Clearance for vaccine studies
Allergy Therapeutics PLC
10 May 2005
Allergy Therapeutics announces clearance from Health Canada for vaccine studies
Allergy Therapeutics plc, the specialty pharmaceuticals company focused on
allergy vaccines, announces today that it has received clearance from Health
Canada, the country's federal department for health, to commence its studies
into Ragweed vaccines.
Ragweed pollen is the principal airborne allergen in North America where it
affects approximately 55% of all allergic rhino-conjunctivitis sufferers.
The studies are 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.
If successful, the study will allow submission for registration in H1 2006,
offering the possibility of a first marketing authorisation for a Pollinex
Quattro product in time for the 2007 season. Should such a registration be
achieved, Allergy Therapeutics intends to conduct post-marketing studies to
collect further safety and efficacy data which will be supportive to the
registration applications made in other territories, in particular the USA.
This announcement follows the opening of an Investigational New Drug (IND)
application with the Federal Drug Administration (FDA) to conduct pre-pivotal
studies in humans with Allergy Therapeutics' Grass pollen product.
Keith Carter, CEO of Allergy Therapeutics, commented:
"This is a particularly pleasing development, being the first pivotal Pollinex
Quattro study and especially given the efficiency of Health Canada's process. We
have continued to make strong progress since the flotation in October 2004 in
line with our stated strategy. The Company has strengthened its focus on product
development and we have continued to build on our international sales and
marketing efforts."
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For further information:
Allergy Therapeutics 01903 844720
Keith Carter, Chief Executive
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