Vernalis PLC Regulatory News (VER)

3 Jun 2009 07:00



3 June 2009

Vernalis plc: Interim Management Statement 

for the period to 3 June 2009

Vernalis plc (LSE: VER) today publishes its interim management statement for the period 1 January 2009 to 3 June 2009.

Key Events

On 27 March 2009 Vernalis announced that Biogen Idec (NASDAQ: BIIB), presented headline data at its 25 March 2009 R&D Day from two Phase IIa studies of BIIB014 (Vernalis' V2006), an oral compound for the treatment of Parkinson's disease which was well tolerated and showed dose dependent clinically relevant effects in patients with both early and late stage Parkinson's disease. Interim results from the Phase IIa studies of BIIB014 were favourable and support continued development of BIIB014. Biogen Idec also announced that it is currently in discussions with regulators surrounding the design of a registration program of BIIB014 in this patient population. Biogen Idec is conducting and funding all development of this programme and will pay milestones and royalties to Vernalis on the successful development and commercialisation of the product.

On 28 April 2009, Vernalis announced that it proposed to raise approximately £22.1m (net of expenses) through a fully underwritten Placing and Open Offer together with a share capital reorganisation. All the proposed resolutions were passed at the General Meeting held on 18 May 2009 and the Company's issued share capital as at 19 May 2009 consisted of 58,117,245 Ordinary Shares of 20 pence each with voting rights.

Also on 28 April 2009, as part of the results for the year ended 31 December 2008, the Company announced that it had selected a pre clinical candidate V158866 targeting FAAH (Fatty Acid Amide Hydrolase) for the management of pain. V158866 advanced into pre-clinical development in March 2009. Inhibition of the enzyme FAAH results in elevated anandamide, a substance that acts centrally to relieve pain.

On 7 May 2009 Vernalis announced a new three-year joint oncology research collaboration with Servier, France's largest privately-owned pharmaceutical company, focused on the discovery of drugs for a new undisclosed target. Under the terms of the collaboration, which uses Vernalis' proprietary fragment and structure-based drug discovery platform, Vernalis will receive fees together with milestones and royalties on future sales of the product. Vernalis and Servier already have an existing collaborative agreement to develop two promising oncology targets involved in protein-protein interactions. 

On 2nd June 2009 Vernalis announced marketing approval for frovatriptan in South Korea had been received from the Korean FDA on 29th May 2009. Frovatriptan will be marketed in South Korea by SK Chemicals and under the terms of their agreement Vernalis will receive a milestone payment.

Outlook

The outlook for the Group in 2009 is transformed from that faced at the end of 2008 following the arrival of a new management team, together with the proceeds of the successful fundraising. The proceeds from this equity financing, coupled with cost containment efforts provide the Group with cash resources through the first half of 2011. We will make further investment in V3381 and aim to complete recruitment of the Phase IIb neuropathic pain study by the end of year with data available in 2010. Other key programmes earmarked for investment are V158866 a novel pain compound targeting FAAH and a late stage Chk1 oncology research programme for which a pre-clinical development candidate is expected to be announced during this year. We will focus our 2009 partnering efforts on V85546 for inflammatory disease and V1512 for Parkinson's disease where we see the greatest potential to secure deals.

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Enquiries:

Vernalis Contacts

Ian Garland, Chief Executive Officer  +44 (0) 118 977 3133David Mackney, Chief Financial Officer 

Brunswick Group

Jon Coles  +44 (0) 20 7404 5959Justine McIlroy

Notes to Editors

About Vernalis

Vernalis is a development stage pharmaceutical company developing a pipeline of clinical and early stage programmes. The company currently has seven product candidates in clinical development (two of which are partnered) and two programmes in pre-clinical trials (one with a partner) and other competitive research programmes. Our collaborations are with leading, global pharmaceutical companies including 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.