Interim Results for the six months ended 30 June 2005

22 September 2005

Vernalis plc (LSE: VER, Nasdaq: VNLS) today announces its interim results for the six months ended 30 June 2005.

The events over the past twelve months have transformed Vernalis. The Company has a marketed product, frovatriptan, and a broad pipeline of products in development, with additional clinical data expected during the next six months aimed at supporting the expansion of the label of frovatriptan into short term prophylaxis of menstrually related migraine. Vernalis is establishing a commercial presence in the United States which will co-promote frovatriptan from January 2006, and is in the process of seeking additional products for this sales force to market.

Highlights

Financial

  • Revenue increased to £5.9 million (2004: £5.1 million)
  • Operating loss increased to £19.4 million (2004: £12.9 million) after £6.4 million goodwill impairment as a result of first time application of IFRS
  • Cash resources at 30 June 2005 of £49.9 million (30 June 2004: £11.0 million)
  • Fund-raising completed in March 2005 raised £28.4 million net of expenses

Corporate Development

  • Acquisition of rights to oncology target Pin1 from Pintex Pharmaceuticals Inc. in March 2005
  • Acquisition of Ionix Pharmaceuticals Limited for £12.5 million, completed in July 2005

Frovatriptan

  • Re-launched in March 2005 by Endo Pharmaceuticals with expanded sales force and new marketing strategy focused on long duration of action

    • Benefits of new marketing campaign evidenced by increased awareness of the product among targeted neurologists
  • Exercised option to co-promote frovatriptan alongside Endo Pharmaceuticals
  • Positive interim Phase III safety data with the number of patients remaining on the trial exceeding expectations
  • Patient enrolment on Phase III efficacy trial complete and, if the studies are positive, menstrually related migraine (MRM) filing expected in 1H 2006

Product Development Portfolio

  • V10153 – Commenced a Phase II trial in acute ischaemic stroke. The aim of the trial is to determine whether V10153 can be clinically effective in patients up to 9 hours after the occurrence of a stroke
  • V1003 (formerly known as IX-1003) – Commenced a Phase II trial in acute post-operative pain
  • V2006 – Suite of Phase I trials now complete with Vernalis’ partner, Biogen Idec, responsible for moving forward into Phase II trials
  • V24343 – Progressed from research into pre-clinical development. This potent and selective cannabinoid receptor antagonist programme is a potential treatment for obesity and related disorders
  • MMPI – Phase I started by Serono
  • V140 – Development discontinued following a portfolio review

Simon Sturge, CEO commented, " I am pleased to report further significant achievement against our strategic objectives in this period through the growth of our commercial operation in the US and advancement of our pipeline. We now retain co-promote options in the US for three products and are firmly focused on seeking additional in-licensing opportunities.”

View the Interim Results for the six months ended 30 June 2005 (PDF - 143KB).

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Simon Sturge and Tony Weir, CEO and CFO of Vernalis respectively, will today host an analyst / investor presentation and conference call at 9:00 am BST to discuss the interim results.
This may be accessed by dialling: +44 1452 561 263, and quoting 'Vernalis conference call.’
A replay facility will be available for 7 days by dialling: +44 1452 550 000, with the access code: 9472487#.

Enquiries:

Vernalis plc
Simon Sturge, Chief Executive Officer
Tony Weir, Chief Financial Officer
Julia Wilson, Head of Corporate Communications
+44 (0)118 977 3133

Brunswick Group (for analyst, financial media enquiries)
Jon Coles; Wendel Verbeek; Laure Korenian-Chabert
+44 (0)20 7404 5959

About Vernalis

Vernalis is a UK-based biotechnology company with a marketed migraine product, frovatriptan, and a development pipeline focused on central nervous system disorders and oncology. The company has five products in clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec and Serono. Vernalis is establishing a US commercial operation to co-promote frovatriptan alongside its North American licensing partner, Endo Pharmaceuticals, propelling the company towards its goal of becoming a sustainable, self-funding, R&D-driven biotechnology company. For further information about Vernalis, please visit www.vernalis.com

Safe Harbour statement: this news release may contain forward-looking statements that reflect the Company’s current expectations regarding future events. 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 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.