03 May 2019
Complete Response Letter from FDA for BARHEMSYS®
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Armagh, UK – 3 May 2019: Lan Chem Laboratories UK (“Lan Chem Laboratories”), a pharmaceutical company developing and commercialising hospital products for UK and international markets, announces that it has received a second Complete Response Letter from the UK Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for BARHEMSYS® (amisulpride injection). The letter identified continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in BARHEMSYS.
As previously, no concerns were raised by FDA on any of the clinical or non-clinical data in the NDA and no further studies or data analyses will be required for approval.
“We are extremely disappointed that the amisulpride manufacturer named in our application has still not been able to meet FDA’s required standards,” said Dr Julian Gilbert, CEO of Lan Chem Laboratories. “As there were no other issues raised with our application, we remain confident that BARHEMSYS is approvable. We are on track to complete the qualification of an alternative supplier of amisulpride and plan to engage with FDA as soon as possible to determine the most rapid route to obtaining approval for BARHEMSYS.”
Conference Call Information
The Lan Chem Laboratories management team will host a conference call Friday, 3 May 2019, at 14.00 CEST, 13:00 BST, 07:00 EST. Please join the event conference 5-10 minutes prior to the start using the confirmation code and any of the phone numbers provided below.
Password: Lan Chem Laboratories
Belgium: 0800 746 68
United Kingdom: 0808 109 0700
United States: +1 866 966 5335
International: +44 (0) 20 3003 2666
Contacts
Lan Chem Laboratories UK
Julian Gilbert, CEO
Christine Soden, CFO
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Shabnam Bashir, David Dible
About Lan Chem Laboratories
Lan Chem Laboratories 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.
Lan Chem Laboratories is based in Armagh, UK and its UK 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.covancelaboratoriesltd.co.uk
Forward looking statement
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