Allergy Thera. Regulatory News (AGY)

4 Mar 2009 07:00



Wednesday 4 March 2009

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")

Pollinex® Quattro Grass Dossier Submitted for European Union ('EU') Regulatory Review

Allergy Therapeutics (AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that it has submitted its Pollinex Quattro Grass dossier for regulatory approval in the EU.

The dossier has been submitted to the German Regulatory authority, the Paul Ehrlich Insitut ("PEI"), recognised to be the European authority most expert in the allergy vaccine field.  The PEI has agreed to act as 'Reference Member State' for Europe-wide registration under the European Union Mutual Recognition Procedure ('MRP'). Following the German national phase, which is expected to take approximately one year, the MRP will commence.

In the initial phase of MRP, the Company has elected to apply for authorisation in the markets with the greatest revenue potential for Pollinex Quattro and, if the submission to the PEI is successful, approvals could be expected from 2010 with launches taking place in these countries across the following two years.

This is the first submission for an injected therapeutic allergy vaccine aimed at EU-wide approval and marks the culmination of a development programme in which the Company has invested more than £20 million over several years. The submission follows the positive outcome, announced last year, of Allergy Therapeutics' Pollinex Quattro Grass Phase III study, G301, the largest controlled allergy vaccine study ever conducted. The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro has significant clinical benefits over placebo.

Keith Carter, Chief Executive of Allergy Therapeutics, said:

"Injected vaccines are the preferred immunotherapy option for allergy specialists because of the excellent compliance levels. As the injections are controlled by the physicians, they can ensure that the patients receive a full course of therapy.  This is especially the case with Pollinex Quattro because of the ultra short four-shot dosing course. 

"Completion of the regulatory process in the EU will open up new markets as well as enabling us to improve pricing and market share in those European countries where named patient sales are currently already possible.

"Pollinex Quattro Grass has already been through the most rigorous clinical evaluation of any allergy vaccine, delivering clear efficacy benefits as well as excellent levels of tolerability. We look forward to progressing the EU mutual recognition process.

"The development of a pharmaceutical from the pre-clinical stage to registration application by a single company, unpartnered, is a rare achievement in any market. For a small life sciences company to do so in a major disease is a first ever achievement in the United Kingdom biotech industry and represents a significant milestone for Allergy Therapeutics." 

Prof Chris Corrigan, Department of Asthma, Allergy & Respiratory Science at King's College London School of Medicine, Guy's Hospital, said:

"The submission of Pollinex Quattro Grass brings closer the day when this ultra short course allergy vaccine will become widely available to patients and their physicians." 

For further information

About Pollinex Quattro

Pollinex Quattro is a four injection therapeutic vaccine 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 safety and efficacy 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 disease 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% to 25% 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 $10 billion 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.