Genzyme Corporation (CAMBRIDGE, Mass.) announced that it has received European approval to expand the CE mark labeling for Synvisc® (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder. Genzyme expects to begin marketing Synvisc in the EU with its new label immediately.

Approval of this new label will broaden the use of Synvisc beyond its established use in knee and hip OA patients. Synvisc has been shown in European clinical trials to provide up to 12 months of pain relief in knee OA.

The approval of Synvisc for ankle and shoulder OA pain follows clinical studies of these two joints that were conducted in Europe and the filing of data from these trials. The studies were prospective, multicenter, open investigations that took place in several countries throughout Europe. Both studies found treatment with 1 or 2 injections of Synvisc to be well tolerated, and data show that Synvisc significantly decreases pain due to OA in the ankle and shoulder.

Data from the ankle study have been accepted for presentation at the 70th annual meeting of the American College of Rheumatology (ACR) in Washington DC, on November 10-15, 2006, and data from the shoulder study will be presented at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in San Diego, California, on February 14-18, 2007. Both abstracts also will be presented at the Osteoarthritis Research Society International (OARSI) World Congress on Osteoarthritis in Prague, the Czech Republic, on December 7-10, 2006.

In January 2005, Genzyme reacquired from Wyeth the full sales and marketing rights to Synvisc in the US, as well as Germany, Poland, Greece, Portugal, and the Czech Republic, in exchange for an initial payment of $121.0 million in cash to Wyeth in 2005 and $0.3 million of acquisition costs. Genzyme will make a series of additional contingent payments to Wyeth based on the volume of Synvisc sales in the covered territories. These contingent payments could extend out to June 2012, or could total a maximum of $293.7 million, whichever comes first. Synvisc is marketed in more than 60 countries and has been used to treat more than 3 million people. Synvisc revenues reached $219 million in 2005 and $117 million for the first half of 2006.

Synvisc is currently approved in the US for treatment of pain due to OA of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics (eg, acetaminophen). Synvisc is injected directly into the knee joint three times, 7 days apart, over a 15-day period (days 1, 8, and 15). Completion of the full three-injection treatment course is necessary to achieve the greatest benefit. Most patients feel the greatest pain relief 8 to 12 weeks after beginning treatment. Genzyme is pursuing a label expansion in the US that would include the hip indication.

Synvisc, manufactured and distributed by Genzyme Biosurgery (a division of Genzyme Corporation), is an elastoviscous fluid containing hylan polymers produced from chicken combs. Hylans are derivatives of hyaluronan (sodium hyaluronate), a natural complex sugar of the glycosaminoglycan family. Hyaluronan is a long-chain polymer containing repeating disaccharide units of Na-glucuronate-N-acetylglucosamine.

Genzyme is conducting pivotal trials of Synvisc 2 (two or fewer injections for at least 6 months pain relief) and hylastan SGL-80 (a microbial formulation), potential next-generation visco-supplementation products under development for the treatment of OA pain. Enrollment has been completed in the trial of Synvisc 2, and Genzyme is planning for product launch in 2007 in Europe and the US, and a US launch of hylastan in 2008. Genzyme also expects to launch Synvisc in the US for use in the hip during the first half of 2007.

According to Genzyme, current competition for Synvisc includes SupartzR, a product manufactured by Seikagaku Kogyo that is sold in the US by Smith & Nephew Orthopaedics and in Japan by Kaken Pharmaceutical Company under the name Artz®; Hyalgan®, produced by Fidia Farmaceutici SpA and marketed in the US by Sanofi-Aventis; OrthoviscR, produced by Anika Therapeutics, Inc, marketed in the US by Johnson & Johnson and marketed outside the US through distributors; Euflexxaâ„¢, a product manufactured and sold by Ferring Pharmaceuticals and marketed in the US and Europe; and DurolaneR, manufactured and distributed outside the US by Q-Med AB. Durolane and Euflexxa, the most recently approved products in Europe and the US, respectively, are produced by bacterial fermentation, as opposed to Synvisc, which is avian-sourced. In addition, the treatment protocol for Durolane is a single injection, as compared to Synvisc's three-injection regimen (although the single injection offers a shorter duration of pain relief). Production via bacterial fermentation and treatment with a reduced number of injections may represent competitive advantages for these products.

—A. Techman