AzurRx BioPharma Announces Entry into Packaging, Labeling and Distribution Agreement with Creapharm Clinical Supplies
9 May 2020
AzurRx BioPharma, Inc., a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has entered into an agreement with Creapharm Clinical Supplies (“Creapharm”), a leader in clinical trial supply services, for the packaging, labelling and distribution of Phase 2 clinical trial drug product supply of its MS1819 therapy for the treatment of exocrine pancreatic insufficiency (EPI).
Under the terms of the agreement, Creapharm will package, label, provide qualified person (QP) release and distribute AzurRx’s MS1819 clinical trial drug product for both the upcoming Phase 2b OPTION 2 Monotherapy and the ongoing Phase 2 Combination Therapy clinical trials for the treatment of EPI in patients with Cystic Fibrosis (CF). MS1819 clinical trial drug supply will be sent directly to clinical sites in the U.S. and in Europe, including, Poland, Hungary, Spain and Turkey from Creapharm’s U.S. and European depots, respectively.
James Sapirstein, CEO of AzurRx BioPharma stated, “We are very pleased to have Creapharm as our clinical trial packaging and distribution partner for both the Phase 2b OPTION 2 trial in the U.S. and Poland and the Phase 2 Combination Therapy trial in Hungary and additional countries in Europe including Spain and possibly Turkey. Despite the disruptions in global supply and distribution from the COVID-19 pandemic our clinical trial supply chain is firmly in place and we are on track to both initiate the OPTION 2 trial and to expand the Combination Therapy trial.”
“We are delighted to support AzurRx in managing drug product supply for these two clinical trials and proud that our team has successfully been able to take up the challenge of meeting AzurRx’s specifications and timelines.“ said Eric Placet, CEO of CREAPHARM GROUP.
About AzurRx BioPharma, Inc.
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The Company is focused on the development of its lead drug product candidate, MS1819, a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.
CREAPHARM CLINICAL SUPPLIES provides pharma and biotech companies worldwide with a variety of services including clinical primary and secondary packaging, EU QP-Release and global distribution services. CREAPHARM CLINICAL SUPPLIES, a division of the CREAPHARM GROUP, is headquartered in France with three pharmaceutical plants: Reims (France), Le Haillan (France) and Atlanta (USA). Additional information can be found at www.creapharm.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. 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 304
Brooklyn, NY 11226
Investor Relations contact:
LifeSci Advisors, LLC.
Hans Vitzthum, Managing Director
1 International Place, Suite 1480
Boston, MA 02110