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Titan Pharmaceuticals, Inc. TITAN PHARMACEUTICALS PROVIDES PROBUPHINE UPDATE AFTER MEETING WITH U.S. FOOD AND DRUG ADMINISTRATION Regulatory Path Defined for New Drug Application South San Francisco, CA

Key Takeaway: TITAN PHARMACEUTICALS PROVIDES PROBUPHINE UPDATE AFTER MEETING WITH U.S. FOOD AND DRUG ADMINISTRATION Regulatory Path Defined for New Drug Application South San Francisco, CA October 26, 2011 Titan Pharmaceuticals, Inc. (TTNP.OB) today announced that it met with the U.S. Food

Full Press Release Details

TITAN PHARMACEUTICALS PROVIDES PROBUPHINE UPDATE AFTER
MEETING WITH U.S. FOOD AND DRUG ADMINISTRATION
Regulatory Path Defined for New Drug Application
South San Francisco, CA
October 26, 2011 Titan Pharmaceuticals, Inc. (TTNP.OB) today announced that it met with the U.S. Food and Drug Administration (FDA) for a Pre-New Drug Application (Pre-NDA) meeting regarding Probuphine , an innovative
subcutaneous implant formulation of the marketed drug buprenorphine. Based upon this meeting, Titan believes that its Phase 3 clinical program completed to date is acceptable to the FDA to support submission of an NDA via the 505(b)(2) pathway and
that no additional clinical efficacy or safety studies are required to support the submission. The company has also received clear guidance from the FDA on the requirements for submitting an NDA for consideration to be designated as a Priority
Review. Titan has received initial comments from the FDA regarding manufacturing and non-clinical information and is in ongoing discussions with the agency to confirm these requirements. The company will confirm the overall regulatory path forward
upon receipt of formal meeting minutes from the FDA in the coming weeks and will provide a further update at that time.
extremely pleased with this preliminary outcome as we believe it enables Titan to move forward rapidly and efficiently with our ongoing partnership discussions for Probuphine and continue to advance the program s regulatory process toward an
NDA submission, said Sunil Bhonsle, president of Titan.
Probuphine is designed to deliver six months of continuous round-the-clock, long-term therapeutic levels of the drug buprenorphine following a single
subcutaneous treatment. Buprenorphine, an approved agent for the treatment of opioid addiction, is currently available mainly in the form of sublingual tablet and film formulations. The safety and effectiveness of treatment with Probuphine has been
demonstrated in several late-stage and Phase 3 studies conducted to date, including a 163-patient placebo-controlled study which demonstrated clinically meaningful and statistically significant treatment with Probuphine over a 24-week period and was
published in the Journal of the American Medical Association (JAMA) and a confirmatory study of 287 patients that showed statistically significant efficacy versus placebo and non-inferiority with a currently marketed sublingual formulation of
Probuphine was developed using ProNeura , Titan s continuous drug delivery system that consists of a small, solid
rod made from a mixture of ethylene-vinyl acetate (EVA) and a drug
substance. The resulting product is a solid matrix that is placed subcutaneously, normally in the upper arm in a simple office procedure, and is removed in a similar manner at the end of the
treatment period. The drug substance is released slowly, at continuous levels, through the process of diffusion. This results in a constant rate of release similar to intravenous administration.
About Titan Pharmaceuticals
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.
CONTACT:
Titan Pharmaceuticals, Inc. Pure Communications
Sunil Bhonsle, 650-244-4990 Dan Budwick, 973-271-6085
President dan@purecommunicationsinc.com
Last updated: Oct 26, 2011