NIH awards Titan $7.6M grant for Probuphine clinical development

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.