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Early in the development of VELCADE®, Millennium recognized its potential utility for treating cancer patients who have few other therapeutic options. Highly motivated by this recognition, Millennium worked closely with leading clinical researchers and regulatory authorities to make VELCADE available for patients as soon as possible. As a result, the timetable for clinical development and approval of VELCADE was unusually rapid; the FDA granted the first approval for U.S. marketing just over four and a half years after the first patient received VELCADE in a clinical trial.
VELCADE is currently approved in more than 75 countries worldwide, including the U.S., Canada, the European Union and a number of countries within Latin America and Southeast Asia. VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Research and Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.
Ortho Biotech Products, L.P. and the Janssen-Cilag group of companies are responsible for commercialization in the EU and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan.
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