WENDY EMANUEL (MEDIA RELATIONS) HARRY ROHME (MEDIA RELATIONS)
GENENTECH, INC. NOVARTIS PHARMACEUTICALS CORPORATION
(650) 225-7739 (973) 781-5151
SUSAN BENTLEY (INVESTOR RELATIONS) JOE SCHEPERS (INVESTOR RELATIONS)
GENENTECH, INC. NOVARTIS CORPORATION
(650) 225-1034 (908) 522-6899
ISABEL CORDOVA (INVESTOR RELATIONS)
TANOX, INC. (THE TROUT GROUP)
(415) 567-3300 EXT. 14
GENENTECH AND NOVARTIS SUBMIT APPLICATION FOR FDA
APPROVAL OF ANTI-IGE ANTIBODY
SOUTH SAN FRANCISCO, CA, EAST HANOVER, NJ, AND HOUSTON, TX, JUNE 5, 2000 -
Genentech, Inc., Novartis Pharmaceuticals Corporation and Tanox Inc. announced
today that the companies have submitted a Biologics License Application (BLA) to
the U.S. Food and Drug Administration (FDA) for anti-IgE (rhuMAb-E25), a
recombinant humanized monoclonal antibody to immunoglobulin E (IgE). Anti-IgE
may represent the first in a new class of therapies that block IgE. Genentech,
Novartis Pharma AG and Tanox have a collaboration on the development of
Anti-IgE is designed to intervene early in the allergic process by binding to
circulating IgE, an antibody that triggers the release of inflammatory
mediators. These mediators are involved in the allergic cascade and cause the
symptoms of allergy. Anti-IgE prevents IgE from binding to mast cells, thereby
blocking the consequent release of these inflammatory mediators.
"We are very excited to have reached this significant milestone to submit our
license application for the anti-IgE antibody to the FDA," said Arthur D.
Levinson, PhD, chairman and chief executive officer, Genentech.
"Asthma and allergies impact the quality of life for millions of people
worldwide everyday in a variety of ways," said Jerry Karabelas, head of Novartis
Healthcare Operations and chief executive officer of Novartis Pharma AG.
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Novartis Pharma AG has filed for marketing approval of anti-IgE with health
authorities in the EU, Switzerland, Australia and New Zealand.
Clinical data on anti-IgE were presented in March 2000 at the 56th Annual
Meeting of the American Academy of Allergy, Asthma and Immunology. Additional
clinical data will be presented at the European Respiratory Society meeting in
August 2000. Safety and efficacy data for anti-IgE will be reviewed by the FDA.
Genentech, Inc. is a leading biotechnology company that discovers, develops,
manufactures, and markets human pharmaceuticals for significant unmet medical
needs. Fourteen of the currently approved biotechnology products stem from
Genentech science. Genentech markets eight biotechnology products directly in
the United States. The company has headquarters in South San Francisco,
California, and is traded on the New York Stock Exchange under the symbol DNA.
Novartis Pharmaceuticals Corporation, located in East Hanover, New Jersey,
is an affiliate of Novartis AG, a world leader in healthcare with core
businesses in pharmaceuticals, consumer health, generics, eye-care, and animal
health. In 1999, the Group (including Agribusiness) achieved sales of USD 21.7
billion and invested more than USD 2.8 billion in R&D. Headquartered in Basel,
Switzerland, Novartis employs about 82,400 people and operates in over 140
countries around the world. The Group recently announced plans to spin off its
Crop Protection and Seeds sectors and to merge them with the agrochemicals
business of AstraZeneca in the second half of 2000. Novartis AG American
Depository Shares are traded on the New York Stock Exchange under the symbol
Tanox, Inc. is a biotechnology research and development company with
headquarters in Houston, Texas. Tanox identifies and develops therapeutic
monoclonal antibodies designed to address significant unmet medical needs in the
areas of immunology, infectious diseases and cancer. Tanox is collaborating in
the development of certain anti-IgE antibodies with Novartis Pharma AG and
Genentech, Inc. In addition, Tanox is developing a number of monoclonal
antibodies to treat other diseases or conditions. The company is traded on the
Nasdaq National Market under the symbol TNOX.
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The foregoing press release contains forward-looking statements that can be
identified by terminology such as "expects", "potential", "suggests", "may",
"will", or similar expressions. Such forward-looking statements involve known
and unknown risks, uncertainties and other factors that may cause the actual
results to be materially different from any future results, performance, or
achievements expressed or implied by such statements. In particular,
management's expectations regarding future research development results could be
affected, by among other things, uncertainties relating to clinical trials and
product development; unexpected regulatory delays or government regulation
generally; the company's ability to obtain or maintain patent and other
proprietary intellectual property protection; and competition in general.