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  • The FDA will publish information concerning advisory panel during this week

The FDA will publish information concerning advisory panel during this week

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The FDA will publish information concerning advisory panel during this week On Friday November 21 the FDA, Food and Drug Administration, the American regulatory authority, will hold a advisory panel. The panel will discuss possible approval of RESTYLANE in the USA. Information on what will be dealt with by this panel will be published on the FDA's website at the latest 24 hours before the panel. The address is: www.fda.gov/ohrms/dockets/ac/cdrh03.html. On February 10 Q-Med announced the divesture of the North American business with regard to RESTYLANE, RESTYLANE Fine Lines and RESTYLANE Perlane to the American company Medicis. Q-Med received a first payment of USD 58.2 million at the beginning of March. 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. USD 29.1 million will be paid after sales approval of RESTYLANE Perlane. When certain sales criteria have been met a further USD 19.4 million will be paid to Q-Med. The deal generates a total of USD 160 million for Q-Med. Queries should be addressed to: Bengt Ågerup, 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 or +46(0)18-474 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 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. ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2003/11/17/20031117BIT00220/wkr0001.doc http://www.waymaker.net/bitonline/2003/11/17/20031117BIT00220/wkr0002.pdf