RESTYLANE approved for sales in USA

UPPSALA, Sweden, Dec. 12, 2003 (PRIMEZONE) -- The FDA (Food and Drug Administration), the American regulatory authority, has approved RESTYLANE for sales in USA.

The FDA's approval of RESTYLANE means that Q-Med will receive the second payment of USD 53.3 million from the American company Medicis, which has held the rights to sell and market RESTYLANE in USA and Canada since March.

"RESTYLANE is the only non-animal hyaluronic acid based product for the filling out of wrinkles which has been approved for the US market. The approval is further proof of the product's safety and quality. This will also strengthen our dominant position in other markets," says Bengt Agerup, Q-Med's President and CEO.

With the launch in USA Q-Med will begin to manufacture RESTYLANE for Medicis. Q-Med is the exclusive manufacturer of the product. Medicis anticipates that they will be able to begin to sell RESTYLANE in USA within the coming months.

Agerup concludes by saying, "We are happy that Medicis can now begin sales in USA and we know that they have every chance of succeeding. As it is estimated that the American market for esthetic products represents half of the world market, these sales will be of great significance for Q-Med."

Queries should be addressed to:

Bengt Agerup, President and CEO, Ph:+46(0)70-974 90 25. Fredrik Hallstan, Manager, Investor Relations and Corporate Communications, Ph:+46(0)70-974 90 15.

Note: Q-Med AB operates under the name of Q-Med Scandinavia, Inc. in the USA.

The deal with Medicis

On February 10, Q-Med announced the divestiture of the North American business with regard to RESTYLANE, RESTYLANE Fine Lines and RESTYLANE Perlane to the American company Medicis.

At the beginning of March Q-Med received a first payment of USD 58.2 million. The second payment of USD 53.3 million will be made to Q-Med now that the FDA has approved RESTYLANE. USD 29.1 million is due after sales approval of RESTYLANE Perlane. When certain milestones have been met a further USD 19.4 million is due to Q-Med. In total the deal generates USD 160 million for Q-Med. Furthermore, Q-Med retains the rights to exclusive manufacture of the three products for the North American market for 10 years.

Medicis Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological, pediatric and podiatric conditions. Medicis has leading branded prescription products in a number of therapeutic categories, including acne, asthma, eczema, fungal infections, hyperpigmentation, photoaging, psoriasis, rosacea, seborrheic dermatitis and skin and skin-structure infections. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. Medicis is listed on the New York Stock Exchange under the trading symbol "MRX."

RESTYLANE RESTYLANE is Q-Med's product both for the filling out of wrinkles and folds in the face and for filling out lips. The product is based on Q-Med's NASHA technology (Non-Animal Stabilized Hyaluronic Acid). RESTYLANE was approved for sales in Europe in September 1996. RESTYLANE is sold in just over 60 markets in Europe, South America and Asia, via Q-Med's eight sales companies or through distributors. RESTYLANE is a market leader in all these markets. Comparative clinical studies with other similar products have demonstrated RESTYLANE's superiority.

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 RESTYLANE 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 440 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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