DELRAY BEACH, Fla., Nov. 10, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has signed a binding letter of intent 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 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.”
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) 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. Additional information on the Company can be found at www.azurrx.com.
Founded in 1999, Asymchem (stock code: 002821.SZ) is a leading global integrated Contract Development and Manufacturing Organization (CDMO) providing innovative drug R&D and manufacturing. Asymchem is supported by 5000 employees based in PR China, US, and EU and has a strong mission to drive efficiency through continuous technological advances for smarter, greener, and more cost-effective manufacturing to support pharmaceutical clinical research and commercialization. For more information, please visit www.asymchem.com.
This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
For more information:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 327F
Brooklyn, NY 11226
Investor Relations contact:
LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
1 International Place, Suite 1480
Boston, MA 02110