Allergy Thera. Regulatory News (AGY)

9 Jul 2009 07:00



9 July 2009

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")

Key Technology Patent for Pollinex® Quattro in Japan granted 

Allergy Therapeutics (AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that it has been granted a broad technology patent for Pollinex® Quattro by the Japanese Patent Office. The patent covers the use of allergens in combination with tyrosine and monophosphoryl lipid A (MPL®).

Pollinex Quattro is a modern, adjuvanted vaccine and has a unique short dosing course of four injections. Approval of the patent follows the submission of the Pollinex Quattro Grass dossier for regulatory approval in the European Union on the 3rd of March and the announcement in 2008 of the successful completion of Phase III studies for both Pollinex Quattro Grass and Pollinex Quattro Ragweed. These two studies are the largest controlled allergy vaccine studies ever conducted. In both studies the primary efficacy endpoint was met and Pollinex Quattro demonstrated significant clinical benefits in efficacy, safety and patient compliance over placebo.

As part of the Company's strategy to meet growing demand for Pollinex Quattro, Allergy Therapeutics has been conducting pre-clinical work with Japanese Cedar which is the single most significant pollen in Japan. The Company will proceed with clinical trials when a suitable partner is found. Compelling evidence of the efficacy and of the safety profile of Pollinex Quattro means that the Company is in a strong position to attract potential partners in Japan.

Keith Carter, Chief Executive of Allergy Therapeutics, said: "29 million people suffer from allergic rhinitis in Japan. It is a large and growing market in which we have successfully secured patent protection for Pollinex Quattro allowing us, through partners, to exploit fully the opportunity this market presents."

 For further information

About Pollinex® Quattro

Pollinex® Quattro is a four injection therapeutic vaccine which is being developed for the treatment of allergic conditions which offers same season relief in as little as three weeks after treatment. It is a family of specific standardised vaccines representing a potentially extensive franchise for Allergy Therapeutics and is a novel entrant in the multibillion dollar global allergy market. It is currently available in Europe on a named patient basis.

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® and Cervarix®.

Evidence of the efficacy and of the safety profile of Pollinex Quattro has been established through clinical trials in North America and Europe. Furthermore, substantial exposure data in more than 130,000 patients is available from the sale of 'named patient' products in Europe.

About Seasonal Allergic Rhino-conjunctivitis

Seasonal allergic rhino-conjunctivitis is commonly referred to as hayfever when it is caused by pollen. It is a widespread condition that usually occurs during the pollen season. It is characterized by sneezing, rhinorrhea, nasal congestion and pruritus of the nose, eyes or throat. It is a type I hypersensitivity response in which allergen binds to immunoglobulin E on the surface of mast cells. This response leads to the release of histamine, prostaglandins and leukotrienes, which cause the inflammation, itching and redness.

Datamonitor has estimated that prevalence rates for allergic rhino-conjunctivitis of 15 per cent to 25 per cent are to be found in Europe with grass identified as the most significant allergen. IMS estimates that sales in 2006 of allergic rhino-conjunctivitis therapies were in excess of ten (10) billion USD in the seven major global markets.

About Allergy Vaccination

Allergy vaccination or immunotherapy is an effective way of modifying or avoiding disease by influencing the immune system. It is essentially a reinforcement of the body's own defence mechanisms and is similar to preventative vaccination against infectious disease; an area of medicine that has met with spectacular success. In allergy vaccination the mechanism is regarded as a correction of the immune system towards a more normal, non-allergic, response.

Allergy vaccination attacks the underlying cause of the problem and provides a patient benefit which is usually long lasting. The World Health Organisation recognises allergy vaccination as the only treatment to target the immunological cause of allergy with the ability to modify disease progression (to more severe allergy and to asthma), decreasing symptoms in the short term and offering long term anti-inflammatory benefits which prevent the development of persistent disease. Allergy vaccination, therefore, has the potential of offering patients a cure for their disease.

About Allergy Therapeutics

Allergy Therapeutics plc is a London Stock Exchange (AIM) listed, integrated specialist pharmaceutical company focused on allergy vaccination. It has a growing, profitable core business achieving sales of allergy vaccines of £31 million in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. The Company is expanding its infrastructure with operations also in the United Kingdom, Poland, the Czech Republic, Slovakia and Austria.