Titan Pharmaceuticals, Inc. today announced that it has received an Office Action from the U.S. Patent and Trademark Office (PTO) rejecting the claims in the Company's method of use patent application for the use of Probuphine in the treatment of opioid addiction and chronic pain.
Probuphine is Titan's novel, subcutaneous implant formulation in development that delivers six months of buprenorphine, and is presently covered by U.S. and European patents licensed from Massachusetts Institute of Technology with terms that expire in 2009 and 2010 respectively. This does not impact the expected data exclusivity protection following product approval of 3 years in the U.S. (Hatch- Waxman Act) and 10 years in Europe, although it may make partnering in the U.S. more difficult. Titan is preparing a response to this Office Action to be submitted to the PTO.
Probuphine is designed to provide continuous, long-term therapeutic levels of the drug buprenorphine, an approved agent for the treatment of opioid addiction. 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.
Titan Pharmaceuticals is focused primarily on the late-stage development and commercialization of innovative treatments for central nervous system disorders. Probuphine, which utilizes Titan's proprietary ProNeura long term drug delivery technology, has demonstrated positive results in Phase III testing for treatment of opiate addiction, and the Company is planning to develop this validated sustained drug delivery technology for other potential treatment applications in which conventional treatment is limited by variability in blood drug levels and poor patient compliance. Products based on ProNeura technology can provide controlled drug release on an outpatient basis over extended periods of up to 6-12 months. Titan also has two other products, gallium maltolate and DITPA, in earlier stages of development.