BROOKLYN, N.Y., Oct. 20, 2017 (GLOBE NEWSWIRE) -- 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
This press release contains forward-looking statements within the meaning of the Private Securities Litigations Reform Act of 1995. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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