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Executive Summary

CETUS-BEN VENUE RECEIVES FIRST GENERIC DOXORUBICIN approval March 17. The company is building inventory for the launch. Doxorubicin will be the sixth generic anticancer drug marketed by the 50/50 joint venture between the biotech firm, Cetus, and generic drug manufacturer Ben Venue Labs. The drug will be available in 10, 20 and 50 mg vials for injection, and in 2 mg/ml single-dose vials of 5, 10 and 25 ml for infusion. The ANDA approval for the finished form of doxorubicin follows by three months the approval of SICOR's (Societa Italiana Corticosteroidi) ANDA for bulk doxorubicin. Cetus-Ben Venue has established an exclusive distribution agreement with U.K.-based ALCO Chemicals for rights to market the product in the U.S. and Canada. ALCO is a distributor for SICOR's bulk doxorubicin. Erbamont's branded doxorubicin product, Adriamycin, discovered and marketed in the U.S. by Erbamont's subsidiary Adria Labs, is currently the largest selling anti-cancer drug. FDA has approved the antibiotic for 12 indications including breast, bladder, small cell lung and ovarian cancers, and various leukemias and lymphomas. Cetus-Ben Venue estimates Adriamycin sales at over $ 140 mil. last year in the U.S. and Canada. Adria recently filed suit against FDA in an effort to revise the antibiotic monograph for doxorubicin solution, published in September 1988 ("The Pink Sheet" Feb. 13, T&G-3). Cetus-Ben Venue says that the SICOR manufacturing process fits within the higher purity levels Adria is seeking in the final monograph rule. The monograph requires that bulk doxorubicin be produced at a 90% purity level for the injectable solution form. Because Adria is required by FDA to manufacture bulk doxorubicin at a 97% purity level, the company argues that the monograph unfairly allows other companies to produce the drug at a lower standard of purity. Erbamont Italian subsidiary Farmitalia has prompted an Italian government-sponsored inquiry into SICOR's bulk doxorubicin manufacturing practices in an effort to protect its process patent for the product. Although the doxorubicin product patent expired in June 1988, Erbamont asserts that its process patent, which expires April 1991, covers bulk doxorubicin production. Cetus-Ben Venue says that the SICOR manufacturing process for bulk doxorubicin is different from the Farmitalia technique, and, therefore, does not infringe the process patent. The Cetus-Ben Venue venture markets methotrexate, vinblastine, calcium leucovorin and fluorouracil in addition to doxorubicin. The company has 11 ANDAs pending.

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