License Agreement
Dechra Pharmaceuticals PLC
29 May 2003
Issued by Citigate Dewe Rogerson on behalf of Dechra Pharmaceuticals PLC
Date: Thursday 29th May 2003
Immediate Release
Dechra Pharmaceuticals PLC
Dechra secures North American Product Development and Marketing Rights
Dechra Pharmaceuticals PLC ('Dechra' or 'the Group') has today signed a
sub-license agreement with Bioenvision Inc. ('Bioenvision') for the Intellectual
Property to the chemical compound, Trilostane. Under the agreement, Dechra has
been granted exclusive rights to the intellectual property in Trilostane in
respect of animal health applications, including the veterinary development and
marketing of Trilostane rights for veterinary drug applications in the USA and
Canada.
Trilostane is the active ingredient in Vetoryl(R) the veterinary drug which has
been successfully developed and marketed in the UK by Dechra's subsidiary,
Arnolds Veterinary Products ('Arnolds'). The chemical entity has been highly
effective in the treatment of Cushing's syndrome, an endocrine disorder in dogs,
where since its launch in October 2001 in the UK, annualised sales have exceeded
£900,000. This agreement will enable Dechra to introduce its Vetoryl product
into the substantial North American market.
On completion of the sub-license agreement, an initial payment of US$1.25
million has been made by Dechra to Bioenvision. In addition, US$750,000 will
become payable by Dechra on completion of the submission of its New Animal Drug
Application ('NADA') with a further US$3 million becoming due once the marketing
authorisation is granted by the United States Food and Drug Administration
('FDA'). Dechra anticipates that the submission will be filed within two years.
Following the successful development and launch of Vetoryl in North America,
royalties will be paid by Dechra to Bioenvision based on annualised sales. No
payments will be made by Dechra until sales in any consecutive 12 month period
reach US$10 million, when a one-off payment of US$200,000 will be made, together
with a 2% royalty fee on sales from that point. Royalty payments increase to 3%
and 4% at such time as sales reach US$15 and US$20 million respectively in
subsequent consecutive 12 month periods.
Ian Page, Chief Executive, Dechra Pharmaceuticals said today:
'Key to our future growth strategy is the low risk development of new marketing
authorisations within the Group's veterinary pharmaceutical portfolio both in
the UK and internationally. The North American veterinary pharmaceutical market,
where there is a high level of awareness of Cushing's Disease, is some ten times
larger than in the UK. The introduction of Vetoryl into this sophisticated
market represents a significant opportunity for Dechra.
Dr Christopher B. Wood, Chairman and Chief Executive Officer, Bioenvision added:
'We look forward to partnering Dechra through its specialist operation Arnolds
who are internationally recognised for their skills and understanding of the
veterinary markets. The expansion of Trilostane into North America gives both
Companies a great opportunity to achieve significant returns from a drug which
has already been successfully proven in the UK and where there is currently no
effective alternative drug for the treatment of Cushing's'.
Enquiries:
Dechra(R) Pharmaceuticals PLC Arnolds Veterinary Citigate Dewe Rogerson
Products Ltd
Ian Page, Chief Ed Torr, Managing Fiona Tooley
Executive Director
Ian.page@nvs-ltd.co.uk Ed.torr@arnolds.co.uk Tel:+44 (0) 121 455 8370
Tel: +44 (0) 1782 771100 Tel: +44(0)1743 441632 Mobile +44 (0) 7785 703523
fiona.tooley@citigatedr-bham.co.uk
Simon Evans, Group
Finance Director
Tel: +44 (0) 1782 771100
www.dechra.com
Editors Notes
Cushing's syndrome
Cushing's (cancer) is one of the most commonly diagnosed endocrine disorders in
dogs. It affects middle-age to older dogs and breeds such as miniature and toy
poodles, boxers, dachshund and small terrier breeds are particularly susceptible
to the syndrome.
It can also affect other older animals such as horses who at the same time can
also develop laminitis, a disabling, painful condition of the feet that can be
difficult to treat.
Vetoryl(R)
Vetoryl(R) developed and launched to the UK market in 2001 by Arnolds is
manufactured at Dechra's facility, Dales Pharmaceuticals and marketed and
distributed under the Arnolds brand.
The chemical entity Trilostane has been highly effective in the treatment of
Cushing's syndrome, an endocrine disorder in dogs, where it selectively blocks
glucocorticoid synthesis, reducing serum cortisol levels. Research has shown
that, by controlling the clinical signs of the disease, symptoms in over 90% of
dogs with the condition have been relieved
About Dechra Pharmaceuticals PLC
www.dechra.com
Dechra Pharmaceuticals are specialists in the UK and international veterinary
and animal healthcare markets. Key to the Group's strategy is the development of
its veterinary pharmaceuticals portfolio.
Quoted on the London Stock Exchange (under pharmaceuticals and biotech: Reuters:
DPH.L), the business is split into four businesses: National Veterinary Services
('NVS'), Arnolds Veterinary Products ('Arnolds'), Dales Pharmaceuticals Limited
('Dales'), NationWide Laboratories/Cambridge Specialist Laboratory Services.
Arnolds Veterinary Products Limited
www.arnolds.co.uk
Arnolds is one of the most well respected and recognised brand names in the
veterinary markets and holds a leading position in several specialist veterinary
pharmaceutical sectors of the UK market such as endocrinology, local anaesthesia
and equine anti-inflammatory with strong positions in several other companion
animal sectors. Its pipeline in product development remains centred around:
cardiology, endocrinology, respiratory and oncology.
About Bioenvision Inc.
www.bioenvision.com
Bioenvision (OTCBB: BIOV.OB) is an emerging biopharmaceutical company primarily
focussed on the acquisition, development and distribution of compounds and
technologies for the treatment of cancer.
The Company has a broad pipeline of products for the treatment of cancer,
including: clofarabine, Modrenal(R) (for which Bioenvision has obtained regulatory
approval for marketing in the United Kingdom for the treatment of
post-menopausal breast cancer), and other products in clinical trials.
Bioenvision is also developing anti-infective technologies, including the OLIGON
technology, an advanced biomaterial that has been approved for certain
indications by the FDA in the U.S.A.
May 2003
This information is provided by RNS
The company news service from the London Stock Exchange