Acacia Pharma announces US FDA approval of BYFAVO™ (remimazolam) for procedural sedation

CAMBRIDGE (UK), INDIANAPOLIS (US) – Acacia Pharma (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. Approximately 25 million such procedures take place annually in the US, of which ~90% use moderate sedation.

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.

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.

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

 

About ByFavo (remimazolam)

ByFavo is an ultra-short-acting and reversible intravenous benzodiazepine sedative/anesthetic designed for use during invasive medical procedures, such as during colonoscopy and bronchoscopy. Approximately 24.5 million such procedures take place annually in the US, of which around 90% used moderate sedation. This represents a market opportunity estimated to be >$500 million per year.

ByFavo has demonstrated efficacy and safety in an extensive clinical trial programme involving 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. ByFavo acts more quickly than the available alternatives of the same pharmaceutical class for the same indication (e.g. midazolam) and is safer than other alternatives for the same indication (e.g. propofol) and can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. The NDA for ByFavo was submitted to the US FDA in April 2019 and has a target review (“PDUFA”) date of 5 April 2020.

About Acacia Pharma

Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new nausea & vomiting treatments for surgical and cancer patients. The Group has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.

The Group's lead project, BARHEMSYS® (intravenous amisulpride) for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV), has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.

Acacia Pharma is based in Cambridge, UK and Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. For more information, visit the company's website at www.acaciapharma.com.

About Gilde Healthcare

Gilde Healthcare is a specialized healthcare investor managing over €1.4 billion ($1.5 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare's venture & growth capital fund invests in fast growing companies active in digital health, medtech and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare's private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. For more information, visit the company's website at www.gildehealthcare.com.