The U.S. Food and Drug Administration (“FDA”) Has Approved PERLANE for Sales in the USA.
STOCKHOLM, Sweden--(BUSINESS WIRE)--FDA’s approval of PERLANE means that Q-Med (STO:QMED) (NASDAQ:QMED) will receive the final purchase sum from the agreement 2003 of USD 29.1 million from the American company Medicis, which holds the rights to sell and market PERLANE in the USA and Canada. Q-Med is the exclusive manufacturer of the product. Medicis anticipates that it will be able to begin selling PERLANE in the USA within 30 days.
PERLANE consists of a crystal-clear gel that is injected into the skin for the filling out of deeper folds and wrinkles and for the treatment of lips. In the USA the approval only comprises the filling out of folds and wrinkles. The product is based on Q-Med’s patented technology, NASHA, for the production of stabilized, non-animal hyaluronic acid and has been approved in Europe since the year 2000.
Medicis is a leading specialty pharmaceutical company in the USA within dermatology that offers products for, amongst other things, the treatment of acne, asthma, hyperpigmentation, psoriasis, eczema, skin infections and a large number of other skin-related conditions. Medicis is listed on NYSE (MRX).
Q-Med AB is a rapidly growing and profitable biotechnology/medical device company. The company develops, manufactures, markets and sells primarily medical implants. The majority of the products are based on the company's patented technology, NASHA™ for the production of stabilized non-animal hyaluronic acid. The product portfolio today contains: RESTYLANE for the filling out of lips and facial wrinkles and for facial contouring, DUROLANE, for the treatment of osteoarthritis of the hip and knee joints, DEFLUX for the treatment of vesicoureteral reflux, VUR, (a malformation of the urinary bladder) in children, ZUIDEX, for the treatment of stress urinary incontinence in women and SOLESTA, for the treatment of fecal incontinence. Sales are made through the company's own subsidiaries or distributors in over 70 countries. Q-Med today has just over 600 co-workers, with approximately 400 at the company's head office and production facility in Uppsala, Sweden. Q-Med AB is listed in the Large Cap segment of the OMX Nordic Stock Exchange in Stockholm.
NASHA, DUROLANE, SOLESTA, ZUIDEX, IMPLACER, DEFLUX and all product names within the RESTYLANE family are trademarks that belong to Q-Med AB.
In the US, Q-Med AB's affiliate is the wholly-owned subsidiary Q-Med Scandinavia, Inc.
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Contacts
Q-Med AB Erika Kjellberg Eriksson, +46 (0)70-974 90 20 Vice President and CFO
