Harrow Health, Inc., an ophthalmic‑focused healthcare company, today announced that it has entered into an agreement with Sintetica, S.A., a growing pharmaceutical company focused on analgesics, local anesthetics and sterile injectable solutions, to acquire the marketing and supply rights in the U.S. and Canada for AMP-100, a patented ophthalmic surgical drug candidate. When approved, AMP-100 will provide ocular surface anesthesia during ophthalmic interventions such as cataract surgery and intravitreal injections, which are estimated to total over 10 million procedures annually in the U.S.(1)
AMP-100 is a patented, innovative ocular surface anesthetic drug candidate, with safety and efficacy supported by a robust pre-clinical and clinical program, including a recently completed Phase 3 study that successfully compared the efficacy and tolerability of AMP-100 to current standards of care. Sintetica intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in late 2021. When approved, the active ingredient used in AMP-100 will be the first approved use of this active ingredient in the U.S. ophthalmic market.
Commenting on the acquisition, Mark L. Baum, CEO of Harrow Health, said, “This transaction reflects Harrow Health’s commitment to continued growth by adding new high-value products to our portfolio. The acquisition of rights to market and sell AMP-100 in the U.S. and Canada will further fortify our greatest commercial strength – providing thousands of U.S. eyecare professionals and their patients with novel ophthalmic surgical products. When approved, we expect to fully leverage our wholly owned, efficient, scalable, and tech-enabled ImprimisRx ophthalmic-focused commercial and distribution platform to market AMP-100 to our ‘front-of-the-eye-focused’ customer base, such as cataract and refractive surgeons. In addition, we intend to invest in expanding our commercial footprint to include retina-focused surgeons to fully leverage the market potential of AMP-100.”
“We have a sound business strategy for commercializing our promising and innovative products in countries around the world,” added Miro Venturi, Corporate CEO for Sintetica, S.A. “We are convinced that Harrow Health, with its knowledge and expertise in ophthalmology and commitment to providing high‑quality medications, is the optimal choice for Sintetica to partner with to bring AMP‑100 to the U.S. market.”
Under the terms of the agreement, Sintetica will be responsible for regulatory filings for the product in the U.S. The agreement provides for upfront and milestone payments to Sintetica as well as per unit royalties on sales of AMP-100, when successfully commercialized. Harrow Health will have marketing rights for the U.S. and Canada, while Sintetica will retain the marketing rights in other countries.
B. Riley Securities acted as financial advisors to Harrow Health for the transaction.
