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Parexel To Handle Valeant NDA/MAA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Valeant Pharmaceuticals International has appointed Parexel International to develop, coordinate and prepare the New Drug Application (NDA) and the European Marketing Authorization Application (MAA) for Valeant’s investigational compound retigabine. Retigabine is a novel neuronal potassium-channel opener that is being studied in Phase III trials as an adjunctive treatment for partial-onset seizures in patients with epilepsy. Valeant anticipates filing both applications in mid-2008.

“Parexel’s regulatory expertise is anticipated to play a critical role in our development of retigabine,” said Wesley P. Wheeler, Valeant’s president North America and R&D. “Valeant is committed to developing innovative drugs for neurological disorders, with a special focus on epilepsy. Parexel’s global presence and long experience with NDA and MAA filings will be invaluable in the regulatory filing process for retigabine.”

“We are pleased to have this opportunity to assist Valeant with the development and submission of the NDA and MAA for retigabine,” said Alberto Grignolo, Ph.D., Corporate Vice President and General Manager of PAREXEL Consulting. “We are looking forward to working with them on this important project.”

In April, Valeant published positive Phase II data for retigabine. Two international pivotal Phase III trials (RESTORE1 and RESTORE2) are currently underway to further investigate the efficacy and safety of retigabine as an adjunctive treatment for partial-onset seizures in patients with refractory epilepsy.

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