Dynacure Announces Strategic Collaboration and Option Agreement with Nippon Shinyaku
November 10, 2021 at 08:00 am
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Dynacure announced that Dynacure and Nippon Shinyaku Co., Ltd. have entered a long-term strategic development and commercialization agreement. Nippon Shinyaku has obtained an exclusive option to acquire development and commercial rights from Dynacure to develop DYN101, an investigational antisense oligonucleotide product candidate designed to be a disease-modifying medicine for treatment of the majority of Myotubular and Centronuclear Myopathies (CNM) in both adult and pediatric patients living with this rare life-threatening disorder in Japan. DYN101 is currently being evaluated in a Phase 1/2 clinical trial, UNITE-CNM (DYN101-C101), at multiple clinical sites in Europe. DYN101 has been granted orphan drug designation by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and rare pediatric disease designation by the FDA. There is currently no FDA-, EMA- or Pharmaceuticals and Medical Devices Agency (PMDA)- approved therapeutic treatment for CNM. Under the terms of the agreement, Nippon Shinyaku has secured opt-in rights to pursue the development and commercialization of DYN101 in Japan upon analysis of interim data from the Phase 1/2 study, UNITE-CNM. These interim data are anticipated during the second half of 2022. Dynacure will retain rights to rest of world development and commercialization. Dynacure will receive an initial payment of $5 million. The agreement also includes option exercise fee as well as clinical, regulatory and commercial milestone payments of up to $82 million at maximum, in addition to a supply price based on net sales.
Nippon Shinyaku Co., Ltd. is a Japan-based company principally involved in the manufacture and sale of pharmaceutical products and functional foodstuffs. The Company operates in two business segments. The Pharmaceutical segment is involved in the manufacture and sale of urinary system therapeutic agents, blood cancer therapeutic agents, pain, inflammation and allergic therapeutic agents, digestive system therapeutic agents, cardiovascular systems and metabolic therapeutic agents. The Functional Foodstuff segment involves in the manufacture and sale of health food materials, quality stability preservatives, protein preparation, spice and seasoning products. The Company is also involved in the business support business, non-life insurance agency business, as well as the provision of real estate leasing services.