AzurRx BioPharma and Mayoly Spindler Announce MS1819-SD Investigational Medicinal Product Dossier (IMPD) Submission
AzurRx BioPharma Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), announced the submission of an Investigational Medicinal Product Dossier (IMPD) for its lead product MS1819-SD, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) and cystic fibrosis (CF).
This Investigational Medicinal Product Dossier (IMPD) has been submitted through the European Medicines Agency clinical trial portal for approval prior to opening of clinical centers in France as part of the ongoing clinical study in chronic pancreatitis and other indications. The IMPD includes information related to the quality, manufacture and control of the MS1819-SD, as well as data from clinical and non-clinical studies.
“This IMPD submission reflects the continued geographic expansion of our MS1819-SD clinical trial program and upon approval will allow us to open clinical trial sites in France,” said Thijs Spoor, CEO of AzurRx BioPharma. “We are proud of the outstanding efforts of our scientific team as we reach this important regulatory milestone.”
About MS1819, a Recombinant Lipase
MS1819, a recombinant lipase derived from the yeast Yarrowia Lipolytica, is in development for the treatment of exocrine pancreatic insufficiency (EPI) associated with chronic pancreatitis (CP) and cystic fibrosis (CF). Early Phase Ib data in EPI patients treated with MS1819 showed a favorable safety profile and encouraging preliminary signals of efficacy.
There are approximately 100,000 patients in the U.S. with EPI caused by CP according to the National Pancreas Foundation and more than 30,000 patients with EPI caused by CF according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills. The U.S. market for such EPI porcine replacement therapy pills in 2016 was estimated to be approximately $950 million in the U.S. and $1.5 billion globally according to IMS data and Wall Street estimates.
AzurRx and Laboratoires Mayoly Spindler are party to a joint research and development agreement and are collaborating on the development of a yeast derived recombinant lipase for the oral treatment of Exocrine pancreatic insufficiency (EPI). Under terms of their partnership agreement, AzurRx has marketing rights for the recombinant Lipase in various geographies, including exclusive rights for North America.
About AzurRx BioPharma, Inc.:
AzurRx BioPharma, Inc. (NASDAQ:AZRX) is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. MS1819 recombinant lipase for exocrine pancreatic insufficiency is the company’s lead development program, and additional early stage research is being conducted for the prevention of hospital-acquired infections. The company is headquartered in Brooklyn, NY, with scientific operations based in Langlade, France. Additional information on the company can be found at www.azurrx.com
About Laboratoires Mayoly Spindler, SAS
Mayoly Spindler is a French, independent, family-owned pharmaceutical company, active in research, development, manufacturing, registration and marketing of pharmaceuticals and dermocosmetics in more than 70 countries. The company aims to become a global reference in gastroenterology and dermocosmetics. Mayoly Spindler is headquartered in the Paris area of France, and employs 800 people worldwide.
Mayoly Spindler website address: www.mayoly-spindler.com