Cambridge, UK and Indianapolis, US – 6 November 2018: Acacia Pharma Group plc (“Acacia Pharma” or “the Company”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has resubmitted its New Drug Application (NDA) for Barhemsys (amisulpride injection) to the US Food and Drug Administration (FDA).
On 8 October, the Company announced that it had received a complete response letter identifying deficiencies relating to the pre-approval inspection of the contract facility employed to manufacture amisulpride, the active pharmaceutical ingredient in Barhemsys. No defects were noted in the purity or stability of the active ingredient, or in the manufacturing process or quality of the finished product. In addition, 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.
The contract manufacturer has worked closely with the Company to prepare its Corrective and Preventive Action (CAPA) plan to robustly address the outstanding deficiency at its facility. The CAPA has now been submitted to the FDA by the contract manufacturer. As a result of these efforts, Acacia Pharma has resubmitted the NDA for Barhemsys. Within 30 days of resubmission FDA will classify it as either Class 1 (review completed within two months of receipt) or Class 2 (review completed within six months of receipt). Further updates in relation to these events will be provided in due course.
“Our contract manufacturer has worked diligently to institute a corrective and preventative action plan that we are confident will rectify the deficiency identified by the FDA. I would like to thank all those involved for their swift actions. We continue to plan for a launch in the first half of 2019.” said Dr Julian Gilbert, CEO of Acacia Pharma.
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 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.
Source: Acacia Pharma Group plc
Posted: November 2018
- FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys – October 8, 2018
- Acacia Pharma Announces FDA Acceptance of NDA Filing For Baremsis for the Management of Post-Operative Nausea & Vomiting – January 4, 2018
Barhemsys (amisulpride) FDA Approval History
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