Vernalis PLC Regulatory News (VER)

12 Nov 2009 07:00



12 November 2009

Vernalis plc: Interim Management Statement 

for the period to 12 November 2009

Vernalis plc (LSE: VER) today publishes its interim management statement for the period 1 July 2009 to 12 November 2009.

Key Events

On 16 July 2009 Vernalis announced that it had earned a $1.5 million milestone under its Hsp90 oncology collaboration with Novartis. The milestone was triggered by the start of Phase I clinical trials of an oral Hsp90 inhibitor (NVP-HSP990) in a range of solid tumours.

On 21 July 2009 Vernalis announced that it had selected a pre clinical development candidate, V158411, from its Checkpoint Kinase 1 (Chk1) oncology research programme. V158411 has shown activity in pre-clinical cancer models when administered with commonly used cytotoxic agents, and has drug-like characteristics and appropriate pharmacokinetic properties. Because Chk1 inhibitors are used in conjunction with chemotherapy drugs, they can potentially be used to treat a broad range of tumour types including breast, prostate, colorectal and melanoma. They may also be used in haematological cancers such as leukaemia.

On 6 August 2009 Vernalis announced it entered into an exclusive collaboration, option and license agreement with GlaxoSmithKline relating to a Vernalis research programme against an undisclosed oncology target. During the research phase Vernalis will continue to apply its expertise in Structure Based Drug Design (SBDD) technologies to progress novel development candidates against the target. The deal is structured as a risk-sharing agreement, with Vernalis responsible for drug discovery activities and GSK for pre-clinical development.

On 15 September 2009 Vernalis announced it had completed patient enrolment into the randomised phase of the V3381 (indantadol) Phase II IN-STEP study. The study, evaluating further the safety and efficacy of indantadol in patients with neuropathic pain due to diabetes, is being conducted at sites in the US, Canada, UK and Czech Republic. Headline data is now expected around the end of the first quarter 2010.

As previously announced John Slater left the Company on 30 September 2009 and Alison Hood has been appointed to the role of General Counsel and Company Secretary.

On 6 October 2009 Vernalis announced it had initiated a pilot study of indantadol (V3381), a novel dual-acting NMDA antagonist & MAO inhibitor, in patients with chronic cough. The study is being 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 first patients in this study have started dosing and full recruitment and study results are expected in the first half of 2010.

Outlook

The Group remains on target to achieve its key value driving goals. We anticipate having Phase IIb data from V3381 in neuropathic pain around the end of Q1 2010.  V158866, our novel pain compound targeting FAAH and V158411 our Chk1 oncology drug candidate, are both progressing in pre-clinical development and are both targeted to commence Phase 1 studies in 2010. Partnering remains focussed on V85546 for inflammatory disease and we continue to pursue opportunities to extract value from our Parkinson's disease programme V1512.

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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.

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.