D&A Pharma SAS

The EU review of Eisai’s Alzheimer’s drug lecanemab was delayed this week because of a procedural issue at the European Medicines Agency. On Friday, Eisai said that a March 19 question-and-answer session on lecanemab at the Committee for Medicinal Products for Human Use (CHMP) didn’t end up happening because of a separate legal issue that came days before. The delay is related to a court case between D&A Pharma and the EMA. The Court of Justice of the European Union’s ruling on the case from March 14 has “implications on EMA’s policy on the handling of competing interests of experts” in scientific advisory groups that provide advice to help evaluate drugs, according to Eisai.

PARIS, June 22, 2023 /PRNewswire/ -- At the beginning of June, the health authorities hammered it home once again: "The health, social and economic consequences of alcohol consumption represent a burden for French society." The results are alarming: every year in France, alcohol is the cause of 49,000 deaths and an estimated social cost of 118 billion euros.1 Two figures that dramatically sum up the human and financial cost of alcohol dependence, the second leading cause of death after tobacco. Yet there is a drug whose efficacy has recently been reaffirmed, and which has been prescribed in Italy and Austria for over 30 years to 300,000 patients. Its name is Alcover. Its active ingredient, sodium oxybate, was discovered by French professor Henri Laborit, and is used to help alcohol-dependent people maintaining abstinence. A university thesis on the subject has just been published by the Faculty of Medicine at the University of Amsterdam. Validated by some of Europe's leading specialists in alcohol dependence, and meeting the most recent methodological and regulatory standards, its results confirm the efficacy, tolerability and safety of sodium oxybate in maintaining abstinence, particularly in severely dependent patients. They also further strengthen the efficacy and safety data on the basis of which the European Medicines Agency was able to confirm in 2018 the positive benefit-risk profile of the treatment as prescribed in Italy and Austria. Behind these scientific advances, the hope that this treatment will soon be authorized in France would represent a major step forward for thousands of alcohol-dependent patients, their families and public finances. 1. Santé publique France About D&A Pharma: D&A Pharma is a pharmaceutical company founded in 2006 by Patrice Debrégeas. The company's mission is to help people live better without their addictions. Since 2007, D&A Pharma has been developing treatments for addictions and orphan diseases based on well-established active ingredients, formulated by experts working in collaboration with competent international clinicians, statisticians and regulatory experts. Since 2015, D&A Pharma has been developing a sodium oxybate-based drug for the treatment of alcohol dependence. D&A Pharma has provided a financial support to Julien Guiraud for the conduct of his PhD thesis and has sponsored several studies presented in the thesis. (Link to thesis: ) Press contact : Gildas de la Monneraye - [email protected]eu Logo - SOURCE D&A Pharma

MONTBONNOT, France, June 7, 2023 /PRNewswire/ -- While several effective treatments (benzodiazepines) are currently available for the treatment of alcohol withdrawal syndrome, there is an unmet medical need in the abstinence maintenance phase. With its broad mechanism of action on the brain's reward system, sodium oxybate has shown very positive new results confirming its efficacy in the treatment of alcohol dependence and which are presented in the PhD thesis of Julien Guiraud that was carried out at the faculty of medicine of the University of Amsterdam. These new studies included 1,082 patients and were conducted by Julien Guiraud and a group of international experts under the supervision of renowned professors in the field of addiction treatment: Prof. W. van den Brink: Professor of Psychiatry and Addictology at the University of Amsterdam Medical School (Netherlands) Prof. A.E. Goudriaan: Professor of Addictology, specialist in the neurobiology of addiction, University of Amsterdam Medical School (Netherlands) Prof. R. Spanagel: Professor, Scientific Director of the Institute of Psychopharmacology, Central Institute of Mental Health. Mannheim Medical School, University of Heidelberg (Germany) The thesis is based on double-blind randomized trials and meta-analyses of eight studies that investigate the heterogeneity of within- and across-study results. These trials and meta-analyses confirm the efficacy, the good tolerance and the safety of sodium oxybate in the maintenance of abstinence, particularly in severe alcohol-dependent patients. Sodium oxybate has a broad mechanism of action, acting on several neurobiological systems within the brain's reward system. At therapeutic doses, sodium oxybate mimics the mechanism of action of alcohol, without its toxicity in the body, and without the problem of transfer of dependence. Alcohol dependence currently affects 3.4% of the general population aged 18 to 64 in the European Union (EU). It is one of the main causes of morbidity (mental health conditions, cardiovascular disease, cancers, etc.) and mortality (49,000 deaths per year attributed to alcohol dependence in France)1. In addition, the social cost of alcohol in France is estimated at 120 billion euros per year2. For 30 years, Italy and Austria have been successfully using sodium oxybate to help many patients overcome alcohol dependence. Given the urgency of the ever-growing medical need, these studies can be used to extend the marketing authorization of sodium oxybate to other EU countries, such as France, where alcohol dependence remains a major public health issue. 1. Source : Santé publique France 2. Source : OFDT About D&A Pharma: D&A Pharma is a pharmaceutical company founded in 2006 by Patrice Debrégeas. The company's mission is to help people live better without their addictions. Since 2007, D&A Pharma has been developing treatments for addictions and orphan diseases. Since 2015, D&A Pharma has been developing a sodium oxybate-based drug for the treatment of alcohol dependence. D&A Pharma has provided a financial support to Julien Guiraud for the conduct of his PhD thesis and has sponsored several studies presented in the thesis () Logo - Gildas de la Monneraye, [email protected] SOURCE D&A Pharma