Genzyme Corp. and its exclusive worldwide partner, Inamed Corp., won FDA approval to market Hylaform gel as a nonsurgical dermal filler for moderate to severe facial wrinkles and folds.
Cambridge, Mass.-based Genzyme will manufacture the gel while Santa Barbara, Calif.-based Inamed will be responsible for marketing and distribution. Financially, Genzyme is poised to earn a milestone on regulatory clearance and undisclosed royalties on sales.
Hylaform will be launched immediately.
While Genzyme doesn't commonly work in the cosmetic arena, Dan Quinn, company spokesman, told BioWorld Today the firm is in on the deal because it has expertise working with hyaluronic acid (HA), the main ingredient in Hylaform. HA, a naturally occurring complex sugar found throughout all living organisms, is the basis of other Genzyme products including Synvisc, a treatment for osteoarthritis of the knee, and Sepra, a product used to reduce or eliminate the occurrence of adhesions or scar tissue following surgery.
Quinn said Genzyme is well equipped to manufacture Hylaform, but signed Inamed as the exclusive worldwide marketing and distribution partner because of its expertise and experience in cosmetic products. Inamed adapted Genzyme's HA (Hylan-B gel) for dermal use, Dan Cohen, Inamed's vice president for global government affairs, told BioWorld Today.
In the skin, HA fills the space between collagen and elastin fibers, replenishing the natural volume lost during aging, while delivering nutrients and hydration, the partners said in a statement. The body will naturally absorb Hylaform gel over time, meaning wrinkle treatments will not last indefinitely. FDA approval of Hylaform was based on data from a 12-week clinical trial, therefore Inamed cannot label the product as being useful beyond three months. However, off-label use in Europe of HA products coupled with other factors such as the depth of wrinkles or folds has led Inamed officials to believe that Hylaform treatments could last six to eight months, Cohen said.
The most commonly reported adverse events during the trial included erythema, bruising and swelling, which were typically mild in severity and procedure-related.
Genzyme inherited HA via its December 2000 acquisition of Ridgefield, N.J.-based Biomatrix Inc. That transaction combined Biomatrix, Genzyme Tissue Repair and Genzyme Surgical Products to form Genzyme Biosurgery, a firm that uses biomaterials and biological products to enhance or replace conventional surgical procedures. (See BioWorld Today, March 7, 2000.)
Inamed's other dermal filler products sold in the U.S. include human collagen-based products CosmoDerm and CosmoPlast, and bovine-based collagen fillers known as Zyderm and Zyplast. In other business Friday, Genzyme lost its appeal of an unfavorable jury verdict in a patent infringement lawsuit against Atrium Medical Corp., of Hudson, N.H. A statement released by Atrium said Delaware district court Judge Mary Pat Thynge upheld a unanimous jury decision that found that Atrium's Express Dry Suction Chest Drains did not infringe the five chest drain medical device patents litigated by Genzyme. The jury trial concluded in November 2002.
Genzyme's stock (NASDAQ:GENZ) closed Friday at $46.46, down 64 cents, while Inamed's (NASDAQ:IMDC) closed at $55.50, up $2.