Monday September 25, 6:05 am Eastern Time
Press Release
Titan Announces Positive Results for Zomaril Phase
III Clinical Trial in Schizophrenia
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sept. 25, 2000--Titan
Pharmaceuticals (AMEX:TTP - news), today announced positive safety and efficacy data
from a large scale, controlled, phase III study of Zomaril(TM) (iloperidone), a new drug
currently in development for the treatment of schizophrenia. The global trial, conducted by Novartis (NYSE:NVS - news),
involved more than 600 patients at more than 40 centers throughout the US, Europe, Canada, Australia and South Africa and
was designed to assess the ability of Zomaril to control safely and effectively the positive and negative symptoms in
schizophrenia patients.
The results demonstrated that both dose levels of Zomaril used in the study achieved a highly statistically significant reduction in
the symptoms of schizophrenia as assessed by the Brief Psychiatric Rating Scale. These findings were also supported by highly
statistically significant improvements in the total score for the Positive and Negative Syndrome Scale with both dose levels. In
addition, the study confirmed that Zomaril possesses an excellent tolerability profile with no extrapyramidal symptoms, little
weight gain and no effect on serum prolactin. Full details of the study results will be presented at international psychiatry
congresses next year.
In announcing the results, Titan Chairman and CEO, Dr. Louis R. Bucalo, called these results very promising and stated, ``We
are very excited about these results from the Novartis development program. With this recent progress, we are further
encouraged that Zomaril may represent an important new option for patients with schizophrenia.''
In November 1997 Novartis Pharma AG entered into an agreement with Titan Pharmaceuticals for the rights to develop,
manufacture and market Zomaril worldwide with the exception of Japan. The study is part of a Novartis program called
`ReALIZe' (Research to Assess the Long-term Impact of Zomaril), which comprises seven different studies being conducted at
some 300 centers around the world. To date, more than 3200 patients have participated in ReALIZe studies, which are
designed to evaluate the safety and efficacy of Zomaril against various end-points.
Titan Pharmaceuticals, Inc. is a biopharmaceutical company developing proprietary therapeutics for the treatment of central
nervous system disorders, cancer and other serious and life-threatening diseases.
The press release may contain ``forward-looking statements'' within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements
relating to the Company's development program and any other statements that are not historical facts. Such statements involve
risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development,
testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or
inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product markets, the uncertainty
of patent protection for the Company's intellectual property or trade secrets and the Company's ability to obtain additional
financing if necessary. Such statements are based on management's current expectations, but actual results may differ materially
due to various factors, including those risks and uncertainties mentioned or referenced in this press release.
Contact:
Titan Pharmaceuticals, Inc, South San Francisco
Louis R. Bucalo, M.D., 650/244-4990
or
Ruder Finn, Inc., New York
Investors: Wendi B. Green, 212/593-6374
or
Media: Sarah O'Connell, 212/583-2724 |
