Teva Pharmaceutical Industries Ltd. and Xenon Pharmaceuticals Inc. recently announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to the investigational drug XEN402 being developed for the treatment of pain associated with erythromelalgia. 

Xenon and Memorial University signed an agreement in November 2000 to collaborate on three genetic diseases prevalent in Newfoundland and Labrador. The agreement with Memorial was negotiated through the university’s technology commercialization arm, the Genesis Group. Since then, according to David King, president of the Genesis Group, the Faculty of Medicine has received $331,000 in milestone payment and $175,000 in collaborative research funding. In addition, the Genesis Group and Memorial University have received $94,000 as their share of a milestone payment.

Since the agreement with Xenon in 2000, genetic researchers at Memorial’s Faculty of Medicine have collaborated in identifying the gene linked to hereditary sensory and autonomic neuropathy type II (HSAN II). The researchers involved were neurologist Dr. William Pryse-Phillips and geneticists Drs. Banfield Younghusband, Mary O’Driscoll and Roger Green. Xenon cloned and validated the gene.

The most recent development of the investigational drug XEN402 is for pain associated with erythromelalgia (EM), a rare autosomal dominant condition characterized by debilitating spontaneous or easily evoked attacks of symmetrical burning pain in the feet and hands, typically associated with elevated skin temperature and redness of the skin.

Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to novel drugs intended to treat rare disease or conditions affecting fewer than 200,000 people in the U.S. This designation confers special incentives to the drug developer, including tax credits towards the cost of clinical trials and prescription drug user fee waivers and may entitle a period of seven years of U.S market exclusivity upon FDA approval.

Xenon is a privately owned, rare disease company based in Vancouver, B.C., which develops innovative medicines based on genetically validated drug targets. Teva Pharmaceutical is a global pharmaceutical company headquartered in Israel.