12.03.2020 – COSMO Pharmaceuticals N.V.

Cosmo announces Brief Extension of FDA Review Period for NDA for BYFAVO™, an ultra-short Acting and Reversible Anesthetic for Procedural Sedation

Cosmo announces Brief Extension of FDA Review Period for NDA for BYFAVO™, an ultra-short Acting and Reversible Anesthetic for Procedural Sedation

Dublin, Ireland – March 12, 2020- Cosmo Pharmaceuticals N.V. (SIX: COPN) today announces that the US Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for BYFAVO™ (remimazolam) by up to 90 days in order to complete its review of additional data submitted in January and February 2020.

FDA has set a new Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on the NDA of no later than 5 July 2020 (previous PDUFA target date was 5 April 2020).

Acacia Pharma in-licensed the US commercialization rights to BYFAVO from Cosmo Pharmaceuticals N.V. in January 2020.


BYFAVO™ (Remimazolam) is an ultra-short-acting and reversible intravenous benzodiazepine sedative/anesthetic designed for use during invasive medical procedures, such as during colonoscopy and bronchoscopy. Approximately 24.5 million such procedures take place annually in the US, of which around 90% use moderate sedation.

BYFAVO™ has demonstrated efficacy and safety in an extensive clinical trial programme involving around 2,400 volunteers and patients. Data so far indicate that Remimazolam has a rapid onset and offset of action combined with a good cardio-respiratory safety profile. BYFAVO™ is designed to act more quickly than the available alternatives of the same pharmaceutical class for the same indication (e.g. midazolam) and can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary.

Cosmo in-licensed the US rights to BYFAVO™ from Paion AG in 2016 and together they have progressed the product candidate through to registration. The NDA for BYFAVO™ has been filed with the US FDA in April 2019 and the new target PDUFA action date is 5 July 2020.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and 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 its novel Artificial Intelligence device to be used in coloscopies and GI procedures. Further, Cosmo has licensed Aemcolo™ to Red Hill Biopharma and is the licensee for U.S. of the novel agent for procedural sedation, remimazolam, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com


Full Year Results 2019, Zurich

April 3, 2020

Annual General Meeting, Amsterdam

May 28, 2020


Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70


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