21 November 2018
Positive BARHEMSYS™ Rescue Treatment Data Published in Anesthesiology
Cambridge, UK and Indianapolis, US – 21 November 2018: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces that data and analyses from its positive Phase 3 clinical trial of BARHEMSYS™ (intravenous amisulpride) as rescue treatment of established post-operative nausea & vomiting (PONV) have been published (Habib et al1) in the online edition of the leading peer-reviewed journal Anesthesiology, the official publication of the American Society of Anesthesiologists. Positive headline results were first announced by the Company in February 2017.
Dr Ashraf Habib, Professor of Anesthesiology at Duke University School of Medicine and chief investigator of the study, said: “The key unmet need in PONV is the rescue of patients who develop nausea or vomiting, despite having received the current standard-of-care antiemetic prophylaxis. The results from this published Phase 3 trial are very encouraging as they showed that BARHEMSYS was effective at rescuing patients who had failed prophylaxis, without causing sedation. If approved, BARHEMSYS would offer physicians and patients a new option for the rescue treatment of PONV.”
A New Drug Application (NDA) for BARHEMSYS, including data from this and three other positive Phase 3 trials, is under review by the US Food and Drug Administration (FDA). The extensive clinical trial programme has studied the safety and efficacy of BARHEMSYS for investigational new uses in the treatment of established PONV, whether or not prior prophylaxis was given, and the prevention of PONV, alone or in combination with other antiemetics.
Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer, added: “About one-third of surgical patients who receive prophylactic antiemetics prior to surgery still go on to suffer from PONV and this represents an important challenge for the surgical team. This is especially the case as no other antiemetic has been shown in a prospective trial to be effective in that setting. If BARHEMSYS is approved by FDA for this indication, we believe it will become a valuable part of the antiemetic armamentarium and an important option for patients and physicians in the US.”
Habib, A.S. et al. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis – A Randomized, Placebo-controlled Phase III Trial. Anesthesiology 2018, doi:10.1097/ALN.0000000000002509 [epub ahead of print]
PONV is a common complication of surgery, occurring in approximately 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anaesthetic gases and opioid pain-killers and is particularly common following gynaecological, abdominal, breast, eye and ear operations, especially those lasting an hour or more.
The Company estimates that approximately 65 million surgical procedures are conducted in the US each year that require injectable analgesia and are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for prophylactic and rescue treatment comprises an estimated 34 million treatment events annually.
PONV has been ranked as the most undesirable of all surgical complications by patients and contributes significantly to patient anxiety and distress. PONV can delay hospital discharge; result in re-admission after in-patient procedures; and lead to day-case patients being admitted to hospital, all of which can result in significantly increased healthcare costs.
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation 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™ for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. A New Drug Application (NDA) for BARHEMSYS is under review by the US Food and Drug Administration (FDA). 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 its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. www.acaciapharma.com
Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Shabnam Bashir, David Dible
+44 20 7638 9571
Forward looking statement
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.