Dublin – October 5, 2017 – Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the Agency has accepted the submission of its New Drug Application (NDA) seeking market approval for Methylene Blue MMX™ (formerly LuMeBlue™) in the United States. The acceptance of the NDA reflects the FDA’s determination that the application is sufficiently complete to permit a substantive review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of May 21, 2018 to complete its review.
Alessandro Della Chà, Chief Executive Officer of Cosmo Pharmaceuticals, commented: “We are very happy that the FDA has accepted our NDA submission and started the formal review process. This is a positive step towards bringing another innovative drug candidate to patients and strengthening our gastrointestinal franchise. Our NDA is expected to show that Methylene Blue MMX™ improves the colonoscopy procedure, increasing the detection of adenomas and cancers, thus delivering a unique solution that satisfies the unmet medical needs of patients and endoscopists”.
As the review process progresses, FDA feedback on the proposed brand name of the drug has indicated that LuMeBlue™ may conflict with another product in the approval process, thus the Company is currently selecting other brand names for Methylene Blue MMX™.
Methylene Blue MMX™ is a first-in-class drug candidate based on Cosmo Pharmaceutical’s proprietary MMX delivery technology, which flags the lesions prior to colonoscopy thus enhancing the detection of abnormal or dysplastic areas in the colon. In the phase III clinical trial, Methylene Blue MMX™ attained the statistically significant primary endpoint (p-value: 0.009) by identifying 17.71% more patients with adenomas or carcinomas than HDWL (High Definition White Light) colonoscopy, the most advanced standard of care today. Adenomas were found in 56.3% of all subjects when using Methylene Blue MMX™, in contrast to 47.8% with HDWL. The NDA is expected to show that Methylene Blue MMX™ helps to increase the Adenoma Detection Rate (ADR) substantially beyond the current standard of care in endoscopic procedures. This increase has an important clinical relevance: it’s known from scientific literature that for each 1% increase in ADR, a 3% decline in incidence of interval cancer and a 5% decline in incidence of fatal colorectal cancer (CRC) should be expected.
When identifying the lesions in a previously unseen and unrivalled fashion, Methylene Blue MMX™ specifically flags more histologically proven adenoma, and particularly non-polypoid lesions and diminutive adenomas, than HDWL, helping to significantly lower the false positive rate (FPR) more than standard of care by 14.4% (p-value: < 0.0001).
This high value diagnostic efficacy will help endoscopists provide patients with a more life-saving treatment result and determine a more accurate timeframe for the subsequent colonoscopy procedure (endoscopic surveillance): patients could be referred to a next colonoscopy within one to three years if adenomas are detected instead of in ten years if no adenomas are detected, with a substantial impact on the risk of interval cancer occurrence.
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 imaging 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.
Tel: +353 (1) 8170 370
jmanieri@cosmopharma.com
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