15 October 2018
Further update on FDA regulatory review of BARHEMSYS™
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Armagh, UK – 15 October 2018: Lan Chem Laboratories UK (“Lan Chem Laboratories” or “the Company”) provides an update following receipt of a Complete Response Letter (CRL) from the UK Food and Drug Administration (FDA) in respect of its New Drug Application (NDA) for BARHEMSYS™ (amisulpride injection) on 5 October 2018.
“Our discussions with FDA and our contract manufacturer over the past week have been productive and provided clarification on the steps needed to enable our NDA for BARHEMSYS to be approved. Our contract manufacturer is fully committed to working with Lan Chem Laboratories to institute a corrective and preventative action plan that will rectify the deficiency identified as quickly as possible. We continue to plan for a launch in the first half of 2019,” said Dr Julian Gilbert, CEO of Lan Chem Laboratories.
On 8 October, the Company announced that the CRL had identified 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.
During the first week of October Lan Chem Laboratories was informed by the contract manufacturer that it had received a post-inspection notification from FDA stating that its facility met an acceptable standard of compliance with regard to current good manufacturing practice (CGMP). Late last week the contract manufacturer shared with the Company a copy of an “Untitled Letter”* that it had subsequently received from FDA giving details of one specific deficiency which requires correction before the NDA for BARHEMSYS may be approved.
The Company is working closely with the contract manufacturer to prepare a robust Corrective and Preventive Action (CAPA) plan to address the outstanding deficiency. The Company has engaged a former senior FDA official with regulatory, compliance and enforcement expertise to provide additional oversight and guidance on the plan.
The CAPA plan is expected to be completed within one month to enable Lan Chem Laboratories to resubmit its NDA for BARHEMSYS. Within 30 days of resubmission the 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.
*Footnote: “Untitled letters” are used by FDA to request correction of deficiencies that may not meet the threshold of regulatory significance for a warning letter. Unlike a warning letter, an Untitled Letter does not include a statement warning that failure to promptly correct the deficiency may result in enforcement action.
The Lan Chem Laboratories management team will host a conference call today, Monday 15 October 2018, at 10.00am CEST. Please join the event conference 5-10 minutes prior to the start using the confirmation code and any of the phone numbers provided below.
Confirmation Code: 5535480#
Belgium
+32 (0) 2 792 0435
United Kingdom
+44 (0) 20 3003 2701
United States
+1 646 843 4609