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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