SangStat Files For Thymoglobulin
SangStat has filed a new drug submission in Canada for Thymoglobulin (rabbit antithymocyte globulin) for prevention of solid organ transplant rejection. The company will take over distribution of the drug in Canada from Connaught Labs, which has been selling the drug under Canada's emergency drug release program, in January 1995.
SangStat acquired the exclusive rights to develop and market Thymoglobulin in the USA and Canada from Pasteur Merieux Serums, a subsidiary of Rhone-Poulenc, at the end of last year. SangStat recently initiated a pivotal Phase III clinical study to support a New Drug Application filing in the USA. Patients in the study will receive Thymoglobulin or a currently-available antilymphocyte globulin therapy for solid-organ graft rejection episodes and will be followed for a period of three months to monitor primary and secondary outcome endpoints.
The drug is currently registered in 26 countries, and is a market leader in Europe. Pasteur Merieux will continue to manufacture Thymoglobulin for SangStat and market it outside North America.
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