Amneal Pharmaceuticals has signed an agreement with Kashiv BioSciences to license orphan drug K127 (pyridostigmine) to treat myasthenia gravis.
Myasthenia gravis is a rare, autoimmune neuromuscular disorder that develops due to destruction of neurological junction receptors by antibodies.
Under the agreement, Amneal receives exclusive rights to the new drug application (NDA), as well as commercialisation of the candidate in the US.
Kashiv will carry out all development and clinical activities necessary for US Food and Drug Administration (FDA) approval, while Amneal will submit the NDA and commercialise the product.
In turn, Amneal will make an upfront payment of $1.5m to Kashiv, which may also receive an additional $16.5m in development and regulatory milestones. Kashiv is also eligible for sales royalties.
Kashiv BioSciences president and chief scientific officer Navnit Shah said: “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.
“Amneal has a history of developing and commercialising speciality products and we look forward to working with them to bring K127 to patients suffering from myasthenia gravis.”
Kashiv Pharma became Kashiv BioSciences in January following the company’s acquisition of biotechnology company Adello Biologics.
Under a previous development partnership with Amneal, Kashiv BioSciences has ten approved generic products and 13 additional generics in development.
K127 has completed a proof-of-concept Phase I pharmacokinetic (PK) study and phase II and III trials are expected to be conducted in the future.
Amneal expects the product to boost its central nervous system (CNS)-focused pipeline.
Amneal Pharmaceuticals speciality commercial senior vice-president Joseph Todisco said: “The collaboration with Kashiv reinforces our commitment to grow our Speciality portfolio of pipeline and currently marketed products.
“We will continue to explore opportunities to leverage our development and commercialisation capabilities within the CNS space to bring new treatment options to patients.”