UPPSALA, Sweden, March 12, 2002 (PRIMEZONE) -- Q-Med is deepening the analysis of the results from the DUROLANE/placebo study. A high level of safety shown but it does not show a statistically significant effect of the treatment with DUROLANE compared to sodium chloride solution for the indication osteoarthritis of the knee.
The clinical trial on DUROLANE compared with sodium chloride solution has been evaluated against the conditions which were agreed upon with the FDA regarding safety and effect with a view to obtaining sales approval in the USA.
It emerged that the study successfully showed a high level of safety but did not show a statistically significant effect of treatment with DUROLANE compared to sodium chloride solution for the indication osteoarthritis of the knee. Today Q-Med therefore decided to:
- Deepen the analysis of all study results for DUROLANE in order to find, if possible, the cause of the current results. - Supply the product in the markets where it is today used and furthermore continue with the clinical trials which have been started.
In view of the fact that the product was intended to be licensed out, Q- Med is affected only marginally in the short term as no significant net revenues have been budgeted for this year. If the investigation cannot uncover any facts which strengthen the competitiveness of the product the delay in the long term will, however, mean a loss of income in relation to the internal prognoses which exist above all concerning the US market. By focusing on a number of new products and areas of use, which the company is already developing, revenues will probably came faster than planned from these interesting product investments.
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 USA for the treatment of vesicoureteral reflux (malformation of the urinary bladder) in children. ZUIDEX 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 280 employees, with 180 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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