Product approval in 19 European countries
(Lysaker, Norway, 17 January 2006). Based on the approval of Glucomed®, granted by the Swedish Medical Products Agency on 4 August 2005, Navamedic launched an MRP application in 24 additional EU/EEA countries on 18 October. The 90 day procedure thus ended on 16 January 2006 and Navamedic has received notice that its product has been approved in 19 countries in addition to Sweden as Reference Member State. Five countries have so far not approved the application.
Osteoarthritis is the most widespread form of arthritis, and glucosamine is a generic active ingredient against osteoarthritis symptoms. Navamedic considers the glucosamine market an attractive high growth opportunity, and believes Glucomed® will be a highly competitive product. The company is currently building a network of marketing and distribution partners across Europe.
Navamedic expects National Marketing Authorizations to be issued in most of the 19 countries over the next months, following approval of national product information for doctors and patients. The product will be marketed under Glucomed® and other brands names. Countries having approved the application are Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia and Spain.
- We are happy to see that a majority of the EU/EEA states have approved our product for medicinal use. This is in line with the regulatory trend we have foreseen. We will now focus on the launch of our product in those markets where we already have established sales, marketing and distribution agreements and intensify the work in expanding our distribution network further, says CEO Øyvind Brekke in Navamedic.
Austria, France, Germany, Greece and the United Kingdom have so far not approved the product. Outstanding issues are mainly related to these authorities' evaluation of the efficacy documentation of the active substance. The application will now be referred to EU's co-ordination group for mutual recognition and decentralised procedures (CMD), and further to EU's pharmaceutical committee (CPMP) if consensus is not achieved in the CMD.
- We believe our application is supported by sufficient documentation to demonstrate the efficacy of the product, and this view is supported by Swedish Medical Products Agency and shared by the 19 additional countries. We look forward to present our view to the EU committees in the months to come, says Brekke.
If the case is not resolved in the relevant committees, the EU Commission will be the final deciding authority, in which case the process is estimated to take approximately 18 months. A decision by the EU Commission will be valid for all countries involved in Navamedic's MRP application.
For further information, please contact:
Øyvind S. Brekke, CEO
E-mail: oyvind.brekke@navamedic.com
Office: +47 67 11 25 40
Mobile: +47 91 19 81 64
Jon W. Ringvold, CFO/IRO
E-mail: jon.ringvold@navamedic.com
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 based medicines. Glucosamine is a generic active ingredient against osteoarthritis with 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 by capitalising on proprietary production technology. The company's products will be sold through a network of sales, marketing and distribution partners in each country. Navamedic's product Glucomed® was approved as a medicine against osteoarthritis by the Swedish Medical Products Agency in August 2005.