Saturday, October 07, 2017
Therapix Biosciences Ltd., a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced it has entered into an exclusive agreement with Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, for the formulation, development and clinical manufacturing of THX-TS01, a first-in-class, proprietary investigational drug candidate for the treatment of the symptoms of Tourette Syndrome.
Pursuant to the agreement, Catalent will develop THX-TS01 in softgel form in support of Therapix's clinical development program and in accordance with current good manufacturing practice (cGMP). The formulation, development, analytical and cGMP manufacturing activities will be conducted at Catalent's primary softgel development and manufacturing facility in St. Petersburg, Florida.
Ascher Shmulewitz, M.D., Ph.D., Therapix's Chairman of the Board of Directors, said, "This is the first time that two cannabinoids, Tetrahydrocannabinol and Palmitoylethanolamide, which we believe work synergistically, are being combined in a proprietary single dose that may potentially provide a turnkey solution to addressing the symptoms of Tourette Syndrome. Our objective in developing THX-TS01 is to enable the commercialization of a more effective treatment for the symptoms of this devastating, unmet medical need. We believe that this agreement may bring us one step closer to this goal."
Dr. Shmulewitz continued, "This agreement with Catalent—a world-class drug development, delivery and supply organization—reflects our belief in the promise of THX-TS01 as we look forward to advanced-stage clinical trials and, if successful, commercialization. We could not be more pleased with Catalent as our new development and manufacturing partner."
"The potential benefits of combining Tetrahydrocannabinol and Palmitoylethanolamide into a fully-optimized single dose, are manifold," said Adi Zuloff-Shani, Ph.D., Therapix's Chief Technology Officer. "This unique formulation could offer an enhanced biological effect and extended duration greater than that presented by administration of each component on its own."