 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
 |
|
|||||||||||||||
 |
 |
 |
|
|||||||||||||
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
|
|||
 |
|
|||||||||||||||
 |
|
|||||||||||||||
Titan Product Candidates
Probuphine™Product Overview
The investigational products are at various stages of development as listed below.
In addition to the potential royalty revenues from iloperidone, Titan is currently focused on adding value to the company from these assets, particularly Probuphine. Additional information on Probuphine and other programs are available in the next sections. If you are interested in learning more, please contact Sunil Bhonsle, President, at sbhonsle@titanpharm.com
Disclaimer for Chart
Information about Titan’s R&D pipeline is updated on a quarterly basis, based on publicly available information. Although we make a good faith effort to keep this content as current as possible, we do not have a duty to update information posted on our web site, and we will not be liable for any failure to update such information.
Probuphine™
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 U.S. 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/naloxone HCl dihydrate) and Subutex® (buprenorphine HCl ), with worldwide sales of over $1.1 billion in 2009. Approximately $900 million of these sales were in the United States. Since its U.S. approval in 2002, the number of doctors certified to prescribe buprenorphine has grown to approximately 20,000 in 2010.
Click to enlarge graphic
Other Clinical Development Opportunities
Other ProNeura™ Applications
ProNeura is Titan's sustained drug delivery technology utilized in Probuphine®, with additional potential applications where conventional treatment is limited by variability in blood drug levels and poor patient compliance. ProNeura is a 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 in-office procedure, and is removed in a similar manner at the end of the treatment period, for at least six months. The drug substance is released slowly, at continuous levels, through the process of diffusion. This results in non-fluctuating and stable blood levels, similar to intravenous administration. Titan retains an exclusive worldwide license to certain patents relating to this long-term drug delivery system, and has conducted non-clinical experiments with potential treatments for Parkinson's Disease and other CNS disorders.
Partnered Product Candidates
Fanapt® (iloperidone)
Fanapt is an atypical antipsychotic approved by the U.S. FDA on May 6, 2009 for the treatment of schizophrenia. Fanapt's unique binding profile to dopamine and serotonin receptors may potentially provide a highly differentiated treatment for patients suffering from schizophrenia. Novarties Pharma, AG, has licensed the rights to commercialize Fanapt in the U.S. and Canada, and commenced marketing the product in the U.S. in Q1, 2010. Titan is entitled to receive royalties on global net sales of Fanapt equal to 8% on annual net sales up to $200 million, and 10% on annual net sales above $200 million for the life of the licensed patents. Titan incurs no ongoing expenses associated with this royalty income.