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SICOR OFFICIALS WILL BE QUESTIONED BY ITALIAN MAGISTRATE

Executive Summary

SICOR OFFICIALS WILL BE QUESTIONED BY ITALIAN MAGISTRATE in an investigation into alleged doxorubicin patent piracy, the Milan-based pharmaceutical company SICOR disclosed in a recent release. "The Italian judicial investigation has been underway for over a year, and the magistrate has now decided to question four employees/directors of SICOR concerning this matters," Societa Italiana Corticosteroidi (SICOR) said. The investigation involves allegations that SICOR is violating Montedison's process patent for doxorubicin and that SICOR obtained trade secrets for the manufacturing process from former employees of Montedison's pharmaceutical subsidiary Farmitalia Carlo Erba. SICOR stated that of the employees to be questioned "only two have previously been employeed by Montedison companies, but neither has been associated with the production of doxorubicin hydrochloride." The firm maintained that it "is confident that at the conclusion of the investigation the company and its employees will by fully cleared of any wrongdoing." SICOR, which received the first generic approval for bulk doxorubicin in December, is the bulk supplier for Cetus-Ben Venue, which is the only company to date to receive approval to market a generic doxorubicin product in the U.S. ("The Pink Sheet" March 27, T&G-14). SICOR said that for its fermentation process it uses "a micro-organism which is different from the micro-organism used by Farmitalia Carlo Erba." The company contends that it "has developed its own chemical synthesis and has applied for independent process patents in Italy and the U.S. covering this technology, which in no way infringes the patent rights of Farmitalia Carlo Erba." Montedison's U.S. affiliate Erbamont recently initiated patent infringement filings against Cetus and Bristol-Myers, alleging that the two companies' doxorubicin products infringe on its process patent ("The Pink Sheet" April 17, T&G-16). Erbamont's court submissions follow filings by Cetus and Bristol-Myers for declaratory judgments of patent invalidity, unenforceability and non-infringement. Bristol-Myers has an ANDA pending; approval may be forthcoming soon for that application. Erbamont's branded doxorubicin product, Adriamycin, is marketed in the U.S. by its subsidiary, Adria Labs. Erbamont estimates annual sales of Adriamycin in the U.S. at about $160 mil. The process patent for Adriamycin expires in April 1991. In the release, SICOR also addressed the publicity over vials of counterfeit Adriamycin "seized by Dutch authorities early last year." The company said that "judicial investigations initiated last April, in Milan, by an Italian magistrate" include a report that states that "the substance contained in the seized vials is not of SICOR origin." SICOR added that at the time of seizure its production plant for doxorubicin was not yet completed. "These facts clearly indicate that SICOR was not and could not have been involved in the manufacturing and sales of counterfeit doxorubicin," the release says.
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