Novartis Oncology Changes Trade Name of Investigational Agent Glivec(TM) to Gleevec(TM) in the United States

Novartis Oncology and U.S. Food and Drug Administration Agree to Name Change

to Prevent Possible Confusion of Gleevec with Other Pharmaceutical Products



Apr 30, 2001, 01:00 ET from Novartis Oncology

    EAST HANOVER, N.J., April 30 /PRNewswire/ -- Novartis Oncology announces
 that beginning today, the investigational agent Glivec(TM), formerly known
 worldwide as STI571, will be known in the United States by the trade name
 Gleevec(TM) (imatinib mesylate).
     The change in name was made in an agreement with the U.S. Food and Drug
 Administration (FDA) to avoid possible confusion that might occur with other
 pharmaceutical products in the U.S.
     The trade name Glivec(R) (imatinib) will continue to be used in countries
 outside the United States.  The correct pronunciation for both names is
 GLEE-VEK.
     Novartis Oncology submitted a new drug application for Gleevec in the U.S.
 on February 27, 2001 for treatment of patients with chronic myeloid leukemia
 in the blast crisis, accelerated phase or in chronic phase after failure of
 interferon-alpha therapy.  Applications were also submitted globally and came
 fewer than three years after the initiation of human clinical trials with the
 agent.
     On March 7, 2001 the FDA designated Gleevec for priority review.  Priority
 review status is granted by the FDA to products which treat serious or
 life-threatening diseases and are considered to be a potential therapeutic
 improvement over existing therapies.  In addition, the agent was designated as
 an Orphan Drug by regulatory authorities in the United States, European Union
 and Japan.
     The application is still under consideration by the U.S. FDA.
 
     This release contains certain "forward-looking statements" relating to the
 company's business, which can be identified by the use of forward-looking
 terminology such as "will," "possible improvement," "potential," "seeking
 marketing authorizations," or similar expressions, or by discussions of
 strategy, plans or intentions.  Such statements include descriptions of a new
 product, Gleevec, for which the company has filed global marketing
 applications.  Such statements reflect the current views of the company with
 respect to future events and are subject to certain risks, uncertainties and
 assumptions.  Many factors could cause the actual results, performance or
 achievements of Gleevec to be materially different from any future results,
 performances or achievements that may be expressed or implied by such
 forward-looking statements.  Some of these are uncertainties relating to
 unexpected regulatory delays, future clinical trial results, government
 regulation or competition in general, as well as factors discussed in the
 company's Form 20F filed with the Securities and Exchange Commission.  Should
 one or more of these risks or uncertainties materialize, or should underlying
 assumptions prove incorrect, actual results may vary materially from those
 described herein as anticipated, believed, estimated or expected.
 
     About Novartis
     Novartis Oncology is a business unit under Novartis AG.  It has operations
 within Novartis Pharma AG in Switzerland as well as Novartis Pharmaceuticals
 Corporation in the United States.  Novartis  (NYSE:   NVS) is a world leader in
 healthcare with core businesses in pharmaceuticals, consumer health, generics,
 eye-care, and animal health.  In 2000, the Group's ongoing businesses achieved
 sales of CHF 29.1 billion (USD 17.2 billion) and invested approximately CHF
 4.0 billion  (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland,
 Novartis employs about 67,600 people and operates in over 140 countries around
 the world.   For further information please consult http://www.novartis.com.
 
     Media Only
     In the U.S., contact:
     Gloria C. Stone
     Novartis Oncology
     Tel: + 973-781-5587
     Fax: + 973-781-6211
 
 
     Nicole Preiss                  Investors Only
     Ruder-Finn                     Kamran Tavangar
     Tel: + 212-593-5813            Novartis Corporation
     Fax: + 212-715-1557            Tel: + 212-830-2433
 
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X88222431
 
 

SOURCE Novartis Oncology
    EAST HANOVER, N.J., April 30 /PRNewswire/ -- Novartis Oncology announces
 that beginning today, the investigational agent Glivec(TM), formerly known
 worldwide as STI571, will be known in the United States by the trade name
 Gleevec(TM) (imatinib mesylate).
     The change in name was made in an agreement with the U.S. Food and Drug
 Administration (FDA) to avoid possible confusion that might occur with other
 pharmaceutical products in the U.S.
     The trade name Glivec(R) (imatinib) will continue to be used in countries
 outside the United States.  The correct pronunciation for both names is
 GLEE-VEK.
     Novartis Oncology submitted a new drug application for Gleevec in the U.S.
 on February 27, 2001 for treatment of patients with chronic myeloid leukemia
 in the blast crisis, accelerated phase or in chronic phase after failure of
 interferon-alpha therapy.  Applications were also submitted globally and came
 fewer than three years after the initiation of human clinical trials with the
 agent.
     On March 7, 2001 the FDA designated Gleevec for priority review.  Priority
 review status is granted by the FDA to products which treat serious or
 life-threatening diseases and are considered to be a potential therapeutic
 improvement over existing therapies.  In addition, the agent was designated as
 an Orphan Drug by regulatory authorities in the United States, European Union
 and Japan.
     The application is still under consideration by the U.S. FDA.
 
     This release contains certain "forward-looking statements" relating to the
 company's business, which can be identified by the use of forward-looking
 terminology such as "will," "possible improvement," "potential," "seeking
 marketing authorizations," or similar expressions, or by discussions of
 strategy, plans or intentions.  Such statements include descriptions of a new
 product, Gleevec, for which the company has filed global marketing
 applications.  Such statements reflect the current views of the company with
 respect to future events and are subject to certain risks, uncertainties and
 assumptions.  Many factors could cause the actual results, performance or
 achievements of Gleevec to be materially different from any future results,
 performances or achievements that may be expressed or implied by such
 forward-looking statements.  Some of these are uncertainties relating to
 unexpected regulatory delays, future clinical trial results, government
 regulation or competition in general, as well as factors discussed in the
 company's Form 20F filed with the Securities and Exchange Commission.  Should
 one or more of these risks or uncertainties materialize, or should underlying
 assumptions prove incorrect, actual results may vary materially from those
 described herein as anticipated, believed, estimated or expected.
 
     About Novartis
     Novartis Oncology is a business unit under Novartis AG.  It has operations
 within Novartis Pharma AG in Switzerland as well as Novartis Pharmaceuticals
 Corporation in the United States.  Novartis  (NYSE:   NVS) is a world leader in
 healthcare with core businesses in pharmaceuticals, consumer health, generics,
 eye-care, and animal health.  In 2000, the Group's ongoing businesses achieved
 sales of CHF 29.1 billion (USD 17.2 billion) and invested approximately CHF
 4.0 billion  (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland,
 Novartis employs about 67,600 people and operates in over 140 countries around
 the world.   For further information please consult http://www.novartis.com.
 
     Media Only
     In the U.S., contact:
     Gloria C. Stone
     Novartis Oncology
     Tel: + 973-781-5587
     Fax: + 973-781-6211
 
 
     Nicole Preiss                  Investors Only
     Ruder-Finn                     Kamran Tavangar
     Tel: + 212-593-5813            Novartis Corporation
     Fax: + 212-715-1557            Tel: + 212-830-2433
 
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X88222431
 
 SOURCE  Novartis Oncology

RELATED LINKS

http://www.us.novartis.com