Vernalis initiates Pilot Study of V3381 in patients with chronic cough

06 October 2009

Vernalis plc (LSE: VER) today announces that it has initiated a pilot study of indantadol (V3381), a novel dual-acting NMDA antagonist & MAO inhibitor, in patients with chronic cough. V3381 has already completed a Phase IIa trial in patients with neuropathic pain and a second study in this indication has just achieved full recruitment.

The pilot study is being conducted specifically in patients with chronic cough who do not have an obvious underlying reason for the cough, such as a persistent chest infection, asthma or gastro-oesophageal reflux. This type of cough is believed to be caused by over-sensitivity of the nerves supplying the respiratory tract and so has many parallels with neuropathic pain.

The study will be run in collaboration with Professor Ashley Woodcock from the University Hospitals of South Manchester NHS Foundation and will be conducted in up to 20 patients with chronic cough. The study will utilise a new objective cough monitor developed by Professor Woodcock's team to determine whether indantadol is likely to have any effect on cough frequency. If the pilot study indicates an effect, further randomised studies may be conducted.

Chronic cough affects between 10-20% of the non-smoking population. Chronic intractable cough is an under-recognised and under-treated phenomenon. Chronic cough patients have on average a cough history of greater than six years, and report many physician contacts, with multiple investigations and unsuccessful trials of treatment. Chronic cough also substantially impacts on a patient's quality of life with an average of 240 coughs in a 24 hour period, half are clinically depressed, and two thirds of women with chronic cough have urinary incontinence.

Commenting on the study, Ian Garland, CEO of Vernalis, said \"There are currently no specific therapies approved for treatment of chronic cough and there have been no new effective anti-tussives for many decades. By initiating this pilot study we will be taking the first steps to developing a treatment for this distressing condition.\"

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Enquiries:

Vernalis Contacts  
   
Ian Garland, Chief Executive Officer +44 (0) 118 989 9360
David Mackney, Chief Financial Officer  
   
Brunswick Group  
   
Jon Coles +44 (0) 20 7404 5959
Justine McIlroy  

Notes to Editors

About Vernalis
Vernalis is a development stage pharmaceutical company with significant expertise both in de novo fragment and structure-based drug discovery and pre-clinical and clinical development. The Group has seven product candidates in clinical development (three of which are partnered), two programmes in pre-clinical, as well as other competitive research programmes. Our technologies, capabilities and products are endorsed by collaborations with leading, global pharmaceutical companies including GSK, Biogen Idec, Novartis, Servier, Chiesi, Menarini, and Endo.

Product Indication Pre-Clinical Phase I Phase II Phase III Marketing Rights
Priority Programmes
V3381 Neuropathic Pain X Worldwide
V2006 Parkinson's Disease X Biogen Idec
V85546 Inflammatory Disease X Worldwide
NVP-AUY922 Cancer X Novartis
NVP-HSP990 Cancer X Novartis
V3381 CC Chronic Cough X Worldwide
V158866 Pain X Worldwide
V158411 (Chk1) Cancer X Worldwide
Progress through partnering
V1512 Parkinson's Disease X Worldwide
(excl. Italy)
V10153 Ischaemic Stroke X Worldwide

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 Frova® 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.