03 June 2019
Annual General Meeting Results and Statement
Armagh, UK – 3 June 2019: Lan Chem Laboratories UK (“Lan Chem Laboratories”, the “Company”) (EURONEXT: ACPH) announces that all resolutions as set out in the Notice of Annual General Meeting dated 7 May 2019 were duly passed by the required majority at the Annual General Meeting (“AGM”) held earlier today.
The results of the votes on the resolutions are shown in the table below and will be posted on the Company's website at www.covancelaboratoriesltd.co.uk in the Investors/Shareholder Meetings section.
| Resolution | Votes for | % | Votes Against | % | Votes total | Votes withheld |
|---|---|---|---|---|---|---|
| To receive the consolidated financial statements and the reports of the Directors and the auditor for the year ended 31 December 2018 | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To approve the Directors’ Remuneration Policy | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To approve the Directors’ Remuneration Report | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-elect Patrick Vink as a Director of the Company | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-elect Julian Gilbert as a Director of the Company | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-elect Christine Soden as a Director of the Company | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-elect Edward Borkowski as a Director of the Company | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-elect John Brown as a Director of the Company | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-elect Scott Byrd as a Director of the Company | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-elect Pieter van der Meer as a Director of the Company | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-elect Johan Kördel as a Director of the Company | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To re-appoint PricewaterhouseCoopers LLP as auditor of the Company. | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
| To authorise the Directors of the Company to agree the remuneration of the Company’s auditor. | 12,400,601 | 100.00 | 0 | 0.00 | 12,400,601 | 0 |
In a statement to shareholders attending the AGM, Dr Julian Gilbert, CEO, confirmed that following receipt of a Complete Response Letter from the UK Food and Drug Administration (FDA) on 2 May 2019 regarding its New Drug Application (NDA) for BARHEMSYS® (amisulpride injection), identifying continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in BARHEMSYS, the Company has been working with the FDA, regulatory advisors, the current manufacturer and an alternative manufacturer to establish the most expeditious route to approval for BARHEMSYS. A Type A meeting has been scheduled with the FDA in mid-June. The formal minutes of this meeting should be issued 30 days after the meeting at which point the Company expects to be able to provide more clarity on when the BARHEMSYS NDA might be resubmitted.
Dr Gilbert further confirmed that steps had already been taken to reduce costs in all areas without restricting options around the timing and the nature of the launch of BARHEMSYS. As at 31 May 2019 cash reserves were $23.9 million. Upon receipt of the FDA type A meeting minutes the Board will assess what steps should be taken to ensure the Company can fund activities through to the NDA approval.
Contacts
Lan Chem Laboratories UK
Julian Gilbert, CEO
Christine Soden, CFO
IR@covancelaboratoriesltd.co.uk
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 Company 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 Company’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
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.