ACACIA PHARMA PROVIDES UPDATE ON FDA REGULATORY REVIEW OF BARHEMSYS(TM)
Published: Oct 08, 2018
- FDA issued a Complete Response letter to Acacia Pharma on Friday 5 October
- Only issue raised relates to FDA inspection of contract manufacturer of active ingredient
- No other quality or manufacturing deficiencies noted
- No clinical safety or efficacy issues identified and no requirement for further clinical studies or data analyses
- Conference call scheduled for 09.30 CEST
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 - 8 October 2018: Acacia Pharma Group plc ("Acacia Pharma"), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for BARHEMSYS(TM) (amisulpride injection).
The letter identified that deficiencies had been reported during a recent pre-approval FDA inspection of the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in BARHEMSYS. No inadequacies were noted regarding the purity or stability of the active ingredient, or the manufacturing process or quality of the finished product.
Furthermore, no concerns were raised by FDA on any of the clinical or non-clinical data in the application and no further studies or data analyses will be required for approval.
"We are surprised to have received this Complete Response Letter, which relates solely to issues at the facility of our contract drug substance manufacturer. We intend to seek urgent clarification from FDA and the contract manufacturer as to the status and procedure for resolution of the deficiencies that have been identified. We believe that such resolution could occur quickly, and we continue to prepare for an anticipated launch in the first half of 2019. We are very encouraged that FDA has not identified any problems with the extensive clinical and non-clinical data package submitted on BARHEMSYS, nor with the quality of the finished product." said Dr Julian Gilbert, CEO of Acacia Pharma.
Conference Call Information
The Acacia Pharma management team will host a conference call Monday 8 October 2018, at 09.30 CEST. Please join the event conference 5-10 min prior to the start using the confirmation code and any of the phone numbers provided below.
|Belgium||+32 (0)2 400 6926|
|United Kingdom||+44 (0)330 336 9411|
|United States||+1 646-828-8193|
Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson (Financial PR)
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, BARHEMSYS(TM) for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. 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
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.