Gensia Sicor Announces Court's Denial of Zeneca's

29.03.1999, 15:32

Motion for Preliminary Injunction Against FDA IRVINE, Calif. (ots-PRNewswire) - Gensia Sicor Inc. (Nasdaq:GNSA) today announced that on Friday, a judge in the U.S.District Court in Baltimore, Maryland denied Zeneca Inc.'s motionfor a preliminary injunction against the Food and DrugAdministration ("FDA"). The preliminary injunction would haveforced the FDA to rescind its approval of Gensia Sicor's genericformulation of Propofol Injectable Emulsion 1% with sodiummetabisulfite. "We are not surprised that the court was able to come to alogical decision in this matter by seeing through the fictitiousclaims made by Zeneca regarding the FDA's alleged failure toadequately address safety issues before approving Gensia Sicor'sformulation of propofol," said Michael D. Cannon, president ofGensia Sicor Pharmaceuticals. "We have always maintained thatthis lawsuit is without merit and is just one more tactic byZeneca in their quest to prevent a lower-cost alternative totheir product from entering the market. "We continue to support the FDA in their defense of this suitand remain confident that their decision will be upheld by thecourts," continued Cannon. "In fact, we have already begunproduction of propofol and have focused our attentions onpreparing for a successful commercial launch of propofol in thesecond quarter of this year." Gensia Sicor Inc. is a vertically integrated pharmaceuticalcompany with proven expertise in the development, manufacturingand marketing of injectable pharmaceuticals and in the productionof specialty bulk drug substances utilizing synthesis orfermentation. The company is focused on the worldwide oncologyand injectable pharmaceutical markets. Gensia Sicor's commercialpharmaceutical businesses include Gensia Sicor Pharmaceuticals,Inc., a California-based manufacturer and marketer of multisourceinjectable drugs, SICOR-Societa Italiana Corticosteroidi S.p.A.and Diaspa S.p.A., both of Milan Italy, and Sicor de Mexico, S.A.de C.V. in Toluca, Mexico all which produce specialty bulk drugsubstances, and Lemery, S.A. de C.V. in Mexico City whichmanufactures injectable and oral finished multisource drugproducts. Gensia Sicor's company offices are located in Irvine,CA. This press release contains forward looking statements thatare subject to risks and uncertainties that could cause actualresults to differ materially from those set forth in the forwardlooking statements, including whether Gensia Sicor's propofolproduct will have a successful commercial launch, whether thatlaunch will occur in the second quarter, whether Gensia Sicor'spropofol product will receive market acceptance and those mattersset forth in the risk factors section of Gensia Sicor's filingson Forms 10-K and 10-Q with the Securities and ExchangeCommission. These forward looking statements represent theCompany's judgment as of the date of this press release. TheCompany disclaims any intent or obligation to update theseforward looking statements. For more information on the Company, visit Gensia Sicor's newweb site at www.gensiasicor.com. News releases are also availableat no charge through PR Newswire's News On-Call fax service. Fora menu of available news releases or to retrieve a specificrelease made by Gensia Sicor, call 800-758-5804, extension354050. Please retain these numbers for future reference. otsOriginal Text Service: Gensia Sicor Inc. Internet:http://www.newsaktuell.de Contact: Laurie W. Little of GensiaSicor Inc., 949-455-4879; or Carolyn Bass or Jim Byers, 415-296-7383, or Patricia Walsh, or Mark Owen, 212-850-5600, all ofMorgen-Walke Associates, Inc., for Gensia Sicor Inc. CompanyNews On-Call: http://www.prnewswire.com/comp/354050.html or fax,800-758-5804, ext. 354050 Web site: http://www.gensiasicor.com

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