AzurRx BioPharma, Inc. (NASDAQ: AZRX) Breaking News - December 21, 2016

AzurRx BioPharma Announces First Three Patients Included in Phase IIa Study with MS1819-SD for Endocrine Pancreatic Insufficiency

BROOKLYN, N.Y.--(BUSINESS WIRE)- December 21, 2016 - AzurRx BioPharma Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, announced today that in partnership with Mayoly Spindler, a European pharmaceutical company, that the first three patients in the Phase IIa clinical trial with MS1819-SD for patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) have been enrolled.

The open-label, dose escalation Phase II study is being conducted in two sites in Australia, The Royal Adelaide Hospital and Linear Clinical Research in Perth, as well as two sites in New Zealand, P3 Research in Wellington and CCST in Christchurch. The study is projected to complete 12-15 patients with EPI caused by chronic pancreatitis over the next several months.

The primary objective of this Phase II study is to investigate the safety of escalating doses of MS1819-SD in patients with CP. The secondary objective is to investigate the efficacy dose response of MS1819-SD in these patients by analysis of the coefficient of fat absorption (CFA) and its change from baseline. Safety will be assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests.

The Company anticipates reporting data periodically during this trial, with results from the first group of patients enrolled expected to be reported in the first half of 2017.

Thijs Spoor, President and CEO of AzurRx, said “The enrollment of the first patient/first patients in our Phase II study is a significant milestone in the clinical development of MS1819. We look forward to further demonstrating MS1819’s effect in reducing the conditions associated with chronic pancreatitis and improving the lives of EPI patients.

“We are excited to play an instrumental role in helping to develop new therapies for a range of human conditions” said Dr. Richard Stubbs, Managing Director of P3 Research, in Wellington, New Zealand. “We are committed to being a leader in trialling medicines that have significant potential to change patient care.”


MS1819-SD, an oral non-systemic biologic capsule, is a recombinant enzyme that is derived from the yarrowica lipolytica lipase, and is entirely plant-based/vegan. In early animal and human trials, it has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency of this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

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 cystic fibrosis 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 2015 was estimated to be $820 million in the U.S. and $1.5 billion globally according to Wall Street estimates.

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 dermo-cosmetics 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 750 people worldwide.

Mayoly Spindler website address: www.mayoly-spindler.com

About Endocrine Pancreatic Insufficiency:

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. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

About MS1819

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. In an animal model, the in-vivo activity of MS1819 was superior to the activity seen in-vivo using the standard of care porcine pancreatic extracts. A previous study has found that MS1819 was well tolerated in humans with no serious adverse events.
Information about the trial can be found on the following website:
http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ms1819&isBasic=True

Forward-Looking Statements:

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 development and testing of our drug candidates, the regulatory approval process, our ability to secure additional financing, the protection of our patent and intellectual property, the success of strategic agreements and relationships, and the potential commercialization of any product we may successfully develop. 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.

For more Information:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 217
Brooklyn, NY 11226
Phone: 646.699.7855
http://www.azurrx.com
info@azurrx.com
 

Source: AzurRx BioPharma, Inc.
 

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Recent AzurRx BioPharma, Inc. News:

AzurRx BioPharma Announces Agreement in Principle with TransChem for MTAN Inhibition Technology

BROOKLYN, N.Y.--(BUSINESS WIRE)- December 6, 2016 - AzurRx BioPharma Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, announced today that it has reached an agreement in principle with TransChem, Inc. to license TransChem's proprietary transition state chemistry technology for MTAN inhibition.

MTAN plays a key role in bacterial quorum sensing. Specifically, MTAN (methylthioadenosine/S-adenosylhomocysteine nucleosidase) disrupts the synthesis of autoinducers essential for bacterial quorum sensing. The absence of nucleosidase in mammals suggests that MTAN is likely to be an attractive target for antimicrobial design. While the proposed TransChem license is intended to cover a range of compounds and bacterial species specific targets, at this time, the Company’s initial focus for research and development is H. Pylori and its ability to form biofilms.

Thijs Spoor, President and CEO of AzurRx BioPharma, Inc. , stated “We believe this technology will enable us to tackle one of the major frontiers in medicine, the impact of bacterial biofilms on humans. This proposed license from TransChem will be a step forward in positioning AzurRx BioPharma to become a significant player in the development of non-systemic therapies for gastrointestinal and infectious diseases. We look forward to entering into a definitive license agreement for this groundbreaking technology in the coming weeks as we believe that the addition of these compounds to our portfolio potentially will allow us to drive transformational benefits to patients and the health care system."

According to the Centers for Disease Control, two-thirds of the global population is infected with the Heliobacter pylori (H. pylori) bacteria, in the U.S. H. pylori causes more than 90% of duodenal ulcers and up to 80% of gastric ulcers, and infected persons have a 2-6 fold increased risk of developing gastric cancer compared with uninfected counterparts. According to Persistence Market Research, the global peptic ulcer drug market is expected to reach $40 billion by 2022, with North America and Europe accounting for 67% of this market.

About Transition State Chemistry
The transition state is the moment at which the chemical bond either breaks or reforms. It is the exceedingly short time during which there is an equal probability of moving atoms to form new products or returning them to their original configuration. By replicating a shape that exists for the femtosecond lifetime of the transition state, and creating a chemical copy of that shape, it becomes possible to completely halt the action of the enzyme and freeze an enzymatic reaction. These synthetic mimics are called "transition-state analogs," which have shown extremely high potency in pre-clinical models. Because of their specificity and potency, transition-state analogs provide a novel approach that could revolutionize drugs development.

About MTAN
The U.S. Food and Drug Administration's milestone approval in 2001 of the first MTAN inhibitor, imatinib, was followed by a steady approval of MTAN inhibitors over the next 10 years. To date, the FDA has approved 28 small-molecule MTAN inhibitors, half of which were approved in the last 3 years.

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


Forward-Looking Statements:

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.

For more Information:
AzurRx BioPharma, Inc.
760 Parkside Avenue, Suite 217
Brooklyn, NY 11226
Phone: 646.699.7855
http://www.azurrx.com
info@azurrx.com
 

Source: AzurRx BioPharma, Inc.

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Recent AzurRx BioPharma, Inc. News:

AzurRx CEO Provides Shareholders With a "State of the Union" Communication

BROOKLYN, N.Y.--(BUSINESS WIRE)- December 1, 2016 - AzurRx BioPharma Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal (“GI”) diseases, announced today the release of a Company overview as presented by AzurRx's President & CEO, Thijs Spoor.

Mr. Spoor began the communication by stating, "This Company overview serves to provide shareholders with a perspective on AzurRx, its evolution and future potential. Let me begin with the fundamentals. We have a clear, focused plan for value creation, building our pipeline assets with a short-term, lower-risk development pathway, an experienced management team and first-class advisors.

We believe that our focus on non-systemic therapies represents a new frontier for developing therapies. Our pipeline, led by MS1819 and followed by AZX1101, is moving ahead and we have further strengthened and we continue to expand our global patent portfolio. Non-absorbable drugs are a unique subset of orally administered agents that exert their therapeutic effects locally in the GI tract. In contrast to traditional drugs, which are designed to be rapidly absorbed, achieve therapeutic plasma levels, and then be eliminated by multiple pathways, non-absorbable drugs are designed to only act locally in the gut. It is our belief that if drugs are not absorbed into the bloodstream, then it is very difficult for them to reach the liver, heart, brain or other organs, and thus we believe that the chance of having serious side effects is decreased.

MS1819
We continue to make progress with our lead agent MS1819-SD, a yeast derived recombinant lipase, for the treatment of exocrine pancreatic insufficiency (“EPI”) related to chronic pancreatitis (“CP”) and cystic fibrosis. We previously announced the initiation of the Phase II trial of MS1819 in EPI due to CP. We anticipate active participation from the sites in Australia and New Zealand in this un-blinded dose escalation trial, with initial results anticipated in the first half of 2017. With a potentially superior efficacy profile, we expect MS1819 to provide a true clinical benefit to EPI patients, offering materially improved efficacy and a dramatically reduced pill burden. Commercially, the EPI market, consisting of porcine derived products, was estimated to be approximately $1.5 billion in 2015 and is projected to increase to approximately $2.85 billion by 2023, according to market research firm Transparency Market Research.

AZX1101
Our second development stage agent, AZX1101, is a complex biologic in development for the prevention of nosocomial (hospital acquired) bacterial infections. Discovered in-house at AzurRx’s labs, AZX1101 acts by blocking the activity of a broad range of antibiotics from acting within the GI tract, thereby preventing toxicity of intravenous antibiotics to gut bacteria, and thus maintaining a healthier gut flora balance. We expect to file an Investigational New Drug Application for AZX1101 in 2017. While the potential applications of AZX1101 are broad, we intend to develop this agent for the prevention of clostridium difficile (C. diff) infection. The Centers for Disease Control has estimated that roughly 1.7 million hospital associated infections (i.e. ~5% of the number of hospitalized patients) cause or contribute to 99,000 deaths each year in the U.S., with the annual cost ranging from $4.5 billion to $11 billion.

Expanding Management
We have a terrific team of experienced, dedicated professionals at both our French and U.S. locations and intend to continue to strengthen our management and advisory boards with clinical experts in the fields of gastroenterology, cystic fibrosis, and infectious disease.

Value Creation
In summary, with MS1819 and AZX1101, we have a clear, focused plan for value creation, with significant milestones over the next 6-12 months. We also plan to bolster the team’s capabilities as the Company expands into the rapidly evolving infectious disease and microbiome space. Thijs Spoor, CEO of AzurRx, noted; “It is clear that novel therapies are urgently needed for gastro-intestinal and infectious diseases and we are focused on driving forward the development of our pipeline to provide patients around the world with new products that provide true clinical benefit. This is an exciting time for AzurRx as we build towards near-term value inflections.”

About AzurRx BioPharma 
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.

Forward-Looking Statements
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 development and testing of our drug candidates, the regulatory approval process, our ability to secure additional financing, the protection of our patent and intellectual property, the success of strategic agreements and relationships, and the potential commercialization of any product we may successfully develop. 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.

Source: AzurRx BioPharma, Inc.

AzurRx BioPharma and Mayoly-Spindler Announce Initiation of Phase II Clinical Trial of MS1819-SD for Exocrine Pancreatic Insufficiency in Chronic Pancreatitis Patients

BROOKLYN, N.Y.--(BUSINESS WIRE)- Nov 17, 2016 - AzurRx BioPharma Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, announced today that in partnership with Mayoly Spindler, a European pharmaceutical company, the initiation of a Phase II clinical trial evaluating the safety and efficacy of MS1819-SD in patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP).

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 cystic fibrosis according to the Cystic Fibrosis Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

The open-label, dose escalation Phase II study is being conducted in two sites in Australia, The Royal Adelaide Hospital and Linear Clinical Research in Perth as well as two sites in New Zealand, P3 Research in Wellington and CCST in Christchurch. The study is projected to enroll approximately 12 patients with EPI caused by chronic pancreatitis over the next several months. Dr. Quoc Nam Ngyuen, Associate Professor in the Department of Gastroenterology at the Royal Adelaide Hospital is the principal investigator for the study.

The primary objective of this Phase II study is to investigate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary objective is to investigate the efficacy of MS1819-SD in these patients by analysis of the coefficient of fat absorption and its change from baseline. Safety will be assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests. Initial study results from the MS1819-SD Phase II study are expected in the first half of 2017.

"Today's announcement marks another step forward for AzurRx in helping to define the future for treating patients with exocrine pancreatic insufficiency,” said Thijs Spoor, President and CEO of AzurRx. “We are very pleased that our Phase II trial for MS1819 will be developed with such prestigious institutions. We believe that non-systemic therapies have the ability to make significant improvements in patients living with a variety of diseases where selective targeting of the therapy while specifically avoiding non-target organs will provide physicians around the world with meaningful improvements in patient care and will provide patients with innovative therapies designed to improve their quality of life."

“We are very pleased to begin this phase IIa dose escalation trial. We strongly believe that such a product could have a significant improvement for the treatment of Exocrine Pancreatic Insufficiency,” stated Stephane Thiroloix, Mayoly Spindler Laboratories’ CEO. 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, Mayoly Spindler granted AzurRx 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 dermo-cosmetics 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, France, and employs 750 people worldwide.
Company website address: www.mayoly-spindler.com

About Endocrine Pancreatic Insufficiency:
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. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss.

About MS1819
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. In an animal model, the in-vivo activity of MS1819 was similar to the activity seen in-vivo using the standard of care porcine pancreatic extracts. A previous study has found that MS1819 was well tolerated in humans with no serious adverse events.

Information about the trial can be found on the following website:
http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ms1819&isBasic=True

Forward-Looking Statements:
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.

For more Information:
AzurRx BioPharma, Inc. 760 Parkside Avenue, Suite 217, 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

Source: AzurRx BioPharma, Inc.

AzurRx BioPharma Inc. (Nasdaq: AZRX) to Ring The Nasdaq Stock Market Closing Bell
 

BROOKLYN, N.Y.--(October 19, 2016)-- AzurRx BioPharma Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, will visit the Nasdaq MarketSite in Times Square in celebration of its recent IPO.

In honor of the occasion, Thijs Spoor, President and CEO, will ring the Closing Bell.

Where:Nasdaq MarketSite – 4 Times Square – 43rd & Broadway – Broadcast Studio

When:Wednesday, October 19, 2016 – 3:45 p.m. to 4:00 p.m. ET

AzurRx Contact:Martin Krusin
646-699-7855
info@azurrx.com

Nasdaq MarketSite:Emily Pan
(646) 441-5120
emily.pan@nasdaq.com

Feed Information:Fiber Line (Encompass Waterfront): 4463

Gal 3C/06C 95.05 degrees West
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DL 3811 Vertical
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SR 13.235
DR 18.295411
MOD 4:2:0
DVBS QPSK

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About AzurRx BioPharma, Inc.:AzurRx BioPharma, Inc. (Nasdaq:AZRX) 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 Brooklyn, NY, with scientific operations based in Langlade, France.

About NasdaqNasdaq (Nasdaq:NDAQ) is a leading provider of trading, clearing, exchange technology, listing, information and public company services across six continents. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today's global capital markets. As the creator of the world's first electronic stock market, its technology powers more than 70 marketplaces in 50 countries, and 1 in 10 of the world's securities transactions. Nasdaq is home to more than 3,700 listed companies with a market value of approximately $9.3 trillion and nearly 18,000 corporate clients. To learn more, visit: nasdaq.com/ambition or business.nasdaq.com.

-NDAQA-

Source: NASDAQ, Inc.
 

AzurRx BioPharma Announces Pricing of Initial Public Offering

BROOKLYN, N.Y.--(BUSINESS WIRE)-- AzurRx BioPharma Inc. (NASDAQ: AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, announced today that its initial public offering of 960,000 shares of common stock has been priced at $5.50 per share. Total gross proceeds from the offering will be $5,280,000.

The shares will begin trading on October 11, 2016 on the NASDAQ Capital Market under the ticker symbol "AZRX." The underwriters have a 45-day option to purchase up to 144,000 additional shares of common stock from AzurRx to cover over-allotments, if any. The Company intends to use the net proceeds of the offering to conduct the necessary validation testing on the MS1819 capsules that will be used in future clinical studies, to conduct the phase 2a trial, and for working capital and general corporate purposes.

WallachBeth Capital, LLC and Network1 Financial Securities, Inc. acted as co-book running managers and ViewTrade Securities Inc. acted as a co-manager for the offering.

AzurRx’s registration statement relating to these securities was declared effective as of October 11, 2016 by the U.S. Securities and Exchange Commission. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, and by contacting WallachBeth Capital, LLC, Attention: Capital Markets, 100 Wall Street, Suite 6600, New York, NY 10005, by telephone at 646-998-7605, or by email at cap-mkts@wallachbeth.com or Network 1 Financial Securities, Inc., Attention: Keith Testaverde, by telephone at 800-886-7007 or by mail at 2 Bridge Avenue, Suite 241, Redbank, NJ 07701.

This news release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About AzurRx BioPharma, Inc.:

AzurRx BioPharma, Inc. (NASDAQ: AZRX) 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 Brooklyn, NY, with scientific operations based in Langlade, France.

http://cts.businesswire.com/ct/CT?id=bwnews&sty=20161012005235r1&sid=acqr7&distro=nx&lang=en

View source version on businesswire.com: http://www.businesswire.com/news/home/20161012005235/en/

AzurRx BioPharma
Martin Krusin, + 1 646-699-7855
Vice President
mkrusin@azurrx.com

Source: AzurRx BioPharma Inc.
 

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About AzurRx BioPharma, Inc.:

MAzurRx BioPharma is a development stage biopharmaceutical company (NASDAQ: AZRX) focused on the development of recombinant proteins for the treatment of gastrointestinal diseases and microbiome related conditions. Our therapeutic products will be administered to patients as oral non-systemic biologics. The company currently has two products in its pipeline: MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (for cystic fibrosis and chronic pancreatitis patients) and AZX1101, a recombinant enzyme for the prevention of hospital-acquired C.difficile infections. The company is headquartered in New York City, with scientific operations in Langlade, France.

Welcome from the President

At AzurRx, we describe our company as “business led, science driven, and clinically advanced”— and at the forefront of developing therapies for digestive disorders. Since our beginning as a small research focused company, we have come a long way toward achieving our goal of being a fully integrated biotechnology company delivering the highest quality therapies possible to persons afflicted gastric impacted diseases. Our core technologies of next-generation enzymes are novel and advanced approaches to treating disease.

Our medicines in development represent a step forward in the fight to treat the many people living with diseases that impact their daily life and ability to thrive. But ours is clearly not the only approach. At every step of the way along this journey, we have been committed to the notion that there is no one right answer for how best to treat these many diseases. This understanding led us to explore the potential to improve existing enzyme therapies for various gut disorders. And now we have taken a step further on the continuum of innovation to develop our own proprietary next generation enzyme therapies.

We do all of this work with the knowledge that there are so many persons each living with their own hopes and dreams of a world where there is a treatment or even cure for their particular disease. We know as well that for so many individuals and families, time is of the essence. As President of AzurRx, you have my commitment that we strive to live our mission each day, knowing as you do that we often need to beat time as well as nature. We believe this AzurRx commitment is reflected in our strong scientific capabilities, our global clinical excellence in enzyme drug development and in our passion for patient advocacy. I came into this industry unexpectedly after watching so many children with cystic fibrosis have problems just getting enough nutrition to survive. Thanks for reading this note- and for the trust that so many of you have placed in us.

Core Expertise/Platform Technology:

AzurRx's core scientific team has 100+ years of deep experience covering Hepato-Gastroenterology and Infectious Diseases, clinical practice, basic scientific research and translational medicine, pharmaceutical R&D and university board leadership.

Proteomics (protein engineering, production and characterization);
Non-Systemic Therapeutic Biologics (bio-engineered therapies in capsule or liquid form that act locally);
Gasteroenterology/Gasterohepatology (pancreas, GI tract) and Infectious Diseases

Programs

MS1819 lipase, Phase IIa

Non-systemic, yeast derived recombinant enzyme
Oral non-systemic capsule for treatment of exocrine pancreatic insufficiency (EPI) in patients with chronic pancreatitis (CP) and cystic fibrosis (CF)
Demonstrates superior in vitro characteristics (i.e. high potency, activity in long chain fats, stability in protease and bile salt environments), eliminates pork viral contamination risk
Phase IIa in vivo safety and efficacy profile shows promise to improve on standard porcine-derived therapy
AZX1101 beta lactamases, preclinical

Oral, non-systemic medicine to act locally in the GI tract to prevent nosocomial (hospital-acquired) infections by resistant bacterial strains induced by parenteral administration of β-lactam antibiotics.


Team

Thijs Spoor, President

Mr. Spoor has been the President, Chief Executive Officer and a member of the board of directors of Fluoropharma Medical, Inc. since February 14, 2011, and has been the Chairman of the board of directors of Fluoropharma Medical, Inc. since June 14, 2012. Mr. Spoor was the CFO for Sunstone BioSciences from February 2010 through September 2010. Prior to joining Sunstone BioSciences, he worked as a consultant at Oliver Wyman from December 2008 through February 2010, focusing on helping pharmaceutical and medical device companies. Mr. Spoor was an equity research analyst at J.P. Morgan from July 2007 through October 2008 and Credit Suisse from November 2005 through July 2007, covering the biotechnology and medical device industries. Prior to his career on Wall Street, Mr. Spoor worked in the pharmaceutical industry spending 11 years with Amersham /GE Healthcare where he worked in 7 countries in a variety of roles including setting up GMP facilities, accountability for the nuclear cardiology portfolio and most recently as the Director of New Product Opportunities leading the PET strategic plan. Mr. Spoor holds a Nuclear Pharmacy degree from the University of Toronto as well as an M.B.A. from Columbia University with concentrations in finance and accounting.

Daniel Dupret, PhD, Chief Scientific Officer

Dr. Dupret joins after serving as President of ProteaBio Europe, a wholly-owned European subsidiary of Protea Biosciences. He joined Protea Biosciences in October 2008 to launch and manage ProteaBio Europe. Previously, Daniel founded Proteus SA in 1998 and served as its President and CEO from 1998 to 2007. He founded Appligene SA in 1985 and served as CSO, President, and CEO, respectively, until 1998. From 1982 to 1985, he served as Project Leader at Transgene SA. In parallel to his Biotechnology career, Mr. Dupret was an expert for the French government and the European commission in grant commission and funding of young biotech companies. From 2003 to 2007, he served as President of the Board of the University of Nîmes. Dr. Dupret received his PhD. at the Medical University of Strasbourg.

George Harb, MD, MPH, Head Clinical Development

A pharmaceutical industry physician executive with over 15 years of experience in global drug development in clinical development in gastroenterology and virology, involving biologics and small molecules. Most recently, Dr. Harb was Vice President of Clinical Development and Operations at Aptalis Pharma where he led clinical development programs in cystic fibrosis, ulcerative colitis, peptic ulcer and eosinophilic esophagitis. He led the registration of a small molecule drug- telbuvidine- for hepatitis B, and the launch of two biologics: peg-interferon (hepatitis C) and human recombinant hyaluronidase (pediatric hydration). Trained in Internal Medicine, Clinical Pharmacology, and Epidemiology, he spent the initial part of his career in academic medicine at University of Miami, and private practice before joining Roche Laboratories in 1998 as US Medical Director Viral Hepatitis, with responsibilities to lead the US medical affairs team for the launch of peg-interferon alpha 2a. He oversaw KOL development, advisory boards, speaker training, medical education programs, development of promotional materials and publication planning and implementation. As Global Executive Director at Novartis, he led the phase III clinical registration studies for hepatitis B, NDA preparation and submission, NDA and label negotiations with health authorities, phase IIIb and IV clinical program development, and launch in the US, Europe, China and many Asian countries. From 2007 to 2012 at Baxter Healthcare, Dr. Harb had medical strategic oversight for cardiovascular drug (Brevibloc) and human recombinant hyaluronidase (pediatric and adult hydration), including Life Cycle Management, clinical program development, supplemental NDA submissions/geographic expansions. He holds a medical degree from the American University of Beirut, with advanced degrees in Public Health and Epidemiology.

Martin Krusin, Vice President for Finance and Business Development

Mr. Krusin is an experienced executive with over 15 years of business development, strategic marketing, financing and operating experience in the healthcare, financial services, and consulting sectors. Prior to joining AzurRx BioPharma as VP for Business Development in 2012, Mr. Krusin was Director of Business Development at Clewed (a business services and investment partnership); an Experienced Commercial Leader at GE Capital in its Global Sponsor Finance, Healthcare Financial Services, and Capital Solutions units; Vice President of Marketing & Sales and Director of Business Development at Electro-Optical Sciences (now MelaSciences); and an analyst in the Emerging Markets Strategic Planning Group at Citigroup. Mr. Krusin received a MBA from Columbia Business School in finance and marketing, a MPhil. in political economy from Oxford University, and a BA in international relations from Swarthmore College.

Philippe Jais, MD, PhD, Director of Medical Research and Translational Medicine

Dr. Jais joined ProteaBio as Director of Medical Research and Translational Medicine in October 2012. Philippe has +15 years’ experience in clinical development, Translational Medicine and Hepato-Gastroenterology. From 2011 to 2012 he served as Global Clinical Development Leader at LFB Biotechnology. In 2010, held the position of Scientific Director at Hoffmann-LaRoche. From 2004 to 2010, he served as Clinical Research Director, then Expert Scientist genomic biomarkers at Solvay Pharma. From 1999 to 2003, Philippe served as Director of Medical Research and Pharmaco-genomics at Genset SA. Prior to his career in biotechnology and pharmaceuticals, he received his board certification in Hepatogastroenterology and served as Assistant in the Hepatogastroenterology department at Bichat Hospital (Paris, France). He received his PhD in Human Molecular Genetics at University Paris VII and served as Assistant in Molecular Biology at Bichat Hospital (Paris, France). Philippe has co-founded two Biotech companies, Chiasma Laboratories in 2004, and Eukarÿs SAS in 2010. Dr. Jais received his PhD. in human molecular genetics at the Molecular Genetics Laboratory, Institut Gustave Roussy, University Denis Diderot Paris VII and his MD, specialization in Hepato-Gastroenteroloy-Nutrition, at the University Denis Diderot Paris VII.

Luc Lebreton, PhD, R&D, Programs Director

Dr. Lebreton joined AzurRx in June 2015 after serving as R&D Programs Director at Eyevensys from 2013-2015. Previously he served as Therapeutic Area Leader in occular diseeases at Abbott (formerly Solvay Pharmaceuticals) from 2009-2013 and as the Global R&D Programs Director at Solvay Pharmaceuticals from 2007-2009. From 2001-2007 he held several roles at Laboratoires Fournier including Research Program Manager, Chemistry Group Leader/Senior Medicinal Chemist, and Chemistry Lab Manager from 2001-2007. Dr. Lebreton received his PhD in pharmaco-chemistry at the University of Paris VII.

Yves Leblond, PhD, Director of Research and Development

Dr. Leblond joins after serving as the R&D director for the development of pharmaceutical drug products at ProteaBio Europe since 2009. Yves has more than 25 years’ experience in multi-national pharmaceutical companies. From 2002 to 2009, he held the position of R&D director for LMS Laboratories. From 1991 until 2002, he was the head of the non-clinical drug safety department for the Fournier Group. From 1986 to 1991, he served as the head coordinator in the drug safety department for Synthelabo Group. From 1984 to 1986, Yves was the head of the preclinical department at Boerhinger Laboratories. Yves has expertise in pharmacology/toxicology and pharmacokinetic/metabolism in addition to multiple projects managed (more than 6 international products developed) in various therapeutic areas such as cardiovascular, anti-inflammatory, immunosuppressive and gastro-intestinal diseases. Yves received his PhD. from University Paris XI.

Mathieu Schué, PhD, Head of Laboratory

Dr. Schué joins after serving as Project Leader for the development of a new therapeutic protein (AZX1101), to be associated with antibiotics, at ProteaBio Europe since 2009. He is also involved in the API aspects (cell banking, API production and characterization) of the MS1819 pharmaceutical development. Dr. Schué graduated first as a chemical engineer at “Ecole Nationale Supérieure de Chimie de Montpellier” (ENSCM), Montpellier with specialization in biochemistry and molecular biology and then with a PhD in molecular microbiology at the University of Birmingham, UK. With three years of post-doctoral positions at “Commissariat à l’Energie Atomique” (CEA) at Cadarache, and CNRS, Marseille, he has gained solid expertise in biotechnology (recombinant protein expression and purification) and enzymology (molecular and structural characterizations). Dr. Schué received his Ph.D. in molecular microbiology at the University of Birmingham in the UK.

Raymond Lowing, PhD, Director of Regulatory Compliance

Dr. Lowing has more than 26 years experience in different posts within Pharmaceutical Quality and Compliance at Sanofi-Aventis. He has covered all areas of Quality Assurance in his career with responsibilities including Site GLP and GMP Head of Quality, Global GLP, GMP and GCP Quality Compliance Coordinator Research and Development, and Associate Vice President Quality and Compliance R&D GLP. Following his PhD in Biochemical Toxicology at Surrey University, Ray worked for the UK Government Health and Safety Executive as a Senior Scientist heading up pathology laboratories and performing safety evaluation on industrial compounds prior to Marketing Authorization. In 1982 Ray became the first Principal Inspector for GLP Compliance for the UK Government setting up and performing inspections for the UK Monitoring Authority and also with the EPA and FDA in establishing the UK-USA Mutual Acceptance of Data Agreement. Ray was part of the Global Expert team involved in the re-writing of the OECD GLP Regulations in 1997 and also part of the joint FDA–Industry team writing the second version of the DIA Red Apple Document on the Use of Computerized Systems in GLP. During his career Ray has published more than a dozen papers in scientific journals and given more than 30 presentations at different National and International Conferences. Dr. Lowing received his Ph.D. in biochemical toxicology at the University of Surrey in the UK.

Board of Directors

Ed Borkowski, Chairman and Director

Mr. Borkowski served as the Chief Financial Officer of ConvaTec Healthcare, CareFusion Corporation and Mylan, Inc. and in a variety of finance positions at Pharmacia, American Home Products, Cyanamid and at Arthur Andersen. Mr. Borkowski holds a Bachelor of Science in Economics and Political Science from Allegheny College and a Master in Business Administration in Finance and Accounting from Rutgers University.

Alastair Riddell, MD, PhD, Director

Dr. Riddell joined the board in September 2015. He is a seasoned biotech entrepreneur with over 32 years experience in the pharmaceutical, life science and biotech industries. After 10 years directing clinical trials of oncology and intensive care products for companies including Celltech and Centocor, he spent 5 years managing sales and marketing for monoclonal antibodies, oncology and imaging products for Centocor and Amersham International (now GE Healthcare). This led to 12 years as a biotech CEO for Pharmagene, Paradigm Therapeutics and Stem Cell Sciences. He was also a Board member of the BIA for 10 years and Chair or senior independent director of 3 other biotech companies (CXR Biosciences, Surface Therapeutics, Sareum). He is currently Chairman of and investor in Definigen Ltd and Executive Chairman of Silence Therapeutics plc (AIM). Overall he has been a main board member of industry companies continuously for over 17 years.

City experience as CEO includes a successful IPO on the main list of UK stock exchange for Pharmagene in 2000, CEO of Stem Cell Sciences listed on both the UK AIM list and Australian ASX and as NED for Sareum on the UK AIM list. Fund raising achievement totals over £150m in investment capital from VCs in private rounds and from institutional investors in public offerings. Corporate deals as CEO include 2 trade sales to public companies, Paradigm Therapeutics to Takeda, Stem Cell Sciences to Stem Cells Inc (NASDAQ) and as Chairman, Surface Therapeutics to Serentis (both latter companies private).

Commercial deals include multimillion £ research collaborations with major pharmaceutical companies and major product launches internationally. He began his professional career as a medical doctor and Army officer with 6 years experience in a variety of hospital specialties and in general practice.

Maged Shenouda, Director

Mr. Shenouda joined the Board of Directors in October 2015. He has over 25 years of experience in the pharmaceutical and securities industries. Most recently, Mr. Shenouda was the Head of Business Development and Licensing at Retrophin, Inc. Prior to that, he served as the Head of East Coast Operations at Blueprint Life Science Group, a strategic investor relations consultancy. Mr. Shenouda spent the bulk of his career as an equity analyst with senior level positions at Stifel Nicolaus, UBS and JP Morgan, covering a broad range of small and large cap biotechnology companies. Mr. Shenouda started his sell-side career with Citigroup and Bear Stearns where his coverage universe focused on U.S and European pharmaceutical companies. Before entering Wall Street, Mr. Shenouda was a management consultant with PricewaterhouseCoopers' Pharmaceutical Consulting practice and also spent time in pharmaceutical sales, having worked as a hospital representative and managed care specialist for Abbott Laboratories' Pharmaceutical Products Division. Mr. Shenouda earned a B.S. in pharmacy from St. John's University and is a registered pharmacist in New Jersey and California. He also received an M.B.A. from Rutgers University Graduate School of Management.

Thijs Spoor, Director

Mr. Spoor has been the President, Chief Executive Officer and a member of the board of directors of Fluoropharma Medical, Inc. since February 14, 2011, and has been the Chairman of the board of directors of Fluoropharma Medical, Inc. since June 14, 2012. Mr. Spoor was the CFO for Sunstone BioSciences from February 2010 through September 2010. Prior to joining Sunstone BioSciences, he worked as a consultant at Oliver Wyman from December 2008 through February 2010, focusing on helping pharmaceutical and medical device companies. Mr. Spoor was an equity research analyst at J.P. Morgan from July 2007 through October 2008 and Credit Suisse from November 2005 through July 2007, covering the biotechnology and medical device industries. Prior to his career on Wall Street, Mr. Spoor worked in the pharmaceutical industry spending 11 years with Amersham /GE Healthcare where he worked in 7 countries in a variety of roles including setting up GMP facilities, accountability for the nuclear cardiology portfolio and most recently as the Director of New Product Opportunities leading the PET strategic plan. Mr. Spoor holds a Nuclear Pharmacy degree from the University of Toronto as well as an M.B.A. from Columbia University with concentrations in finance and accounting.

Scientific Advisory Board

Dr. Philip Toskes

Head of HepatoGastroenterology Dept. at the University Hospital of Florida Consultant to FDA on pancreatic enzyme replacement and clinical investigator with various PPE studies.

Dr. Fréderic Carrière

Head of UMR 7282 CNRS – IBSM (Marseilles, France) and a lipase enzyme expert and member of the expert working committee at the United States Pharmacopeia (USP) on the development of lipase monographs and testing chapters.

Dr. René Laugier

Head of the Hepato-Gastroenterology department at the University Hospital of Marseille La Timone. A recognized specialist of pancreatic disorders.

Dr. Mark Lowe

Professor of Pediatrics, University of Pittsburgh School of Medicine. A recognized expert in pediatric gastroenterology for exocrine pancreatic insufficiency in children with cystic fibrosis.
 

SOURCE: http://www.azurrx.com

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