Acacia Pharma Announces US FDA Approval of BYFAVO™ (remimazolam) for injection for the Induction and Maintenance of Procedural Sedation

 

 

• 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 is the second Acacia Pharma product approved by the FDA in 2020 and extends its portfolio of new products for anesthesia

 

• Conference call scheduled for 9:00 am ET / 3:00 pm CET, Monday 6 July

 

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.

 

 

Cambridge, UK and Indianapolis, US – 2 July 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, announces that the US Food and Drug Administration (FDA) has approved BYFAVO™ (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. 

 

Acacia Pharma in-licensed the commercial rights to BYFAVO for the US from Cosmo Pharmaceuticals NV in January 2020. Remimazolam was developed by Paion AG.

 

The approval of BYFAVO will help to further strengthen Acacia Pharma’s financial resources, as previously announced, the Company will now have access to an additional €25 million debt facility from Cosmo. Acacia Pharma will make a €30 million upfront payment for the license of BYFAVO to Cosmo, triggered by the approval, consisting of €15 million in cash and €15 million in ordinary shares of Acacia Pharma stock. The €10 million of net cash that Acacia Pharma will receive will be available to help fund the US launch of BYFAVO.

 

“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.”

 

“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 by 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.

 

Dr. Jim Phillips, CEO of PAION AG, commented: “The US 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 US 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.”

 

“BYFAVO is an important addition to the limited selection of drugs available for procedural sedation,” said Acacia Pharma’s Chief Medical Officer, Dr. Gabriel Fox. “BYFAVO demonstrated clear patient benefits in its extensive clinical trial program, offering very rapid onset and offset of action coupled with an incidence of cardio-respiratory and other adverse reactions similar to that seen in patients in the placebo group. We are grateful to all the clinical investigators and patients who made this approval possible through their participation in the development program.”

 

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. See Important Safety Information at the end of this press release and Prescribing Information.

 

Acacia Pharma’s first product, BARHEMSYS^® (amisulpride injection) was approved by the FDA on 26 February 2020 for the treatment and prevention of postoperative nausea and vomiting (PONV) in adult patients and the company intends to launch both BARHEMSYS and BYFAVO in the US during the second half of 2020.

 

It should be noted that BYFAVO may not be marketed in the US until the Drug Enforcement Administration has determined its scheduling under the Controlled Substances Act, which is expected to take place within the next few months.

 

Conference Call Information

 

The Acacia Pharma management team will host a conference call Monday 6 July 2020, at 9:00 am ET / 3:00 pm CET.

 

Participants can pre-register at any time using this link and they will receive a PIN to access the call:

 

https://www.speakservecloud.com/register-for-call/338b92c9-88fb-4649-ad3a-90a62c9732d9

 

Dial-in numbers:

 

UK: +44 33 0606 1122

US: +1 646 585 9191

Belgium: +32 3 808 7133

The Netherlands: +31 20 795 6615

 

For other international numbers, click here

 

Conference call room number: 099697

Participant PIN (if not pre-registered): 5855

 

The presentation will be available for download prior to the conference call in the Investors section of the Acacia Pharma website (www.acaciapharma.com) in Financial Reports and Presentations.

 

A recording of the conference call will be available in the same place for 30 days following the call.

 

The conference call presentation can be accessed prior to the call by visiting the investors section of the Company's website (Financial Reports and Presentations) at www.acaciapharma.com. A recording of the conference call will be available in the same place for 30 days following the call.