PARIS, March 31 /PRNewswire/ -- DrugAbuse Sciences SAS of Paris today announced that the European Patent Office granted a European patent (Patent number 117 1132) covering its extended release injectable technology for administering naltrexone. This patent, which was previously granted in the US, covers the composition of injectable naltrexone microspheres to reduce consumption of heroin and alcohol.
DrugAbuse Sciences holds an exclusive worldwide license from Southern Research Institute (Southern Research, Birmingham, Alabama, USA) to develop a long-acting version of Naltrexone based on these patents. DrugAbuse Sciences Naltrexone Depot product is currently evaluated in Phase III clinical trials.
DrugAbuse Sciences is developing this new naltrexone formulation to produce a unique, long-acting medication designed as a once-per-month administration rather than the typical daily dosing regimen for the treatment of alcoholics and heroin abusers. The Company's Naltrexone Depot, currently in Phase III clinical trials, frees patients from the daily decision to take their medication. Medication non-compliance using daily tablets is a major problem for alcoholics and drug addicts. Sustained release injectable formulations offer a major potential benefits to patients and clinicians. A single administration per month provides a continuous therapy to patients and may therefore improve treatment compliance and outcome.
"With the recognition of both the US and European Patent Offices for this important patent, the company believes that it holds a strong portfolio of patents to successfully develop and commercialize its lead product candidate Naltrexone Depot. Furthermore, as illustrated by the recent European Patent Office's technical board of appeal's decision in favor of Southern Research (Alkermes vs Southern Research  26 June 2002), the Company believes that the key patents protecting its lead product candidate provide strong intellectual property protection to the Company," said Philippe Pouletty, MD, founder and chairman of the board.
Robert Floch, CEO added: "To date, DrugAbuse Science has completed a Phase III clinical trial on Naltrexone Depot which showed very promising results; the Company intends to start the second Phase III clinical trial in 2004. Our goal is to rapidly complete the development of Naltrexone Depot for treatment of alcoholism and opiate addiction and to move other product candidates forward."
There are an estimated 27 million alcoholics and 6 million cocaine or heroin addicts in Europe and the U.S. In the U.S. alone, the National Institutes of Health estimates that $197 billion is lost each year due to absenteeism and loss of productivity at work due to alcohol and drug abuse. A 2003 US government study indicated that 15.9 million Americans ages 12 years and older were heavy drinkers, which was 19% higher than previously thought. There are a similar number of patients in need of therapy in Europe.
DrugAbuse Sciences
DrugAbuse Sciences is the first biopharmaceutical company focused solely on developing therapies for treatment of substance abuse, with an innovative portfolio of proprietary product candidates. Naltrexone Depot -- a depot formulation of naltrexone for monthly intramuscular injections -- is being developed for the treatment of alcohol abuse and opiate addiction. A first phase III trial was completed and the company plans to conduct a second Phase III trial to support potential market approval. The company also plans to further develop DAS-431 -- a dopamine D1 receptor agonist -- for treatment of cocaine addiction, Buprenorphine Depot -- a depot formulation of buprenorphine for monthly intramuscular injections -- for the maintenance therapy of opiate addictions and additional products in the field of substance abuse. AlcoholMD.com(TM), an educational web site sponsored by DrugAbuse Sciences, is designed to provide clinicians, patients and their families with easy access to information and services related to alcohol abuse treatment and care.
Southern Research Institute
Southern Research Institute is an independent, not-for-profit center for scientific research affiliated with the University of Alabama at Birmingham. For more than 60 years, Southern Research scientists and engineers have been in the front rank of research in many areas, including pre-clinical drug design and drug development. Institute scientists are pioneers in the development of depot formulations ... injectable microspheres and implantable rods. Drug-delivery programs range from feasibility studies, pre-clinical development, scale up and clinical trial material production. Clinical trial materials can be made for Phase I, II, and III trials in Southern Research's Class 100 and Class 10,000 cGMP manufacturing suites. For more information contact Dr. Thomas Tice, Director, Pharmaceutical Formulations at tice@sri.org or see http://www.southernresearch.org/drug_delivery.
This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding the company's (i) technologies, product candidates, intents and goals, and (ii) research and development plans. Forward-looking statements reflect DrugAbuse Sciences' current estimates with respect to future events. Actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated. There can be no assurance that the company will have sufficient funding to develop its product candidates, that any product candidate under development will be found effective, safe, approved, or be manufactured in sufficient quantities at an economical cost, or that any product will not infringe the proprietary rights of third parties or will result, if approved, in significant revenues and market share.
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CONTACT:
Caroline Carmagnol of Alize PR
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DrugAbuse Sciences SAS