Genzyme Corp. said Thursday that it will soon start clinicaltrials of Vianain, its proposed entry in the burn treatmentmarket.
Vianain becomes Genzyme's (NASDAQ:GENZ) ninth product toenter clinical trials, including three that have been approvedfor sale in the U.S. or international markets.
The Phase I/II multicenter-site trials are expected to involvebetween 20 and 50 patients, said Donna LaVoie, manager ofpublic relations for the Cambridge, Mass., company. The trialsare expected to take six months. "We anticipate Vianain will beon the market in 1995," she said.
Preclinical studies indicated that Vianain, a formulation of twoproprietary enzymes, may offer a significant advantage in burntreatment because it can rapidly remove burned tissue toprepare the wound for skin grafts. Genzyme said it has patentsor applications covering the two enzymes, ananain andcosmosain, their production, pharmaceutical composition anduse.
Vianain received orphan drug designation last February for thetreatment of severe burns.
The estimated potential U.S. market for Vianain is between $75million and $100 million a year, the company said. About100,000 people are hospitalized annually in the U.S. withsevere burns, according to the National Center of HealthStatistics.
The only enzyme approved for burn care is Travase, which isproduced by Boots-Flint Inc., Genzyme said.
Genzyme's major product, Ceredase to treat Gaucher's disease,generated $40 million in sales in the nine months following itsapproval in April 1991. Two other products have beenapproved, but have not yet entered the market: Provisc forophthalmic use, which Alcon Laboratories plans to market, andGenzyme's tissue plasminogen activator (t-PA), which ispending sales in Japan.
Genzyme has two products in Phase III trials: r-GCR to treatGaucher disease, and Thyrogen, used as an adjunct in treatmentof thyroid cancer.
Other products in clinical trials are three hyaluronic acid (HA)products to reduce the incidence and severity of post-surgicaladhesions; HAL-C has OB/Gyn, cardiac and abdominalindications; and HAL-F has OB/Gyn and abdominal indications,and HAL-S has orthopedic indications.
-- Steve Payne BioWorld Staff
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