Harrow Licenses Canadian Rights to Apotex for Five Branded Ophthalmic Pharmaceutical Products

Rhea-AI Summary

Harrow, Inc. (HROW) and Apotex Inc. announce an exclusive out-licensing agreement for ophthalmic pharmaceutical products in Canada. Apotex will market and distribute VERKAZIA and Cationorm PLUS while seeking approval for VEVYE, IHEEZO, and ZERVIATE. The partnership aims to expand product offerings, improve patient quality of life, and strengthen therapeutic options in the Canadian market.

Insights

Market Research Analyst

The strategic partnership between Harrow, Inc. and Apotex Inc. represents a significant development in the North American pharmaceutical industry, particularly in the specialized field of eyecare. This collaboration allows Harrow to penetrate the Canadian market with its ophthalmic products, leveraging Apotex's established distribution networks and market presence. The exclusive out-licensing agreement for VERKAZIA® and Cationorm® PLUS, coupled with the pursuit of market approval for VEVYE®, IHEEZO® and ZERVIATE®, indicates a proactive approach to expanding product offerings and potentially increasing market share.

From a market research perspective, the move is poised to enhance Harrow's revenue streams and geographical reach. Apotex's strategic focus on expanding its branded pharmaceuticals aligns with current industry trends towards diversification of product lines and strengthening of therapeutic portfolios. This agreement could also signal a competitive response to market demand for innovative and effective treatments in the eyecare segment, reflecting a broader industry shift towards patient-centric care.

Financial Analyst

The financial implications of the licensing agreement between Harrow and Apotex are multifaceted. For Harrow, upfront licensing fees, potential milestone payments and royalties on sales could provide a steady income stream and improve its financial health. Moreover, the deal could reduce the risk and costs associated with the market entry and commercialization in Canada. Investors should monitor the progress of market approvals for the additional products, as these could further impact Harrow's revenue growth and profitability margins.

It's also essential to consider the timing of the deal and its alignment with Harrow's long-term strategic goals. If Harrow can capitalize on Apotex's market position and regulatory experience, the partnership could expedite the approval process for the new treatments, providing a faster route to market and potential competitive advantage. The deal's success will hinge on the effective execution of the marketing strategy and the reception of the products by Canadian healthcare providers and patients.

Pharmaceutical Regulatory Expert

The licensing agreement is contingent upon the successful market approval of three of Harrow's products by Health Canada. The regulatory landscape in Canada is stringent, with a focus on patient safety and efficacy of treatments. The approval process for VEVYE, IHEEZO and ZERVIATE will involve rigorous clinical trials and comprehensive review of the products' safety profiles and effectiveness.

Understanding the specific terms 'calcineurin inhibitor immunosuppressant', 'semifluorinated alkanes' and 'H1 receptor antagonist' is crucial for stakeholders. These terms describe the mechanisms of action of the medications, which are central to their therapeutic value and potential side effects. The novel water-free vehicle used in VEVYE, for example, represents an innovative approach to drug delivery in dry eye disease, which could differentiate it from existing treatments and impact its marketability.

Should the products gain approval, this would not only validate their clinical value but also potentially set a precedent for future products in the pipeline. The regulatory outcome will have a significant impact on the commercial potential of these products in the Canadian eyecare market.

NASHVILLE, Tenn. & TORONTO--(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®.

“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

Source: Harrow, Inc.

FAQ

What is the ticker symbol for Harrow, Inc.?

The ticker symbol for Harrow, Inc. is HROW.

What products will Apotex market and distribute in Canada under the agreement?

Apotex will market and distribute VERKAZIA and Cationorm PLUS in the Canadian market.

What products will Apotex seek approval for in Canada?

Apotex will seek approval for VEVYE, IHEEZO, and ZERVIATE in the Canadian market.

What is VERKAZIA indicated for?

VERKAZIA is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children from four years of age through adolescence.

What is Cationorm PLUS used for?

Cationorm PLUS is an OTC, preservative-free emulsion for the treatment of dry eye symptoms and the treatment of signs and symptoms of ocular allergy.