On October 30, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has received Orphan Designations from the European Commission (EC) for paclitaxel and encequidar ("Oral Paclitaxel") for the treatment of soft tissue sarcoma, following a positive opinion from the European Medicines Agency (EMA) (Press release, Athenex, OCT 30, 2019, View Source [SID1234573893]).
Dr. Rudolf Kwan, Chief Medical Officer of Athenex, commented, "We are very pleased to receive Orphan Designations from the European Commission, as this further recognizes the potential benefits of Oral Paclitaxel. Earlier this year, we shared encouraging early results from a clinical study in angiosarcoma, a form of soft tissue sarcoma, that showed rapid responses in a difficult to treat patient population. We will soon be extending this study to include sites in Europe."
The EC grants Orphan Designation status to support development of medicines for the treatment of diseases that affect fewer than 5 in 10,000 people in the European Union and provide a significant benefit to those affected by the condition. Orphan Designation may provide certain benefits, including protocol assistance, fee reductions, and a ten-year period of market exclusivity if the drug is approved.
The U.S. FDA has granted oral paclitaxel and encequidar an Orphan Drug Designation in the treatment of angiosarcoma.
The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.