ByfavoTreatment for Sedation
Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA
Dublin – April 9, 2019 – Cosmo Pharmaceuticals NV (SIX: COPN) today informed that the Remimazolam NDA has been submitted to FDA. Electronic acknowledgment of the submission shows April 5 as the official date of submission. 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.”
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. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com
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.
This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. 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.
Source: Cosmo Pharmaceuticals NV
Posted: April 2019
- FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation - July 2, 2020
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