Development Update

Dechra Pharmaceuticals PLC 04 September 2007 Issued by Citigate Dewe Rogerson Ltd, Birmingham Date: Tuesday, 4 September 2007 IMMEDIATE RELEASE Dechra(R) Pharmaceuticals PLC An International Veterinary Pharmaceutical Business Vetoryl(R) US - Development Update Dechra Pharmaceuticals PLC ('Dechra') is pleased to announce that the USA Food and Drug Administration ('FDA') has granted Vetoryl Capsules a designation for a minor use in a major species ('MUMS') to treat hyperadrenocorticism due to adrenocorticol tumours in dogs, which account for approximately 15% of Cushings cases. This is the first such designation granted in the USA. The benefit of a MUMS designation is that conditional approval for this minor indication can be received prior to the submission of the efficacy section for the full marketing authorisation. Dechra has also been notified that the FDA considers the safety section to be approved. As indicated in the Preliminary Results statement released today (4 September 2007), the chemistry and manufacturing controls section ('CMC') has been submitted to the FDA for review. Marketing under the MUMS designation can commence once the CMC section is approved. Therefore, it is likely that Dechra will be able to launch the product for this minor indication ahead of management expectations. The application for the full marketing authorisation continues on schedule. Enquiries: Ian Page, Chief Executive Fiona Tooley, Director Simon Evans, Group Finance Director Keith Gabriel, Senior Account Manager Dechra Pharmaceuticals PLC Citigate Dewe Rogerson Today: 0207 638 9571 Today: 0207 638 9571 Mobile: 07775 642222 (IP) or 07775 642220 (SE) Mobile: 07785 703523 (FMT) or 07770 788624 Thereafter: 01782 771100 Thereafter: 0121 455 8370 www.dechra.com corporate.enquiries@dechra.com Notes to Editors Vetoryl Capsules is a novel and patented product for the treatment of Cushing's disease (excess cortisol or hyperadrenocorticism) in dogs. It is the only licensed product within the EU and is the only recognised safe and efficacious veterinary product for the treatment of Cushing's disease around the world. Launched in the UK on a provisional marketing authorisation in September 2001, Vetoryl Capsules has since achieved full approval and has consistently increased market penetration. It also achieved mutual recognition for approval within the EU in 2006 and has now been launched within all the key European territories. In the USA it is currently sold under an FDA waiver scheme. Dechra and the Dechra 'D' logo are registered Trade Marks of Dechra Pharmaceuticals PLC and Vetoryl is a registered Trade Mark of the Dechra Group. This information is provided by RNS The company news service from the London Stock Exchange
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