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D&A Pharma Presents 3 Major Clinical Studies Which Confirm and Extend the Efficacy and Safety of ACOLVER® at the 14th Congress of ESBRA (European Society for Biomedical Research on Alcoholism), Warsaw


9/6/2013 9:32:08 AM

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Paris (France) – September 6, 2013 – D&A PHARMA, a leading company in the Addiction therapeutic area, announces today its strong participation in the 14th Congress of European Company of Biomedical Search on the Alcoholism (ESBRA), which will be held in Warsaw from September 8th to 11th.

During this Congress, D&A PHARMA will present the results of several clinical studies (GATE 1, GATE 2 et GUM) for ALCOVER® (Sodium Oxybate), a breakthrough treatment of alcohol dependence. All presented data confirm that Sodium Oxybate favorably meets the therapeutic objectives set by experts and by health authorities (EMA, FDA) for the management of alcohol-dependence.

- GATE 1 study included 127 dependent patients, confirms the efficacy of ALCOVER® in the processing of the syndrome of weaning occurring at the time of the stop of the alcoholic intoxication.

- GATE 2 study included a 6-month double-blind treatment with ALCOVER® or placebo, followed by a 6-month untreated period. ALCOVER® was statistically significantly better than placebo at 6 months and the difference was maintained at 12 months. Three hundred and fourteen alcohol-dependent patients from 4 European countries participated in GATE 2 study. On September 9th, D&A PHARMA will present in detail the outcomes of these studies in an official satellite symposium of the ESBRA as well as in a poster and oral presentations. The satellite symposium is entitled: « Sodium Oxybate: Breakthrough in the Treatment of Alcohol Withdrawal Syndrome and Maintenance of Alcohol Abstinence ».

These two multicenter studies have been conducted in Germany, Austria, Italy and Poland.

- The GUM study (GHB – Use and Misuse) is a longitudinal retrospective study that has analyzed 604 patient files. Patients had a severe alcohol dependence, and for some of them, co-addictions or psychiatric co-morbidities. The study has been performed from 2005 to 2007 in seven centers from Northern Italy.

The study demonstrated that ALCOVER is effective and safe when prescribed in the therapeutic dose interval: in the treatment of alcoholic withdrawal syndrome (detoxification), 81% of patients were successfully detoxified. In the prevention of relapses and maintenance of alcohol abstinence maintenance, 75% to 80% of patients remained abstinent 12 months after the initiation of alcohol treatment.

Dr Felice Nava, Director of Scientific Committee of the Italian Society of Addiction Medicine (FeDerSerD), commented: “All these studies have proved the efficacy and the safety of Sodium Oxybate on the current criteria of evaluation required by the European Medicines Agency. It is the case both in the treatment of the withdrawal syndrome and in the prevention of alcohol relapses and this, without any addictive effect observed”.

Patrice Debrégeas, chairman of D&A PHARMA, concluded: “We are very proud of all the aggregated clinical data for ALCOVER®. All these long-term studies show the efficacy and the great safety of use of ALCOVER®. In addition to these strong results makes it possible to the patients to avoid to benzodiazepines, strongly sedative drugs, during the detoxification period and to continue the same treatment on the long term, which is unique among anti-alcohol drugs and optimizes significant fact in the treatment of the alcoholic dependence. This is a major competitive advantage and an important benefit for all alcoholic patients. As an independent pharmaceutical company, it is a great honor to present to the largest KOLs’ panel in the field of alcohology and addictology all these major results at a moment when D&A PHARMA is filing for approval in a secured formulation of ALCOVER® several European agencies in order to market the product in the European Union in 2014, while ALCOVER® has been successfully marketed for 20 years in Italy and 14 years in Austria, allowing to treat successfully 350.000 patients who are 100% refunded at 100% by public healthcare organizations”.

In addition to its participation in the 14th Congress of ESBRA, D&A PHARMA will organize on September 7th, 2013, always at Warsaw, its International Expert Board, gathering about thirty leading specialists and fundamental scientists in alcohology and addictology *.

* International Expert Board – D&A PHARMA: Giovanni Addolorato (Catholic University of Rome, Italy), Henri-Jean Aubin (Paul Brousse Hospital – Hospital University of Paris-Sud, France), Marc Auriacombe (Charles Perrens Hospital Center, Bordeaux, France), Philippe Batel (Beaujon Hospital, Clichy, France), Fabio Caputo (University of Bologna, Italy), Jonathan Chick (Spire Edinburgh Hospitals , Scotland), Giancarlo Colombo (Institute of Neuroscience, Cagliari, Italy), Philippe De Witte (UCL, Belgium), Antoni Gual (Hospital Clínic of Barcelona, Espagne), Victor Hesselbrock (University of Connecticut, United-States), Susumu Higushi (Tokyo University of Science, Japan), Eduardo Kalina (Brain Center, University of Buenos Aires, Argentina), Evegny Krupitsky (Pavlov University, Saint Petersburg, Russia), Lorenzo Leggio (Boston University School of Medicine, United-States), Otto Lesch (University of Vienna, Austria), Icro Maremmani (University of Pize, Italy), Charles O’Brien (University of Pennsylvania, Philadelphia, United-States), François Paille (Nancy Hospital, France), Samuel Pombo (Santa Maria Hospital, Lisbon, Portugal), Michel Reynaud (Paul Brousse Hospital, Hospital University of Paris-Sud, France), Helmut-Karl Seitz (Medical Center of Heidelberg, Germany), Rainer Spanagel (University of Manheim, Germany), Robert Swift (Providence Medical Center, United-States), Boris Tabakoff (University of Denver, United-States), Henriette Walter (University of Vienna, Austria), Marcin Wojnar (Medical University of Warsaw, Poland), Thomas Zima (University of Prague, Czech Republic).

About D&A PHARMA

D&A PHARMA is a pharmaceutical company dedicated to the development and the supply of innovative treatments in the fields of various addictions such as alcohol, heroin and cocaine.

The Company intends to quickly develop its activities worldwide with ALCOVER®, a treatment of the alcoholic dependence already prescribed and marketed in Italy and Austria, for which it has acquired the exclusive license. Two other molecules for heroin and cocaine addictions are also under development at clinical and pre-clinical stages. Founded in 2006 by Sabine Cheyrou and Patrice Debrégeas, cofounder of Etypharm, D&A PHARMA headquarters is located downtown Paris (8th District) and the R&D and production site is based in Houdan, 60 km to the west of Paris. The company employs 45 people. For more information, please visit: www.da-pharma.fr

Contacts:

D&A PHARMA

+33 (0) 1 53 04 41 30?

contact@da-pharma.com

Milestones – Press Relations

Bruno Arabian

+33 (0) 1 75 44 87 40

barabian@milestones.fr

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