Titan Pharmaceuticals updates on Probuphine patent application
New research out of the University of Pittsburgh indicates that patients’ perceptions of their own health and balance have an impact on how much they walk. The study was originally published in Physical Therapy (December 2008), the scientific journal of the American Physical Therapy Association (APTA). “The purpose of this cross-sectional study was to investigate
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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.
Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company’s Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil’s chronic pain treatment Duragesic. Shipment of this product has commenced.
Full Post: Teva granted FDA approval for Fentanyl transdermal system
Solianis has just finalised a test series in which patients with diabetes have worn the first configuration of the multisensor system for non-invasive Continuous Glucose Monitoring at home and at work. Results show that the system tracks glucose in these settings and that it is sensitive to hyper- and hypoglycemic glucose excursions. “This is the
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Endo Pharmaceuticals and Indevus Pharmaceuticals, Inc. announced today that they have entered into a merger agreement under which Endo will commence a tender offer to acquire 100 percent of the outstanding shares of Indevus for approximately $370 million, or $4.50 per Indevus share, in cash, and up to an additional approximately $267 million, or $3.00
Full Post: Endo Pharmaceuticals to acquire Indevus Pharmaceuticals
A tiny particle syringe composed of polymer layers and nanoparticles may provide drug delivery that targets diseased cells without harming the rest of the body, according to a team of chemical engineers. This delivery system could be robust and flexible enough to deliver a variety of substances. “People probably fear the effects of some
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The Australian Patent Office has issued Nutraceutix, Inc. a patent for BIO-tract. It is the third international patent, from many patents pending, that the technology has been awarded based on BIO-tract’s ability to protect sensitive ingredients like probiotic organisms from stomach acid on their way to optimal release sites in the intestinal tract. Steve Moger,
Full Post: Nutraceutix issued Australian patent