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This article was originally published in The Tan Sheet

Executive Summary

AMERICAN HOME PRODUCTS CANCELS OTC CHOLESTEROL TEST PACT WITH CHEMTRAK, citing a "change in corporate priorities," Sunnyvale, Calif.-based diagnostics firm ChemTrak said in a recent release. American Home Products received North American marketing rights to CholesTrac Total Cholesterol Test in a December 1991 deal with ChemTrak. AHP dissolved the agreement, effective Oct. 23, in order to focus more of its resources on "high priority" projects such as the collaboration with Lilly on the Rx-to-OTC switch of H[2] antagonist Axid and subsidiary Wyeth-Ayerst's efforts to switch the nonsteroidal anti-inflammatory drug Orudis, AHP said. In March, CholesTrac became the first cholesterol test to be cleared for over-the-counter use by FDA ("The Tan Sheet" March 8, p. 9). CholesTrac is essentially the same test as ChemTrak's disposable cassette-based test AccuMeter, which has been sold by ChemTrak for professional use through distributors since May 1991. At the time of the cholesterol test's approval for OTC marketing, Whitehall said it planned to launch CholesTrac by mid- year. However, ChemTrak reported in July that "its manufacturing scale-up programs for a U.S. over-the-counter launch were behind plan" and that the product would begin shipping to AHP by the end of 1993 at the earliest. Since then, ChemTrak said that it has "put additional programs in place to be able to ship product" to a potential distributor by mid-November and is now "ahead of schedule with respect to [the company's] ability to produce sufficient quantities to support an OTC launch." ChemTrak, which has reclaimed all North American marketing rights to CholesTrac, said that other companies have "expressed potential interest" in marketing the OTC test and that it is "exploring those leads." Under separate distribution agreements, AccuMeter has been marketed in the U.K., Italy, the Middle East, Israel, Korea and Singapore, and was launched in the third quarter in Australia and Hong Kong. Other agreements recently were signed to sell the test in Malaysia, Argentina and with another distributor in Australia. ChemTrak said it is continuing to seek international partners in areas including Germany, France, South Africa and Scandinavia. AccuMeter also is distributed under a 1991 agreement with Bristol-Myers Squibb, which offers the cholesterol test to physicians who use its cholesterol-lowering drug Pravachol (pravastatin). American Home Products and Lilly are in a race to launch the first H[2] antagonist as an over-the-counter antacid. The two companies have been working on the Rx-to-OTC switch project for Axid (nizatidine) since August 1989 and currently are conducting clinical trials to support a switch application. J&J- Merck has already filed an NDA to support an Rx-to-OTC switch of Pepcid (famotidine). The leader in the race, SmithKline Beecham's Tagamet (cimetidine), suffered a setback when a joint meeting of FDA's OTC Drugs and Gastrointestinal Drugs Advisory Committees concluded that the company's clinical trials did not demonstrate that the OTC dose is effective in relieving episodic heartburn ("The Tan Sheet" Sept. 13, p. 1). Wyeth-Ayerst is in the process of developing an OTC switch application for Orudis (ketoprofen), a nonsteroidal anti- inflammatory agent licensed from Rhone-Poulenc Rorer. Orudis has been marketed in the U.S. by Wyeth-Ayerst since 1986.

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