Amneal has signed a licensing agreement with Kashiv BioSciences to develop and potentially commercialize K127, an extended-release tablet of pyridostigmine, for the treatment of myasthenia gravis (MG) in the United States.
The deal offers Amneal exclusive rights over K127 development and marketing in the U.S. and the right to submit a New Drug Application (NDA) seeking the treatment’s approval and, if approved, to commercialize it in the U.S.
Kashiv will be in charge of all development and clinical studies required to help support the NDA while Amneal will be responsible for its filing and for selling the product if it’s approved.
Amneal will make an upfront payment of $1.5 million, which may amount to $16.5 million, pending development and regulatory milestones, together with royalties on net sales of K127.
“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,” Navnit H. Shah, PhD, Kashiv’s president and chief scientific officer, said in a press release.
Pyridostigmine is FDA-approved since 1955 for the treatment of MG symptoms. It is available as an oral solution, tablets, or injectable formulations of pyridostigmine bromide, under the brand Mestinon (produced by Bausch Health). Generic versions of the medication are also available.
K127 was successfully tested in a Phase 1 clinical trial, which demonstrated its favorable pharmacokinetics, or the course of its absorption, bioavailability, distribution, metabolism, and elimination in the body.
Amneal anticipates that future clinical studies will confirm K127’s efficacy and safety, including a Phase 2 and a pivotal Phase 3 trial, the company reports.
“The collaboration with Kashiv reinforces our commitment to grow our specialty portfolio of pipeline and currently marketed products,” Joseph Todisco, Amneal’s senior vice president of specialty commercial, said in the release.
“We will continue to explore opportunities to leverage our development and commercialization capabilities within the [central nervous system] space to bring new treatment options to patients,” he added.