Acacia Pharma Announces US FDA Approval of BARHEMSYS (amisulpride) for the Treatment and Prevention of Postoperative Nausea and Vomiting (PONV) - Seite 4

Acacia Pharma’s lead product, BARHEMSYS for postoperative nausea and vomiting (PONV), has been approved by the US FDA, with US launch planned for 2H 2020.

Byfavo (remimazolam injection), an ultra-short-acting and reversible sedative/anesthetic investigated for use during invasive medical procedures, such as colonoscopy and bronchoscopy, is in-licensed from Cosmo Pharmaceuticals NV for the US market. The NDA for Byfavo has been filed with the US FDA, and the target PDUFA action date is 5 April 2020.

APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy-induced nausea and 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 centered in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

www.acaciapharma.com

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 anesthetic gases and opioid painkillers and is particularly common following gynecological, abdominal, breast, eye, and ear operations, especially those lasting an hour or more. PONV has been ranked as the most undesirable of all surgical complications in some patient surveys, even worse than pain.⁵

Acacia Pharma estimates that approximately 65 million surgical procedures are conducted in the US each year that are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for high-risk prophylactic and rescue treatment comprises an estimated 34 million patients annually.³

About BARHEMSYS

BARHEMSYS is a selective dopamine-2 (D₂) and dopamine-3 (D₃) receptor antagonist, which Acacia Pharma has developed and protected for the management of PONV.

BARHEMSYS is indicated in adults for:

• treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis
• prevention of PONV, either alone or in combination with an antiemetic of a different class

www.BARHEMSYS.com

Important Safety Information for BARHEMSYS (amisulpride) Injection

Contraindication

BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride.