On April 19, 2018 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 Drug Designation from the U.S. FDA for Oraxol for the treatment of angiosarcoma (Press release, Athenex, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343439 [SID1234525530]). Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor).
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Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are pleased to receive Orphan Drug Designation for Oraxol for the treatment of angiosarcoma, a form of malignant blood vessel cancer. This designation represents our commitment to expand the use of Oraxol, in which the active pharmaceutical ingredient is paclitaxel, to additional clinical indications based on the known efficacy of paclitaxel and the observed improved pharmacokinetic profile of Oraxol. This is a parallel development with our clinical studies in metastatic breast cancer and gastric cancer, in which Oraxol has already shown promising efficacy and safety profile. We will be initiating the angiosarcoma clinical study soon."
The FDA grants Orphan Drug status to support development of medicines for the treatment of diseases that that affect fewer than 200,000 people in the United States. Orphan Drug Designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
Athenex previously announced that it had met its enrollment target for the second interim analysis for the Oraxol Phase III clinical trial for metastatic breast cancer and is scheduled to conduct this interim analysis in the third quarter of 2018. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018. Athenex also announced initial results of a clinical study in Taiwan in patients with metastatic breast cancer, as well as results of the first cohort of patients in a study in Taiwan on the combination with ramucirumab (Cyramza, Eli Lilly’s monoclonal antibody against VEGFR2) in patients with gastric cancer.
Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex, in territories including North and Latin Americas, Europe, Japan, greater China and Southeast Asia, Australia and New Zealand. Athenex is leading the registration effort from IND and clinical studies.