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RHONE-POULENC RORER WILL MARKET ORAL QUINOLONE ANTIBIOTIC PENETREX

Executive Summary

RHONE-POULENC RORER WILL MARKET ORAL QUINOLONE ANTIBIOTIC PENETREX (enoxacin) under a sublicensing agreement with Warner- Lambert, announced July 16. Warner-Lambert, which acquired the North American marketing rights to enoxacin from the Japanese firm Dainippon, will receive a royalty based on RPR sales of the antibiotic. RPR will be responsible for manufacturing and marketing Penetrex in North America. RPR said it has begun shipping Penetrex to the trade and will start detailing the antibiotic by August. Warner-Lambert obtained FDA approval of the Penetrex NDA in December 1991 ("The Pink Sheet" Jan. 6, p. 10) but never marketed the product. Enoxacin is indicated for complicated and uncomplicated urinary tract infections and uncomplicated urethral or cervical gonorrhea. Nine months before the drug was approved, former Warner-Lambert Chairman Joseph Williams acknowledged that the firm was "not satisfied" with the then-approvable indications and would pursue broader labeling for upper and lower respiratory tract infections and skin infections. FDA decided to approve Penetrex over the objections of Warner- Lambert, by dropping what it considered to be unapprovable indications and retaining those uses supported by the clinical data. Penetrex was approvable for one year while the company fought to add indications to final approved labeling and was reluctant to submit restricted labeling. RPR Exec VP Randy Thurman called Penetrex "the foundation on which we will build our anti-infective franchise in the U.S." Thurman added that the agreement will "build on our strong partnerships with Dainippon and Warner-Lambert." RPR currently has a joint venture with Dainippon in Europe to develop another quinolone, sparfloxacin. On April 1, RPR and Warner-Lambert announced an agreement to codevelop and comarket sparfloxacin in North America ("The Pink Sheet" April 6, In Brief). Currently in Phase III studies, sparfloxacin "has the potential to become a first-line therapy with once-daily dosing for respiratory tract infections in adults," RPR said. Warner- Lambert separately is continuing Phase I/II studies of the quinolone for Myobacterium avium complex in AIDS patients.

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