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Acacia Pharma Announces Amendment of its Investment Agreement with Cosmo Pharmaceuticals for BYFAVO™

€5 million commercialization milestone to be paid by Acacia Pharma to Cosmo
in New Ordinary Shares

BYFAVO expected to be launched in the United States within the coming weeks

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.

Cambridge, UK and Indianapolis, US – 15 December 2020: Acacia Pharma Group plc (“Acacia Pharma”, the “Group” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, announces an amendment to the terms of its investment agreement with Cosmo Technologies Ltd, a wholly-owned subsidiary of Cosmo Pharmaceuticals N.V. (“Cosmo”) dated 10 January 2020 ("Investment Agreement").

Under the Investment Agreement, Cosmo would have become eligible to receive a €5 million payment from the Company payable in new ordinary shares in the Company ("New Ordinary Shares") conditional upon the first commercial sale of the BYFAVO™ product in the United States ("BYFAVO First Commercial Sale").

On 14 December 2020, the Company and Cosmo entered into an amendment agreement (the “Amendment Agreement”) pursuant to which the Company and Cosmo agreed that, in exchange for Cosmo prioritising the packaging and labelling production run for BYFAVO for supply in the US, the Company shall make the €5 million payment in advance of BYFAVO First Commercial Sale and by no later than 31 December 2020 (subject to the terms of the Investment Agreement, generally).

BYFAV was approved by the US Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It received its Schedule IV designation from the US Drug Enforcement Administration (DEA) on 5 October 2020.

DEA scheduling requirements between July and October this year delayed the final approval and finalization of the BYFAVO label, leading Acacia Pharma to request Cosmo to prioritize the BYFAVO processing schedule during a time when its facility would typically be closed. The agreement to amend the timing for this payment was reached in consideration for Cosmo modifying its production schedule and expediting its packaging and labelling production for BYFAVO.

Acacia Pharma is preparing to launch BYFAVO in the US as soon as possible in the coming weeks.

“We are very excited to be able to bring BYFAVO to the US market,” commented Mike Bolinder, Acacia Pharma’s CEO. “We are grateful to Cosmo for their flexibility and enthusiastic support to help us expedite the supply of BYFAVO into the US supply chain. We look forward to confirming the launch of BYFAVO in the coming weeks as it becomes available to physicians and their patients in the US.”

Payment will be settled by the Company issuing new ordinary shares in the share capital of the Company (the "New Ordinary Shares") to Cosmo, at an issue price of £2.381 (being the 15-day volume weighted average price of the Company's shares prior to the date of the Amendment Agreement). Listing and admission to trading of the New Ordinary Shares on Euronext Brussels remains, in accordance with the Investment Agreement, conditional upon the necessary regulatory approvals being obtained from the FCA and the Belgian FSMA. A further announcement will be made once approval has been obtained and admission of the New Ordinary Shares to trading on the regulated market of Euronext Brussels has become effective.

The New Ordinary Shares will rank pari passu in all respects with the Company's existing ordinary shares in issue.

Following the issue of the New Ordinary Shares, the Company's total issued share capital will comprise 89,597,951 ordinary shares with one voting right per share. The Company does not hold any ordinary shares in treasury. Therefore the total number of voting rights in the Company will be 89,597,951.


Acacia Pharma Group plc

Mike Bolinder, CEO

Gary Gemignani, CFO

+44 1223 919760 / +1 317 505 1280


International Media

Mark Swallow, Frazer Hall, David Dible

Citigate Dewe Rogerson

+44 20 7638 9571

US Investors

LifeSci Advisors

Irina Koffler

+1 917-734-7387

Media in Belgium and the Netherlands

Chris Van Raemdonck

+32 499 58 55 31


About Acacia Pharma

Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy. The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.

Acacia Pharma's first product, BARHEMSYS® (amisulpride injection) is available in the US for the management of postoperative nausea & vomiting (PONV).

BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. BYFAVO is in-licensed from Paion UK Limited for the US market.

APD403 (intravenous and oral amisulpride), a selective dopamine antagonist 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 has its US headquarters in Indianapolis, IN and its R&D operations are centred in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

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Last Updated: 15-Dec-2020