Moxatag Supply Update

 

 

19 May 2016
LSE: VER

Moxatag Supply Update

Vernalis plc ("Vernalis" or the "Company") was informed yesterday that Suir Pharma Limited ("Suir") of Clonmel Ireland, the sole source supplier of finished dosage form Moxatag®, has been placed into Provisional Liquidation.

Information is limited at this time, but the liquidator has indicated that it intends to seek a purchaser for the business as a going concern.

Suir has already supplied launch stocks of Moxatag® to Vernalis, which are currently stored at Vernalis' third party warehouse in the US and are available for supply to wholesaler customers. The timing of further supplies is now uncertain as Suir is currently the only approved supplier under the Moxatag® NDA.

Whilst the launch of Moxatag® will still occur this summer, the uncertainty over further supply will impact Vernalis' additional promotion of Moxatag®. This additional promotion will now occur when there is more certainty over the timing of routine ongoing supply.

This will not have a material impact on our financial position or our trading results for the financial years ending 30 June 2016 and 2017.

The Company expects to provide a further update on publication of its financial results for the year ended 30 June 2016.

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Enquiries:

Vernalis plc:

 +44 (0) 118 938 0015

Ian Garland, Chief Executive Officer

 

David Mackney, Chief Financial Officer 

 

Canaccord Genuity Limited (Nominated Adviser):

+44 (0) 20 7523 8000

Dr Julian Feneley

 

Henry Fitzgerald-O'Connor

 

Emma Gabriel

 

Shore Capital (Joint Broker)

+44 (0)20 7408 4090

Bidhi Bhoma

 

Toby Gibbs 

 

FTI Consulting:

+44 (0) 20 3727 1000

Ben Atwell

 

Simon Conway 

 

Stephanie Cuthbert

 

Notes to Editors

About Vernalis
Vernalis is a revenue generating, commercial stage pharmaceutical company with significant expertise in drug development. The Group has three approved products: Tuzistra® XR targeting the US prescription cough-cold market; Moxatag®, a once-a-day formulation of the antibiotic, amoxicillin, indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years and older; and frovatriptan for the acute treatment of migraine. It has an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough-cold market as well as eight programmes in its NCE development pipeline. Vernalis has also significant expertise in fragment and structure based drug discovery which it leverages to enter into collaborations with larger pharmaceutical companies. The Company's technologies, capabilities and products have been endorsed over the last five years by collaborations with leading pharmaceutical companies, including Asahi Kasei Pharma, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier, Taisho, and Tris.

For further information about Vernalis, please visit www.vernalis.com.

Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialisation of its NCE pipeline, the Company's ability to successfully commercialise its cough-cold products and Moxatag® through its own sales force, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of Tuzistra® XR, Moxatag®, frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.

 

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T: 0118 938 0000
F: 0118 938 0001

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To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and drugsafety@propharmagroup.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch