Q-Med's product for the treatment of osteoarthritis in the knee approved in Europ

Q-MED'S PRODUCT FOR THE TREATMENT OF OSTEOARTHRITIS IN THE KNEE APPROVED IN EUROPE · Q-Med's product DUROLANE for the treatment of osteoarthritis, primarily osteoarthritis in the knee, has today obtained approval for sales in Europe, the so-called CE-mark. "DUROLANE is intended for just one injection in each course of treatment while the competing products which are on the market today use three to five injections. On a worldwide basis these products sell for approximately SEK 6 billion per year and the market is growing, primarily in USA. As the customer group and the potential are so large, we intend to work with one or more partners regarding the distribution of DUROLANE", says Q-Med's President Per Olof Wallström. OSTEOARTHRITIS Osteoarthritis (OA) is a painful and disabling disease which is characterized by gradual degradation of the articular cartilage. The disease usually affects older people, but sports injuries, for instance, can also lead to OA. The knee and hip joints, which bear the body's weight, are the ones most often affected. HYALURONIC ACID'S FUNCTION IN THE JOINTS The body's hyaluronic acid (HA) constitutes a natural part of the synovial fluid and acts in the joints both as a lubricant of cartilage and ligaments and as a shock absorber. It is known that the synovial fluid in joints affected by OA has a much lower viscosity and elasticity than in healthy joints. Injections of HA in the joint to restore the viscosity and elasticity can diminish the pain and improve the mobility of the joint. THE MARKET Osteoarthritis is regarded as the world's most common joint disease. Just over 10 percent of the adult population is estimated to have some form of this disease. It is estimated that approximately 20 million people in Europe, USA and Japan suffer from osteoarthritis in the knee joint, corresponding to approximately 3 percent of the adult population. A third of all people over the age of 60 are estimated to have OA in the knee in some form, which means that as the population becomes older the number of patients with this disease increases. The use of HA products is growing with the introduction of new and better products on the market. The HA products which are on the market today for the treatment of OA in the knee are sold for approximately SEK 6 billion each year. Today the market is mainly in Japan (approximately SEK 3 billion) and USA (just under SEK 2 billion), while the European market (just under SEK 1 billion) has so far been more conservative in the choice of forms of treatment. The American market has the fastest growth. The hyaluronic acid products which are on the market today primarily use HA of animal origin as raw material. They all require repeated injections (3-5) in each course of treatment, which takes 2-4 weeks. DUROLANE DUROLANE, which is based on NASHA, non-animal stabilized HA, as are all of Q-Med's products, is intended for only one injection per treatment. Q- Med intends to show that pain relief and increased mobility are obtained in the affected joint, and that this effect lasts for six months. Q- Med's intention is that DUROLANE will act as a complement to pain treatments (NSAIDs, Cox-2-inhibitors). STUDIES Q-Med has carried out a safety study on just over 100 patients as a basis for the application for CE-marking of DUROLANE. During 2001 a major study will be carried out, which will focus on the effect of treatment with DUROLANE in comparison with a placebo (sodium chloride injection). The study will take place in USA, Sweden and Canada on 320 patients with 6 months' follow-up. These study results will, amongst other things, form the basis of Q-Med's application for the registration of the product in USA, which it is estimated will be able to be submitted at the beginning of 2002. Patients have begun to be included in the study and it is estimated that recruiting will be complete during the summer. DISTRIBUTION As the number of doctors that Q-Med addresses with DUROLANE is so great, cooperation will be established with one or more partners who already have marketing, distribution and sales channels within this area targeting primary health care. Q-Med plans that during 2001 a partnership agreement(s) will be signed for distribution in both Europe and USA, and possibly Japan. May 8, 2001 Uppsala, Sweden Q-Med AB (publ) Per Olof Wallström, President and CEO Queries should be addressed to Per Olof Wallström, President and CEO, on +46(0)70-974 90 70 or Anna Ahlberg, Director of Investor Relations, on +46(0)18-474 90 00 or +46(0)70-974 90 15. Q-Med is a rapidly growing and profitable biotechnology and 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 four areas, Esthetics, Orthopedics, Uro-Gynecology, and Cell Therapy and Encapsulation. 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. The development of MACROLANE for breast augmentation is ongoing. DUROLANE, Q-Med's product for the treatment of osteoarthritis in the knee-joint, is in the clinical documentation phase. DEFLUX is a product which has been approved in Europe for the treatment of vesicoureteral reflux (malformation of the urinary bladder) in children and stress urinary incontinence in women. Since July 2000 Q-Med has held a majority interest in the American biotechnology company Ixion Biotechnology, Inc., which carries out research within cell therapy for diabetes. Q-Med today has 220 employees, with just above 150 at the company's production facility and head office in Uppsala, 20 at Ixion and the remainder in wholly owned foreign subsidiaries. The Q-Med share has been listed on the O-list of the Stockholm Stock Exchange since December 1999. 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 ------------------------------------------------------------ This information was brought to you by BIT http://www.bit.se The following files are available for download: http://www.bit.se/bitonline/2001/05/08/20010508BIT01020/bit0002.doc http://www.bit.se/bitonline/2001/05/08/20010508BIT01020/bit0002.pdf