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 motion
for a preliminary injunction against the Food and Drug
Administration ("FDA"). The preliminary injunction would have
forced the FDA to rescind its approval of Gensia Sicor's generic
formulation of Propofol Injectable Emulsion 1% with sodium
metabisulfite.
"We are not surprised that the court was able to come to a
logical decision in this matter by seeing through the fictitious
claims made by Zeneca regarding the FDA's alleged failure to
adequately address safety issues before approving Gensia Sicor's
formulation of propofol," said Michael D. Cannon, president of
Gensia Sicor Pharmaceuticals. "We have always maintained that
this lawsuit is without merit and is just one more tactic by
Zeneca in their quest to prevent a lower-cost alternative to
their product from entering the market.
"We continue to support the FDA in their defense of this suit
and remain confident that their decision will be upheld by the
courts," continued Cannon. "In fact, we have already begun
production of propofol and have focused our attentions on
preparing for a successful commercial launch of propofol in the
second quarter of this year."
Gensia Sicor Inc. is a vertically integrated pharmaceutical
company with proven expertise in the development, manufacturing
and marketing of injectable pharmaceuticals and in the production
of specialty bulk drug substances utilizing synthesis or
fermentation. The company is focused on the worldwide oncology
and injectable pharmaceutical markets. Gensia Sicor's commercial
pharmaceutical businesses include Gensia Sicor Pharmaceuticals,
Inc., a California-based manufacturer and marketer of multisource
injectable 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 drug
substances, and Lemery, S.A. de C.V. in Mexico City which
manufactures injectable and oral finished multisource drug
products. Gensia Sicor's company offices are located in Irvine,
CA.
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 Gensia Sicor's propofol
product will have a successful commercial launch, whether that
launch will occur in the second quarter, whether Gensia Sicor's
propofol product will receive market acceptance and those matters
set forth in the risk factors section of Gensia 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 Gensia Sicor's new
web site at www.gensiasicor.com. News releases are also available
at no charge through PR Newswire's News On-Call fax service. For
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354050. Please retain these numbers for future reference. ots
Original Text Service: Gensia Sicor Inc. Internet:
http://www.newsaktuell.de Contact: Laurie W. Little of Gensia
Sicor Inc., 949-455-4879; or Carolyn Bass or Jim Byers, 415-296-
7383, or Patricia Walsh, or Mark Owen, 212-850-5600, all of
Morgen-Walke Associates, Inc., for Gensia Sicor Inc. Company
News 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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