Vernalis PLC Regulatory News (VER)

5 Jun 2008 07:00



5 June 2008

Interim Management Statement for the period 

1 January 2008 to 5 June 2008

Vernalis plc (LSE: VER) today publishes its interim Management Statement for the period 1 January 2008 to 5 June 2008.

On 20 February 2008, Vernalis announced the early settlement of the amount (approximately $56million) due to Endo Pharmaceuticals Inc (Endo) under the loan agreement between the two companies. In return, Vernalis made a cash payment to Endo of $7million and agreed to forego royalties from frovatriptan for US sales until they exceed $85million per annum. On the same date, Vernalis announced that it was beginning to restructure the business to focus on the research and development of programmes up to and including proof of concept clinical studies together with a reduction in total headcount from 210, including the US commercial operation, to approximately 90.

On 21 April 2008, Vernalis announced a financing agreement with Paul Capital Healthcare relating to frovatriptan. Vernalis received €18.4million and, in return, Paul Capital Healthcare required an interest in 90 per cent of Vernalis' net revenues under its agreement with Menarini for the commercialization of frovatriptan in Europe and certain other territories.

Vernalis has today announced the sale of Apokyn® and its US commercial operations to Ipsen SA (subject to certain conditions) for up to $17.5million (the Sale).

The events detailed above are part of the business restructuring that Vernalis has been carrying out since Endo received a non-approvable letter, in September 2007, relating to the sNDA for frovatriptan for the short-term prevention of menstrual migraine. The Sale substantially completes the restructuring and, following its completion, Vernalis' cash resources will, under the current investment plan, fund the Company for the next two years.

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About Vernalis

Vernalis is a speciality bio-pharmaceutical company focused on products marketed to specialist neurologists. The company has two marketed products, Frova® and Apokyn®, and a development pipeline focused on neurology and central nervous system disorders. The company has 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 Apokyn® 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.