Cosmo Pharmaceuticals announces Publication of Review of Aemcolo™ as Treatment for Traveler’s Diarrhea in Clinical Drug Investigation

Cosmo Pharmaceuticals announces Publication of Review of Aemcolo™ as Treatment for Traveler's Diarrhea in Clinical Drug Investigation

Highlights Differentiator of MMX® Technology Allowing Targeted Colon Absorption

Dublin - June 21, 2019 - Cosmo Pharmaceuticals N.V. (SIX: COPN), a specialty pharmaceutical company leader in the field of selected gastrointestinal disorders and endoscopy, announced today the publication of a review of Aemcolo™, the Company's broad-spectrum oral antibiotic, in a Clinical Drug Investigation that highlights its safety, effectiveness and advantages over other treatment options.

The review concludes that Aemcolo™, due to Cosmo's proprietary MMX® technology delivering the active drug substance directly to the colon and minimizing its systemic absorption, represents an effective and well tolerated treatment option for non-dysenteric traveler's diarrhea (TD) in adults.

"This review highlights the effectiveness and safety of Aemcolo™ for non-dysenteric diarrhea, as well as its potential advantages over other treatment options. The publication is timely, particularly with the recent ban of chinolonic antibiotics for this indication by EU and US regulators, which opens up a greater market opportunity for Aemcolo™. We are now focusing on expanding the benefits of this product beyond the currently approved indication," says Luigi Moro, Chief Scientific Officer of Cosmo Pharmaceuticals.

In particular, the review highlighted that adult patients in two Phase 3 studies treated with Aemcolo™ experienced a shorter duration of non-dysenteric traveler's diarrhea. In addition, patients treated with ciprofloxacin exhibited a significant increase in the colonization rate by Extended Spectrum β-Lactamase-producing (ESBL) Escherichia Coli, whereas patients treated with Aemcolo™ did not. ESBL are enzymes that confer resistance to most beta-lactam antibiotics, including penicillins, cephalosporins and the monobactam aztreonam. This characteristic of Aemcolo™ provides an important advantage in view of the global concerns regarding the emergence of multi-drug resistant bacteria, which cause infections that are challenging to treat.

The application of Cosmo's MMX® technology to Rifamycin SV to create Aemcolo™ allows the antibiotic to be delivered directly into the colon, thereby avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Aemcolo™ tablets is also thought to increase the colonic delivery of the antibiotic so that an optimized intestinal concentration is achieved and systemic absorption in the small intestine is avoided.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company's proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of its novel Artificial Intelligence device to be used in coloscopies and GI procedures. Further, Cosmo is the licensee for US of the novel agent for procedural sedation, Remimazolam. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com

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