-Primary efficacy endpoint successfully achieved
-Phase III program successfully completed
-excellent safety profile of remimazolam confirmed
Dublin – June 29, 2017 – Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that its licensor, PAION AG (Frankfurt Stock Exchange Prime Standard: PA8) today announced that remimazolam, its ultra-short-acting benzodiazepine sedative/anaesthetic, met the primary endpoint and successfully concluded its U.S. Phase III clinical trial in procedural sedation in patients undergoing bronchoscopy.
This Phase III clinical trial – conducted at 15 sites throughout the U.S. – was a prospective, double-blind, randomized, midazolam- and placebo-controlled study in 446 patients undergoing bronchoscopy for diagnostic or therapeutic reasons. Patients were randomized to receive either remimazolam, midazolam, or placebo in combination with fentanyl for pain control in order to achieve adequate sedation to start and perform the procedure.
The primary endpoint was reached in 82.5% of the patients in the remimazolam arm and 3.4% in the placebo (including midazolam rescue) arm (p-value of ≤ 0.0001).
Overview procedural results:
| Remimazolam | Placebo | Midazolam(Open Label) | |
| Procedural Success | 82.5% | 3.4% | 34.8% |
| Use of Rescue Sedation | 16.2% | 96.6% | 56.5% |
| Time to Start of Procedure | 5.0 min | 17.0 min | 16.0 min |
| End of Procedure to Fully Alert | 6.0 min | 14.0 min | 12.0 min |
| Time to back to normal | 404.0 min | 935.0 min | 478.5 min |
Overall adverse events, treatment-emergent adverse events, and in particular, incidents of hypotension and bradycardia occurred less frequently with remimazolam compared to midazolam.
Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals NV has the exclusive license for the development and commercialization of remimazolam, in the territory of the United States.
Conference call:
PAION AG will hold a conference call (conducted in English) on Thursday, 29 June 2017 at 2:00 p.m. CEST (1:00 p.m. GMT/8:00 a.m. EDT) to present the Phase III headline data.
To access the call, participants may dial from
Germany +49 (0) 69 7104 45598
UK +44 (0) 20 3003 2666
U.S. +1 212 999 6659
other countries: please use the UK number
When prompted, please give the password “PAION”. The conference call will include a slide presentation which can be accessed during the call at: https://paion-events.webex.com/paion-events/j.php?MTID=m0aee605381a79a61f8d4c03dcb0ba93f
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
Half-Year Results July 28, 2017
Contact
Dr. Chris Tanner, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 (1) 8170 370
ctanner@cosmopharma.com
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