Full Press Release Details
TITAN PHARMACEUTICALS PROVIDES ADDITIONAL POSITIVE RESULTS IN
CONFIRMATORY PHASE 3 TRIAL OF PROBUPHINE
Results to be Discussed on Conference Call Today at 8:00 a.m. PT/11:00 a.m. ET;
Data to be Presented in Plenary Session at ISAM 2011 in September
South San Francisco, CA August 16, 2011 Titan Pharmaceuticals, Inc. (TTNP.OB) today announced additional
positive results from its Phase 3 placebo- and active drug-controlled confirmatory clinical study of Probuphine , evaluating the safety and efficacy of its investigational drug in treating patients with opioid dependence. Probuphine was found
to be well tolerated and Probuphine treatment resulted in a significant improvement in the global severity of opioid dependence (p = 0.0003) and overall patient improvement (p = 0.0002) versus placebo, as assessed by clinicians. The additional data
analyses also confirm Probuphine s non-inferiority to the approved drug SUBOXONE . These findings build upon the clinically meaningful and statistically significant top line data announced by Titan in July 2011, which confirmed the
efficacy of Probuphine compared to placebo for two primary endpoints (p < 0.0001 for both). Titan has been invited to present these findings during a plenary session on September 10 and in a poster presentation on September 8 at the
13th annual meeting of the International Society of Addiction Medicine (ISAM) in Oslo, Norway.
clinician, I can say that the advent and introduction of buprenorphine has absolutely changed and improved the landscape of opioid dependence treatment. However, there are also real concerns and increasing worry about medication compliance and
diversion within the current treatment setting, said Walter Ling, M.D., Professor of Psychiatry and Director, Integrated Substance Abuse Programs at the David Geffen School of Medicine at UCLA and a lead investigator in the Probuphine Phase 3
study. Probuphine represents a new, different and potentially improved method of delivering buprenorphine to patients - one that could lessen or eliminate physicians concerns about medication compliance and diversion.
Probuphine is an innovative, subcutaneous implant formulation that delivers a steady, round-the-clock dose of the marketed drug buprenorphine over six
months following a single treatment. Probuphine, designed using Titan s proprietary ProNeura technology, has been developed to reduce the risk of diversion and abuse while assuring compliance to treatment and potentially improved medical
In my opinion, Probuphine combines the right medication with the right delivery system. We all know
that people with opioid addiction may have difficulty taking effective medications reliably, said Dr. Richard N. Rosenthal, Chairman of Psychiatry at St. Luke s-Roosevelt Hospital Center, a teaching hospital of Columbia
University, and past president of the American Academy of Addiction Psychiatry. These Phase 3 trial results confirm that this medication strategy has specific promise in our national battle against opioid dependence, in that it is both
efficacious and reduces the potential risk to patients from missed doses and to the public through intentional or unintentional diversion.
The Phase 3 clinical trial was a randomized, placebo and active-controlled, multi-center study conducted at 20 sites in the U.S. that treated 287
patients, aged 18 to 60 years across three dosing arms: Probuphine (114 patients), the approved and widely-used sublingual formulation of buprenorphine, Suboxone, (119 patients) and placebo implants (54 patients). Patients were treated for up to 24
weeks and the Probuphine and placebo dosing arms were double-blinded, while the Suboxone arm was open-label. Highlights of the additional trial analyses announced today include:
| Probuphine | Placebo | Suboxone | ||||||||||
| Headache | 13.2 | % | 9.3 | % | 16 | % | ||||||
| Upper Respiratory Tract Infection | 8.8 | % | 7.4 | % | 9.2 | % | ||||||
| Depression | 8.8 | % | 3.7 | % | 2.5 | % | ||||||
| Insomnia | 7.9 | % | 14.8 | % | 13.4 | % | ||||||
| Sore Throat | 7.0 | % | 1.9 | % | 3.4 | % | ||||||
| Nausea | 6.1 | % | 1.9 | % | 6.7 | % | ||||||
| Vomiting | 6.1 | % | 1.9 | % | 4.2 | % |
We believe Probuphine represents an important step forward in the treatment of opioid dependence and
are looking forward to sharing additional findings with the scientific and clinical community at the ISAM annual meeting next month and at future medical conferences and in peer-reviewed publications. We are also planning to review the program at a
pre-NDA meeting with the FDA this fall, said Katherine L. Beebe, Ph.D., Principal Investigator for the study and Executive Vice President and Chief Development Officer of Titan. Another near-term priority is to establish a strategic
commercialization partnership and, ultimately, to deliver a safe and effective treatment option for patients with opioid dependence.
The World Health Organization estimates that between 4.6 and 5.2 million individuals in the U.S. and Europe use illicit opioids such as heroin, and
more than 2.0 million individuals in the U.S. alone are addicted to prescription opioid medications. It is estimated that more than 1.0 million people in the U.S. and Europe currently receive pharmacological treatment for opioid addiction.
management will host a live call and webcast on Tuesday, August 16, 2011 at 8:00 a.m. PT (11:00 a.m. ET) to discuss the results of this positive Phase 3 clinical trial of Probuphine in patients with opioid dependence, as well as the
Company s second quarter 2011 results. Joining the Titan management team for the call will be Dr. Ling and Dr. Rosenthal.
live webcast of the call may be accessed by visiting our website at www.titanpharm.com. The call can also be accessed by dialing 1-888-206-4836, participant code: 6514332 five minutes prior to the start time. A replay of the call will be available
on our website approximately two hours after completion of the call and will be archived for two weeks.
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
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.
SUBOXONE is a registered trademark of Reckitt Benckiser Pharmaceuticals Inc.
| CONTACT: | ||||
| Titan Pharmaceuticals, Inc. | Pure Communications | |||
| Sunil Bhonsle, 650-244-4990 | Dan Budwick, 973-271-6085 | |||
| President | dan@purecommunicationsinc.com |