Eiger Biopharmaceuticals Inc's Comment on Supply Chain
The company utilizes contract manufacturers (CMOs) for the production of Zokinvy and Jitixib (lonafarnib). Merck manufactured the drug product for completed lonafarnib Phase 2 clinical studies. Technology transfer for lonafarnib drug substance and product manufacturing to third-party manufacturers has been completed; these manufacturers will supply future HDV clinical trials and commercial supply for HGPS. For the lambda program, technology transfer from BMS to the company's contract development and manufacturing organizations (CDMOs) has been completed, with sufficient inventory obtained under the license agreement to complete Phase 2 and initiate Phase 3 trials. Additional batches of lambda have been manufactured, demonstrating equivalence to BMS materials. Avexitide clinical trial materials are produced by third-party CDMOs. All lonafarnib and lambda products from CDMOs are manufactured in compliance with Good Manufacturing Practice (GMP) standards.
Eiger Biopharmaceuticals Inc's Comment on Supply Chain
The company utilizes contract manufacturers (CMOs) for the production of Zokinvy and Jitixib (lonafarnib). Merck manufactured the drug product for completed lonafarnib Phase 2 clinical studies. Technology transfer for lonafarnib drug substance and product manufacturing to third-party manufacturers has been completed; these manufacturers will supply future HDV clinical trials and commercial supply for HGPS. For the lambda program, technology transfer from BMS to the company's contract development and manufacturing organizations (CDMOs) has been completed, with sufficient inventory obtained under the license agreement to complete Phase 2 and initiate Phase 3 trials. Additional batches of lambda have been manufactured, demonstrating equivalence to BMS materials. Avexitide clinical trial materials are produced by third-party CDMOs. All lonafarnib and lambda products from CDMOs are manufactured in compliance with Good Manufacturing Practice (GMP) standards.
Sources:
Eiger Biopharmaceuticals 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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