AzurRx BioPharma (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced its entry into a binding letter of intent (“LOI”) with Asymchem, a leading global contract development and manufacturing service (“CDMO”) provider, for the development and production of MS1819 for the treatment of exocrine pancreatic insufficiency. Under the agreement, Asymchem will implement fermentation, verify protein expression and ultimately fine-tune the technology suitable for production of MS1819. Asymchem will be responsible for sourcing all materials required for the program under Current Good Manufacturing Practice (“cGMP”) regulatory conditions. “With a fairly competitive landscape for CDMOs, we worked diligently to identify the right partner for our pivotal Phase 3 clinical trial,” said James Sapirstein, president and chief operating officer of AzurRx BioPharma. “Our entire team is very proud of how far we’ve come, and we are excited to move into the next chapter of our clinical development plans for MS1819 with reduced manufacturing costs in the commercial product of our drug. Asymchem has a successful track record working with top pharmaceutical companies in the industry, and I am confident our partnership will steer us on the right path of manufacturing optimization and ultimate commercialization of MS1819.”
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About AzurRx BioPharma Inc.
AzurRx BioPharma is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information, visit the company’s website at www.AzurRx.com.
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