Titan Pharmaceuticals Announces Data Presentations for Probuphine at the 2008 International Society of Addiction Medicine Congress
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 12, 2008 - Titan Pharmaceuticals, Inc. (AMEX:TTP) today announced that scientific presentations of the positive Phase 3 results from the recently completed placebo controlled study of Probuphine in the treatment of opioid addiction, along with additional data from an ongoing open-label Phase 3 trial of Probuphine, will be presented at the 2008 International Society of Addiction Medicine (ISAM) Congress annual meeting being held November 16-20, 2008 in Cape Town, South Africa. Probuphine is a novel, subcutaneous implant formulation of buprenorphine using Titan's ProNeura technology to deliver six months of medication after a single administration.
These data will be presented during a special breakfast symposium at the meeting on Wednesday, November 19, 2008 at 7 a.m. local time: "An Implantable, Six-Month, Sustained-Release Formulation of Buprenorphine: Phase 3 Efficacy and Safety Results." The chairman of this session is Dr. Walter Ling, Professor-in-Residence of Psychiatry and Director of the Integrated Substance Abuse Programs (ISAP) at UCLA, and the co-chairman is Dr. Solomon Rataemane, Convenor of ISAM 2008 and Chairperson of the Department of Psychiatry at the University of Limpopo (Medical University of South Africa). The session will include the following presentations:
-- "History and Use of Buprenorphine for Opioid Addiction," Dr. Walter Ling, Professor-in-Residence of Psychiatry and Director of the Integrated Substance Abuse Programs (ISAP) at UCLA
-- "Phase 3 Results Evaluating the Safety and Efficacy of Probuphine(R): a Six-Month, Sustained-Release Formulation of Buprenorphine," Dr. Paul Casadonte, Clinical Associate Professor, Department of Psychiatry, New York University's Langone Medical Center
-- "Pharmacokinetic Analyses of Plasma Buprenorphine in Patients Treated for 6 Months With Probuphine(R)," Dr. Alan Bye, an independent pharmacology expert and consultant to Titan Pharmaceuticals
In July 2008, Titan announced positive, clinically and statistically significant top-line results from the randomized, double-blind, placebo controlled, multi-center Phase 3 clinical trial of Probuphine, which was also shown to be safe and well-tolerated in this clinical study.
Probuphine, which is currently in development for the treatment of opioid addiction, is a small solid rod made from a mixture of ethylene-vinyl acetate (EVA) and buprenorphine that is designed to provide continuous, non-fluctuating, long-term therapeutic levels of the drug buprenorphine for six months after a single administration. Buprenorphine, an approved agent for the treatment of opioid addiction, is sold mainly in the form of a sublingually delivered tablet under the brand names Suboxone(R) (buprenorphine HCl/nalaxone HCl dehydrate) and Subutex(R) (buprenorphine HCl) with worldwide sales estimated at $0.5 billion.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (AMEX: TTP) is focused primarily on the late-stage development and commercialization of Probuphine, which utilizes Titan's proprietary ProNeura long term drug delivery technology, and has demonstrated positive results in Phase 3 testing for treatment of opiate addiction. Products based on ProNeura technology can provide controlled drug release on an outpatient basis over extended periods of up to 6-12 months and may be useful for other potential treatment applications in which conventional treatment is limited by variability in blood drug levels and poor patient compliance. Titan also has two other products, gallium maltolate and DITPA, in earlier stages of development. For more information, 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.
Robert Farrell, 650-244-4990
Jennifer Beugelmans, 646-596-7473
Executive Vice President & CFO
Posted: November 2008