Vernalis PLC Regulatory News (VER)

14 Nov 2008 07:00



14 November 2008

Vernalis plc: Interim Management Statement 

for the period to 14 November 2008

Winnersh, UK, 14 November 2008, Vernalis plc (LSE: VER) today publishes its interim management statement for the period 1 July to 14 November 2008.

Pipeline Progression (announced today)

Vernalis is currently initiating a Phase IIb study with V3381 for the treatment of neuropathic pain due to diabetes, with the first patients due to be recruited in December this year. The study, which builds on the encouraging data from the recently completed phase IIa study, is a randomised, double-blind, placebo-controlled safety and efficacy trial.  150 patients are to be recruited from up to 20 sites in the US, Canada and Europe with results expected in H1 2010.

Other Highlights

The divestment of Apokyn and the Company's US operating subsidiary, Vernalis Inc., to Ipsen, announced on 5 June 2008, was completed on 1 July 2008. This completed the restructuring of the business that was implemented in February 2008.

In August the Phase IIa study of V10153 in patients who had suffered an ischaemic stroke was successfully completed. 5mg/kg has been identified as a safe dose for evaluation in further clinical studies. The full analysis of data from the trial will be available early next year, after which the next steps in the development of V10153 will be formulated.

In October, Vernalis and Servier achieved the first milestone in the three-year oncology drug discovery collaboration. The milestone gave rise to a payment of €500,000 to Vernalis and marked the solving of the novel crystal structure of an undisclosed oncology target.

In October, Vernalis' pipeline was bolstered with the return of V85546, a Phase II-ready anti-inflammatory drug candidate, from Merck Serono.

In October it was announced that Tony Weir, CFO, will leave the company on 14th November 2008.

Today the Company also announced the appointment of a new Chief Executive Officer and Chief Financial Officer (see separate release).

Financial Outlook

On 1 July 2008, Vernalis had cash resources of £22.9 million. The trading performance and financial position are in line with the Board's expectations, as disclosed in the interim statement issued on 28 August 2008. Current estimates are unchanged and are that Vernalis should have sufficient funds until mid 2010 based on its plans for investment in its R&D programmes and the successful out-licensing of certain programmes.

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Notes to Editors

About Vernalis

Vernalis is a pharmaceutical company with one marketed product, Frova®, and six products in clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec, Endo, Menarini and Chiesi:

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

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.