Cosmo Pharmaceuticals Methylene Blue MMX Regulatory Update: Initial appeal outcome – Next steps

Dublin, Ireland - November 1, 2018 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today provided a regulatory update after receipt of the answer to the initial appeal filed after reception of the Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Methylene Blue MMX, a product for visualization of lesions in patients undergoing colonoscopy to improve overall detection of adenomas and carcinomas.

The agency recognized that Cosmo met both the primary and key secondary endpoints of the pivotal clinical study conducted under the terms of a Special Protocol Agreement.

Nevertheless, the appeal was denied, still requesting a second trial, based on concerns that Cosmo believes were adequately covered by the SPA. Cosmo, therefore, while disappointed by the results of this initial appeal, intends to seek further review and intends to continue to work closely with the agency on a favourable resolution of this matter. A further appeal will thus be timely filed.

Cosmo remains fully committed to bring this potential improvement to existing standard of care for colonoscopy screening to the health care system as soon as possible, to help reduce the overall incidence of life-threatening colon cancer.

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 and launched Eleview, a medical device for polyp and adenoma excision, in the U.S. and it has filed the NDA for Methylene Blue MMX, a diagnostic drug for the detection of colon cancer. In addition, new chemical entities are being developed by its associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo's MMX drugs already on 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

Next events
Credit Suisse, Swiss EQ Mid Cap Conference November 14, 2018
Jefferies Global Healthcare Conference November 15, 2018 in London
Full-year results 2018 reporting March 2019
Annual General Meeting May 2019
Contact:
John Manieri, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: [phone]
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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.

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