GENZYME’s RECOMBINANT CEREDASE WILL ENTER MARKET IN 1992
GENZYME's RECOMBINANT CEREDASE WILL ENTER MARKET IN 1992, Genzyme President and CEO Henri Termeer predicted at a May 9 Alex. Brown-sponsored healthcare conference in Baltimore. "The recombinant form of Ceredase, which would allow us to achieve full market penetration, is about two years behind the first product, and we expect that we will ask the government for approval during 1992 and get approval by the end of that year," Termeer said. The company's placenta-derived Ceredase (glucocerebrosidase) received Treatment IND approval in November as an enzyme replacement therapy for Gaucher's Disease ("The Pink Sheet" Nov. 27, p. 7) and is undergoing expedited review at FDA after a preliminary filing in January. The company expects NDA approval by the end of the year. The fact that Ceredase must be derived from placenta makes the availability of the compound scarce. Currently, only a handful of patients are being treated, both because of the limited supply and because FDA and Genzyme have been slow to arrive at an agreement on the Treatment IND price for the drug ("The Pink Sheet" March 5, T&G-4). Initially, the firm expected that 200 Type I Gaucher's patients would use the drug under the Treatment IND. By the end 1990, however, Termeer said the company should have the "ability to treat 2,000, possibly 3,000 patients" in the U.S. The company had to build a new plant in France to accommodate the supply need. The cost per patient for the first generation product will range from $30,000 to $50,000 per year for the first two years, Termeer said. The company has said that it expects yearly sales of Ceredase to reach $50 to $100 mil. Ceredase is beginning to receive reimbursement by health care payers, Termeer said. "We are being compensated for this on a compassionate [patient need] basis and are working with a number of reimbursement agencies and are receiving a very good response," Termeer commented. "There is an educational task to help insurance companies understand the cost-benefit-relationship" of Ceredase treatment, Termeer maintained, noting that currently, Gaucher's Disease often goes untreated.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth