Rhone-Poulenc Rorer Inc. (RPR) will market Enzon Inc.'soncology drug Oncaspar (pegaspargase) in the U.S., pending FDAapproval, Enzon announced Wednesday.
Under the licensing agreement, Enzon will receive $6 million inlicensing payments and a 50 percent profit share. Enzon(NYSE:ENZN) of Piscataway, N.J., will manufacture the drug forRPR, which is establishing a specialty sales force to market it.RPR also will utilize its existing hospital sales force.
FDA announced last week that the drug is approvable fortreating patients with acute lymphoblastic leukemia (ALL) whoare hypersensitive to native L-asparaginase. A product licenseapplication was filed with FDA in January 1991.
The drug is a modified form of the enzyme L-asparaginase,which has been shown to be effective in treating ALL.However, 78 percent of patients treated with this form of thedrug develop dose-limiting hypersensitivity reactions, even tothe point of anaphylaxis. Enzon's polyethylene glycol (PEG)-conjugated asparaginase has an increased serum half-life and isless immunogenic than the unmodified enzyme.
Enzon and RPR are also working on a plan to explore newindications for Oncaspar. Enzon's director of communications,Debora Demarest, said the companies have not yet decidedwhat indications to pursue. RPR will conduct future trials thatwill be directed by a steering committee composed ofrepresentatives from Enzon and RPR.
In April, Enzon received approval in Russia to market Oncasparfor therapeutic use in a variety of cancers, and in March thecompany filed an application to market the drug in Germany.
RPR (NYSE:RPR), which is based in Philadelphia, has agreementswith several other biotechnology companies. These include ajoint venture with Applied Immune Sciences Inc. to develop aninternational network of cell therapy centers, a joint venturewith The Immune Response Corp. to develop AIDSimmunotherapeutics and a licensing agreement with NovenPharmaceuticals for Noven's transdermal estrogen system.
-- Brenda Sandburg News Editor
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