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Executive Summary

BAXTER WILL DISTRIBUTE RECONSTITUTED ADRIAMYCIN under a multiyear agreement with Erbamont N.V. The agreement, which is renewable after three years, allows Baxter to distribute reconstituted Adriamycin (doxorubicin) in 50 and 250 ml pharmacy bulk packages, once regulatory approval is obtained, and ureconstituted Adriamycin for use in hospitals and physicians' offices. Baxter will be one of many distributors of unreconstituted Adriamycin. The agreement calls for "a joint effort between Baxter and Erbamont to obtain regulatory approvals from [FDA] for Adriamycin and other anti-cancer drugs in Baxter's premixed program," Baxter said in a Feb. 16 release. Baxter has an ANDA suitability petition for the reconstituted doxorbicin product pending at FDA. The company estimates that it will submit an ANDA application for repackaged doxorubicin within the next three months. Adriamycin is still covered by a patent. Baxter noted that it is in discussions with other manufacturers for partnerships similar to the one with Erbamont. Baxter's reconstituted chemotherapeutics program includes: Bristol-Myers's Platinol (cisplatin), Blenoxane (bleomycin), and Mutamycin (mitomycin); and vinblastine; and cyclophosphamide, fluorouracil, methotrexate, and vincristine, all of which are available generically, but are also marketed by Erbamont. In October 1987, FDA approved Baxter's ANDA suitability petition for reconstituted cisplatin. FDA said, however, that the ANDA application would require Bristol-Myers to make complete chemistry and manufacturing information available to the company ("The Pink Sheet" Oct. 12, T&G-6). Bristol-Myers has been unwilling to supply the information, saying that Baxter's reconstitution of cisplatin into plastic containers makes the product a "new drug." Platinol is covered by a patent until 1996. FDA and Baxter are currently in litigation over the marketing of a number of Baxter's reconstituted chemotherapeutics and antibiotics. Discussions on the new drug status of the products have been ongoing since 1985. FDA seized 15 of Baxter's reconstituted anti-cancer and antibiotic products in May 1987 from Travenol's Regional Compounding facility in Morton Grove, Illinois because the products were considered new drugs being marked without an approved NDA ("The Pink Sheet June 1, T&G-6). Baxter said that through discussions with FDA it hopes to bypass further litigation by developing some type of format to allow marketing of its reconstituted products. Baxter markets a number of reconstituted antibiotics under approved ANDAs, including SmithKline's Ancef (cefazolin) and Cefizox (ceftizoxime), Merck's Mefoxin (cefoxitin), Pfizer's Cefobid (cefoperazone), Hoechst's Claforan (cefotaxime), and Roche's Rocephin (ceftriaxone). The company is also working to gain approval of reconstituted products with the following companies: Glaxo for Fortaz (ceftazidime), Beecham for Ticar (ticarcillin disodium), Squibb for Azactam (aztreonam), Upjohn for Cleocin (clindamycin phosphate). Reconstituted ticarcillin disodium was one of the antibiotics that FDA seized from Baxter's Illinois facility.

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