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Tonix Pharmaceuticals Licenses Technology for Treating Prader-Willi Syndrome, a Rare Genetic Eating Disorder, from the French National Institute of Health and Medical Research (Inserm)
Expands Proprietary Uses of Tonix’s Potentiated Oxytocin for Intranasal Administration Disorder Stunts Growth of Newborns and, Paradoxically, Can Cause
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Expands Proprietary Uses of Tonix’s Potentiated Oxytocin for Intranasal Administration Disorder Stunts Growth of Newborns and, Paradoxically, Can Cause Excessive Hunger During Childhood and Beyond CHATHAM, N.J., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix has licensed technology using oxytocin-based therapeutics for the treatment of Prader-Willi syndrome and non-organic failure to thrive disease from Inserm. The licensing agreement has been negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National Institute of Health and Medical Research), Aix-Marseille Université and Centre Hospitalier Universitaire of Toulouse. The co-exclusive license allows Tonix to expand its intranasal potentiated oxytocin development program to a new indication. The new program at Tonix has the designation TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. The patents covering the technology are expected to provide market exclusivity for the co-licensees in the U.S. and Europe through 2031, which exclusivity could be extended after marketing authorization by a Supplemental Protection Certificate in Europe or a Patent Term Extension in the U.S., independent of other Tonix-held patents covering the formulation and oxytocin potentiation technologies for intranasal administration. “Prader-Willi syndrome is a rare genetic disorder of failure to thrive in infancy and uncontrolled appetite and obesity in childhood and adulthood with no approved treatments available,” said Tonix’s President and Chief Executive Officer, Seth Lederman, M.D. “With the license from Inserm Transfert, we have the opportunity to expand our ongoing efforts with intranasal potentiated oxytocin to this new indication. Since Prader-Willi syndrome is an orphan disease that occurs in approximately one in 15,000 births, we plan at the appropriate time to submit an application to the U.S. Food and Drug Administration for Orphan Drug and Fast Track designations for TNX-2900.” Prader-Willi syndrome results in physical, mental and behavioral problems. A key feature of Prader-Willi syndrome in infants is a lack of suckling and poor muscle strength which l...