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Executive Summary

GYNEX, CABOT, AND ADEZA HAVE EXPRESSED INTEREST IN MARKETING RU-486 in the U.S. for manufacturer Roussel-Uclaf, according to letters from the three firms to Rep. Wyden (D-Ore.). Startup biopharmaceutical maker Gynex, gynecological device specialist Cabot Medical and gynecological/obstetric biotech startup Adeza Biomedical all sent letters to Wyden declaring their interest in licensing Roussel-Uclaf's abortifacient drug, which the company has refused to market in the U.S. due to concerns about reprisals from pro-life activist groups. The letters from the three companies are enclosed in a Dec. 2 letter from Wyden to Roussel-Uclaf President Edouard Sakiz asking the French company to market RU-486 through a U.S. partner. Wyden said his letter is a reaction to a Nov. 15 New York Times article in which Roussel-Uclaf's director of endocrinology research Andre Ulmann said it is unclear whether the company will market RU-486 in the U.S. despite President-elect Bill Clinton's statements in support of such a move. The article also quoted Ulmann as saying that only a few likely licensing partners for RU-486 exist in the U.S. Referring to the three firms expressing interest in RU-486, Wyden told Roussel-Uclaf: "I am confused at your company's apparent frustration with regard to identifying a likely U.S. partner...given that at least four companies have indicated ...that they are greatly interested in a licensing agreement." Wyden enumerated "the elements of an ideal small-company partner in this regard": "a limited consumer product line, decreasing its vulnerability to anti-abortion boycott" and "some expertise in, and an established distribution system for, products related to clinical gynecology and birth control." Referring to Gynex, Cabot and Adeza, Wyden said: "Likely licensing partners have been identified in this letter and I am sure that many others exist." In addition to openly supporting the marketing of RU-486 in the U.S., the Clinton Administration will likely make the lifting of the import ban currently on the drug a top priority. The issue is included in HHS transition materials being prepared for the new Administration ("The Pink Sheet" Nov. 30, p. 5). Gynex' Nov. 17 letter states that the company wants to "restate our interest in light of the increased publicity about RU-486 and the possible changes that might occur in its potential marketing due to the election of Bill Clinton." In an Aug. 10 letter to Wyden arguing that it is "well qualified to manage the development and eventual marketing of RU-486," Gynex had written that "because Gynex is a small company we may not be subject to the political considerations faced by a larger company that might take on the RU-486 development task." In a Nov. 23 letter to Wyden's office, Cabot Chairman and CEO Warren Wood said he last spoke to Roussel-Uclaf "about two years ago," when the French firm said it "did not plan to bring it [RU- 486] to the U.S. nor did they have any interest in discussing this possibility with a U.S. company." Wood said that although it is not a pharmaceutical company, Cabot is interested in RU-486 because "we believe that the marketing and distribution for RU-486 more closely parallels that of a medical device than a drug" due to its in-patient use.

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