Titan Announces Award of NIH Grant for Probuphine Clinical Development

SOUTH SAN FRANCISCO, Calif.--(Business Wire)--
Titan Pharmaceuticals, Inc (Pink Sheets:TTNP) today announced that the National
Institutes of Health (NIH) has awarded a Research and Research Infrastructure
Grand Opportunities grant to the company through the American Reinvestment and
Recovery Act of 2009 (ARRA). The two year grant for Probuphine clinical
development is expected to provide approximately $7.6 million, with the first
year award of approximately $ 5.6 million now made available to Titan by the
NIH. This grant will be administered by the National Institute on Drug Abuse
(NIDA). These funds will directly support a substantial part of the second Phase
3 clinical study to confirm the safety and efficacy of Probuphine for the
treatment of opioid addiction. Probuphine is an innovative, long-term,
implantable formulation of buprenorphine that is designed to provide a constant,
low level of drug for six months following a single treatment. It has the
potential to address the key issues of treatment non-compliance and illicit
diversion often reported with the currently available sublingual pill
formulation.

Probuphine has been shown to be safe and effective in the three Phase 3 studies
that have been completed to date, specifically:

* A six-month, double-blind, placebo-controlled safety and efficacy trial,
* A six-month, open-label re-treatment safety trial, and
* A pharmacokinetic safety study.

Data from these studies have been presented at the International Society of
Addiction Medicine 2008 Annual Meeting in Cape Town, South Africa, and the
American Society of Addiction Medicine 2009 Annual Meeting in New Orleans, LA.

"Seeking new and better medications for treating addiction is an important part
of NIDA`s mission," says Dr. Nora Volkow, NIDA director. "If successful, this
study will broaden the options for treating opioid dependence and give
physicians and their patients meaningful information on comparative risks and
benefits."

"This collaboration with NIDA will enable us to conduct the second,
registration-directed, placebo-controlled trial of Probuphine as required by the
FDA and significantly accelerate completion of the Phase 3 development program.
We appreciate the support and guidance of our investigators which was
instrumental in the success of this grant application, and we look forward to
working closely with the NIDA Clinical Trial Network (CTN) in conducting this
important study with the first patient expected to be enrolled in Q1 2010," said
Dr. Katherine L. Beebe, Principal Investigator of the NIH study, and Senior Vice
President of Clinical Development and Medical Affairs at Titan.

The pivotal Phase 3 study will be a three arm, six-month, randomized, active-
and placebo-controlled trial of Probuphine in recently diagnosed patients with
opioid addiction. The active control will be the sublingual formulation of
buprenorphine, Suboxone. Approximately 250 subjects will be enrolled across
20-25 experienced and qualified clinical sites, including many that are part of
NIDA`s Clinical Trial Network.

"We are very pleased to be awarded this NIH grant, and appreciate the support of
NIDA in the development of Probuphine," said Sunil Bhonsle, President of Titan.
"This substantial award recognizes the importance of developing effective
treatments for treating opioid addiction, an ever increasing problem in the
United States and elsewhere in the world," added Marc Rubin MD, Executive
Chairman of Titan.

Probuphine Development Program

Probuphine represents an innovative technology that offers a number of potential
advantages over existing therapies and may improve treatment outcome.
Specifically, as an implantable delivery system, it significantly improves
treatment compliance, reduces the risk of diversion, and also greatly lowers
overall patient exposure to buprenorphine plasma levels over an extended
treatment period compared to the currently-marketed, sublingual formulation. The
first pivotal study in this Phase 3 program enrolled 163 subjects and
consistently demonstrated across a number of outcome measures that Probuphine is
a safe and effective treatment for opioid addiction. In this initial study, the
FDA-required primary efficacy endpoint and key secondary endpoint were
successfully met. Additional Phase 3 studies completed include a six-month
open-label retreatment trial in 62 subjects demonstrating the safety of
Probuphine for up to one year and a nine-subject pharmacokinetic study comparing
relative bioavailability of Probuphine and sublingual tablets. Further
discussions with the Food and Drug Administration (FDA) to confirm the final
requirements of the Probuphine development program are also planned prior to
commencing the next Phase 3 study.

The prosecution of the method of use patent application for Probuphine continues
and on September 4 2009 Titan provided a complete response to the US Patent and
Trademark Office (USPTO) addressing all the comments in the non-final office
action letter issued by the USPTO in early summer.

Research and Research Infrastructure Grand Opportunities Program

The purpose of the Research and Research Infrastructure Grand Opportunities
program is to support high impact ideas and large-scale research projects that
accelerate critical breakthroughs, early and applied research on cutting-edge
technologies, and new approaches to improve the synergy and interactions among
multi and interdisciplinary research teams. This initiative is being offered to
help fulfill the goals of the American Recovery and Reinvestment Act to help
stimulate the economy through support of biomedical and behavioral research. The
ARRA will provide economic stimulus to the nation while furthering the NIH
mission to uncover new knowledge that will lead to better health for everyone.

For more information on ARRA funding, visit grants.nih.gov/recovery. To track
the progress of Health and Human Services activities funded through the recovery
act, visit www.hhs.gov/recovery. To track all federal funds provided through the
recovery act, visit http://www.recovery.gov/.

About Titan Pharmaceuticals

For information concerning Titan Pharmaceuticals, Inc., please visit the
Company's website at www.titanpharm.com.

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, adverse side effects
or inadequate therapeutic efficacy of the Company's drug candidates that could
slow or prevent product development or commercialization, the uncertainty of
patent protection for the Company's intellectual property or trade secrets, and
the Company's ability to obtain additional financing. 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
referred to in this press release.

Titan Pharmaceuticals, Inc.
Sunil Bhonsle, 650-244-4990
President
sbhonsle@Titanpharm.com

Copyright Business Wire 2009