Cambridge, UK and Indianapolis, US – 9 July 2018: Acacia Pharma Group plc (“Acacia Pharma”, the “Company” or the “Group”), (EURONEXT: ACPH) provides an unaudited operating update for the first half 2018 (six months ended 30 June 2018). Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients targeting a specific unmet need to improve patient outcomes and lower hospital costs.
Dr Julian Gilbert, CEO of Acacia Pharma, commented: “The Group has made important progress during the first half 2018 preparing for the launch, if approved, of BARHEMSYS(TM) for the treatment and prevention of post-operative nausea & vomiting (PONV) in surgical patients. This condition affects millions of people in the US each year despite the use of existing antiemetics and is a major cause of patient distress, as well as often resulting in delayed recovery and increasing hospital costs. BARHEMSYS has been developed to provide anaesthetists with the first new antiemetic for many years to better manage PONV and improve patient outcomes.
“Our strategy is to launch BARHEMSYS in the US through our own commercial operation. The development of this organisation and our pre-commercialisation activities in the US are on track: we have hired experienced individuals to the leadership team across all core commercial functions and are building out the team at all levels. Our discussions with FDA since acceptance of the NDA have been encouraging and, with a strong financial position, we expect to be well-positioned to execute our launch plan pending regulatory approval.”
Operational Highlights for the First Half 2018
In January, Acacia Pharma announced that it received notice from the US Food & Drug Administration (FDA) that its New Drug Application (NDA) for intravenous amisulpride (BARHEMSYS) was accepted and indicated a target PDUFA date of 5 October 2018. If approved, BARHEMSYS could become an important new option for the 16 million surgical patients who suffer PONV despite having received prior prophylaxis with standard antiemetics, an area where no other antiemetics have been successful in clinical studies; and in preventing PONV in combination with standard antiemetics in the 18 million patients at high risk of developing it.
In March, Acacia Pharma raised €40 million in its Initial Global Offering in conjunction with its listing on Euronext Brussels. The funds are being deployed primarily to build the sales and marketing infrastructure and undertake marketing, supply chain and other preparatory activities to launch BARHEMSYS into the US hospital market in 2019.
In April, Acacia Pharma announced appointments to four key positions as a step towards building its US commercial organisation. In line with its strategy, Acacia Pharma is continuing to successfully recruit experienced sales, marketing, regulatory and operations people to support the launch of BARHEMSYS, each of whom brings significant and relevant commercial experience in launching and marketing hospital pharmaceutical products in the US. The leadership team collectively has more than 155 years of industry experience and over 60 pharmaceutical launches.
The Group is on track with its launch readiness plans. Contracts have been negotiated with suppliers to deliver the logistics, distribution and order and receivables management needs upon approval, negotiations with major wholesalers and national accounts are being planned and processes under way to ensure the Group is licensed to sell BARHEMSYS in each of the key US states. Advisory Board meetings have been held at five important medical meetings delivering insights into the marketing, positioning and pricing of the product.
In May, FDA confirmed conditional approval to the tradename BARHEMSYS, which has replaced the previously used BAREMSIS®.
In June, Acacia Pharma and FDA held a late-cycle review meeting on BARHEMSYS. FDA indicated that an Advisory Committee was not planned and indicated a target PDUFA date of 5 October 2018.
On 29 June 2018, the Company secured a credit facility of up to $30 million with Hercules Technology Growth Capital, Inc. (“Hercules”) (NYSE: HTGC) providing additional funding to support the intended US launch of BARHEMSYS, drawing $10 million under the facility at closing. As at 30 June 2018 the Group’s cash and cash equivalents totalled $47.2 million (£35.7 million).
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
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(TM) for post-operative nausea & vomiting (PONV), has generated positive results in Phase 3 clinical studies and an NDA has been accepted for filing by the US FDA for marketing approval. 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
BARHEMSYS comprises a low dose intravenous formulation of the marketed dopamine antagonist amisulpride, which Acacia Pharma has developed for the completely new, patent-protected use of management of PONV.
Data generated by Acacia Pharma indicate that BARHEMSYS is an effective, safe dopamine antagonist that can treat established PONV and prevent PONV from occurring, when used alone or in combination with other antiemetics. The Company believes that BARHEMSYS can be used:
to rescue patients who develop PONV despite having received prior standard of care PONV prophylaxis (5HT3 antagonist and corticosteroid, alone or in combination), and
prophylactically to prevent PONV in combination with standard of care (5HT3 antagonist and/or corticosteroid) in the highest risk patients.
A New Drug Application (NDA) submission for BARHEMSYS, including data from four positive Phase 3 studies and more than 3,300 surgical patients and healthy volunteers, is currently under review by the US Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of 5 October 2018 to complete its review.
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 Group 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.
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.