UPPSALA, Sweden, May 6, 2002 (PRIMEZONE) -- In the clinical study in the USA where the Swedish company Q-Med's* product RESTYLANE has been compared with a competing collagen-based product, the effect with RESTYLANE was better in six times more patients than with the product it was being compared with. Submission of the application for registration in the USA is now proceeding according to plan.
A clinical study was started during 2001 where Q-Med's product RESTYLANE, for the correction of wrinkles, is compared with a competing collagen product. The study comprises a total of 138 patients who have been treated at six leading clinics in the U.S.A. Follow-up has now taken place after six months.
The results from the follow-up show that 56.9% of the patients have a better remaining effect from the treatment with RESTYLANE compared with the competing product, while the corresponding figure for the competing product is only 9.5 percent (p (less than) 0.0001*). This means that RESTYLANE shows a better effect in 6 times as many patients compared with the competing product. A difference in effect in favour of RESTYLANE was seen in all clinics. The patients' own assessment of the results also showed better results for RESTYLANE in 52.6 percent and for the collagen product in only 5.8 percent of all cases (p (less than) 0.0001**), which means that RESTYLANE showed a better effect than the collagen product in nearly ten times more patients.
The effect of the treatment was measured using a five-point scale, where the prerequisite for clinically significant treatment results was that the patient showed a one point better effect than the competing product at the given point in time. The patient and the evaluating doctor were "blind," that is they had no information about which product had been used for each wrinkle. The wrinkles which were treated were so-called "nasolabial wrinkles," which run from the bridge of the nose to the corner of the mouth. Each patient received treatment with both products, one on each side.
Both products displayed a similar frequency of local treatment-related reactions (e.g. redness or tenderness), the great majority of which were mild or moderate in nature and with a duration of no more than one week. No cases of serious treatment-related side-effects have occurred during the study.
The study is continuing with follow-up up to 12 months in order to measure safety.
The results from the clinical study will form the basis of the registration application for the product with the FDA (Food and Drug Administration), the American regulatory authority. The application for registration of the product will be submitted as planned to the authorities by the middle of the year at the latest.
** In the U.S.A, Q-Med is acting under the name of Q-Med Scandinavia,
Inc.
*p-value = The probability of obtaining the observed result, or an even
more positive result, on the assumption that the treatments
are equally effective.
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 and 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.
If you have any questions, please contact:
Bengt Agerup, President and CE Sofia Wahlberg
Tel: 018-474 90 00 Director of Media and Information
or 070-974 90 25 Tel: 018-474 90 00
or 073-326 91 36
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
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