Allergy Thera. Regulatory News (AGY)

22 Sep 2008 07:00



Monday 22 September 2008

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")

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

First ever large scale allergy vaccine study showing proof of 

safety and efficacy in Ragweed patients

Further confirmation of Pollinex Quattro safety and efficacy following recently announced results from Pollinex Quattro Grass study

Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, today announces positive results from its Pollinex Quattro Ragweed Phase III study, R301, the second largest controlled allergy vaccine study ever conducted. The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro Ragweed has statistically significant clinical benefits over placebo. On 14 May 2008, Allergy Therapeutics announced that its earlier study, Pollinex Quattro Grass ("G301"), had met its primary efficacy endpoint in what is still the largest allergy vaccine study ever conducted. 

Allergy Therapeutics intends to use the results of the ragweed study to support a Marketing Approval Application in Canada with a submission planned for 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 R301 examined the safety and efficacy of Pollinex Quattro Ragweed in the treatment of seasonal allergic rhino-conjunctivitis ("SAR") caused by ragweed pollen. R301 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 993 patients at up to 85 centres in the United States and Canada. Due to a clinical hold placed on the study by the Food and Drug Administration in the United States related to an adverse event in G301, only 381 patients received all four injections, nevertheless, the study met its primary endpoint with Pollinex Quattro Ragweed demonstrating a statistically significant 12% benefit over placebo (p=0.0478) in this complete treatment group.

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

"This trial provides us with back to back proof of the safety and efficacy of Pollinex Quattro and is truly a scientific breakthrough for allergic patients. Having successfully completed the largest ever allergy vaccine study with our grass product we are pleased to be able to announce the successful completion of the second largest ever study. There is no other allergy vaccine in development or on the market with this depth of proof. We look forward to utilising this data to gain a Canadian registration for Pollinex Quattro ragweed and in support of efforts to continue to make available to patients a much more convenient and rapid treatment for their pollen allergies."

For further information

About the R301 study

Study R301 was a double-blind placebo-controlled study conducted in 85 centres in the United States and Canada. A total of 993 patients were recruited into the study and randomised to receive Pollinex Quattro Ragweed or placebo. Patients were scheduled to receive 4 injections of either Pollinex Quattro or placebo treatment over three weeks prior to the 2007 ragweed pollen season. Patients recorded rhino-conjunctivitis symptoms and medication intake over the course of the 2007 pollen season. 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 study population that completed treatment by receiving all four injections. 

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 £31 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.