UPPSALA, Sweden, Sept. 17, 2003 (PRIMEZONE) -- Q-Med (Other OTC:QMDAF): The American regulatory authority FDA, Food and Drug Administration, has now confirmed that RESTYLANE is scheduled for an Advisory Panel later this fall. The meeting will be held Friday, November 21, 2003.
"A confirmed date for a Advisory Panel brings us is one step closer to a approval for RESTYLANE in the USA," says Bengt Agerup, CEO.
"The fact that RESTYLANE is reviewed by the world's leading experts in the esthetic field, expects to further strengthen the product's position as market leader and prove that our stabilized hyaluronic acid is safer and better then our competitor's," concludes Agerup.
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.
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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