Cosmo Pharmaceuticals Methylene Blue MMX Regulatory Update:

Type A Meeting Request filed to FDA

Dublin - June 28, 2018 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that it has submitted a Type A Meeting Request and Briefing Document to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated May 21, 2018. The purpose of the meeting is to confer upon issues identified by the FDA in the CRL and to ask the Agency for reconsideration of the submitted NDA. The meeting should take place in about 30 days; thus, Cosmo expects it in late July/beginning of August 2018.

About Methylene Blue MMX

Methylene Blue MMX is a novel application of methylene blue, a coloring agent that is used to stain the mucosa to discover pre-cancerous lesions and polyps in the colon. The objective is to deliver methylene blue along the length of the entire colon via the MMX™ technology thus enabling endoscopists to better detect pre-cancerous and cancerous lesions and polyps throughout the entire colon.

In late 2016, Cosmo completed an extensive phase III trial in 18 leading centers in North America and Europe. The full analysis and per protocol set included 1,205 and 1,137 subjects, respectively. The primary endpoint was superiority over standard of care, which is high definition white light endoscopy. The trial met the primary endpoint by demonstrating that 17.7% more patients with adenomas were detected than in the standard of care arm (p value 0.009).

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. 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 Eleview™, a medical device for polyp excision and is developing Methylene Blue MMX®, a product for the detection of colon cancer and has a large shareholding in Cassiopea S.p.A., a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products. Cosmo's MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for Ulcerative Colitis that is licensed globally to Nogra and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in the USA to Santarus/Salix/Valeant and in the Rest of the World to Ferring. 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

Financial Calendar

Half-Year Results

July 26, 2018

Contact

John Manieri, Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 (1) 8170 370

jmanieri@cosmopharma.com

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.

This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.

This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.

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.


Media Release (PDF)



Provider
 Channel
 Contact
EQS Group Ltd., Switzerland
switzerland.eqs.com


 newsbox.ch
www.newsbox.ch


 Provider/Channel related enquiries
cs.switzerland@eqs.com
+41 41 763 00 50