Cosmo announces submission to FDA of New Drug Application for Rifamycin SV MMX

Cosmo announces submission to FDA of New Drug Application for

Rifamycin SV MMX

Rifamycin SV MMX Is Eligible for Additional Market Exclusivity and Priority Review in the United States

Drug Candidate Offers Significant Anti-Infective Properties and

Unique Delivery Mechanism for Treatment of Traveler's Diarrhea

Dublin - March 20, 2018 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that the New Drug Application (NDA) for Rifamycin SV MMX has been submitted to the U.S. Food and Drug Administration seeking market authorization for the treatment of traveler's diarrhea under an expedited review process in the US.

The U.S. Food and Drug Administration has granted the Qualified Infectious Disease Product (QIDP) and Fast Track designations for Rifamycin SV MMX, for the treatment of patients with traveler's diarrhea. Under QIDP and Fast Track designations, the Rifamycin SV MMX application is eligible for Priority Review.

"There have not been any new chemical entities approved, with no-systemic absorption and superior anti-inflammatory properties, to treat colonic infections in years. The QIDP and its accelerated review process, expecting a potential approval by the end of the year, highlights the importance of treating colonic infections with our new antibiotic to address this unmet medical need," said Alessandro Della Chà, Chief Executive Officer of Cosmo Pharmaceuticals. "We look forward to a fruitful interaction with the FDA as we work to bring Rifamycin SV MMX to patients."

Rifamycin SV MMX is a New Chemical Entity (NCE) in the United States and eligible for 5 years of NCE market exclusivity. If approved, Rifamycin SV MMX will be eligible for an additional five years of market exclusivity based on the QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act. This gives Cosmo a 10-year exclusivity period: 5 years for the new chemical entity (NCE) and 5 years for the Gain Act bringing the protection to 2028.

GAIN creates incentives for the development and review of antibacterial and antifungal drug products that treat serious and life-threatening infections. With QIDP designation, Rifamycin SV MMX is now eligible for this expedited review process. Fast track is a process the FDA designed to facilitate the development, and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need. Priority Review is one of the Fast Track provisions. The program's purpose is to get important new drugs to the patient earlier.

Phase III clinical trials of Rifamycin SV MMX in traveler's diarrhea have been completed in the US and EU. The Phase III program demonstrated Rifamycin SV MMX's superiority as compared to placebo (p-value = 0.0008) and its non-inferiority as compared to Ciprofloxacin (p-value = 0.0033), the worldwide standard of care.

A Marketing Authorization Application is under evaluation in several European Countries under a DCP application promoted by Falk Pharma, our licensee for the Europe and some other Territories.

About Rifamycin SV MMX

Rifamycin SV MMX is a pharmaceutical product candidate employing rifamycin SV engineered with Cosmo Pharmaceuticals' MMX® technology. Rifamycin SV MMX is a broad spectrum, semi-synthetic, orally non-absorbable antibiotic which can be used for the treatment of bacterial infections of the colon such as traveler's diarrhea. The application of MMX® technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Rifamycin SV MMX tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus abating its systemic absorption in the small intestine.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal Disorders and Endoscopic Procedures. The Company's proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn's Disease, and Colon Infections. In addition, the Company has developed a medical device for polyp and adenoma excision and is has completed clinical trials of formerly LuMeBlue™, a diagnostic drug for the detection of colon cancer as well as new chemical entities that are being developed by the associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo's MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Santarus/Salix/Valeant and in the Rest of the World to Ferring as Cortiment®. Cosmo's proprietary MMX® technology is at the core of the Company's product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon. For further information on Cosmo, please visit the Company's website: www.cosmopharma.com

Contact

John Manieri, Head of Investor Relations

Cosmo Pharmaceuticals N.V.

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Disclaimer

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.

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This press release does not constitute an "offer of securities to the public" within the meaning of Directive 2003/71/EC of the European Union (the "Prospectus Directive") of the securities referred to in it (the "Securities") in any member state of the European Economic Area (the "EEA"). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.

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