Ocuphire Pharma has entered into an exclusive license agreement with FamyGen Life Sciences for the development and commercialization of Nyxol across three indications in US, Europe, Japan, India, China, and other global markets. Viatris has also agreed to commercialize Nyxol after receiving all necessary regulatory approvals, according to a separate announcement made with Famy.
Ocuphire will get a $35 million cash payment up front as per the license agreement's conditions. Ocuphire will oversee the clinical, manufacturing, and regulatory efforts necessary for the FDA clearance of all three Nyxol indications, including Nyxol+Low-Dose Pilocarpine, while Famy will finance the development of Nyxol.
Ocuphire has the potential to obtain a $10 million milestone payment upon FDA approval later in 2023 with the planned NDA submission for the reversal of mydriasis indication, and thereafter to receive additional regulatory milestones for presbyopia and night vision problems indications. Famy will take on development in the non-US markets in addition to sponsoring Ocuphire's development of Nxyol in the US.
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.
“Famy and Ocuphire have been engaging for several months, in a collaborative spirit, to conclude 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,” Mina Sooch, MBA, founder and CEO of Ocuphire, said in a company 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. In addition, the upfront payment and development funding provided by this transaction markedly improve our cash position into 2025, allowing us to expedite the registration trials for presbyopia and night vision disturbances and to execute our late-stage development strategy for the APX3330 retina program,” Ms. Sooch added.