RALEIGH and DURHAM, N.C., Aug. 19 /PRNewswire-FirstCall/ -- Smith & Nephew (NYSE: SNN; LSE: SN) Biologics & Spine is proceeding to the next stage in the approval process for the U.S. launch of DUROLANE(R) Single Injection, Stabilized Hyaluronic Acid.
Representatives from the product developer, Q-Med AB of Sweden ("Q-Med"), and their global commercial partner, Smith & Nephew met today with the FDA's Orthopaedic and Rehabilitation Devices Advisory Committee to discuss clinical evidence for the use of DUROLANE(R) in the treatment of knee pain caused by osteoarthritis ("OA").
The FDA Advisory Committee did not recommend DUROLANE(R) for immediate approval, requesting further information as part of the Premarket Approval ("PMA") process for the product. Smith & Nephew plans to work with Q-Med and the FDA to provide the data required.
Mark Augusti, President of Smith & Nephew Biologics & Spine, said: "We are committed to expanding our range of HA therapies in the United States. Use of our multi-injection SUPARTZ(R) Joint Fluid Therapy as a treatment for knee OA continues to increase and we are exploring its potential for other indications."
Q-Med CEO and founder Bengt Agerup said: "We are continuing the clinical development of DUROLANE(R) in collaboration with Smith & Nephew to provide satisfactory clinical evidence of DUROLANE(R)'s performance. We remain committed to our goal of providing U.S. physicians and patients access to a non-animal single injection product."
Ken Reali, SVP and General Manager of Biologics & Spine, added: "Our meeting with the Advisory Committee on single injection DUROLANE(R) provided some very useful and valuable feedback on our Premarket Approval application. We intend to work with our Q-Med partners and the FDA to initiate the next steps in making this highly successful global product available to U.S. patients."
Smith & Nephew and Q-Med have an exclusive partnership for the global development and commercialization of DUROLANE(R). It is already marketed in 32 countries, including Canada, and has been used to treat the symptoms of OA in more than 350,000 patients worldwide.
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Editors Notes:
- DUROLANE(R) is produced using the unique NASHA(TM) (Stabilized Non-Animal Hyaluronic Acid) technology, a patented process for the production of stabilized hyaluronic acid. DUROLANE(R) is a transparent gel which contains high levels of HA (Hyaluronic Acid). HA is a naturally occurring molecule that provides lubrication and cushioning in a normal joint.
