Cambridge, UK and Indianapolis, US - 11 April 2018: Acacia Pharma Group plc ("Acacia Pharma", the "Company" or the "Group"), (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients, has made substantial progress in expanding its US commercial operations for the intended launch of intravenous amisulpride (BAREMSIS®) with four key appointments. The new hires bring significant and relevant commercial experience in launching and marketing hospital pharmaceutical products in the US and have been recruited, as planned, ahead of the target PDUFA date for BAREMSIS of 5 October 2018.
Mike Bolinder, Chief Commercial Officer of the Group's US subsidiary, Acacia Pharma, Inc., commented: "Filling these key roles with these experienced leaders with such relevant experience provides the Group with a strong foundation for the intended US commercialisation of BAREMSIS. We are delighted to welcome them all to the team and look forward to getting our launch preparations underway. It is a great achievement for Acacia Pharma to attract such high calibre professionals, and to deliver the first key element of our commercialisation strategy so soon after completing our recent Initial Global Offering."
The new members of Acacia Pharma's US commercial team are:
Rye Dalton, Vice President of Commercial Operations and Analytics. Rye has over 20 years in the industry and extensive experience in the hospital setting. He has run commercial operations for launches focused on the surgical setting at Otonomy, Inc. for OTIPRIO® and Cadence Pharmaceuticals, Inc. for OFIRMEV® injection for the management of mild to moderate pain.
Jim DiPofi, Vice President of Sales. Jim brings over 28 years of experience in the industry, primarily focused on the hospital market. Jim was recently the VP of Sales at Braeburn Pharmaceuticals, Inc. and previously at Mallinckrodt Pharmaceuticals, Inc. (following its acquisition of Cadence Pharmaceuticals), where he played a key role in the launch success of OFIRMEV.
Shiella Radel, Executive Director of KOL and HCP Marketing Strategy. Shiella has over 30 years' experience in the industry, primarily in hospital-focused startup companies, and has extensive expertise in communicating with, and meeting the needs of, key opinion leaders (KOLs) and health care practitioners (HCPs). She also joins from Mallinckrodt Pharmaceuticals where she worked with Jim and Rye in delivering the launch and sustained success of OFIRMEV.
James Singell, Executive Director of Marketing Strategy and Operations. James joins from Eli Lilly and Company where he spent more than 25 years in leadership roles covering sales, marketing and new product development and launch in the global, US and key affiliate markets in a broad range of therapeutic areas, including oncology, neuroscience, autoimmune disorders and drug delivery devices.
| Acacia Pharma Group plc |
Julian Gilbert, CEO
Christine Soden, CFO
|+44 1223 875130|
| Citigate Dewe Rogerson |
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, BAREMSIS 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
BAREMSIS 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 BAREMSIS 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 BAREMSIS can be used:
A New Drug Application (NDA) submission for BAREMSIS, 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.