Allergy Therapeutics PLC
14 June 2007
14 June 2007
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")
Pollinex(R) Quattro Grass Phase III Study Fully Recruited
On track to launch the first approved ultra-short course allergy vaccine in 2009
Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company
focused on allergy vaccination, today announces that its Pollinex Quattro Grass
Phase III trial begun in January, the first ever global allergy vaccine
programme, has been fully recruited and that the path to marketing approval
during 2009 is now clear.
Following discussion with the FDA, the Company confirms that the trial has been
fully recruited with a total of 1,028 patients from 94 centres in 4 countries.
The majority of the patients, 620, have been recruited in the United States,
with 291 in Canada and a further 117 from European centres. Data collection is
ongoing and to date the early discontinuation rate has been extremely low.
The primary objective of this double blind, randomised trial is to compare the
efficacy of Pollinex Quattro Grass versus placebo. Evidence of the safety and
efficacy of Pollinex Quattro has been established through earlier clinical
trials in Europe. Furthermore, substantial exposure data in more than 90,000
patients is available from the sale of 'named patient' products in Europe.
In addition, the Company has agreed the safety study protocol for Pollinex
Quattro Grass with the FDA; the set-up for this study has already begun.
Initial results are expected around the end of Q1 2008 with full data expected
in mid-year. These trials, if successful, are suitable for registration in both
the United States and Europe. For the US a Biologics License Application
("BLA") submission is planned for early in the second half of 2008 and Allergy
Therapeutics remains on track to launch Pollinex Quattro as the first approved
allergy vaccine in the United States in 2009.
The market opportunity is considerable with the American Academy of Allergy,
Asthma and Immunology estimating that 33 million allergy injections a year are
given in the United States. Allergic rhinitis (hay fever) is a large and
growing problem. Prevalence estimates vary on a country by country basis but
range from 14-29% of the total population*. Worldwide over 150m people are
estimated to suffer from allergic rhinitis and the prevalence is increasing*.
There is a substantial unmet medical need in a market currently worth an
estimated US$12 billion per annum.
* Decision Resources Allergic Rhinitis June 2005
Keith Carter, Chief Executive of Allergy Therapeutics, said:
"The path to registration of Pollinex Quattro Grass is now clear. The speed with
which we were able to recruit speaks very favourably for the product's profile,
with no other allergy vaccine promising such rapid administration and efficacy.
This is very attractive to patients suffering from both moderate and severe
hayfever, offering a highly effective, 4-shot vaccine over just a three week
period.
"This is the first full Phase III registration trial for an allergy vaccine
undertaken in the United States and a successful outcome has the potential to
transform allergy treatment by providing a safe, effective and highly convenient
method of vaccination for the first time."
For further information
Allergy Therapeutics +44 (0) 1903 845 820
Keith Carter, Chief Executive
Tom Holdich, R&D Director
Financial Dynamics +44 (0) 207 831 3113
David Yates
Ben Brewerton
About Pollinex Quattro
There are three programmes of subcutaneous immunotherapy in clinical
development; Pollinex Quattro Grass, Pollinex Quattro Ragweed & Pollinex Quattro
Tree, all of which are based on proprietary technologies. A submission for
licensure for Pollinex Quattro Ragweed is currently under review by Health
Canada. In addition, an oral MPL vaccine development recently completed its
first phase II study, with some exciting results.
Pollinex Quattro vaccines contain three distinct technologies which act
synergistically. Natural allergens are chemically modified to improve safety and
allow for delivery of higher doses. These are combined with a depot technology
to provide prolonged activity and further improved tolerability. Finally, the
immune response is specifically enhanced and directed by an adjuvant,
monophosphoryl lipid A (MPL). MPL is a Toll-Like 4 Receptor (TLR4) agonist and
has been extensively tested in Pollinex Quattro and other late stage and
registered vaccines including GlaxoSmithKline's Fendrix(R) and Cervarix(R)
About Allergy Therapeutics plc
Allergy Therapeutics plc is a UK AIM-listed specialty pharmaceutical company
focused on allergy vaccination. It has a profitable core business achieving
sales of allergy vaccines of over £24m in Germany, Italy, Spain and other EU
markets through its own sales and marketing infrastructure.
Allergy Therapeutics is now running the two largest international allergy
vaccine trials ever conducted with pivotal Phase III studies well underway for
Pollinex Quattro Grass and Pollinex Quattro Ragweed. The Company is well placed
to launch in 2009 the first approved allergy vaccines in the United States.
This information is provided by RNS
The company news service from the London Stock Exchange
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Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
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