Allergy Therapeutics PLC
31 January 2007
31 January 2007
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")
Successful end of Phase II meeting with FDA on Pollinex(R) Quattro Ragweed
Second Phase III allergy vaccine programme expected to commence in March
FDA agrees to single pivotal Phase III trial for registration
Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company
focused on allergy vaccination, announces that it has concluded a successful end
of Phase II meeting with the US Food and Drug Administration ("FDA") for its
ultra short course allergy vaccine Pollinex Quattro Ragweed.
Following a broad ranging review of Pollinex Quattro's preclinical,
manufacturing and clinical data, and subject to minor clarifications, the FDA
has accepted the Company's plans to conduct a single pivotal Phase III trial for
registration.
With a clear understanding of the path to achieve the regulatory submission, the
Company is finalising preparations for a randomised, placebo-controlled,
double-blind study to confirm the efficacy and safety of Pollinex Quattro in
patients with seasonal allergic rhinitis due to ragweed pollen exposure. The
investigators study kick off meeting is planned for beginning of February with
first dosing expected in March.
The company announced on 23 January 2007 that it had begun dosing patients in
its Phase III trial for Pollinex Quattro Grass - the first ever global allergy
vaccine trial.
Pollinex Quattro is an ultra-short course vaccine requiring only four shots over
three weeks and incorporates the TLR4 agonist adjuvant MPL(R). In contrast, for
example in the United States, existing vaccine treatments typically require
between 16 and 50 injections taken under specialist supervision prior to the
start of the hayfever season. Pollinex Quattro therefore has the potential to
transform allergy treatment by providing a safe, effective and highly convenient
method of vaccination. The Company has three programmes of Pollinex Quattro
allergy vaccines in clinical development: Grass, Tree and Ragweed.
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 87,000 patients is available from the named patient programme
in Europe.
The market opportunity is considerable with the American College of Allergy,
Asthma & Immunology identifying ragweed pollen as the number one cause of
seasonal allergies. 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:
"We recently announced the first patient dosed in our pivotal Phase III Pollinex
Quattro Grass trial. Today's announcement confirms that we are in the enviable
position of having two allergy vaccines in late stage of clinical development.
We have just opened a new manufacturing facility in the UK, part of a
significant investment programme to ramp up production capacity ahead of the
expected registration of these products next year.
"We believe these products are best in class, and will provide an important new
treatment option for the millions of moderate to sever allergy sufferers."
For further information
Allergy Therapeutics +44 (0) 1903 844 722
Keith Carter, Chief Executive
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. Collectively these
form the "Caution: Allergen" programme. Pollinex Quattro Ragweed is currently
under review by Health Canada. In addition, an oral vaccine development is
completing its first phase II study.
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 desensitization 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.
This information is provided by RNS
The company news service from the London Stock Exchange
This information is provided by RNS
The company news service from the London Stock Exchange
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