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Expanded MS1819-SD Global Commercialization Rights Now Owned by AzurRx BioPharma along with Full Development Rights

  • AzurRx materially expands global commercial rights, with full development control of MS1819 program
  • Mayoly retains certain commercial rights, while obtaining a sizeable equity interest in AzurRx BioPharma, Inc. (AZRX) shares.

BROOKLYN, N.Y., April 02, 2019 (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, announces expanded commercialization rights to MS1819-SD as a result of the acquisition of intellectual property surrounding MS1819-SD from Laboratoires Mayoly Spindler, SAS.

Under the terms of the asset purchase agreement, AzurRx will now have commercialization rights in substantially all international territories.  Mayoly Spindler will retain commercialization rights in certain territories and pay AzurRx undisclosed royalties for sales in these territories.  AzurRx will also now have complete project control.  In consideration for owning the patents to MS1819-SD, Mayoly received an equity interest in AzurRx as well as certain cash payments in the future.

“We are delighted by the realignment of our partnership with Mayoly Spindler,” said Thijs Spoor, CEO of AzurRx BioPharma, Inc.  “We believe that owning the patents to MS1819-SD further streamlines project terms and more fully corresponds with our respective strategic and geographic objectives.” 

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-SD 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 regarding 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 900 people worldwide.
Mayoly Spindler website address: www.mayoly-spindler.com

About MS1819-SD

MS1819-SD, supplied as an oral non-systemic biologic capsule, is a recombinant enzyme that is derived from the yarrowia lipolytica lipase, and unlike the standard of care, does not contain any animal products.

Additional information about the ongoing OPTION MS1819-SD with cystic fibrosis patients can be found at:
https://clinicaltrials.gov/ct2/show/NCT03746483?term=ms1819&rank=2 

About Exocrine Pancreatic Insufficiency:

EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. This deficiency can be responsible for greasy diarrhea, fecal urge and weight loss.

There are approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation and more than 30,000 patients with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

Forward-Looking Statements:

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful continuation and results of the Company’s phase IIa clinical study of MS1819-SD, allowance of patent applications and continued protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the phase IIa clinical development activities described above. These and other risks and uncertainties are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. The Company undertakes no obligation to publicly update or revise any forward-looking statements.

CONTACT:
For more Information: 
AzurRx BioPharma, Inc. 
760 Parkside Avenue, 
Suite 304 
Brooklyn, NY 11226 
Phone: 646.699.7855 
http://www.azurrx.com
info@azurrx.com

For more Information: 
Laboratories Mayoly Spindler 
6 Avenue de l'Europe 
B.P. 51 - 78401 
CHATOU Cedex - France 
Phone: +33(0)1 34 80 57 00 
Fax: + 33(0)1 34 80 41 11 
http://www.mayoly-spindler.com  
contact@mayoly.com