Acacia Pharma Announces Brief Extension of FDA Review Period for NDA for BYFAVO™, an Ultra-short Acting and Reversible Anesthetic for Procedural Sedation
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 – 12 March 2020: Acacia Pharma Group plc (“Acacia Pharma”, the “Group” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, announces that the US Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for BYFAVO™ (remimazolam) by up to 90 days in order to complete its review of additional data submitted in January and February 2020.
FDA has set a new Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on the NDA of no later than 5 July 2020 (previous PDUFA target date was 5 April 2020).
Acacia Pharma in-licensed the US commercialization rights to BYFAVO from Cosmo Pharmaceuticals N.V. in January 2020.
About BYFAVO™
BYFAVO (remimazalom) 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% use moderate sedation.
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 good cardio-respiratory safety profile. BYFAVO is designed to act more quickly than the available alternatives of the same pharmaceutical class for the same indication (e.g. midazolam) and can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary.
Cosmo in-licensed the US rights to BYFAVO from Paion AG in 2016 and together they have progressed the product candidate through to registration. The NDA for BYFAVO has been filed with the US FDA in April 2019 and the new target PDUFA action date is 5 July 2020.
Contacts
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
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Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Frazer Hall, David Dible
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About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy. The Company has identified important and commercially attractive unmet needs in these areas that its product pipeline aims to address.
Acacia Pharma's lead product, BARHEMSYS® (intravenous amisulpride) is approved in the US for the treatment and prophylaxis of postoperative nausea & vomiting (PONV), with US launch planned for H2 2020.
BYFAVO™ (intravenous remimazolam), an ultra-short-acting and reversible sedative/anesthetic for use during invasive medical procedures, such as colonoscopy and bronchoscopy, is in-licensed from Cosmo Pharmaceuticals for the US market. The NDA for BYFAVO has been filed with the US FDA and the target PDUFA action date is now 5 July 2020.
APD403 (intravenous and oral amisulpride), a selective dopamine antagonist 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 its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.
Forward looking statements
This announcement includes forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as “believe”, “expect”, “intend”, “may”, “plan”, “will”, “should”, “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospectus, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.
