Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Nuvelution Pharma Inc. today announced their partnership to develop AUSTEDO (deutetrabenazine) tablets for the treatment of tics associated with Tourette syndrome (TS) in pediatric patients in the US.
The agreement provides a risk-sharing funding framework for progressing a promising pipeline opportunity into an approved product, with a success-based investment return for Nuvelution. Under the terms of the agreement, Nuvelution will fund and manage clinical development, driving all operational aspects of the Phase III program, which will start later this year. Teva will lead the regulatory process and be responsible for commercialization. Upon FDA approval of AUSTEDO in TS, Teva will pay Nuvelution a pre-agreed return on its invested capital.
Teva president of Global R&D and CSO Dr. Michael Hayden said, "More than 130,000 children with Tourette syndrome in the US endure significant distress, stigmatization and isolation due to their motor and phonetic tics. Nuvelution is the ideal partner to help us realize the potential of this medication in Tourette syndrome and to help bring it to patients as quickly as possible."
"Following the successful development programs for AUSTEDO in chorea associated with HD and Tardive Dyskinesia, we believe this partnership represents a win, win, win scenario for patients, Teva and Nuvelution, and our investors Clarus and Novo Holdings A/S," said Sandy Zweifach, President and CEO of Nuvelution Pharma Inc. "We are confident, and ready, to rapidly move this program through Phase III, focused on delivering a successful development conclusion."
Published by Globes [online], Israel business news - www.globes-online.com - on September 19, 2017
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