Allergy Thera. Regulatory News (AGY)

18 Jul 2005 07:01

Allergy Therapeutics PLC18 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 onallergy vaccines, today issues the following pre-close trading update relatingto the financial year ended 30 June 2005. The preliminary results for the yearwill be announced in the week commencing 12 September 2005. Sales for the year are expected to meet current market expectations. Sales ofPollinex(R) Quattro, Allergy Therapeutics' award-winning four-shot allergyvaccine, show growth of 42% over the same period last year. The company bookedits first milestone receipt of £1m from its Canadian partner, Allerpharma, towhom Allergy granted exclusive rights to market Pollinex(R) Quattro in Canada.Allergy's cash position remains strong, currently with free capital ofapproximately £15 million, despite development spend of approximately £6m forthe year ending 30 June 2005, £2m more than market expectations. Developmentspend will accelerate in 2005/06 to higher than previously expected levels. Allergy is on track to conduct pivotal Phase III clinical trials during the 2006pollen season. These studies will be multi-centre, multi-national, conducted inboth North America and Europe - Allergy Therapeutics is the only allergy vaccinecompany known to have such a programme of world-wide studies, including the USA. Prior to being authorised to conduct clinical (human) trials, companies have toreceive approval from the relevant regulatory authorities. In this regard the USand Canadian authorities - the FDA and Health Canada respectively - arerecognised as amongst the most demanding in the world. In recent months thecompany has opened 2 INDs with the US FDA, covering Pollinex Quattro vaccinesagainst seasonal allergic rhino-conjunctivitis (hay fever) caused by Grass andTree pollen. The company has also had 6 CTAs approved by Health Canada, coveringRagweed and Tree vaccine programmes. These open authorisations to conduct trials using US and Canadian subjects covera number of pre-phase III studies, ranging from small skin test studies to alarge phase IIb double-blind placebo-controlled efficacy study to be conductedin the Environmental Exposure Chamber (EEC, also known as a 'pollen challengechamber') 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 anMPL(R)-based vaccine for allergy to Ragweed pollen in Canada - it is thereforeour first pivotal clinical trial with Pollinex Quattro. Recruitment for thefirst 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 aprogramme of work with sublingual therapy. Initial information on the potentialimmunological benefit of sublingual MPL is also expected early in 2006. -ends- Allergy Therapeutics 01903 844720Keith Carter, Chief ExecutiveIan Postlethwaite, Finance Director Bell Pottinger 020 7861 3232Dan de BelderEmma Charlton This information is provided by RNS The company news service from the London Stock Exchange