Emerald Health Pharmaceuticals, a division of Emerald Health Therapeutics (TSXV:EMH), announced the European Medicines Agency (EMA) granted an Orphan Designation for their lead molecule, EHP-101, treating systemic scleroderma.
As quoted in the press release:
This chronic autoimmune disease causes severe fibrosis of the skin and internal organs and is associated with significant morbidity and mortality.
Orphan Designation provides potential incentives from the EU to develop a medicine for a rare disease, including protocol assistance, reduced fees, funding from the European Commission for clinical trials, and protection from competition once the medicine is placed on the market, including ten years of market exclusivity.
“The EMA’s granting of Orphan Designation for EHP-101 for scleroderma adds additional value when combined with the US FDA’s recent granting to us of Orphan Drug Designation, giving us further incentive and opportunity to advance a possible solution for patients suffering from this terrible disease that has no cure,” said Jim DeMesa, MD, CEO of EHP. “Since we are developing EHP-101 for multiple sclerosis as well as scleroderma, we now have indications for small patient populations at the same time that we plan our clinical studies for more prevalent diseases.”