Harrow Health, Inc. announced it has acquired the U.S. and Canadian commercial rights for specific branded ophthalmic products from Santen Pharmaceutical Co., Ltd.
Hold up … didn’t the company (quite literally) just purchase something?
Indeed they did.
They have also announced the purchase of the U.S. and Canadian commercial rights to Novaliq’s newly-FDA-approved VEVYE (cyclosporine ophthalmic solution) 0.1%, indicated to treat the signs and symptoms of dry eye disease (DED).
Read more about that deal here.
Gotcha. So which Santen products are included in this agreement?
A combination of six U.S. and two Canadian products, which include:
- U.S.
- Flarex (fluorometholone acetate ophthalmic suspension) 0.1%
- 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%
- Indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis.
- Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05%
- Indicated 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%
- Indicated for the treatment of vernal keratoconjunctivitis in children and adults
- Zerviate (cetirizine ophthalmic solution) 0.24%
- Indicated for treatment of ocular itching associated with allergic conjunctivitis.
- Freshkote PF (preservative-free OTC lubricant)
- Active ingredients: Polyvinyl Alcohol 2.7% and Povidone 2%
- For use as a protectant to prevent further irritation or to relieve dryness of the eye along with temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
- Flarex (fluorometholone acetate ophthalmic suspension) 0.1%
- Canadian
- Verkazia (cyclosporine ophthalmic emulsion) 0.1%
- Cationorm PLUS (preservative-free artificial tear)
- For use to protect the ocular surface and relieves the discomfort and irritation due to dry eye caused by prolonged use of contact lenses or environmental conditions.
Any notable callouts?
Of note, Natacyn is currently the only FDA-approved topical ophthalmic antifungal medication, while Verkazia (approved in 2021) is a patented and “orphan-designated product” for vernal keratoconjunctivitis, according to Harrow Chairman and CEO Mark L. Baum.
Give me some specifics.
Harrow will receive the exclusive U.S. and Canadian rights for product manufacturing and commercialization of VERKAZIA as well as the exclusive rights in Canada for product manufacturing and commercialization of Cationorm PLUS.
Any upfront payments?
Yup .. Santen is receiving an upfront payment for the asset transfer and out-licensing; the company will also be eligible for royalties on any net sales of Verkazia and Cationorm PLUS.
How about the financing?
The companies have not released financial details of the agreement; however, Harrow reported that financing was provided via an expansion of its credit facility (with funds managed by Oaktree Capital Management).
The transaction is also expected to reduce Harrow’s combined leverage ratio of adjusted EBITDA (earnings before interest, taxes, depreciation, and amortization)—which is a measure of the company’s ability to generate cash flow—to debt.
Significance for Harrow?
These acquisitions add to Harrow’s growing ophthalmic portfolio—which, aside from the purchase of VEVYE, also includes five branded products from Novartis earlier this year—and brings the company one step closer to its goal of becoming a leader among U.S. ophthalmic pharmaceutical companies.