BRIDGEWATER, N.J.--(BUSINESS WIRE)--
‒ Expands Amneal’s Central Nervous System (CNS) Focused Development Pipeline with Orphan Drug ‒
Amneal Pharmaceuticals, Inc. (AMRX), 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.
Amneal Pharmaceuticals, Inc. (AMRX), headquartered in Bridgewater, NJ, is an integrated pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.
Amneal has an extensive portfolio of more than 300 generic medicines and is expanding its portfolio to include complex dosage forms in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system disorders and parasitic infections. For more information, visit www.amneal.com.
About Kashiv BioSciences, LLC
Since its establishment in 2011, Kashiv BioSciences has evolved into a premier, fully integrated biopharmaceutical company offering next-generation drug delivery technologies, biosimilars, and specialty biopharmaceutical products.
Kashiv is built on patient-focused innovation and leverages its expertise in small and large molecules to develop a clinically differentiated pipeline of novel compounds and biosimilars with lead candidates in various therapeutic areas, including CNS, endocrinology, cancer, and several debilitating orphan diseases. Kashiv plans to commercialize its products via strategic partnerships, and for select products, through the creation of an in-house specialized sales and marketing organization. For more information, visit www.kashivbiosciences.com
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Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the “Company”). Such risks and uncertainties include, but are not limited to: the commercial success of K127; our ability to successfully develop and commercialize new products; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition as well as consolidation of institutional buyers and payers on our ability to set prices; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our dependence on third party suppliers and distributors for raw materials for our products and certain finished goods; the impact of global economic conditions; and legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives. A further list and descriptions of these risks, uncertainties and other factors can be found in the Company’s most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2018, as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov, www.amneal.com or on request from the Company.