COSMO PHARMACEUTICALS N.V. Cosmo Pharmaceuticals Announces US FDA Approval of BYFAVOTM (remimazolam injection) for the Induction and Maintenance of Procedural Sedation
Dublin, Ireland - 2 July 2020: CosmoPharmaceuticals announced today that the US Food and Drug Administration (FDA) has approved BYFAVOTM (remimazolam injection) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. BYFAVOTM 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.
BYFAVOTM, 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 BYFAVOTM 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 BYFAVOTM 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 BYFAVOTM, into each so that they could potentially have a more stable and efficient marketing organization. The approval of BYFAVOTM 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 BYFAVOTM into a resounding success", said Alessandro Della Chà, CEO of Cosmo Pharmaceuticals.
"We are very pleased to announce today the approval of BYFAVOTM 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 BYFAVOTM 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 (BYFAVOTM) 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 BYFAVOTM 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 BYFAVOTM was evaluated in three pivotal studies in 969 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 630 received BYFAVOTM. In these studies, the most common adverse reactions (incidence greater than 10%) following BYFAVOTM administration were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. The labeling for BYFAVOTM includes a Boxed Warning regarding appropriate training of personnel and equipment that must be available when administering BYFAVOTM, during sedation and during the recovery period of the procedure. The Boxed Warning also addresses risks from concomitant use of BYFAVOTM with opioid analgesics and other sedative hypnotics.
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