Two U.S. Bioscience Inc. products were recommended for approval bythe European Union's Committee for Proprietary Medicinal Products(CPMP), the West Conshohocken, Pa., company said Tuesday.The products are Ethyol (amifostine), a selective cytotherapeutic agent,for which the company has an amended new drug application (NDA)pending in the U.S.; and NeuTrexin with concurrent leucovorinadministration, as an alternative therapy for treatment of moderate-to-severe Pneumocystis carinii pneumonia in refractory AIDS patients.NeuTrexin was cleared for marketing in the U.S. last December.The committee's recommendation, which means approvals in variouscountries is likely in coming months, also bodes well for the U.S. filingon Ethyol. That's why Alex. Brown & Sons Inc. analyst David Webberupgraded the stock (AMEX:UBS) from neutral to buy.U.S. Bioscience stock shot up $1.38, or 21 percent, to close at $7.88per share. More than 1.25 million shares were traded.Ethyol, the more significant of the products, was recommended forapproval in nine of the 12 Eurpoean Union (EU) countries to reducethe neutropenia-related risk of infection due to the combination ovariancancer regimen of cyclophosphamide and cisplatinum. It was notrecommended in Denmark, Ireland and the Netherlands, countrieswhere U.S. Bioscience will go back and discuss the product further,Robert Kriebel, the company's senior vice president, finance andadministration, told BioWorld."For a company of our size, only seven years old, this is an importantmilestone," Kriebel said. "We're delighted by that event."Webber told BioWorld that the key remains first in getting approval inthe U.S., then the timing of that approval and finally the ability of theproduct to penetrate the U.S. market."The recommendation," Webber wrote in increasing his rating, "shouldlead to approval and launch in Europe within several months. Therecommendation, which was based on data from all 242 patients in thepivotal clinical trial, also increases our optimism about the outlook forU.S. approval."He said U.S. approval could come as soon as mid-1995, which wouldmake U.S. Bioscience profitable next year.Schering-Plough Corp. acquired exclusive marketing rights to Ethyolfrom U.S. Bioscience. Schering-Plough was to pay an up-front fee andmilestone payments up to $10 million as various European approvalsare obtained. The deal is structured so that the companies would sharesales forces after five years, and U.S. Bioscience would get fullmarketing rights back after seven years.Webber projected first-year revenues from U.S. Bioscience's share ofEuropean sales would be $5 million to $10 million, then increase about$5 million each of the next few years. By contrast, he said, the U.S.market potential is $350 million to $400 million.The company, however, already had trouble with its first U.S. filing.An FDA advisory panel in February 1992 refused to recommendEthyol approval without additional data showing it prevents ordecreases toxicities caused by chemotherapeutic agents, and that itdoesn't decrease the anti-tumor effect of the chemotherapy drugs. Theamended NDA included analysis of the 242-patient ovarian cancertrial, about half of whom were accrued after the FDA's 1992 requestfor a larger patients population.The updated information was also provided to the CPMP. Thecompany originally filed for European approval in September 1992.Last week the company filed for approval in Canada.Ethyol currently is being tested in Phase II trials for breast and lungcancers, and in a trial as a selective protector of healthy tissues in headand neck cancer patients receiving radiation therapy. The drug was firstlooked at during a U.S. Army research project to identify a radiation-protection drug, and was selected as the most active compound frommore than 4,400 that were screened. n
-- Jim Shrine
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