Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA

Cosmo Pharmaceuticals NV informed that the Remimazolam NDA has been submitted to FDA. Therefore within 60 days, by June 4, FDA will communicate whether the NDA has been filed for review to proceed.

"We are very happy to have been able to submit the NDA of Remimazolam. With over 20 million gastrointestinal procedures requiring sedation performed in an outpatient setting annually, we believe there is significant market opportunity for Remimazolam in the U.S., the world’s largest pharmaceutical market. Remimazolam will further strengthen our pipeline of innovative products", said Alessandro Della Chà, CEO of Cosmo Pharmaceuticals. "If everything goes well, approval should be expected within a year from now."

About Remimazolam

Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/ anesthetic that has shown positive results in clinical Phase III trials. In the human body, Remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, Remimazolam can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. During clinical studies, Remimazolam demonstrated efficacy and safety with around 2,400 volunteers and patients. Data so far indicate that Remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.

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. 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 Eleview™, a medical device for polyp excision and is developing Methylene Blue MMX®, a product for the detection of colon cancer, has licensed Remimazolam for the territory of the US from Paion and has a large shareholding in Cassiopea S.p.A., a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products. Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for Ulcerative Colitis that is licensed globally to Nogra and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in the USA to Santarus/Salix/Valeant and in the Rest of the World to Ferring. 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.

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