Teva pain treatment gets FDA orphan drug status

XEN402 is being developed in collaboration with Xenon for the treatment of erythromelalgia (EM), a rare pain disease.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Xenon Pharmaceuticals Inc. announced today that the US Food and Drug Administration (FDA) has granted orphan-drug status to the investigational drug XEN402 being developed for the treatment of pain associated with erythromelalgia (EM).

EM is 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 erythema (redness of the skin). Symptoms are generally induced by exercise, prolonged standing, exposure to heat, and changes in humidity. The pain can be so severe that it can lead to suicide, and adequate treatment remains very challenging.

Orphan drug status is awarded by the FDA to novel drugs intended to treat rare diseases or conditions affecting fewer than 200,000 people in the US. This designation confers special incentives on the drug developer, including tax credits towards the cost of clinical trials, prescription drug user fee waivers and may entitle a period of seven years US market exclusivity after FDA approval.

In December 2012, Teva and Xenon signed a collaborative development and exclusive worldwide license for XEN402. Under the agreement, Teva paid Xenon an upfront fee of $41 million and will pay development, regulatory, and sales-based milestones totaling up to $335 million. Xenon is entitled to royalties payable on sales and an option to participate in commercialization in the US.

Teva president of global R&D and chief scientific officer Dr. Michael Hayden said, "Through development of this drug, we hope to address the significant unmet medical need for patients who suffer from chronic pain related to erythromelalgia. XEN402, which inhibits the SCN9A sodium channel, is being developed as a non-opioid approach to pain management."

Xenon CEO Simon Pimstone said, “We are excited by the promise XEN402 has shown in early proof-of-concept trials and are committed to its development as a novel therapy for the treatment of pain associated with erythromelalgia.”

Published by Globes [online], Israel business news - www.globes-online.com - on April 23, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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