After U.S. financial markets closed yesterday, clinical-stage, ophthalmic biopharmaceutical company Ocuphire Pharma Inc. (OCUP:NASDAQ), which is focused on advancing and commercializing small-molecule therapies for use in treating refractive and retinal eye disorders, announced that it has entered into an exclusive license agreement with FamyGen Life Sciences Inc. (Famy) to develop, market and commercialize Nyxol® in the U.S., Europe, China, India, Japan, and other unnamed global markets.
The license agreement terms call for Nyxol Eye Drops to be developed and marketed for three separate indications, which include dim light or night vision disturbances (NVD), presbyopia, and pharmacologically induced mydriasis. The company pointed out that its licensing partner Famy previously executed collaborative agreements with global healthcare firm Viatris Inc. (VTRS:NASDAQ) to commercialize Nyxol after regulatory approvals are granted for each of the three individual indications.
The company's Founder and CEO, Mina Sooch, MBA, commented, "This partnership provides a clear pathway to completing development and regulatory activities and executing a successful U.S. and global commercial launch of Nyxol through Viatris . . . 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."
"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", CEO Sooch added.
When Nyxol is launched commercially, Ocuphire will be entitled to receive tiered double-digit royalties through 2040 on worldwide net sales and will be eligible to receive additional payments if certain sales milestones and thresholds are met.
Under the terms of the license agreement, Famy has agreed to pay Ocuphire an upfront payment in the amount of US$35 million and will fund the development of Nyxol through receipt of U.S. Food and Drug Administration (FDA) approvals.
For its part, Ocuphire will be responsible for managing all required clinical and manufacturing activities and related FDA regulatory submission filings for each of the three Nyxol indications, including Nyxol+Low-Dose Pilocarpine.
Ocuphire expects that it will be ready to submit a New Drug Application (NDA) this quarter for Nyxol for reversal of mydriasis, and if the application is approved by the FDA, the company will be eligible to receive a US$10 million milestone payment during 2023. If the firm is able to meet additional regulatory milestones for presbyopia and night vision disturbances indications, it may receive potential milestone payments for those achievements as well.
The agreement stipulates that Famy is responsible for development efforts in non-US markets. When Nyxol is launched commercially, Ocuphire will be entitled to receive tiered double-digit royalties through 2040 on worldwide net sales and will be eligible to receive additional payments if certain sales milestones and thresholds are met.
Ocuphire advised that it has established collaborative agreements with both Famy and Viatris to develop and commercialize Nyxol® eye drops. The company explained that Nyxol is designed to reduce pupil size and is being developed for use in reversing pharmacologically induced mydriasis (RM), presbyopia, and NVD. The firm indicated that Nyxol is presently being evaluated in a Phase 3 presbyopia and NVD clinical trial and mentioned that it expects to submit an NDA for RM in Q4/22.
The report advised that FamyGen Life Sciences is highly focused on drug development and identification of in-license opportunities for clinical-stage assets. The firm also possesses the expertise and resources to provide the strategic funding required to advance these assets forward to regulatory approvals. According to the report, Famy has compiled a strong ophthalmic portfolio.
Ocuphire Pharma is a clinical-stage biopharmaceutical company based in Farmington Hills, Mich. that is engaged in the development and commercialization of medications used to treat refractive and retinal eye disorders. The company's drug development pipeline includes two small-molecule candidates designed to target both the front and back-of-the-eye indications.
Ocuphire is developing Nyxol® Eye Drops as a potential treatment for the reversal of mydriasis, presbyopia, and night vision disturbances. To date, Nyxol has been studied in more than 650 patient subjects across numerous Phase 1, 2, and 3 clinical trials. In addition, the firm is developing an oral tablet product candidate known as APX3330 for use in treating retinal and choroidal vascular diseases such as diabetic retinopathy and diabetic macular edema. The company has completed a total of 11 Phase 1 and Phase 2 studies of aPX3330 in more than 340 individuals.
Ocuphire Pharma started the day with a market cap of around US$43.28 million, with approximately 20.81 million shares outstanding and a short interest of about 1.5%. OCUP shares opened nearly 7% higher today at US$2.22 (+US$0.14, +6.73%) over yesterday's US$2.08 closing price. The stock traded today between US$2.20 and US$2.68 per share and closed for trading at US$2.49 (+US$0.41, +19.71%).
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