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Press Release

Acacia Pharma Secures $30 Million Credit Facility with Hercules Technology Growth Capital to Support Intended Commercialisation of BARHEMSYS(TM) for Post-operative Nausea & Vomiting in the US

Acacia Pharma Group plc
Posted on: 02 Jul 18

Cambridge, UK and Indianapolis, US - 2 July 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 secured a credit facility of up to $30 million with Hercules Technology Growth Capital, Inc. ("Hercules") (NYSE: HTGC) to support the intended US launch of intravenous amisulpride for the treatment and prevention of post-operative nausea & vomiting (PONV), which is expected to be launched under the tradename BARHEMSYS(TM) following the conditional approval by the US Food & Drug Administration. As previously announced, the target PDUFA date for BARHEMSYS is 5 October 2018.

The first tranche of $10 million was drawn at the closing of the new credit facility. The existing credit facility with Silicon Valley Bank of £3.75 million was repaid in full prior to closing, accelerating payments that would otherwise have been due over the next 12 months. The second tranche of $10 million can be drawn, at Acacia Pharma's option and subject to FDA approval of BARHEMSYS for the management of PONV.

Christine Soden, Chief Financial Officer of Acacia Pharma, commented: "The proceeds from this credit facility provide Acacia Pharma with additional funding to support our commercialisation activities in the US as we continue to prepare for the launch, if approved, of BARHEMSYS. This is in line with our financing strategy set out during our recent Global Offering. We appreciate the support of Hercules, and its confidence in BARHEMSYS and our management team and look forward to a long and productive working relationship."

The third tranche of $5 million can be drawn at any time within 21 months of closing and is conditioned upon Acacia Pharma securing additional finance from the issue of equity or subordinated debt. A fourth tranche of $5 million may be made available at Hercules' option at any time prior to 31 March 2020. General terms of the loan agreement include interest-only payments for 21 months until 31 March 2020 (18 months if the second tranche is not drawn). Thereafter, Acacia Pharma will repay the loans in equal monthly payments of principal and interest through the scheduled maturity date of 31 December 2021. 

Contacts 

Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO

+44 1223 919760
Citigate Dewe Rogerson 
Mark Swallow, Shabnam Bashir, David Dible

+44 20 7638 9571

 

About Hercules Technology Growth Capital, Inc.
Hercules is the leading and largest specialty finance company focused on providing senior secured venture growth loans to high-growth, innovative venture capital-backed companies in a broad variety of technology, life sciences and sustainable and renewable technology industries. Since inception (December 2003), Hercules has committed more than $7.6 billion to over 420 companies and is the lender of choice for entrepreneurs and venture capital firms seeking growth capital financing.
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 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
About BARHEMSYS TM
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 (5HT 3  antagonist and corticosteroid, alone or in combination), and
  • prophylactically to prevent PONV in combination with standard of care (5HT 3  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.
About PONV
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.



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Acacia Pharma Group plc via GlobeNewswire
HUG#2202400
GlobeNewswire
globenewswire.com

Last updated on: 03/07/2018

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