UPPSALA, Sweden, June 19, 2002 (PRIMEZONE) -- The application for registration in order to obtain marketing approval in the U.S.A. has been submitted according to plan to the FDA (Food and Drug Administration), the American regulatory authority. The application is based, amongst other things, on a clinical study in the USA where the Swedish company Q-Med's(1) product RESTYLANE was compared with a competing collagen-based product. In the study, which has been described in a previous press release, it was shown that six times more patients had a better effect with RESTYLANE than with the product it was being compared with.
Q-Med AB (Publ)
If you have any questions,
please contact:
Bengt Agerup, President and CEO Johan Hahnel
Tel: +46 (0) 18-474 90 00 Director of Investor
Relations
or +46 (0)70-974 90 25 Tel: +46 (0)18-474 90 00
or +46 (0)70- 231 08 07
(1) In the USA, Q-Med is acting under the name of Q-Med Scandinavia, Inc.
Q-Med AB (publ), Seminariegatan 21, SE-752 28 Uppsala, Sweden. Corporate identity number 556258-6882. Tel: +46(0)18-474 90 00. Fax: +46(0)18-474 90 01. E-mail:info@q-med.com. Home page: www.q-med.com
About Q-MED AB
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. Q-Med's operations focus on the four areas of Esthetics, Orthopedics, Uro-Gynecology, and Cell Therapy and Encapsulation. The products PERLANE, RESTYLANE and RESTYLANE Fine Lines are used for the filling out of lips and facial wrinkles and today account for the majority of sales. Development of MACROLANE for body contouring, for example breast augmentation, is ongoing. 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 U.S.A. for the treatment of vesicoureteral reflux (malformation of the urinary bladder) in children. ZUIDEX together with the injection device IMPLACER for the treatment of stress urinary incontinence in women is estimated to be available in Europe in the middle of 2002. Since July 2000 Q-Med has owned a majority interest in the American biotechnology company Ixion Biotechnology, Inc., with research within cell therapy for diabetes. Q-Med today has approximately 310 employees, with 210 at the company's production facility and head office in Uppsala, 20 at Ixion and the remainder in wholly owned foreign sales companies. 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/2002/06/19/20020619BIT01320/wkr0001.doc http://www.waymaker.net/bitonline/2002/06/19/20020619BIT01320/wkr0002.pdf