*As of September 23, 2014 - 50% enrolled.
Probuphine®-This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
First received: July 1, 2014
Last updated: July 8, 2014
Last verified: July 2014
Continuous Drug Delivery Technology
The continuous drug delivery system 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 inner part of 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 dissolution. This results in a stable blood level similar to intravenous administration. Such long-term, linear release characteristics are generally desirable as this avoids peak and trough level dosing that poses problems for many Central Nervous System (“CNS”) and other disease settings.
This continuous drug delivery technology was developed to address the need for a simple, practical method to potentially provide continuous drug administration on an outpatient basis over extended periods of up to 6-12 months. In addition to Probuphine, which is the first product to complete clinical testing that has utilized this proprietary continuous drug delivery technology, Titan has conducted initial non-clinical studies with long-term delivery of dopamine agonists demonstrating the potential of this product in the treatment of Parkinson’s disease in non-clinical models of the disease.
Fanapt (iloperidone) is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia currently being marketed by Novartis Pharma AG (“Novartis”) in the U.S. Titan is entitled to a royalty of 8-10% of net sales of Fanapt under a sublicense agreement with Novartis that is based on a U.S. patent which expires in October 2016 (does not include a possible six-month pediatric extension).
Titan has entered into several agreements with Deerfield Management LP (“Deerfield”), which entitle Deerfield to most of the future royalty revenues related to Fanapt in exchange for cash and debt considerations, the proceeds of which have been used to advance the development of Probuphine and for general corporate purposes. Titan has retained a portion of the royalty revenue from net sales of Fanapt in excess of specified annual threshold levels; however, based on sales levels to date, it is unlikely that Titan will retain any revenue from Fanapt in the next several years, if ever. Titan does not incur any ongoing expenses associated with this product. Company Overview
Titan Pharmaceuticals, Inc is a biopharmaceutical company focused in the development of products for the treatment of central nervous system (CNS) diseases. Titan's first out licensed product, Fanapt® (iloperidone) is an atypical antipsychotic approved in the U.S. in May 2009 for the treatment of schizophrenia in adult patients. It is currently marketed in the U.S. by Novartis Pharma, AG, and Titan is entitled to receive 8-10% of global annual sales as royalty revenue for the term of the licensed patents.
Titan's second product, Probuphine, is nearing completion of the Phase 3 clinical development program in the treatment of opioid addiction. Probuphine is a novel, subcutaneous implant formulation of buprenorphine designed to deliver six months of medication following single treatment. This product has already demonstrated strong positive results in the first controlled Phase 3 study for the treatment of opioid addiction. The confirmatory Phase 3 study is currently being conducted at 20 sites in the U.S., and the results of this study are expected in Q2, 2011. Additional information on the Probuphine program is available in the PRODUCTS section of this website.
The Company's common stock is traded on the OTC Bulletin Board Markets ([TTNP.OB] www.otcbb.com) quotations system. For further information please contact firstname.lastname@example.org
Sunil Bhonsle, M.B.A.
Executive Vice President and Chief Development Officer
Katherine L. Beebe, Ph.D.
Marc Rubin, M.D.
Board of Directors