Thursday, November 07, 2019
Amneal Pharmaceuticals, Inc., today announced that it has entered into a licensing agreement with Kashiv BioSciences, LLC for the development and commercialization of Kashiv’s orphan drug K127 (pyridostigmine) for the treatment of Myasthenia Gravis. Through this partnership, Amneal gains exclusive rights within the United States (U.S.) to the New Drug Application (NDA) and commercialization of K127.
Under the terms of the agreement, Kashiv will be responsible for all development and clinical work required to secure Food and Drug Administration approval and Amneal will be responsible for filing the NDA and commercializing the product. Kashiv will receive an upfront payment of $1.5 million and is eligible to receive development and regulatory milestones totaling $16.5 million. Kashiv is also eligible to receive tiered royalties from the low double-digits to mid-teens on net sales of K127.
“The collaboration with Kashiv reinforces our commitment to grow our Specialty portfolio of pipeline and currently marketed products,” said Joseph Todisco, Senior Vice President, Specialty Commercial of Amneal. “We will continue to explore opportunities to leverage our development and commercialization capabilities within the CNS space to bring new treatment options to patients.”
“K127 is being developed as an innovative once-daily, extended-release tablet formulation of pyridostigmine, to provide rapid onset and 24-hour coverage for improved symptom control, better compliance, tolerability, and quality of life in treating Myasthenia Gravis patients,” said Navnit H. Shah, Ph.D. President and Chief Scientific Officer of Kashiv. “Amneal has a history of developing and commercializing specialty products and we look forward to working with them to bring K127 to patients suffering with Myasthenia Gravis.”
K127 has shown successful proof of concept in a Phase I PK study. Phase II studies are anticipated as well as pivotal Phase III clinical endpoint studies.
Myasthenia gravis is a rare autoimmune neuromuscular disease whereby antibodies destroy receptors in the neurological junction, causing extreme muscle weakness with exertion. The orphan disease affects approximately 60,000 patients in the U.S.