Bausch Health to Acquire Option to Purchase Assets of Allegro Ophthalmics

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LAVAL, Quebec and SAN JUAN CAPISTRANO, Calif.— Bausch Health Companies
(NYSE/TSX: BHC) and Bausch + Lomb, its leading global eye health business, and Allegro Ophthalmics LLC,  a privately held biopharmaceutical company, announced Monday that Bausch Health (through its affiliate) has entered into an agreement to acquire an option to purchase all ophthalmology assets of Allegro, including global rights for risuteganib (Luminate), Allegro's lead investigational eyecare compound. The investigational compound is believed to simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases such as intermediate dry Age-related Macular Degeneration (AMD), according to the announcement.

Allegro is focused on the development of novel therapies that regulate integrin functions for the treatment of ocular diseases, the announcement noted.

Bausch Health’s option payment totaling $50 million would be made in two tranches, with the first payment of $10 million upon signing. Allegro intends to raise additional funding, following which, Bausch Health will make a second payment of $40 million, which is expected to be made in 2021. If Bausch Health then elects to exercise the option, additional payments will be payable, according to Monday’s announcement.

It is estimated that as many as 16 million people in the U.S. have AMD. Globally, the prevalence of AMD is expected to reach 196 million people worldwide this year and to increase to 288 million by 2040. Approximately 90 percent of people diagnosed with AMD have dry AMD, for which there are currently no treatments, according to the Bausch announcement.

"As part of the ongoing transformation of Bausch Health, we continue to seek strategic opportunities to build up our pipeline in core businesses, including Bausch + Lomb, our global eye health business,” Bausch Health chairman and chief executive officer Joseph Papa said in the announcement. “The addition of the ophthalmic assets of Allegro would significantly enhance our comprehensive portfolio of products for AMD. If approved, risuteganib may be the first treatment indicated to help reverse vision loss due to dry AMD and would address a significant unmet medical need affecting millions of people globally."

Vicken Karageozian, MD, president and chief executive of Allegro, added, “Allegro is excited to partner with Bausch Health, an established global player in ophthalmology that values the potential of risuteganib and our integrin-regulating platform as much as we do. As we prepare for our Phase 3 clinical program, we look forward to working closely with Bausch Health on the united goal of one day being able to offer a treatment option to the millions of people who are currently losing their vision to dry AMD.”

Risuteganib is an investigational integrin-regulating therapy that is believed to reduce mitochondrial dysfunction involved in intermediate dry AMD. By targeting multiple pathways, risuteganib may help reduce the cellular burden of oxidative stress and restore retinal homeostasis. Two concurrent Phase 3 studies evaluating the use of intravitreal risuteganib to treat intermediate dry AMD are expected to begin within the next 12 months, according to the announcement.

Other ophthalmology assets of Allegro include ALG-1007, a topical integrin regulator under investigation for the treatment of dry eye disease. It is currently in Phase 2 development outside the U.S.