UPPSALA, Sweden, Sept. 11, 2003 (PRIMEZONE) -- Q-Med AB has for some time had discussion with the American regulatory authority FDA, Food and Drug Administration, regarding a possible advisory panel about RESTYLANE.
A time for a possible discussion has not been announced by the FDA. Nor has Q-Med received any information about which issues that should be subject for discussion.
On February 10, Q-Med divested the North American business with regard to RESTYLANE, RESTYLANE Fine Lines and PERLANE to the American company Medicis. The deal is expected to generate USD 160 million, which will be paid to Q-Med in several stages as and when certain agreed conditions are met. Q-Med received the first payment of USD 58.2 million at the beginning of March, after which Medicis themselves took over sales in Canada. The second payment of USD 53.3 million will be made to Q-Med when sales approval has been received for RESTYLANE from the FDA.
Queries should be addressed to:
Bengt Agerup, President and CEO
Ph: 46-70-974 90 25.
Fredrik Hallstan, Manager, Investor Relations and
Corporate Communications
Ph: 46-70-974 90 15.
Note: Q-Med AB operates under the name of Q-Med Scandinavia, Inc. in the USA.
Q-Med is a rapidly growing and profitable biotechnology/medical device company that develops, produces and markets medical implants. All products are based on the company's patented technology for the production of NASHA - Non-Animal Stabilized Hyaluronic Acid. The products RESTYLANE, RESTYLANE Fine Lines and PERLANE are used for the filling out of lips and facial wrinkles and today account for the majority of sales. DUROLANE, Q-Med's product for the treatment of osteoarthritis of the knee joint, has been approved in Europe since May 2001. DEFLUX is a product which has been approved in Europe and the USA for the treatment of vesicoureteral reflux (malformation of the urinary bladder) in children. ZUIDEX for the treatment of stress urinary incontinence in women has been sold in Europe since July 2002. Since July Q-Med today has 430 employees, with approximately 290 at the company's production facility and head office in Uppsala. The Q-Med share was first listed on the O-list of the Stockholm Stock Exchange in December 1999.
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