Navamedic second quarter results 2006
(Lysaker, Norway, 22 August. 2006) Highlights in the quarter included the signing of a marketing and distribution agreement with a leading pharmaceutical company in France, submittal of requests for national Marketing Authorisations in 18 countries, and loan and support grants from Innovasjon Norge covering a significant part of the capital expenditure of the company's chitin factory which is under construction.
During the quarter, Navamedic has applied for national marketing authorisations in 18 of the 19 countries which approved of the company's product in January 2006. So far, the company has obtained authorisations from three countries and plans for a launch in Iceland in the third quarter. Application countries may await the arbitration opinion from the Committee for Medicinal Products for Human use (CHMP) with regards to final national approval of the product under the rules of the EU Mutual Recognition Procedures. Based on information from the CHMP, Navamedic is expecting this opinion in either September or October. The CHMP opinion will in all likelihood be followed by a formal decision with the same outcome in a Standing Committee of the EU Commission 2-3 months later. The above mentioned marketing and distribution agreement in France is also dependent on final product approvals, as well as obtained reimbursement in France.
The company's first product - Glucomed for symptomatic relief of osteoarthritis of the knee - was launched in Sweden in December 2005, but sales have been limited because of issues regarding generic substitution with existing products in the Swedish market. The case has been referred to the court (Länsretten) in Uppsala, Sweden, and Navamedic does not expect significant sales until a decision concerning generic substitution has been resolved.
Despite the outlook for limited sales in 2006, the Board of Directors and the management of Navamedic believe in a positive development and a strong growth outlook for the company in the longer term.
The Q2 2006 report can be downloaded from:
The Q2 2006 presentation can be downloaded from:
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.