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LILLY's TAZIDIME (CEFTAZIDIME) LAUNCH SET FOR FIRST WEEK IN DECEMBER FOLLOWING NOV. 20 APPROVAL; REP. WAXMAN SAYS ANTIBIOTICS ARE NOT ELIGIBLE FOR EXCLUSIVITY

Executive Summary

Lilly's Tazidime (ceftazidime) will enter the U.S. market in December following FDA approval of an antibiotic form 6 application for the third generation cephalosporin on Nov. 20. The injectable cephalosporin was approved by FDA in four months based on an abbreviated antibiotic application. Lilly said the product will be available to hospitals during the first week of December. Lilly said the suggested net trade for Tazidime is the same as that for Glaxo's Fortaz, $13.30/gm. Tazidime is available in 500 mg/10 ml, 1 gm/10 ml, 2 gm/100 ml, 1 gm/100 ml, and 2 gm/20 ml. The Lilly approval will test the strength of Glaxo in the U.S. hospital market. After a five-month headstart, the Glaxo sales force will now be up against Lilly's experienced position in hospital antibiotics. For Lilly, ceftazidime will be the first major new antibiotic introduction since Moxam in late 1981. Ceftazidime was originally introduced to the U.S. market by Glaxo in July of this year with the tradename, Fortaz. Lilly claims marketing rights to the product under a non-exclusive license agreement with Glaxo from 1969. Glaxo has recently sought to delay Lilly's entry. The U.K. company petitioned FDA for five years of exclusive marketing under provisions of the Waxman/Hatch law ("The Pink Sheet", Nov. 11, T&G-2). Glaxo also filed suit Nov. 14 against FDA and HHS in the U.S. district court in Raleigh, N.C., motioning for a preliminary injunction to halt approval of Lilly's ceftazidime. The court denied the motion Nov. 19. Lilly's response to the Glaxo petition indicates a keen interest in the cephalosporin. Lilly went as far as to argue against the applicability of Waxman/Hatch exclusivity provisions to antibiotics in general to defend its rights to the Glaxo product("The Pink Sheet", Nov. 18, T&G-4). Rep. Waxman (D-Calif.) stepped into the fray with a Nov. 19 letter to FDA. Responding to the agency's Nov. 12 Federal Register announcement that Glaxo had filed a petition for exclusivity, Waxman stated: "Your position, 'that antibiotics are not subject to the provisions of Title I of the Drug Price Competition and Patent Term Restoration Act of 1984' is the correct interpretation of the Act." Waxman explained that "Congress considered applying these exclusivity rules and other provisions of Title I of the Act to antibiotics as well as to drugs approved under section 505. However, we chose to limit Title I and the exclusivity rules to drugs approved under section 505." He added that "in contrast, Congress specifically included antibiotics in Title II of the Act." Glaxo also tried to hold up the Lilly application at FDA by claiming that its NDA contained specifications for levels of high molecular weight polymer in the drug substance which me-too applications should be required to duplicate. Lilly countered that claim by maintaining that it had shared development information with Glaxo on how to determine polymer levels. FDA published accepted standards for ceftazidime injection in the Nov. 22 Federal Register that address the polymer level issue. FDA requirements for certification include results of tests and assays on ceftazidime pentahydrate for high molecular weight polymer content. FDA also specified the gel permeation chromatographic assay for high molecular weight polymer. FDA also addressed the question of pyridine content in the batch. The agency identifies the equipment, procedure, and system suitability test to be used for high-performance liquid chromatographic assay for pyridine.
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