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Cosmo Pharmaceuticals N.V.. (3/27/17). "Press Release: Cosmo Announces further Expansion of Endoscopy Pipeline with Filing for EU Approval of New Medical Device Qolotag to Enhance Diagnosis in Sigmoidoscopies". Dublin.

Region Region EU (European Union)
Organisations Organisation Cosmo Pharmaceuticals N.V. (SIX: COPN)
  Group Cosmo Pharmaceuticals (Group)
  Organisation 2 EU (govt)
Products Product Qolotag®
  Product 2 medical device
Persons Person Della Chà, Alessandro (Cosmo Pharmaceuticals 201507 CEO)
  Person 2 Tanner, Chris (Cassiopea 201507 CFO + Head of Investor Relations + Cosmo Pharmaceuticals CFO + Head IR before UBS)
     


Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that it has filed for EU approval of its new medical device named Qolotag. Approval is expected within June 2017 and marketing within year end.

Qolotag is a single use enema formulation composed of a liquid emulsion made with a special polymer and dyed with methylene blue. It has been fully developed internally by Cosmo. Qolotag cleanses the sigmoid colon and the rectum prior to the sigmoidoscopy and simultaneously stains the rectal mucosa enhancing the tissues' structure. This improves the visualization of the lesions and the diagnosis of dysplasias and bowel diseases during the procedure.

Qolotag is mainly targeted at patients with inflammatory bowel disease that frequently need to have yearly sigmoidoscopies for dysplasia detection. In the EU alone it is presumed that there are around 2 million persons with inflammatory bowel disease.

Qolotag has been filed for approval in the EU as a medical device. The regulatory pathway of Qolotag in the US is currently under assessment.

Upon its approval, Cosmo intends to license Qolotag for the EU.

Alessandro Della Chà, CEO of Cosmo, commented: “Qolotag further proves the capacity of Cosmo to expand its product line in the endoscopy market. This product fulfills the needs of gastroenterologists to make a faster and more detailed assessment of dysplasia in patients with Inflammatory Bowel disease without recurring to colonoscopy. It is a further testimony to our ability of providing innovative solutions to unmet needs.”


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 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


Next events

Annual General Meeting May 24, 2017
Half Year Report July 28, 2017


Contact

Dr. Chris Tanner, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 (1) 8170 370
ctanner@cosmopharma.com


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.

   
Record changed: 2017-04-04

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