Oct 1 2011
ViroPharma Incorporated (NASDAQ: VPHM) today announced the license of worldwide rights from Intellect Neurosciences, Inc. (OTCBB: ILNS) to its clinical stage drug candidate, OX1, being developed for the treatment of Friedreich's Ataxia (FA), a rare, hereditary, progressive neurodegenerative disease.
OX1, or indole-3-propionic acid (IPA), is a naturally occurring, small molecule that has potent anti-oxidant properties that can protect against neurodegenerative disease. In a recent Phase 1 safety and tolerability study conducted in the Netherlands, OX1 was demonstrated to be safe and well tolerated at all dose levels tested. ViroPharma expects to initiate a phase 2 study within 12 to 18 months after completion of longer term toxicology studies. ViroPharma intends to file for Orphan Drug Designation upon review of the phase 2 proof of concept data.
Under the terms of the agreement, ViroPharma has exclusive worldwide rights to develop and commercialize OX1 for the treatment, management or prevention of any disease or condition covered by Intellect's patents. ViroPharma paid Intellect Neurosciences a $6.5 million up-front licensing fee and will pay additional milestones based upon defined events. The maximum of these milestone payments assuming successful advancement to market could amount to $120 million. The company will also pay a tiered royalty of up to a maximum percentage of low teens, based on annual net sales.
"The mission of ViroPharma is to improve the health of patients suffering from serious diseases and unmet medical needs, and Friedreich's Ataxia clearly fits in that class," said Vincent Milano, ViroPharma's chief executive officer. "FA robs children and young adults of muscle coordination leading to loss of mobility, energy, speech, and hearing, and presents a significant risk of diabetes and life shortening cardiac disease. While OX1 is early in development, this novel therapy has the potential to be a solution for this unmet need, and to make a significant difference in the lives of patients suffering from this rare disorder, and their families and caregivers."
Jennifer Farmer, MS, CGC, Executive Director, Friedreich's Ataxia Research Alliance (FARA) commented, "We are very pleased that ViroPharma is advancing the clinical research of OX1 in Friedreich's Ataxia. Sadly, there are currently no FDA-approved treatments for this devastating disease. We look forward to working with ViroPharma to advance this therapy forward, through building collaborative efforts with our clinical research network and connecting them to the patient community through our worldwide patient registry."