- Expands Amneal’s Neurology Presence into Spasticity
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and Saol
Therapeutics, a private specialty pharmaceutical company (“Saol”),
today announced a definitive agreement under which Amneal will
acquire Saol’s Baclofen franchise, including Lioresal® and
LYVISPAHTM as well as a pipeline product under development. The
acquisition expands Amneal’s commercial institutional and specialty
portfolio in neurology while adding commercial infrastructure in
advance of its entry into the biosimilar institutional market. The
transaction is expected to be accretive to Amneal’s adjusted EBITDA
and adjusted earnings per share results for 2022.
Lioresal® is an intrathecal baclofen product delivered through
an implantable intrathecal pump for use in the management of severe
spasticity of cerebral or spinal origin for the institutional
market. It has approximately $25 million in annual net revenue.
LYVISPAHTM is a baclofen oral granules (5, 10 and 20 mg) specialty
product recently approved by the U.S. Food and Drug Administration
(FDA) for the treatment of spasticity. The product is expected to
launch in 2022 leveraging Amneal’s neurology commercial team.
Together, Amneal expects these two products to generate between $40
and $50 million in combined annual net revenues by 2025.
As part of the transaction, Amneal is adding Saol’s experienced
institutional commercial team for Lioresal® that can be utilized to
support future product launches, including three oncology
biosimilar products, filgrastim (biosimilar for Neupogen®),
pegfilgrastim (biosimilar for Neulasta®) and bevacizumab
(biosimilar for Avastin®). Amneal expects to launch all three
biosimilars in 2022, subject to approval by FDA.
“This acquisition is highly aligned with Amneal’s long-term
growth strategy adding to our specialty and biosimilars businesses.
In specialty, we see LYVISPAHTM fitting well with our neurology
portfolio and pipeline. In addition, Lioresal® is a durable product
with a long-established presence in the institutional market that
we look to leverage as we prepare to commercialize our biosimilars
in 2022 and beyond,” said Chirag and Chintu Patel, Co-Chief
Executive Officers.
“For over 5 years, the Saol team has worked to reinvigorate the
Lioresal® brand and develop new treatment options, like LYVISPAHTM,
for patients struggling with spasticity. We are excited to see
these products find their new home at Amneal along with many of our
team members that have been critical to our success,” said David
Penake, CEO of Saol Therapeutics.
Baclofen is a skeletal muscle relaxant used to treat muscle
spasms caused by spinal cord injury, multiple sclerosis, and other
conditions. It was first approved by the FDA in 1977. Important
Safety Information includes a boxed warning on abrupt
discontinuation, which can result in sequalae and in rare cases,
has advanced to multiple organ-system failure and death. Reported
adverse drug reaction includes convulsion, hypotension, hypotonia,
somnolence, dizziness, nausea and headache. Animal data indicates
it may cause fetal harm.
See Package Insert (PI) for full prescribing information
including boxed warning and complete safety information:
Lioresal®:
https://lioresal.com/wp-content/uploads/2019/03/Lioresal-PI-01-2019.pdf
LYVISPAHTM:
https://lyvispah.com/content/uploads/2021/11/LYVISPAH-USPI-NOVEMBER-2021-FDA-approved.pdf
Terms of the Transaction
Under the terms of the transaction, Amneal will pay
approximately $83.5 million of cash at close, and certain royalties
(low double-digits) based on annual net sales for certain acquired
products. The transaction will be financed with cash on hand and is
expected to close in the first quarter of 2022, subject to the
satisfaction of customary closing conditions, including clearance
under the Hart-Scott Rodino Antitrust Improvements Act.
Advisors
Morgan Lewis & Bockius LLP served as legal counsel to
Amneal. SVB Leerink served as exclusive financial advisor and Mayer
Brown LLP served as legal counsel to Saol Therapeutics.
About Amneal Pharmaceuticals, Inc.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully-integrated essential medicines company.
We make healthy possible through the development, manufacturing,
and distribution of generic and specialty pharmaceuticals,
primarily within the United States. The Company has a diverse
portfolio of approximately 250 products in its Generics segment and
is expanding across a broad range of complex products and
therapeutic areas, including injectables and biosimilars. In its
Specialty segment, Amneal has a growing portfolio of branded
pharmaceutical products focused primarily on central nervous system
and endocrine disorders, with a pipeline focused on unmet needs.
Through its AvKARE segment, the Company is a distributor of
pharmaceuticals and other products for the U.S. federal government,
retail, and institutional markets. For more, please visit
www.amneal.com.
About Saol Therapeutics
Saol Therapeutics (pronounced "Sail") is a privately held,
biopharmaceutical company with operations in Roswell, GA, Dublin,
Ireland and Hamilton, Bermuda. Saol is focused on commercial and
clinical development activity in central nervous system disorders
such as spasticity, pain management, and orphan diseases. Saol has
a robust pipeline of novel, mid-to-late stage development programs
in osteoarthritis, focal spasticity and pyruvate dehydrogenase
complex deficiency (PDCD). For more information, visit
www.saolrx.com.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are
not historical facts, may be forward-looking statements (as defined
in the U.S. Private Securities Litigation Reform Act of 1995). Such
forward-looking statements include statements regarding
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operations; expected operating results and financial performance;
impact of planned acquisitions and dispositions; whether and when
the required regulatory approvals will be obtained; whether and
when the other closing conditions will be satisfied and whether and
when the transaction will close; whether and when the Company will
be able to realize the expected financial results and accretive
effect of the transaction; how customers, competitors, suppliers
and employees will react to the acquisition; the Company’s strategy
for growth; product development; regulatory approvals; market
position and expenditures. Words such as “plans,” “expects,”
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the impact of the COVID-19 pandemic; the impact of global economic
conditions; our ability to successfully develop, license, acquire
and commercialize new products on a timely basis; our ability to
obtain exclusive marketing rights for our products; the competition
we face in the pharmaceutical industry from brand and generic drug
product companies, and the impact of that competition on our
ability to set prices; our ability to manage our growth through
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of our Class A Common Stock and the fact that we are controlled by
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Factors” in the Company’s most recent Annual Report on Form 10-K
and in its subsequent reports on Forms 10-Q and 8-K. Investors are
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Forward-looking statements included herein speak only as of the
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version on businesswire.com: https://www.businesswire.com/news/home/20220104005935/en/
Anthony DiMeo Senior Director, Investor Relations
anthony.dimeo@amneal.com
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