Allergy Therapeutics PLC
18 July 2005
Allergy Therapeutics - Trading update
Highlights:
• Sales in-line with market expectations
• Extensive Clinical Trial programme on track
• 2 US Investigational New Drugs (INDs), 6 Canadian and 2 German Clinical
trial applications (CTAs) approved in the last six months
Allergy Therapeutics plc, the specialty pharmaceuticals company focused on
allergy vaccines, today issues the following pre-close trading update relating
to the financial year ended 30 June 2005. The preliminary results for the year
will be announced in the week commencing 12 September 2005.
Sales for the year are expected to meet current market expectations. Sales of
Pollinex(R) Quattro, Allergy Therapeutics' award-winning four-shot allergy
vaccine, show growth of 42% over the same period last year. The company booked
its first milestone receipt of £1m from its Canadian partner, Allerpharma, to
whom Allergy granted exclusive rights to market Pollinex(R) Quattro in Canada.
Allergy's cash position remains strong, currently with free capital of
approximately £15 million, despite development spend of approximately £6m for
the year ending 30 June 2005, £2m more than market expectations. Development
spend will accelerate in 2005/06 to higher than previously expected levels.
Allergy is on track to conduct pivotal Phase III clinical trials during the 2006
pollen season. These studies will be multi-centre, multi-national, conducted in
both North America and Europe - Allergy Therapeutics is the only allergy vaccine
company known to have such a programme of world-wide studies, including the USA.
Prior to being authorised to conduct clinical (human) trials, companies have to
receive approval from the relevant regulatory authorities. In this regard the US
and Canadian authorities - the FDA and Health Canada respectively - are
recognised as amongst the most demanding in the world. In recent months the
company has opened 2 INDs with the US FDA, covering Pollinex Quattro vaccines
against seasonal allergic rhino-conjunctivitis (hay fever) caused by Grass and
Tree pollen. The company has also had 6 CTAs approved by Health Canada, covering
Ragweed and Tree vaccine programmes.
These open authorisations to conduct trials using US and Canadian subjects cover
a number of pre-phase III studies, ranging from small skin test studies to a
large phase IIb double-blind placebo-controlled efficacy study to be conducted
in the Environmental Exposure Chamber (EEC, also known as a 'pollen challenge
chamber') operated by ARI (Canada).
The EEC study is particularly important as, on the basis of a positive outcome,
Allergy Therapeutics will be able to submit a dossier for registration for an
MPL(R)-based vaccine for allergy to Ragweed pollen in Canada - it is therefore
our first pivotal clinical trial with Pollinex Quattro. Recruitment for the
first phase of this study has been completed and treatment initiated.
Preliminary data from this study is expected to be available in Q1 2006.
In addition, 2 further CTAs have been approved in Germany to initiate a
programme of work with sublingual therapy. Initial information on the potential
immunological benefit of sublingual MPL is also expected early in 2006.
-ends-
Allergy Therapeutics 01903 844720
Keith Carter, Chief Executive
Ian Postlethwaite, Finance Director
Bell Pottinger 020 7861 3232
Dan de Belder
Emma Charlton
This information is provided by RNS
The company news service from the London Stock Exchange
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