NEW YORK, NY, July 31, 2014 – AzurRx BioPharma, Inc. today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 2013052180 A1 entitled “Method For Producing Lipase, Transformed Yarrowia Lipolytica Cell Capable Of Producing Said Lipase And Their Uses.”   This patent provides protection until June 2026.

“We are pleased with the issuance of this patent that protects our MS1819 lipase program for patients with exocrine pancreatic insufficiency,” stated Christine Rigby, President and Chief Operating Officer of AzurRx.  “This newly issued patent expands the intellectual property protection for our MS1819 lipase program and provides key coverage of our production and formulation methods. AzurRx now has a license from Laboratoires Mayoly-Spindler to three listed patents on MS1819, with patent protection through June 2026 in the U.S. The recent allowances of this patent also protect the company’s products in Vietnam, Australia and Japan. Former allowances were already delivered in Singapore, Russia, South Africa, Colombia, New Zealand and several European countries.”

MS1819 has successfully completed a Phase I/IIa human clinical trial for the treatment of chronic pancreatitis. AzurRx plans to complete the phase IIb study by 2016, in collaboration with Laboratoires Mayoly-Spindler. The market for the treatment of chronic pancreatitis is well established and growing with estimated annual revenue of over $1 billion. Current therapeutics employ animal-derived, porcine pancreatic extracts (PPEs). However, PPEs suffer from formulation problems, possible transmission of infectious agents (animal extracts), strongly suspected adverse events at high doses (fibrosing colonopathy) and limited effectiveness. AzurRx believes its recombinant lipase MS1819 will effectively address the limitations of the currently commercially-available pharmaceuticals.

About AzurRx BioPharma, Inc.

AzurRx BioPharma aims to become a leader in developing non-systemic, recombinant protein therapies for the treatment of gastrointestinal diseases and related conditions. 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 infection. The company is headquartered in New York, NY, with scientific operations based in Langlade, France.

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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 dermo-cosmetics in more than 70 countries. The company aims to become a global reference in gastroenterology and hydration. Mayoly Spindler is headquartered in the Paris area, France, and employs 750 people worldwide.

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Forward-Looking Statements

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 factors that potentially could materially affect the Company’s financial results, are contained in the Company’s 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.,
1410 Broadway
New York NY 10018 USA
Phone: (646)-699-7855

Laboratoires MAYOLY Spindler, SAS
6 avenue de l’Europe
78400 Chatou France
Phone : +33 1 34 80 55 55


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