Biotech Values

[BioSpecialist]

Allergy vaccine Company << sleeping Giant

The G301 study will form the basis of a submission in early 2009 to the European authorities for the licensure of Pollinex Quattro Grass << Will happen soon

Agy is a fantastic Opportunity ..Please do your own research

Allergy Therapeutics (AGY.L)
MarketCap .. 6 million GBP << 8,7 million US$
Price.. 7p

Major Shareholder
http://www.allergytherapeutics.com/Major-Shareholders.aspx

Presentation 2008
http://www.allergytherapeutics.com/uploads/1ginvestorpresentationsept2008final.pdf

Outlook

Over the coming months we shall be discussing the way forward with the European regulator regarding the approval of Pollinex Quattro Grass and we shall be continuing to prepare our sales and marketing operation across Europe for the launch of the product. In addition, we shall be continuing discussions with the FDA to lift the clinical hold on Pollinex Quattro in the US.

Allergy Therapeutics' core European business remains strong and growing, funded by its existing bank facilities and the cash it increasingly generates. As Allergy Therapeutics moves from the extended period of R&D and operational investment to a core-business focused operating company with growing sales generated by Pollinex Quattro, particularly once approved, its profit margins are expected to improve to the industry average, creating an attractive financial profile for investors.

EU Registration

The G301 study will form the basis of a submission in early 2009 to the European authorities for the licensure of Pollinex Quattro Grass, with the first registration anticipated in or before 2010. The initial target market will be Germany, followed by Italy, Spain, UK and Austria, in each of which we have an existing commercial infrastructure, and France and the Netherlands. These seven countries represent the biggest commercial potential in Europe for the product.

In summary, it has been a year of achievement after many years of investment and hard work by all involved. Allergy Therapeutics today has the first ever clinically proven ultra-short course allergy vaccine and we are poised for submission for registration with the operational infrastructure being prepared to exploit it.

Pivotal Phase III Studies

The successful outcome of G301, Allergy Therapeutics' pivotal Phase III study of Pollinex Quattro Grass, announced on 14 May 2008 was undoubtedly the most important event during the financial year. Conducted predominantly in the United States, G301 was the largest ever Phase III double blind placebo controlled study in the allergy vaccine field and to date is the only study of its type to achieve its primary efficacy endpoint.

After the financial year end we were delighted to learn that R301, a similar phase III trial with our Ragweed allergy vaccine, also met its primary efficacy endpoint which was particularly pleasing as this was the study most negatively effected by the FDA's clinical hold which occurred in the middle of the treatment phase of this study. At the time of writing the data is still being assessed, but achieving a phase III clinical trial end-point when fewer than 40% of the subjects were given the full four-shot treatment is very encouraging and speaks volumes for the efficacy of the Pollinex Quattro range.

Variability characterises clinical trials in the field of allergy. The pollen seasons vary from country to country, area to area, and year to year. The patients recruited into studies vary. The subjective assessment of symptom scores by patients in the studies is prone to variation. The compliance of the subjects to the study protocols is geographically highly variable. During 2007, three other allergy vaccine products were in Phase III studies in the United States and all 'failed'. One of these was a successful European product in the same allergen, in the same geography and even using some of the same study centres as G301. We are therefore very pleased that Pollinex Quattro has been successful in this most stringent of tests.

One of the striking features of the G301 outcome is the robustness of the result. All of the key prospectively defined analyses are positive, showing a robust, clear and statistically significant benefit over placebo. Another feature, which bodes well for the future patient experience with Pollinex Quattro, is the unusually high levels of compliance; all but 5% of the patients completed the course of treatment. In most allergy vaccine studies, including those of sub-lingual products where the main proposed advantage is patient convenience, the compliance levels have been significantly worse and of course in real life, outside the controlled conditions of the clinical trial, compliance is likely to be poorer still. The excellent compliance with Pollinex Quattro is explained by the small number of injections, just four, and the speed of the treatment; it can be completed in as little as three weeks and as close as three weeks to the start of the pollen season. We believe that the result in terms of patients actually receiving the treatment as intended by their physicians will make ultra-short course injected allergy vaccines the treatment of choice for allergy specialists and their moderate to severe allergic patients.