Agreements

* On September 23, 2013, Neurolixis has announced that it has licensed the worldwide development and commercialization rights to two clinical compounds from Pierre Fabre Medicament. The two serotoninergic compounds, F15599 and befiradol, have been tested by Pierre Fabre Medicament in Phase 1 and 2 clinical studies, respectively. Neurolixis plans to study befiradol in Parkinson’s disease patients that exhibit dyskinesia, and F15599 will be evaluated for its ability to normalize irregular breathing in Rett syndrome patients. Neurolixis obtained an exclusive, royalty-­bearing license with regulatory and clinical development milestone payments. Neurolixis’ development and commercialization rights are worldwide, and exclusive in all fields for the licensed compounds. "Our first objective is to run a Phase IIa clinical study with befiradol in Parkinson's disease patients suffering from debilitating levodopa-induced dyskinesia. Levodopa remains the gold standard treatment for Parkinson's disease but, after a few years, it elicits dyskinesia in a majority of PD patients", stated Mark Varney, Neurolixis's president and CEO.

Neurolixis has previously received two grants from the Michael J. Fox Foundation supporting proof-of-principle animal studies to test befiradol’s anti-dyskinetic properties. The Company will also evaluate F15599 for its ability to normalize irregular breathing patterns seen in patients suffering from Rett syndrome, a severe genetically-encoded neurodevelopmental disorder. In preclinical studies, F15599 reversed breathing deficits in transgenic mice with the MeCP2 gene mutation that underlies Rett’s syndrome. Neurolixis has applied to the FDA for orphan drug designation for the treatment of Rett syndrome and will explore orphan drug designations in Europe and in other parts of the world under its worldwide development and commercialization rights.