Allergy Thera. Regulatory News (AGY)

11 March 2013

Allergy Therapeutics plc

("Allergy Therapeutics" or "the Company")

Allergy Therapeutics granted US patent for sublingual administration of MPL adjuvant and vaccine antigens

Allergy Therapeutics (LSE: AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that the US Patent office has granted a broad technology patent relating to the Company's family of MPL®-based sublingual allergy vaccines. This patent (jointly held with Corixa Inc) covers the use of glycolipid adjuvant administered sublingually with one or more antigens, for use in the treatment of allergy or other diseases (infections, cancer or autoimmunity). The patent has already been granted in Europe and Japan.

Allergy Therapeutics' new generation of allergy vaccines use MPL®, an innovative TLR4-agonist, as an adjuvant to boost and accelerate the immune response of an allergy vaccine. Allergy Therapeutics has already conducted and previously published results of a double-blind, placebo controlled, dose ranging Phase IIa 'Proof of Concept' MPL-based oral allergy vaccine study. The study was conducted in 80 grass-sensitive human subjects and involved the addition of MPL to Allergy Therapeutics' ORALVAC® grass pollen vaccine. The results demonstrated that MPL could convey the same benefits in a sublingual vaccine as it does in a subcutaneous vaccine, namely stimulating and re-directing the immune response to give clinical benefit from a shortened course of treatment1.

The development of a convenient, effective, short course, well tolerated oral allergy vaccine would have significant implications for allergy therapy and redefine the market for allergy products. Currently available oral allergy vaccines require prolonged treatment periods which may limit their usefulness. Allergy Therapeutics believes a short course sublingual allergy vaccine has significant potential to capture market share from the oral segment of the allergy vaccine market. The Company will require a partner to advance this opportunity.

Commenting on the granting of the patent, Manuel Llobet, Chief Executive of Allergy Therapeutics, said:

"An adjuvanted oral vaccine for Allergy could have the potential to reduce significantly the length of current oral allergy vaccine treatments and bring a breakthrough product to the oral allergy vaccine segment, as we saw with Pollinex Quattro in the subcutaneous market."

1 Pfaar O et al. Int Arch Allergy Immunol 2011; 154: 336-344

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For further information:

About ORALVAC® and MPL

ORALVAC is a sublingual immunotherapy containing standardized aqueous allergen extracts administered under the tongue as a metered dose. Altogether 17 different allergens (pollens, mites, epithelia and moulds) are available in ORALVAC and up to 4 may be mixed in an individual formulation. The product has been available for 'named patient' use since 1994 and to date it is estimated that approximately 100,000 patients have received treatment. The ORALVAC Compact formulation has recently been launched in Germany and allows for the maintenance dose to be reached on the first day of treatment.

MPL (monophosphoryl lipid A) 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®.

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.

About Allergy Vaccination

Allergy vaccination or allergen immunotherapy is an effective way of modifying or avoiding disease by influencing the immune system. It reinforces the body's own defence mechanisms and is similar to preventative vaccination against infectious disease. In allergy vaccination the mechanism is regarded as a correction of the immune system towards a more normal, non-allergic, response.

Allergy vaccination addresses 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 is a specialty pharmaceutical company focused on allergy vaccination. It has a growing business achieving gross sales for the previous financial year of £43.8 million, mainly in Europe through its own sales and marketing infrastructure and further afield through distributors. The Company is expanding its infrastructure into the Emerging Markets