Vernalis plc: Endo Provides Update on FrovaŽ sNDA
08 April 2008
Vernalis plc (LSE: VER) today announces that Endo Pharmaceuticals Inc. has notified the US Food and Drug Administration (FDA) of the withdrawal of the supplemental new drug application (sNDA) without prejudice to refiling as afforded under 21 CFR 314.65 for Frova® (frovatriptan succinate) 2.5 mg tablets. This sNDA was for the additional indication of Frova® for the short-term (six days per month) prevention of menstrual migraine. Vernalis and Endo are continuing to evaluate the potential for Frova® for this indication and other related indications. In its business restructuring, announced on 20 February 2008, Vernalis based its strategy on the assumption that, for the immediate future, Frova® would only be approved for the acute treatment of migraine.
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Enquiries:
| Vernalis plc | +44 (0) 118 977 3133 |
| Tony Weir, CFO | |
| Brunswick Group | +44 (0) 20 7404 5959 |
| Jon Coles | |
| Justine McIlroy | |
| Alex Tweed |
Notes to Editors
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:
| Product | Indication | Phase I | Phase II | Phase III | Market | Marketing Rights |
| Apokyn® | Parkinson's Disease | x | North America | |||
| Frova® | Migraine | x |
Menarini, Endo (royalties) | |||
| Frova® | Menstrual Migraine Prevention | x |
Menarini, Endo (royalties) | |||
| V1512 | Parkinson's Disease | x |
World Wide (excl. Italy ) | |||
| V10153 | Thrombotic Disorders | x |
World Wide | |||
| V3381 | Neuropathic Pain | x |
World Wide | |||
| V2006 | Parkinson's Disease | x |
Biogen Idec (royalty) | |||
| V24343 | Obesity | x |
World Wide | |||
| AUY922 | Cancer | x | Novartis (royalty) |
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.
