Acacia Pharma announces its intention to launch an initial global offering and to list its shares on Euronext Brussels

Acacia Pharma Group Ltd (“Acacia Pharma” or the “Group”), a pharmaceutical company, focused on the development and commercialisation of hospital products for US and international markets, announces today that it is planning to raise new funds through an Initial Global Offering (the “Global Offer”) with admission of all of its ordinary shares to trading on the regulated market of Euronext Brussels (”Admission”). Acacia Pharma is focused on the development and commercialisation of new products to treat and prevent nausea & vomiting suffered by surgical and cancer patients.

Dr Julian Gilbert, CEO and Founder of Acacia Pharma, commented: “We approach this planned Initial Global Offering with a vision of building a successful US hospital-focused pharmaceutical business around two late-stage products, BAREMSIS® and APD403, and their potential to improve the lives of millions of patients undergoing surgery or cancer therapy. BAREMSIS is under FDA review following four positive Phase 3 trials, and we are confident that, if approved later this year, it could become an important new option for the 16 million surgical patients who suffer post-operative nausea & vomiting (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. The funds from this Global Offer will support our commercialisation plans for BAREMSIS through establishing a direct hospital salesforce in the US and enable us to begin to advance the development of APD403 in chemotherapy induced nausea & vomiting (CINV). We believe this will provide a strong foundation for long-term growth and the creation of shareholder value.”

Group Highlights:

  • Acacia Pharma 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.
  • Acacia Pharma’s lead product candidate, BAREMSIS, has been developed for the management (treatment and prevention) of PONV. A New Drug Application (NDA) for these indications has been filed and accepted for review by the US Food & Drug Administration (FDA) following completion of four positive pivotal Phase 3 trials. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of 5 October 2018 to complete its review.
  • The Group’s second candidate, APD403, has successfully completed two Phase 2 proof-of-concept trials for the management of CINV
  • Acacia Pharma has built strong protection for amisulpride for the management of PONV and CINV underpinned in the US by patent listing in the Orange Book and market exclusivity, which will become available following FDA approval. The initial terms of granted US patents run until 2031 with the potential for further extensions.
  • Acacia Pharma has retained all rights to commercialise BAREMSIS and APD403 in all territories and plans to commercialise them directly in the US through its own hospital sales force and establish licensing and/or distribution agreements with selected pharmaceutical partners outside the US.
  • Acacia Pharma’s management team has extensive experience in the discovery, development and commercialisation of hospital pharmaceutical products and in drug repurposing. The team has strong links with key opinion leaders (“KOLs”) who have input into the Group’s development programmes.

The Group has been and remains supported by a strong syndicate of specialist healthcare investors: since its founding in 2007, the Group has raised approximately £42.5 million of shareholder equity and debt capital, primarily from Lundbeckfonden Invest A/S (“Lundbeckfonden”), Novo Holdings A/S (“Novo”), F-Prime Capital Partners Healthcare Fund III LP (“F-Prime”) and funds advised by Gilde Healthcare Partners B.V. (“Gilde”).


Strategy


Acacia Pharma aims to become a leading hospital-focused pharmaceutical group, providing products for hospital-based anaesthetists and their surgical teams and hospital- and clinic-based oncologists, initially through the development and US commercialisation of its nausea & vomiting product opportunities. The key elements of this strategy are as follows.

  • Complete the registration of BAREMSIS for the management of PONV;
  • Directly commercialise BAREMSIS in the US through its own sales and marketing infrastructure;
  • Establish strategic partnerships for the commercialisation of its products with companies outside the US that have expertise, sales and marketing infrastructure, initially focusing on the major pharmaceutical markets, e.g. Europe; and
  • Leverage the Group’s future US commercial infrastructure to sell APD403 for CINV to oncologists and consider in-licensing or acquiring complementary products or product candidates.

Note

About BAREMSIS for PONV


BAREMSIS (formerly APD421) is an intravenous formulation of amisulpride, a selective dopamine antagonist, which has completed Phase 3 clinical development for the prophylaxis and treatment of PONV, alone and in combination with other antiemetics. An NDA has been accepted for review by the FDA that includes clinical data from four positive pivotal Phase 3 studies and four supporting studies, involving more than 3,300 surgical patients and healthy volunteers. Under PDUFA, FDA has set a target date of 5 October 2018 to complete its review.


The product label being sought for BAREMSIS is for the management of PONV, including the rescue treatment of PONV in patients who have received prior prophylaxis with standard antiemetics and in combination prophylaxis with standard antiemetics in higher risk patients, the two key commercial unmet needs. The Group believe BAREMSIS will have a strong competitive position, as, if approved, it will be the first product specifically labelled for these uses. In addition, the Group is not aware of any other dopamine antagonists in clinical development for the management of PONV.


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 for rescue and prophylactic treatment comprises an estimated 34 million treatment events (comprising 16 million rescue events and 18 million prophylaxis events) and an estimated 50 million doses each year in the US.
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.


In addition, The Patient Protection and Affordable Care Act of 2010 (“Affordable Care Act”) in the US has linked quality of care and patient satisfaction to reimbursement. Appropriate management of PONV is key to improving patient satisfaction scores, and therefore BAREMSIS could provide opportunities to optimise reimbursement as well as for reducing healthcare costs.


About APD403 for CINV


APD403 is based on amisulpride, the same active ingredient as in BAREMSIS, and is being developed as an intravenous injection for cancer patients to be administered immediately before they receive chemotherapy to prevent acute CINV, and as an oral tablet to prevent delayed CINV.
APD403 has successfully completed two Phase 2 trials demonstrating it is well tolerated and effective at preventing acute and delayed CINV. Acacia Pharma intends to advance APD403 into Phase 3 studies following completion of a further Phase 2 study.
About CINV


CINV is one of the most common and feared side effects of cancer chemotherapy. In patients receiving highly emetogenic chemotherapy (e.g. cisplatin and anthracycline/cyclophosphamide in breast cancer) the incidence of CINV is over 90%. There are also many moderately emetogenic chemotherapy agents and regimens which can cause CINV in 30-90% of patients.


Nausea & vomiting can occur on the day of chemotherapy (acute CINV) and can persist for two to five days after chemotherapy (delayed CINV). CINV has a significant effect on quality of life and can compromise patient health. Severe CINV may necessitate a delay or reduction in chemotherapy and can ultimately lead to the withdrawal of treatment. The goal of CINV management is the prevention, rather than treatment, of symptoms.


Use of Proceeds
The Initial Global Offering is expected to be conducted as a private placement with the Company’s new ordinary shares to be offered (i) to certain institutional and other investors in the United Kingdom and elsewhere outside the United States; and (ii) in the United States only to qualified institutional buyers in reliance on an exemption for the registration requirements of the United States Securities Act of 1933, as amended.


Subject to the approval of the prospectus by the Financial Conduct Authority (“FCA”), Acacia Pharma’s home competent authority, the Group intends to offer new ordinary shares in the Initial Global Offering with admission to trading of all shares on Euronext Brussels.

The proceeds of the Global Offer are expected to allow the Group to build the sales and marketing infrastructure and undertake marketing, supply chain and other preparatory activities ready to launch BAREMSIS to the hospital market in early 2019, assuming approval of the NDA in late 2018.
Additionally, the proceeds will be applied to continue the development of APD403 for CINV, strengthen the corporate infrastructure and for other corporate purposes.
Bank Degroof Petercam NV/SA and RBC Europe Limited are acting as Joint Global Coordinators in connection with the Global Offer.

 

About Acacia Pharma


Acacia Pharma is a hospital pharmaceutical group 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 led by an experienced management team. Management, Gilde Healthcare, Lundbeckfonden Ventures, Novo Holdings A/S and F-Prime Capital are the Company’s primary shareholders. Acacia Pharma is based in Cambridge, UK and its US operations are centered in Indianapolis, IN. www.acaciapharma.com

 

 

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