SICOR Announces ANDA Approval for Mesna Injection

Apr 30, 2001, 01:00 ET from SICOR Inc.

    IRVINE, Calif., April 30 /PRNewswire/ -- SICOR Inc. (Nasdaq: SCRI) today
 announced that its wholly owned subsidiary, Gensia Sicor Pharmaceuticals,
 Inc., has received approval of an Abbreviated New Drug Application (ANDA) from
 the Food and Drug Administration (FDA) for Mesna Injection.  This filing was
 originally submitted with a Paragraph III certification and subsequently
 amended with a Paragraph IV certification because the innovator listed an
 additional patent in the Orange Book.  An administrative review by the FDA of
 Orange Book patents applicable to this product determined that the new patent
 was not listed in a timely manner, and that Gensia Sicor did not have to file
 its ANDA with a Paragraph IV certification.  At the FDA's request, Gensia
 Sicor's application was amended to remove the Paragraph IV certification, and
 was then approved by the FDA.
     "We have always maintained that our mesna formulation does not infringe
 the innovator's late listed patent.  This approval will now allow us to come
 to market in 2001 instead of waiting until the 30 month stay period expires in
 2003," stated Carlo Salvi, president and chief executive officer.  "We are
 very pleased with the FDA's decision to grant us full marketing approval for
 mesna and we applaud the Agency's response to this type of  business tactic.
 We are now awaiting the approval of an ifosfamide/mesna kit application, which
 should be positively affected by this decision.  We hope to receive approval
 of the ifosfamide/mesna kit within the next several months."
     The IFEX/MESNEX(R) Injection kit is marketed by Bristol Myers Squibb for
 the treatment of testicular cancer.  In 2000, the IFEX(R)/MESNEX(R) Injection
 kit and MESNEX(R) Injection combined sales in the U.S. were in excess of
 $110 million, as reported by IMS Health, a market research firm.
 
     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 the
 FDA will approve the ifosfamide/mesna kit, whether SICOR will bring mesna to
 market in 2001, whether the ifosfamide/mesna kit will be positively affected
 by this approval 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.sicorinc.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.
 
                      MAKE YOUR OPINION COUNT - Click Here
                http://tbutton.prnewswire.com/prn/11690X13388586
 
 

SOURCE SICOR Inc.
    IRVINE, Calif., April 30 /PRNewswire/ -- SICOR Inc. (Nasdaq: SCRI) today
 announced that its wholly owned subsidiary, Gensia Sicor Pharmaceuticals,
 Inc., has received approval of an Abbreviated New Drug Application (ANDA) from
 the Food and Drug Administration (FDA) for Mesna Injection.  This filing was
 originally submitted with a Paragraph III certification and subsequently
 amended with a Paragraph IV certification because the innovator listed an
 additional patent in the Orange Book.  An administrative review by the FDA of
 Orange Book patents applicable to this product determined that the new patent
 was not listed in a timely manner, and that Gensia Sicor did not have to file
 its ANDA with a Paragraph IV certification.  At the FDA's request, Gensia
 Sicor's application was amended to remove the Paragraph IV certification, and
 was then approved by the FDA.
     "We have always maintained that our mesna formulation does not infringe
 the innovator's late listed patent.  This approval will now allow us to come
 to market in 2001 instead of waiting until the 30 month stay period expires in
 2003," stated Carlo Salvi, president and chief executive officer.  "We are
 very pleased with the FDA's decision to grant us full marketing approval for
 mesna and we applaud the Agency's response to this type of  business tactic.
 We are now awaiting the approval of an ifosfamide/mesna kit application, which
 should be positively affected by this decision.  We hope to receive approval
 of the ifosfamide/mesna kit within the next several months."
     The IFEX/MESNEX(R) Injection kit is marketed by Bristol Myers Squibb for
 the treatment of testicular cancer.  In 2000, the IFEX(R)/MESNEX(R) Injection
 kit and MESNEX(R) Injection combined sales in the U.S. were in excess of
 $110 million, as reported by IMS Health, a market research firm.
 
     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 the
 FDA will approve the ifosfamide/mesna kit, whether SICOR will bring mesna to
 market in 2001, whether the ifosfamide/mesna kit will be positively affected
 by this approval 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.sicorinc.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.
 
                      MAKE YOUR OPINION COUNT - Click Here
                http://tbutton.prnewswire.com/prn/11690X13388586
 
 SOURCE  SICOR Inc.

RELATED LINKS

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