Allergy Therapeutics PLC
19 July 2006
Allergy Therapeutics plc, "Allergy Therapeutics" or "the Company"
Successful review meeting with Japan's Pharmaceutical and Medical Devices Agency
Japan development of Pollinex(R) Quattro progressed
Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company
focused on allergy vaccination, announces today that it has concluded a
successful meeting with the Pharmaceutical and Medical Devices Agency ("PDMA")
in Japan at which the development of its ultra short course vaccine Pollinex(R)
Quattro Grass was discussed.
Following a broad ranging review of preclinical, manufacturing and clinical
data, the PMDA has accepted the Company's plans to conduct further trials for
the eventual registration of Pollinex Quattro in Japan. The substantial data
already available for the grass pollen product forms the basis of a "bridging
programme" to enable use of the same product in the Japanese population.
Allergy Therapeutics has agreement to submission of a Clinical Trial
Notification in Japan and a clear understanding of the path to achieve this
regulatory goal. It is the Company's strategy to proceed with clinical trials
when a suitable partner is found. Together with the compelling evidence of the
safety and efficacy of Pollinex Quattro, the Company believes it is a very
strong position to attract potential partners in Japan for its Grass and
Japanese Cedar development projects.
Keith Carter, Chief Executive Officer of Allergy Therapeutics, said:
"Japanese healthcare standards are among the highest in the world and as the
second largest pharmaceutical market it is not one we intend to ignore. This
announcement provides further reassurance that Allergy Therapeutics' developments are
conceived as global and conducted to the very highest standards.
"29 million people in Japan suffer from allergic rhinitis, a significant portion
because of pollinosis. There are currently no equivalent products available to
treat the cause of this allergy. These facts, combined with aggressive public
health awareness campaigns, contrive to provide a sizeable and readily accessible
marketplace."
-ends-
For further information
Allergy Therapeutics plc +44 (0)1903 845 820
Keith Carter, Chief Executive Officer
Bell Pottinger +44 (0)20 7861 3232
Dan de Belder / Emma Charlton
About Pollinex Quattro
There are three programmes of subcutaneous immunotherapy in clinical
development. The three programmes are Pollinex Quattro Grass, Pollinex Quattro
Tree & Pollinex Quattro Ragweed, all of which are based on proprietary
technologies. Preparations for initiating all three Phase III developments
later this year are well underway and collectively these form the "Caution:
Allergen" programme. In addition there is an oral vaccine development currently
in phase II development. A new product designed to treat allergies due to
Japanese Cedar pollens is being readied for its First in Man 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) (R). 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)
This information is provided by RNS
The company news service from the London Stock Exchange