(PRESS RELEASE) NASHVILLE, TN — Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, announced the signing of agreements with affiliates of Santen Pharmaceutical Co., Ltd. (“Santen”) under which Harrow will acquire certain U.S. and Canadian commercial rights for the following branded products from Santen:
U.S. Products:
- FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, a corticosteroid indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
- NATACYN (natamycin ophthalmic suspension) 5%, a sterile antifungal indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.
- TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, an antibiotic and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
- VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults and holds orphan-drug exclusivity.
- ZERVIATE (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis.
- FRESHKOTE, used as a lubricant to reduce further irritation or to relieve dryness of the eye.
Canadian Products:
- 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, a preservative-free emulsion for the treatment of dry eye symptoms and for the treatment of signs and symptoms of ocular allergy.
Please see select Important Safety Information for these products and links to the Full Prescribing Information.
In commenting on the transaction, Mark L. Baum, chairman and chief executive officer of Harrow, stated, “This acquisition furthers Harrow’s goal of becoming a leader in the top tier of U.S. ophthalmic pharmaceutical companies, makes Harrow’s branded portfolio one of the most comprehensive in the U.S. market, and is expected to be immediately financially accretive upon the transfer of the product marketing authorizations. We are excited to add several high utility and trusted products that serve the ophthalmic surgical market, a market in which we already have a strong presence, and significantly expand the breadth of our portfolio, which will now include the only FDAapproved ophthalmic antifungal; a patented and ‘orphan-designated’ product for the nearly 50,000 Americans suffering from the rare disease vernal keratoconjunctivitis (or VKC); a patented prescription drug to treat ocular itching associated with allergies; and two patented non-prescription brands serving patients managing dry eye symptoms.”
Richard L. Lindstrom, M.D. added, “As an ophthalmic surgeon of nearly 50 years and an advisor to Mark and the Harrow leadership team for many years, I am pleased to see Harrow step up and assemble not only a formidable posterior segment offering with products like IHEEZO and TRIESENCE, but also an impressive array of innovative anterior segment products that U.S. ophthalmologists and optometrists rely on to care for their patients. While some ophthalmic pharmaceutical companies have decided to place less emphasis on the anterior segment despite the growing demand in this category of eyecare, with this acquisition, few companies, if any, can match the scope and depth of Harrow’s ophthalmic product offerings, especially in the anterior segment. I believe this level of commitment to the eyecare professional should further strengthen and expand the many relationships Harrow has been able to forge over the past 10 years.”
Financing for the transaction was provided through the expansion of Harrow’s secured credit facility with funds managed by Oaktree Capital Management, L.P. Harrow management expects the transaction to reduce the Company’s aggregate leverage ratio of adjusted EBITDA to debt.
About Harrow
Harrow Health, Inc. (Nasdaq: HROW) is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten branded FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, a leading U.S. ophthalmicfocused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt.