DUBLIN, IRELAND – February 23, 2018 – ATXA Therapeutics Limited, an early-stage Irish biopharmaceutical company focused on clinical development of novel small molecule drugs to treat Pulmonary Arterial Hypertension (PAH), announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation to the Company's lead clinical candidate NTP42 for the treatment of pulmonary arterial hypertension (PAH). The European Commission formally adopted this decision on February 22, 2018 in accordance with Regulation (EC) No 141/2000 of the European Parliament and of the Council of the European Union.
“Receiving Orphan Drug Designation from the EMA is a key milestone in our long-term development and commercialization strategy for NTP42”, said Prof. Therese Kinsella, ATXA Therapeutics' Founder and Chief Scientific Officer. “There is an urgent need for new therapies that have the potential to address the underlying cause of PAH, and we are committed to advancing NTP42 as a novel approach to treating all aspects of this debilitating disease.”
Orphan Drug Designation is awarded for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition that is rare (affecting not more than five in 10,000 people in the European Union) or where the medicine is unlikely to generate sufficient profit to justify research and development costs. This designation provides ATXA Therapeutics Limited with a number of potential incentives in the EU including protocol assistance, reduced fees and protection from market competition once NTP42 is approved for PAH patients.
About ATXA Therapeutics
Headquartered in Dublin, Ireland, ATXA Therapeutics Limited is a spin-out company from University College Dublin whose primary focus is to advance clinical trials and to secure marketing authorization of novel therapies for the treatment of Pulmonary Arterial Hypertension (PAH), serving a previously unmet medical need by offering improved treatment options to the prescribing physician and new hope for the PAH patient. Founded in May 2015, ATXA Therapeutics Limited is the culmination of over 20 years of extensive research and over €15m of grant funding and a proven track record in understanding of the biology and signalling of the human prostanoid receptors in the cardiovascular disease and oncology setting. For more information, please visit www.atxatherapeutics.com.
Press Contact: info@atxatherapeutics.com