Allergy Thera. Regulatory News (AGY)

14 May 2008 07:00



Wednesday 14 May 2008

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")

Pivotal Phase III Pollinex® Quattro grass study meets primary efficacy endpoint

Largest ever global study shows ultra-short course allergy vaccine is safe and highly efficacious

Filing for European regulatory approval expected in Q1 2009

Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, today announces positive results from its 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 statistically significant clinical benefits over placebo.

Allergy Therapeutics intends to use the results to support a Marketing Approval Application in the European Union with a submission planned for Q1 2009. Allergy Therapeutics believes that Pollinex Quattro has the potential to transform the treatment of allergy, changing the lives of patients and providing an important new tool for the specialists who treat them. The worldwide market for allergy treatments is estimated to be in excess of $10 billion.

Study G301 examined the safety and efficacy of Pollinex Quattro in the treatment of seasonal allergic rhino-conjunctivitis (“SAR”) caused by grass pollen. G301 was a double-blind, placebo-controlled study comparing the symptom/medication score of patients given four injections of Pollinex Quattro to those patients receiving placebo. The trial enrolled 1,028 patients at 94 centres in the United States, Canada and Europe.

Before entry into the study, patients had suffered from SAR for an average of over 20 years and reported having moderate to severe symptoms. Patients were randomly and equally allocated to receive Pollinex Quattro or placebo. In the Intent To Treat population (all patients in the study) there was a 13.3% improvement with Pollinex Quattro over placebo (p = 0.0038), as measured by a reduction of the combined symptom/medication score (the primary efficacy endpoint). In the prospectively defined patient population who fully recorded key outcomes, Pollinex Quattro showed a dramatic improvement of 26.9% over placebo (p = 0.0031) in the same efficacy endpoint.

The data show that the safety and tolerability of Pollinex Quattro was excellent. Discontinuations due to adverse events were low (1.4% in the Pollinex Quattro arm vs. 0.8% in the placebo arm). The majority of adverse events were local reactions such as injection-site itching.

A total of 92% of patients completed the study (withdrawal rates were 8.0% in the Pollinex Quattro arm vs. 8.6% in the placebo arm). Compliance rates were higher than previously recorded in any other comparable allergy vaccine study with 95.7% of patients receiving the planned number of injections. This high level of compliance demonstrates the clear advantages of Pollinex Quattro as a four injection therapeutic vaccine, offering same season relief in as little as three weeks after treatment.  Current therapeutic options are mainly limited to symptomatic therapies and/or conventional allergen immunotherapy which can require up to 90 injections in over three to five years. These long dosing regimes represent a significant treatment and economic burden for allergy sufferers.

Professor Tony Frew, Professor of Allergy and Respiratory Medicine at the Brighton and Sussex Medical School and Past President of the European Academy of Allergology and Clinical Immunology ("EAACI"), said: 

"Proof of efficacy and safety of Pollinex Quattro in this grass study is a breakthrough for allergy sufferers. Patients in this study showed significant and clinically meaningful improvement in their symptoms with a very good safety and tolerability profile. Importantly, because so few injections are required, compliance rates were excellent and this should be an area of focus for clinicians."

Keith Carter, Chief Executive Officer of Allergy Therapeutics, said:

"This is a landmark study and the most important news in the seventy year history of our Company.  This study has delivered decisive proof to clinicians and patients of the value of Pollinex Quattro. It adds to an existing rich pool of data generated on Pollinex Quattro in many thousands of patients over several years and will enable us to file for regulatory approvals in Europe. This product has the potential to redefine the market for allergy products, offering sufferers a safe and effective therapy with a much more convenient treatment regime than is currently available."

Allergy Therapeutics will be presenting the full results of this study in upcoming scientific meetings including the first complete presentation of the data by Professor Tony Frew on 8 June 2008 during the EAACI meeting.

There will be a presentation and conference call for analysts today at 9:00 AM at Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London, WC2A 1PB. Please call Mo Noonan at Financial Dynamics for further details on 020 7269 7116.

For further information

About the G301 study

Study G301 was a double-blind placebo-controlled study conducted in 94 centres in the United States, Canada and Europe. A total of 1,028 patients were recruited into the study and randomised to receive Pollinex Quattro Grass or placebo. Patients were scheduled to receive 4 injections of either Pollinex Quattro or placebo treatment over three weeks prior to the 2007 grass pollen season. Patients recorded rhino-conjunctivitis symptoms and medication intake over the course of the pollen season from May to September. The primary outcome of the study was the difference in combined symptom plus medication score between active and placebo treatment over the four peak pollen weeks of the season assessed in the whole ('Intent-To-Treat') study population. 

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 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® and Cervarix®.

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 100,000 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 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, 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 specialist pharmaceutical company focused on allergy vaccination. It has a growing, profitable core business achieving sales of allergy vaccines of £26 million in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. The Company is expanding its infrastructure and recently commenced operations in the United Kingdom, Poland, the Czech Republic, Slovakia and Austria.

Allergy Therapeutics has certain exclusive intellectual property rights to the use of MPL in both injected and sublingual vaccines. In addition to progressing to Phase III studies with Pollinex Quattro, the Company has completed a Phase I/II oral vaccine study incorporating MPL.