AzurRx BioPharma Inc., a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, has signed a binding letter of intent with Asymchem, a global contract development and manufacturing service (CDMO) provider, for the development and production of MS1819 for the treatment of exocrine pancreatic insufficiency.
 
Under the terms of 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.”
 
“Asymchem is honored to support AzurRx’s team in the preparations for their Phase 3 trial, said Elut Hsu, president of Asymchem. “Asymchem has deep knowledge and extensive experience in the development, optimization and cGMP manufacture of complex recombinant therapies. As one the the leading global CDMOs in the pharmaceutical industry, we look forward to providing our expertise to AzurRx and optimizing MS1819’s greatest potential.”