Harrow Licenses Canadian Rights to Apotex for Five Branded Ophthalmic Pharmaceutical Products
16 2월 2024 - 6:01AM
Business Wire
Harrow, Inc. (Nasdaq: HROW), a leading U.S. eyecare
pharmaceutical company, and Apotex Inc. (“Apotex”), Canada’s
largest pharmaceutical company, today jointly announced an
exclusive out-licensing agreement under which Apotex will market
and distribute VERKAZIA® and over-the-counter (OTC) Cationorm® PLUS
in the Canadian market, and concurrently, pursue market approval in
Canada for VEVYE®, IHEEZO®, and ZERVIATE®.
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“We are pleased to enter the Canadian market through this
partnership with Apotex, which has a proven track record of success
serving Canadian eyecare professionals and their patients,” said
Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “This
exclusive agreement fulfills our commitment to access and
availability of these five important ophthalmic pharmaceutical
products, and we look forward to working closely with our partners
at Apotex over the coming years as they seek approval for VEVYE,
IHEEZO and ZERVIATE in the Canadian market.”
“We are excited to partner with Harrow to provide access to an
innovative branded line of ophthalmic products that complement our
existing portfolio,” stated Allan Oberman, President and Chief
Executive Officer of Apotex. “This alliance expands Apotex’s
product offering in Canada to include innovative patented
pharmaceutical medicines, aligned with our ongoing strategic focus
to further expand our innovative branded pharmaceutical therapeutic
areas of focus in becoming a Canadian-based global health
company.”
“Adding these products strengthens our therapeutic line and
provides Canadian patients with valuable new treatment options,”
adds Mike Woolcock, Senior Vice President, Biosimilars &
Specialty. “We look forward to collaborating with Harrow to expand
this line with VEVYE, IHEEZO, and ZERVIATE upon receiving market
approval to improve the overall patient quality of life in this
category.”
Under the terms of the agreement, Apotex licensed exclusive
rights and marketing authorizations of the following products in
the Canadian market from Harrow:
- VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin
inhibitor immunosuppressant indicated for the treatment of vernal
keratoconjunctivitis (VKC) in children from four years of age
through adolescence.
- Cationorm PLUS, an OTC, preservative-free emulsion for the
treatment of dry eye symptoms and the treatment of signs and
symptoms of ocular allergy.
And for products, Apotex will pursue approval for in Canada:
- VEVYE (cyclosporine ophthalmic solution) 0.1%, a novel
water-free vehicle (perfluorobutylpentane) based on semifluorinated
alkanes, indicated to treat the signs and symptoms of dry eye
disease.
- IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%, a
single-use, low-viscosity gel indicated for ocular surface
anesthesia.
- ZERVIATE (cetirizine ophthalmic solution) 0.24%, a histamine-1
(H1) receptor antagonist indicated for the treatment of ocular
itching associated with allergic conjunctivitis.
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that
produces high-quality, affordable and complex medicines for
patients around the world, with a strategic focus on becoming a
Pan-Canadian Health Champion. Apotex has an integrated portfolio of
generic and innovative branded pharmaceutical products for global
markets. Apotex employs almost 7,000 people worldwide in
manufacturing, R&D, and commercial operations. Apotex medicines
are accessible to patients in more than 75 countries globally.
Through vertical integration, Apotex is comprised of multiple
divisions and affiliates, including Apotex Inc., focused on generic
and specialty innovative medicines in Canada and internationally,
Apotex Corp., an affiliate of Apotex Inc. which markets and sells
products in the United States, and Apobiologix, a division of
Apotex Inc. focused on biosimilar development. For more
information, visit: www.apotex.com
About Harrow
Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical
company engaged in the discovery, development, and
commercialization of innovative ophthalmic pharmaceutical products
for the U.S. market. Harrow helps U.S. eyecare professionals
preserve the gift of sight by making its comprehensive portfolio of
prescription and non-prescription pharmaceutical products
accessible and affordable to millions of Americans each year. For
more information about Harrow, please visit harrow.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such “forward-looking statements.”
Forward-looking statements are based on management's current
expectations and are subject to risks and uncertainties which may
cause results to differ materially and adversely from the
statements contained herein. Some of the potential risks and
uncertainties that could cause actual results to differ from those
predicted include, among others, risks related to: our ability to
successfully implement our business plan and commercialize our
products in a timely manner or at all, obtain necessary approvals
for products in Canada, recruit and retain qualified personnel,
manage any growth we may experience and successfully realize the
benefits of the licensing arrangements; physician interest in and
market acceptance of our products; competition from other
pharmaceutical companies; general economic and business conditions,
including inflation and supply chain challenges; and regulatory and
legal risks and uncertainties related to our operations and the
pharmaceutical business in general. These and additional risks and
uncertainties are more fully described in Harrow’s filings with the
Securities and Exchange Commission (the “SEC”), including its
Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Such documents may be read free of charge on the SEC's web site at
sec.gov. Undue reliance should not be placed on forward‑looking
statements, which speak only as of the date they are made. Except
as required by law, Harrow undertakes no obligation to update any
forward-looking statements to reflect new information, events, or
circumstances after the date they are made, or to reflect the
occurrence of unanticipated events.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240215859659/en/
For Harrow: Investors Jamie
Webb Director of Communications and Investor Relations
jwebb@harrowinc.com 615-733-4737
Media Deb Holliday Holliday
Communications, Inc. deb@hollidaycommunications.net
412-877-4519
For Apotex: Media
media@apotex.com
Harrow (NASDAQ:HROW)
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