The APX3330 drug substance has been optimized and is undergoing development for production scale-up in compliance with cGMP requirements. The drug product manufacturer previously supported cGMP manufacturing for 60 mg and 120 mg tablets, and a reformulated 300 mg dose has been developed and tested for bioavailability. Further process development, scale-up, and validation are planned pending a partnership agreement. Under the Viatris License Agreement, Opus Genetics, Inc. granted Viatris an exclusive license to develop, manufacture, and commercialize PS Products in specified territories. Viatris will reimburse development costs and share costs exceeding a defined threshold. Opus Genetics received an initial payment of $35 million and may receive up to $130 million more upon achieving milestones, in addition to tiered royalties on sales.
Opus Genetics Inc's Comment on Supply Chain
The APX3330 drug substance has been optimized and is undergoing development for production scale-up in compliance with cGMP requirements. The drug product manufacturer previously supported cGMP manufacturing for 60 mg and 120 mg tablets, and a reformulated 300 mg dose has been developed and tested for bioavailability. Further process development, scale-up, and validation are planned pending a partnership agreement. Under the Viatris License Agreement, Opus Genetics, Inc. granted Viatris an exclusive license to develop, manufacture, and commercialize PS Products in specified territories. Viatris will reimburse development costs and share costs exceeding a defined threshold. Opus Genetics received an initial payment of $35 million and may receive up to $130 million more upon achieving milestones, in addition to tiered royalties on sales.
Sources:
Opus Genetics Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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