Vernalis PLC Regulatory News (VER)

11 June 2015

LSE: VER

Vernalis announces CCP-07 starts 12 month stability testing

Vernalis plc today announces that its partner, Tris Pharma, has successfully manufactured 3 registration batches of CCP-07 and material from these batches is now up on stability. CCP-07 is the second programme in Vernalis' cough cold pipeline from its exclusive licensing agreement with Tris Pharma. The first product, Tuzistra™ XR was approved by the FDA on 30 April 2015. 

The CCP-07 NDA submission will include 12 months of stability data and so Tris now anticipates the filing with the FDA to occur during 2016. Further news flow will follow the completion of the pivotal single-dose and multi-dose bioavailability studies anticipated to take place between now and NDA filing.

Tris is developing, on behalf of Vernalis, up to six unique extended-release equivalents to existing immediate-release prescription cough cold treatments. The financial terms of this licensing deal are not disclosed. 

Ian Garland, CEO of Vernalis commented "We are extremely pleased with the continued progression of CCP-07 and look forward to further positive news flow from our cough cold pipeline".

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About Vernalis

Vernalis is a revenue generating, commercial stage pharmaceutical company with significant expertise in drug development. The Group has two approved products; Tuzistra™ XR targeting the US prescription cough cold market 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 AKP, 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 products, 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 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.