FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation


FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation

Dublin, Ireland – 2 July 2020: Cosmo Pharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved Byfavo (remimazolam injection) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Byfavo is a very rapid onset/offset IV benzodiazepine sedative for use during invasive medical procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy. Approximately 25 million such procedures take place annually in the US, of which ~90% use moderate sedation.

Byfavo, which was in-licensed from Paion in June 2016, was sub-licensed by Cosmo to Acacia Pharma Group (“Acacia”) (EURONEXT: ACPH) in January 2020 in a deal involving the acquisition by Cosmo of a substantial stake in Acacia. Recently Cosmo made a further investment in Acacia, bringing its stake to 18.53% of the Acacia share capital. As a result of the approval of Byfavo a regulatory milestone of € 15m payable in Acacia shares is now due and Cosmo’s stake in the company will increase to 24.05%. In addition, Cosmo will receive a cash payment of €15m from Acacia which will be used to make a € 15m payment due to Paion AG by Cosmo and a €25 million loan facility which was agreed between Cosmo and Acacia in January 2020 can now be drawn by Acacia.

Acacia obtained FDA approval for Barhemsys® in February 2020 and the approval of Byfavo™ extends Acacia’s portfolio of new products.

“It is gratifying to see how successfully our new strategy is unfolding. We entered into new partnerships with RedHill Biopharma and Acacia before their own main products were approved, taking substantial equity stakes in these companies and integrating our products, Aemcolo® and Byfavo, into each so that they could potentially have a more stable and efficient marketing organization. The approval of Byfavo follows the approval of RedHill’s Talicia and Acacia’s Barhemsys® and is the third FDA approval in 9 months for products in companies in which we hold an equity stake. We are now looking forward to Acacia Pharma’s transforming Byfavo into a resounding success”, said Alessandro Della Chà, CEO of Cosmo Pharmaceuticals.

“We are very pleased to announce today the approval of Byfavo in the US for procedural sedation in adult patients,” commented Mike Bolinder, Acacia Pharma’s CEO. “This marks the second FDA approval of an Acacia Pharma product since the start of 2020 and another major milestone in our evolution into an integrated hospital pharmaceutical company with strong development and commercialization capabilities. The addition of Byfavo to our product portfolio strengthens our offering to anesthesiologists and enables us to further leverage our commercial infrastructure.

I would like to thank our partners at Paion and Cosmo as well as the Acacia Pharma team and our stakeholders who have enabled us to bring this new and innovative therapeutic to market to address the needs of millions of patients each year undergoing procedures that require sedation.”

Gerard A. Silvestri, MD, MS, Professor of Medicine at the Medical University of South Carolina, Charleston, SC, and past-president of the American College of Chest Physicians, commented: “The approval of remimazolam (Byfavo) is very exciting for proceduralists as the field has not seen new sedation medications added to our armamentarium in decades. The drug performed very well in clinical trials, with excellent sedation effect enabling 80-90% of procedures to be completed successfully. The cardio-respiratory safety profile looked very encouraging and there was a rapid return of patients to consciousness enabling them to be discharged in a timely manner.”

Jim Phillips, CEO of PAION AG, commented: “The U.S. marketing approval of Byfavo marks the most significant milestone in PAION’s history, and I congratulate everyone who has played a role in this important achievement. The U.S. is the world’s largest pharmaceutical market, and we are excited to see the product PAION successfully developed being made available to doctors there. We wish Acacia a highly successful market launch in this important market, and we will be supporting their commercialization efforts. We also look forward to remimazolam being rolled out in other countries around the globe as we and our partners work to gain additional marketing approvals.”

The safety of Byfavo was evaluated in three pivotal studies in 969 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 630 received Byfavo. In these studies, the most common adverse reactions (incidence greater than 10%) following Byfavo administration were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. The labeling for Byfavo includes a Boxed Warning regarding appropriate training of personnel and equipment that must be available when administering Byfavo, during sedation and during the recovery period of the procedure. The Boxed Warning also addresses risks from concomitant use of Byfavo with opioid analgesics and other sedative hypnotics.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the 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 GI Genius™ its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo™ to Red Hill Biopharma and is the licensee of Byfavo™(Remimazolam) for the U.S. for procedural sedation, which it has sub-licensed to Acacia. For additional information on Cosmo and its products 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

Posted: July 2020

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