Probuphine®

Overview

Probuphine is Titan’s novel, subcutaneous implant formulation designed using its ProNeura technology to deliver six months of buprenorphine. Buprenorphine is currently marketed as a sublingual formulation for the treatment of opioid addiction.

In July 2008, Titan announced positive, statistically significant results from its randomized, double-blind, placebo controlled, multi-center Phase III clinical trial of Probuphine for the potential treatment of opioid addiction. Probuphine showed a clinically and statistically significant difference over placebo in illicit opioid use for the primary and key secondary endpoints.

Market Opportunity for the potential treatment of Opioid Addiction

Worldwide, it is estimated that there are 6 million opioid addicts. Approximately one-half of this potential patient population is addicted to illicit opioids, such as heroin, and the other half to prescription drugs, such as oxycontin, methadone, and codeine. Until recently, medication assisted therapies for opioid addiction had been sanctioned to a limited number of facilities in the US. As of 2002, physicians can be certified to prescribe opioid addiction medications in an office setting, which has greatly expanded patient access to opioid addiction pharmaceutical therapies. Currently, there are more than 750,000 people globally receiving medicinal treatment for opioid addiction.

Buprenorphine, one of the currently available opioid addiction treatments in the United States, is sold mainly in the form of a sublingually delivered tablet under the brand names Suboxone® (buprenorphine HCl/nalaxone HCl dehydrate)) and Subutex® (buprenorphine HCl ), with worldwide sales of $450 million in 2006. More than one-half of these sales were in the United States. Since its US approval in 2002, the number of doctors certified to prescribe buprenorphine has grown to approximately 13,000.

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Overview for the potential treatment of Chronic Pain

For many of the same reasons that Probuphine offers potential advantages for opioid addiction, it is a promising candidate for the potential treatment of chronic pain, which represents a larger patient population than opioid addiction and a significant unmet medical need. Buprenorphine is currently approved for the treatment of chronic pain in Europe, primarily utilizing a patch formulation. Probuphine’s long-term delivery and stable blood levels of drug may provide certain advantages in potential treatment of chronic pain.