Harrow acquires Santen’s branded ophthalmic portfolio

According to Harrow, the transaction Includes U.S. and Canadian commercial rights to six therapeutics, including two non-prescription. brands.

Harrow today announced the signing of agreements with affiliates of Santen Pharmaceutical Co., Ltd. to acquire certain U.S. and Canadian commercial rights for six branded products from Santen.

According to the company, U.S. products include:

• 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.
• RESHKOTE, used as a lubricant to reduce further irritation or to relieve dryness of the eye.

And Canadian products that include:

• 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.

Mark L. Baum, chairman and CEO of Harrow, said in a news release the acquisition advances the company’s goal of becoming a leader in the top tier of U.S. ophthalmic pharmaceutical companies, and makes its branded portfolio one of the most comprehensive in the U.S. market.

Baum added in the news release it 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 FDA‑approved 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,” he said in the news release.

Richard L. Lindstrom, MD, as an ophthalmic surgeon of nearly 50 years and an advisor to Baum and the Harrow leadership team for many years, was pleased with the acquisition.

“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,” he said in the news release. “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.

In a separate deal, Santen reached an out-licensing agreement with Visiox Pharmaceuticals Inc. on the rights to product manufacturing, commercialization, and sales of OMLONTI, an eye drop for the reduction of elevated IOP in patients with glaucoma or ocular hypertension.

According to Santen, under the terms of the agreement, Santen grants Visiox exclusive rights in the U.S. for product manufacturing and commercialization of OMLONTI. Santen is eligible to receive sales milestone payments, as well as royalties on net U.S. sales of OMLONTI.