SICOR Announces Rejection of Zeneca's Lawsuit Against the FDA And Settlement of Lawsuit With Protocol Systems, Inc.

SICOR Inc. (Nasdaq: SCRI) today announced that the U.S. District Court in Baltimore, Maryland has entered judgment in favor of Gensia Sicor Pharmaceuticals, Inc., SICOR's wholly owned subsidiary, and the Food and Drug Administration (FDA) in the lawsuit filed by Zeneca, Inc. with regards to the January approval of Gensia Sicor Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Propofol Injectable Emulsion 1% with sodium metabisulfite. The court issued a ruling granting both Gensia Sicor Pharmaceuticals' and the FDA's motion for summary judgment. "We have always maintained that this lawsuit was without merit and was simply a continuation of Zeneca's attempt to block our generic product from reaching the marketplace," said Frank Becker, executive vice president and chief operating officer of SICOR Inc. "By its ruling, the court recognized that the FDA had acted properly in approving our product. Although we consider this ruling to be a resounding success, our primary focus remains on continuing our production of propofol and providing the marketplace with a safe and effective generic alternative." SICOR also announced today that it has entered into a settlement agreement with Protocol Systems, Inc. regarding Protocol's complaint alleging breach of a development and supply agreement that provided for the purchase of a device to be used in Gensia Automedics' GenESA(R) Systems. The settlement was within the liability provision recorded by SICOR in the fourth quarter of 1998 and will not result in further earnings impact to the Company. SICOR Inc. is a vertically integrated specialty pharmaceutical company with proven expertise in the development, manufacturing and marketing of multi-source injectable pharmaceuticals. With a strategy of combining both the production of active pharmaceutical ingredients utilizing chemical synthesis or fermentation and state of the art manufacturing facilities, SICOR's primary focus is on the worldwide injectable pharmaceutical market, which currently includes oncology, anesthesiology, cardiology and other therapeutic areas. SICOR operates several manufacturing facilities in Europe, Mexico and the U.S.A., while maintaining the corporate headquarters in Irvine, California. This press release contains forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward looking statements, including whether Zeneca will not file an appeal to the court's ruling, whether the settlement with Protocol Systems will not result in further financial impact to the Company, and those matters set forth in the risk factors section of SICOR's filings on Forms 10-K and 10-Q with the Securities and Exchange Commission. These forward looking statements represent the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward looking statements. For more information on the Company, visit SICOR's web site at www.gensiasicor.com. News releases are also available at no charge through PR Newswire's News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by SICOR, call 800-758-5804, extension 354050. Please retain these numbers for future reference. ots Original Text Service: SICOR, Inc. Internet: http://www.newsaktuell.de Contact: Laurie W. Little of SICOR Inc., (USA) 949-455-4879; or Carolyn Bass or Jim Byers, (USA) 415-296-7383, or Patricia Walsh or Eric Gonzales, (USA) 212-850-5600, all of Morgen-Walke Associates, Inc. for SICOR, Inc. Company News On-Call: http://www.prnewswire.com/comp/354050.html or Fax: (USA) 800- 758-5804, ext. 354050 Web site: http://www.gensiasicor.com

Klíčová slova SICOR Inc.

Oblast
USA, Kanada, OSN, svět a Arktida (us)

Kategorie

ZASÍLÁNÍ ZPRÁV
Přihlásit k odběru

Upozornění:
Materiály označené značkou Protext nejsou součástí zpravodajského servisu ČTK a nelze je publikovat pod její značkou. Jde o komerční sdělení zadavatele, který je ve zprávě označen a který za ně nese plnou odpovědnost.