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MarketScreener Homepage  >  Equities  >  Swiss Exchange  >  Cosmo Pharmaceuticals N.V.    COPN   NL0011832936

COSMO PHARMACEUTICALS N.V.

(COPN)
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Cosmo Pharmaceuticals N : NV - Methylene Blue MMX approved in Europe for the visualization of colorectal lesions during colonoscopies

08/24/2020 | 08:49am EST

Dublin - Cosmo Pharmaceuticals NV (SIX: COPN) today announced that the European Commission (EC) has approved Methylthioninium Chloride Cosmo, prolonged release tablets (Methylene Blue MMX) for the visualization of colorectal lesions during colonoscopies.

This is the first approval of Methylene Blue MMX and is also the first time an oral drug has been approved to improve the outcome of colonoscopies. The Centralized European licence will be effective simultaneously in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

Mauro Ajani, Chairman of Cosmo, said: 'This approval is wonderful news. Cosmo is finally providing the first oral drug ever approved to help prevent colorectal cancer by improving the quality of the colonoscopy procedure.'

Alessandro Della Cha, CEO of Cosmo, said: 'We are very pleased with the news and we were always convinced that the very good clinical data should have granted approval. Now MB MMX can start to help patients undergoing colonoscopies by improving Adenoma Detection Rate and preventing the miss of many lesions'.

The approval was based on CHMP prior positive opinion based on the data stemming from the single phase III trial performed by Cosmo worldwide in 20 sites involving 1,249 randomised patients. The study was powered to show a statistically significant difference between Methylene blue MMX 200 mg and placebo (corresponding to High-Definition White Light [HDWL] colonoscopy - the current standard of care) in the detection of patients with at least one adenoma or carcinoma (Adenoma Detection Rate [ADR]). The study met its prespecified endpoint: the ADR was higher in the Methylene Blue MMX arm as compared to HDWL colonoscopy (56.29% vs 47.81%, respectively; difference: 8.48%; RRI 17.7%; OR [95% CI]: 1.41 [1.09, 1.81]; p-value: 0.0099).

Important prespecified secondary endpoints showed that Methylene Blue MMX increases the detection of patients with at least one adenoma and does not produce an increase in the False Positive Rate (FPR) as compared to HDWL colonoscopy. Additional endpoints showed that Methylene Blue MMX increases, in particular, detection of non-polypoid (flat) lesions (the most frequently missed lesions).

The indication of Methylene Blue MMX recommended for approval by the CHMP is as a 'diagnostic agent enhancing visualization of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy'.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the 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 GI Genius its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo to Red Hill Biopharma and is the licensee of BYFAVO (Remimazolam) for the US for procedural sedation, which it has sub-licensed to Acacia.

Contact:

Niall Donnelly

Tel: +353 1 817 03 70

Email: ndonnelly@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.

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.

(C) 2020 Electronic News Publishing, source ENP Newswire

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Financials
Sales 2020 53,1 M 64,1 M 64,1 M
Net income 2020 -8,53 M -10,3 M -10,3 M
Net cash 2020 51,0 M 61,5 M 61,5 M
P/E ratio 2020 -132x
Yield 2020 -
Capitalization 1 125 M 1 356 M 1 357 M
EV / Sales 2020 20,2x
EV / Sales 2021 16,7x
Nbr of Employees 261
Free-Float 45,8%
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Mean consensus OUTPERFORM
Number of Analysts 4
Average target price 102,69 €
Last Close Price 77,77 €
Spread / Highest target 43,1%
Spread / Average Target 32,0%
Spread / Lowest Target 21,3%
EPS Revisions
Managers
NameTitle
Alessandro E. Della Chà Chief Executive Officer & Executive Director
Mauro Severino Ajani Executive Chairman
Giuseppe Cipriano Chief Operating Officer
Niall Donnelly Chief Financial Officer & Head-Investor Relations
Davide Malavasi Director-Qualified Person & Technical
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