Ocuphire reaches license agreement for the development and commercialization of Nyxol

The deal with FamyGem Life Sciences covers the development and commercialization of Nyxol eye drops for the reversal of mydriasis, presbyopia and night vision issues.

Ocuphire Pharma Inc. announced it has concluded an exclusive license agreement with FamyGen Life Sciences Inc. for the development and commercialization of Nyxol across three indications in US, Europe, Japan, India, China and other global markets.

According to a news release, in connection with its separately announced transaction with Famy, Viatris Inc. has agreed to commercialize Nyxol following each regulatory approval.

Mina Sooch, MBA, founder and CEO of Ocuphire, pointed out in the news release that Famy and Ocuphire have been engaging for several months, in a collaborative spirit, to reach this agreement.

“This partnership provides a clear pathway to completing development and regulatory activities and executing a successful US and global commercial launch of Nyxol through Viatris,” Sooch said in a news release. “With its strategic commitment to ophthalmics and its global commercial infrastructure, we believe Viatris provides a great opportunity for all of the Nyxol indications to realize their full commercial potential in their respective markets.”

Sooch added that the upfront payment and development funding provided by this transaction markedly improve our cash position into 2025, allowing the company to expedite the registration trials for presbyopia and night vision disturbances and to execute its late-stage development strategy for the APX3330 retina program.

According to the news release, under the terms of the license agreement, Ocuphire will receive an upfront cash payment of $35 million. Famy will fund Nyxol development through FDA approvals, that will be managed by Ocuphire, including clinical, manufacturing, and regulatory activities required for FDA approval of all three Nyxol indications, including Nyxol+Low-Dose Pilocarpine.

Mover, with the upcoming NDA submission for the reversal of mydriasis indication this quarter, Ocuphire has the potential to receive a $10 million milestone payment upon FDA approval later in 2023 and thereafter to receive additional regulatory milestones for presbyopia and night vision disturbances indications. In addition to funding Ocuphire’s development of Nxyol in the US, Famy will undertake development in the non-US markets.

According to the news relase, upon commercialization, Ocuphire will receive tiered double-digit royalties on worldwide net sales through 2040 and is eligible to receive sales milestone payments upon achievement of certain annual sales thresholds.