28 août 2018

ORPHELIA Pharma will be present at CPhI in Madrid
28 août 2018

Hugues Bienaymé, General Manager and Chief Scientific Officer of ORPHELIA Pharma and Mathieu Schmitt, Pharmaceutical Development Director, will be present to the 2018 CPhI to be held in Madrid, Spain, October 9-11, 2018. Please meet us there (contact: mathieu.schmitt@orphelia-pharma.eu).
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28 août 2018

CHMP has adopted a positive opinion for Kigabeq®
28 août 2018

Paris and Lyon, August 28th, 2018 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric drugs in the fields of oncology and neurology, announces today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the issuance of a marketing authorization for the medicinal product Kigabeq® by the European Commission. As Kigabeq® has been exclusively developed for use in children, it should receive a Paediatric Use Marketing Authorization (PUMA). Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug and will be available as scored soluble tablets of 100 mg and 500 mg strengths. Kigabeq® is expected to be used as first-line treatment for infantile spasms, an extremely severe early childhood encephalopathic epilepsy. « We are particularly honoured with this decision which comes after several years of continuous efforts of ORPHELIA Pharma together with our academic partners », comments Hugues Bienaymé, Founder and General Manager of ORPHELIA Pharma. « This positive opinion is a key milestone in the process to make Kigabeq®, our first medicinal product, available to the pediatric community ». « The CHMP has acknowledged the interest of Kigabeq® in improving health of epileptic children. We are eagerly awaiting the final marketing authorisation from the European Commission by October », highlights Gilles Alberici, Chairman of ORPHELIA Pharma. « Kigabeq® is expected to be the fourth human medicine to be granted a PUMA in Europe ». About infantile spasms Infantile spasms, or West Syndrome, is an early childhood epileptic encephalopathy which combines axial spasms in cluster, a marked psychomotor delay and an hypsarythmic electroencephalogram. It is a rare disease with an estimated incidence of around 0.05 per 10,000. It affects infants who were previously normal or children with impaired cognitive development. Children with infantile spasms must be treated rapidly for spasms cessation and to improve prognosis. About ORPHELIA Pharma Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament.
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25 juin 2018

Pierre Attali joins ORPHELIA Pharma Board Of Directors
25 juin 2018

Paris and Lyon, June 25th 2018 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, announces today that Pierre Attali has joined its Board of Directors. Pierre Attali, MD, will bring to ORPHELIA Pharma his expertise in clinical development, especially in oncology, acquired during a 30-year career in pharmaceutical and biotech companies. Dr. Attali was successively Head of Clinical Research Department, Licensing Director and General Manager at Synthelabo, Chief Operating Officer and Chief Medical Officer at Bioalliance / Onxeo, Chairman and Chief Executive Officer at Urogene. More recently, he joined Sensorion as Chief Medical Officer and Head R&D. He also founded and managed several biotech companies, such including OSMO, Molecular Engines Laboratories (MEL), and more recently Selexel. Pierre Attali contributed to the development, registration and marketing of more than 10 novel  drugs and formulations, both in Europe and in the United States. He authored numerous peer-reviewed scientific publications and patents. « We are particularly honoured to welcome Pierre at ORPHELIA Pharma » comments Gilles Alberici, Chairman of ORPHELIA Pharma. « His deep knowledge of drug development, especially in the oncology therapeutic area, will be invaluable to us ».  « I am very pleased to join the Board of ORPHELIA Pharma » says Pierre Attali; « I personally know and appreciate the management team since many years. The culture of the company, aiming at improving patient’s care and focusing on paediatric medicines is paramount to my own personal values». About ORPHELIA Pharma Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament.
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28 mars 2018

ORPHELIA at the 2018 BIO Convention in Boston
28 mars 2018

Jeremy Bastid, Chief Development Officer of ORPHELIA Pharma, will attend the 2018 BIO International Convention, to be held in Boston, Massachusetts, June 4-7, 2018. Please meet us there on June 6 or 7 (contact: jeremy.bastid@orphelia-pharma.eu)
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