Nabi and Acambis Sign Agreements for the Production of Clostridium Difficile Specialty Plasma and Intravenous Immune Globulin

Apr 17, 2001, 01:00 ET from Nabi

    BOCA RATON, Fla. and CAMBRIDGE, Mass., April 17 /PRNewswire/ --
 Nabi (Nasdaq:   NABI) announced today that it has signed agreements with Acambis
 (Nasdaq:   ACAM)(LSE: ACM)(formerly Peptide Therapeutics/OraVax, Inc.) for the
 Phase II clinical testing of Acambis' Clostridium difficile toxoid vaccine in
 plasma donors and the production of specialty plasma to be used in the
 manufacture of C. difficile Intravenous Immune Globulin (CdIVIG). Under these
 agreements, Nabi will first vaccinate plasma donors with the experimental
 C. difficile toxoid vaccine at several of Nabi's Biomedical Centers and
 collect specialty plasma units that contain increased levels of antibodies to
 C. difficile toxins. The specialty plasma production program will be conducted
 at Nabi Biomedical Centers under an IND to be submitted by Acambis to the FDA.
 The Nabi Biomedical Centers are licensed by the FDA, utilizing an approved
 system of procedures, and conform to American Blood Resources Association
 (ABRA) Quality Plasma Program (QPP) regulations.
     Nabi will then utilize the specialty plasma in the manufacture of
 C. difficile Intravenous Immune Globulin at Nabi's new biopharmaceutical
 manufacturing facility in Boca Raton, Florida.  The FDA completed its pre-
 approval inspection of the facility in June 2000, and Nabi is awaiting
 licensure.
     "Nabi is pleased to sign its first agreement for contract manufacturing in
 our new biopharmaceutical manufacturing facility in Boca Raton, Florida," said
 David Gury, Nabi's Chairman, President, and CEO.  "We are now positioned to
 generate significant revenues from both the collection of additional specialty
 plasma as well as the manufacture of high-margin products from that plasma."
     Acambis will investigate the effectiveness of CdIVIG in the treatment of
 patients suffering from disease caused by C. difficile.  This bacterial
 pathogen is a major cause of hospital-acquired diarrhea and colitis, which
 primarily affects elderly and immunocompromised patients.  C. difficile
 disease causes substantial morbidity and mortality and also increases
 healthcare costs.  This disease is often triggered by antibiotic usage, and
 subsequent treatment of severe or recurrent disease with antibiotics has
 proven difficult.  Consequently, new non-antibiotic therapies are needed for
 management of this disease.
     Acambis is a biopharmaceutical company researching, manufacturing and
 developing vaccines to prevent and treat infectious diseases. It has
 operations in Cambridge, UK, and in Cambridge and Canton, Massachusetts. It
 has a broad portfolio of vaccine product candidates undergoing clinical trials
 and technology platforms that provide the basis for further vaccine product
 candidates.
     Nabi, a vertically integrated biopharmaceutical company, has a broad
 product portfolio and significant R&D capabilities focused on the development
 and commercialization of drugs that prevent and treat infectious and
 autoimmune diseases. Nabi currently has several clinical trials underway in
 these areas as well as four marketed bio-pharmaceutical products. Nabi has its
 corporate headquarters in Boca Raton, Florida, with principal R&D offices and
 laboratories in Rockville, Maryland. Additional information about Nabi may be
 obtained on the Company's website at: www.nabi.com.
 
     This press release contains forward-looking statements that reflect the
 Company's current expectations regarding future events.  While these
 statements reflect the Company's best current judgment, they are subject to
 risks and uncertainties.  Actual results may differ significantly from the
 results projected herein due to a number of factors, including, but not
 limited to, the need for additional financing and access to capital; the costs
 of research and development; dependence upon third parties to manufacture
 product; the impact on the Company of current industry supply and demand
 factors and the supply of and demand for the Company's individual products;
 margin pressure on the Company's non-specific antibody product line; future
 sales growth prospects for its biopharmaceutical products; the likelihood that
 any product in the research pipeline can receive regulatory approval in the
 U.S. or abroad or be successfully developed, manufactured and marketed; and
 failure to receive licensure for the Boca Raton manufacturing facility.  These
 factors are more fully discussed in the Company's most recent Form 10-K filed
 with the Securities and Exchange Commission.
 
 

SOURCE Nabi
    BOCA RATON, Fla. and CAMBRIDGE, Mass., April 17 /PRNewswire/ --
 Nabi (Nasdaq:   NABI) announced today that it has signed agreements with Acambis
 (Nasdaq:   ACAM)(LSE: ACM)(formerly Peptide Therapeutics/OraVax, Inc.) for the
 Phase II clinical testing of Acambis' Clostridium difficile toxoid vaccine in
 plasma donors and the production of specialty plasma to be used in the
 manufacture of C. difficile Intravenous Immune Globulin (CdIVIG). Under these
 agreements, Nabi will first vaccinate plasma donors with the experimental
 C. difficile toxoid vaccine at several of Nabi's Biomedical Centers and
 collect specialty plasma units that contain increased levels of antibodies to
 C. difficile toxins. The specialty plasma production program will be conducted
 at Nabi Biomedical Centers under an IND to be submitted by Acambis to the FDA.
 The Nabi Biomedical Centers are licensed by the FDA, utilizing an approved
 system of procedures, and conform to American Blood Resources Association
 (ABRA) Quality Plasma Program (QPP) regulations.
     Nabi will then utilize the specialty plasma in the manufacture of
 C. difficile Intravenous Immune Globulin at Nabi's new biopharmaceutical
 manufacturing facility in Boca Raton, Florida.  The FDA completed its pre-
 approval inspection of the facility in June 2000, and Nabi is awaiting
 licensure.
     "Nabi is pleased to sign its first agreement for contract manufacturing in
 our new biopharmaceutical manufacturing facility in Boca Raton, Florida," said
 David Gury, Nabi's Chairman, President, and CEO.  "We are now positioned to
 generate significant revenues from both the collection of additional specialty
 plasma as well as the manufacture of high-margin products from that plasma."
     Acambis will investigate the effectiveness of CdIVIG in the treatment of
 patients suffering from disease caused by C. difficile.  This bacterial
 pathogen is a major cause of hospital-acquired diarrhea and colitis, which
 primarily affects elderly and immunocompromised patients.  C. difficile
 disease causes substantial morbidity and mortality and also increases
 healthcare costs.  This disease is often triggered by antibiotic usage, and
 subsequent treatment of severe or recurrent disease with antibiotics has
 proven difficult.  Consequently, new non-antibiotic therapies are needed for
 management of this disease.
     Acambis is a biopharmaceutical company researching, manufacturing and
 developing vaccines to prevent and treat infectious diseases. It has
 operations in Cambridge, UK, and in Cambridge and Canton, Massachusetts. It
 has a broad portfolio of vaccine product candidates undergoing clinical trials
 and technology platforms that provide the basis for further vaccine product
 candidates.
     Nabi, a vertically integrated biopharmaceutical company, has a broad
 product portfolio and significant R&D capabilities focused on the development
 and commercialization of drugs that prevent and treat infectious and
 autoimmune diseases. Nabi currently has several clinical trials underway in
 these areas as well as four marketed bio-pharmaceutical products. Nabi has its
 corporate headquarters in Boca Raton, Florida, with principal R&D offices and
 laboratories in Rockville, Maryland. Additional information about Nabi may be
 obtained on the Company's website at: www.nabi.com.
 
     This press release contains forward-looking statements that reflect the
 Company's current expectations regarding future events.  While these
 statements reflect the Company's best current judgment, they are subject to
 risks and uncertainties.  Actual results may differ significantly from the
 results projected herein due to a number of factors, including, but not
 limited to, the need for additional financing and access to capital; the costs
 of research and development; dependence upon third parties to manufacture
 product; the impact on the Company of current industry supply and demand
 factors and the supply of and demand for the Company's individual products;
 margin pressure on the Company's non-specific antibody product line; future
 sales growth prospects for its biopharmaceutical products; the likelihood that
 any product in the research pipeline can receive regulatory approval in the
 U.S. or abroad or be successfully developed, manufactured and marketed; and
 failure to receive licensure for the Boca Raton manufacturing facility.  These
 factors are more fully discussed in the Company's most recent Form 10-K filed
 with the Securities and Exchange Commission.
 
 SOURCE  Nabi