Amneal Enters into a Licensing Agreement with Kashiv BioSciences, LLC to Develop & Commercialize K127 for the Treatment of My...
November 06 2019 - 6:30AM
Business Wire
‒ Expands Amneal’s Central Nervous System (CNS)
Focused Development Pipeline with Orphan Drug ‒
Amneal Pharmaceuticals, Inc. (NYSE: 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.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: 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
Safe Harbor Statement
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.
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Mark Donohue (908) 409-6718
Amneal Pharmaceuticals (NYSE:AMRX)
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