Harrow, Inc. has announced an exclusive out-licensing agreement for Apotex, Inc. to market and distribute two ophthalmic products as well as seek market approval for three products in Canada.
Let’s start with those two products.
Apotex is receiving the exclusive licensing rights and market authorizations for the following products in the Canadian market:
VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%
- Indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults
- Patented and “orphan-designated product” for VKC
Note: Harrow acquired the U.S. and Canadian commercial rights from Santen Pharmaceutical Co. Ltd. in July 2023. Our coverage here.
Cationorm PLUS
- Over-the-counter (OTC) preservative-free emulsion
- Indicated to treated dry eye symptoms and signs / symptoms of ocular allergy
And the other three?
Apotex will pursue regulatory approval in Canada for the following products:
ZERVIATE (cetirizine ophthalmic solution) 0.24%
- Indicated for treatment of ocular itching associated with allergic conjunctivitis.
- For use as a protectant to prevent further irritation or to relieve ocular dryness along with temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
VEVYE (cyclosporine ophthalmic solution) 0.1%
- Water-free vehicle (perfluorobutylpentane with no antimicrobial preservatives, oils, or surfactants)
- Indicated to treat signs and symptoms of dry eye disease (DED) via topical ophthalmic use.
Note: Harrow acquired U.S. and Canadian commercial rights from Novaliq GmbH in July 2023. The medication was approved by the FDA in June 2023 with a U.S. commercial launch in January 2024.
IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%
- Single-use, low-viscosity gel indicated for ocular surface anesthesia
- The U.S. commercial launch was in May 2023.
Lastly… why Apotex?
Already based in Canada, the global pharmaceutical company has been focused on producing high-quality, affordable generic medications covering major therapeutic areas, including glaucoma.
Per Apotex CEO and President Allan Oberman, the alliance with Harrow expands the company’s Canadian product offer to include “innovative patented pharmaceutical medicines” to further expand its branded pharmaceutical therapeutic areas of focus.
“Adding these products strengthens our therapeutic line and provides Canadian patients with valuable new treatment options,” stated Mike Woolcock, Apotex’s senior vice president, Biosimilars and Specialty.