Creapharm will package, label and distribute the AzurRx BioPharma’s MS1819 clinical trial drug product
Creapharm to package and supply the MS1819 clinical trial drug product to US and European nations. (Credit: PublicDomainPictures from Pixabay)
Development stage biopharmaceutical company AzurRx BioPharma has signed a packaging, labeling and distribution agreement with Creapharm Clinical Supplies, a division of France-based Creapharm Group, for the MS1819 clinical trial drug product.
Under the agreement, Creapharm will be responsible for packaging, labelling, provide qualified person (QP) release and distribute the Phase 2 clinical trial drug product supply of AzurRx BioPharma’s MS1819 therapy for the treatment of exocrine pancreatic insufficiency (EPI).
The deal covers for 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).
AzurRx BioPharma CEO James Sapirstein of said: “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.”
MS1819 clinical trial drug to be sent to clinical sites in the US and in Europe
Creapharm plans to directly send the MS1819 clinical trial drug supply to clinical sites in the US and in Europe, including, Poland, Hungary, Spain and Turkey from its depots in the US and Europe respectively.
Creapharm Group CEO Eric Placet said: “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.”