STOCKHOLM, Sweden, Nov. 21, 2003 (PRIMEZONE) -- The FDA, Food and Drug Administration, the American regulatory authority, convened an advisory panel on Friday with some of the world's leading experts within plastic surgery. The panel recommended that the FDA approve RESTYLANE in the USA by 6 votes to 3 with certain conditions.
"Both we and Medicis are very pleased with the panel's decision," says Bengt Agerup, President and CEO of Q-Med. Agerup concludes by saying, "The panel's verdict is further support to demonstrate the product's superiority regarding effect and duration. We now hope that the FDA processes the application quickly as we know that there is great demand for RESTYLANE in the USA."
On February 10 Q-Med divested 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.
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. 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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http://www.waymaker.net/bitonline/2003/11/21/20031121BIT00730/wkr0001.doc
http://www.waymaker.net/bitonline/2003/11/21/20031121BIT00730/wkr0002.pdf