucosamine in the treatment of OA.
-Glucosamine is a safe substance and we also remain confident in its therapeutic effects for osteoarthritis symptom treatment. We launched our product Glucomed in the Swedish market in December and will begin rolling out the product in the other countries which have approved the application as soon as we receive national marketing authorisations in each country. We had not expected the EEA countries to reach consensus at this stage, and will continue to prepare the documentation needed in the arbitration process, says CEO Øyvind W. Brekke in Navamedic.
The forthcoming arbitration will end with the EMEA/CHMP submitting its opinion to the EU Commission, which will make the final decision. The EMEA/CHMP will also seek consensus but will submit a recommendation on a majority basis if consensus can not be reached. The EMEA/CHMP is required to reach an opinion within two months but the time limit may be extended to allow Navamedic to present its case, and, in the event of a negative outcome, to request a re-examination of the opinion. A final decision may take up to 12-15 months, and the Commission’s ruling will be binding for all the concerned member states.
Navamedic was listed on Oslo Børs on March 31, 2006.
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.
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- Jon W. Ringvold
- Navamedic ASA
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