Titan Pharmaceuticals Announces Phase 3 Probuphine(R) Data Presentation at the American Society of Addiction Medicine (ASAM) 43rd Medical-Scientific Conference
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 04/20/12 -- Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced that positive efficacy and safety results from its confirmatory Phase 3 clinical trial evaluating Probuphine® in patients with opioid dependence will be presented during a poster presentation at the American Society of Addiction Medicine (ASAM) 43rd Medical-Scientific Conference being held April 19-22, 2012 in Atlanta.
The poster presentation, "Results of a Six-Month, Randomized, Controlled, Confirmatory Phase 3 Trial Comparing the Efficacy and Safety of Buprenorphine Implants to Placebo Implants, and Sublingual Buprenorphine/Naloxone for Opioid Addiction," will be presented by Katherine Beebe, Ph.D., Executive Vice President and Chief Development Officer of Titan, on Friday, April 20, 2012 at 1:30 p.m. ET. Following the presentation, the poster will also be available in the 'Resources' section on the Titan website at www.titanpharm.com.
Probuphine New Drug Application
Probuphine is a novel product that has completed Phase 3 clinical development for the long-term treatment of opioid dependence and a New Drug Application (NDA) preparation is in process. The commercial scale contract manufacturing facility expansion is on schedule with installation of the air-handling equipment and assembly of the modular clean rooms currently in progress. The qualification and validation of the facility and the manufacturing equipment is next and this will commence by the end of April. Preparation of the clinical and non-clinical sections of the NDA is also proceeding as planned. The additional testing required to generate data requested by the FDA as part of the chemistry, manufacturing and control (CMC) section is also progressing on schedule and the NDA is expected to be ready for submission in September 2012.
Probuphine is a subcutaneous implant, capable of delivering continuous and persistent, around the clock blood levels of buprenorphine for six months following a single treatment, enhancing patient compliance and retention. Buprenorphine, an approved agent for the treatment of opioid dependence, is currently available in the form of daily dosed sublingual tablet and film formulations with reported annual sales of over $1 billion in the United States. The safety and effectiveness of treatment with Probuphine has been demonstrated in several clinical 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 buprenorphine.
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
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
CONTACT: For Investors: Titan Pharmaceuticals, Inc. Sunil Bhonsle 650-244-4990 President For Media: Pure Communications Dan Budwick 973-271-6085 email@example.com
Source: Titan Pharmaceuticals, Inc.
Released April 20, 2012