Patent Grant

Allergy Therapeutics PLC 03 December 2004 Allergy Therapeutics plc Allergy Therapeutics granted UK patent for sublingual vaccine Allergy Therapeutics (LSE: AGY), the specialty pharmaceuticals company focused on allergy vaccines, announced today it has been granted the first patent for its family of MPL(R)-based sublingual vaccines, by the UK patent office. Allergy Therapeutics believes a sublingual allergy vaccine has significant potential to capture market share from symptomatic treatments, such as antihistamines, as it could be self-administered at home and prescribed by general practitioners. Allergy Therapeutics is developing a sublingual vaccine incorporating MPL(R), which is at the proof of concept stage, the outcome of which is expected in the first half of 2005. The patent is very broad, covering all antigens, and therefore could cover vaccines for any mucosally-transmitted disease as well as allergy. It has been granted jointly to Allergy Therapeutics and Corixa, from which Allergy Therapeutics originally licenced MPL(R) for use in allergy vaccines. Commenting on the granting of the patent, Keith Carter, Chief Executive of Allergy Therapeutics, said: "The granting of this patent marks a milestone for the company as it is the first we have received for a sublingual product in any jurisdiction. Current sublingual allergy vaccines such as our own Oralvac(R) are efficacious but less so than injected vaccines and only after daily dosing lasting one or more years. It is our hope that the incorporation of our patented adjuvant MPL(R) will result in a more efficacious sublingual vaccine with a short dosing schedule. The sublingual development pipeline is at an early stage but we believe it has the potential to mount a real challenge to the dominance of antihistamines in the treatment of allergies." 3 December 2004 For further information: Allergy Therapeutics 01903 844720 Keith Carter, Chief Executive KBC Peel Hunt Ltd 020 7418 8900 Capel Irwin Grandfield 020 7417 4181 Samantha Robbins NOTES TO EDITORS Allergy market Current allergy treatment is almost exclusively concerned with the management of allergic symptoms using drugs such as anti-histamines and steroids supplemented with, in the case of allergic asthma, drugs to improve breathing such as B-agonists. These medicines are available, as oral or inhaled formulations, by prescription and over-the-counter ("OTC"). Although these palliative drugs provide temporary symptomatic relief, they can be inconvenient to use and can cause unwanted side effects. Most importantly, they need to be administered chronically and do not modify the underlying disease state, nor do they prevent the so-called Allergic March from seasonal/perennial rhino-conjunctivitis to allergic asthma. Sales of these palliative symptomatic anti-allergy drugs exceed US$12 billion. An alternative to this palliative treatment is allergy vaccination (also referred to as specific immunotherapy or de-sensitisation). Allergy vaccination (both injectable and sublingual) is currently the only treatment for Type 1 Allergy hypersensitivity that can alter or cure the underlying disease process. Allergy vaccine market Conventional immunotherapy is a gradual immunisation process in which increasing individualised concentrations of pollen extracts are administered to induce increased tolerance to natural allergen exposure. Practice varies, but typically the procedure involves weekly or monthly doses of the offending allergens which, over time, induce immunological tolerance. Three years or more of allergy vaccination is required for long term effect of the treatment. Because of the number of injections (as many as 180), length of treatment and potential risk of serious side effects, a significant portion of patients do not complete the therapy course. As a result, allergy vaccination has less than a 5 per cent. market share in most markets. It is unsurprising that conventional immunotherapy has not captured a significant portion of the growing market for the treatment and prevention of allergies because its complexity and risk limits its use to qualified allergists and limits its attractiveness to patients. Hence Allergy Therapeutics believes that capturing maximum market share with allergy vaccines will come by improving the characteristics of the products. Allergy Therapeutics' short term, well-tolerated, safe and effective MPL(R)-based vaccines are designed, once registered, to achieve this market expansion. While sublingual vaccines have the advantage of not requiring injections, they currently have the disadvantage of requiring daily administration under the tongue and efficacy (relief from allergic symptoms), usually takes more than one year of vaccine administration before reaching significant levels. The pre-clinical work upon which the newly granted patent is based suggests that a mucosally-delivered MPL(R)-containing vaccine may be effective more rapidly and with fewer doses required. About MPL(R) MPL(R) monophosphoryl lipid A. is a Lipopolysaccharide ("LPS") derived from the cell walls of salmonella minnesota that has been purified and detoxified. The non-specific human immune response system recognises LPS as being derived from bacterial sources and reacts to LPS as though it was a bacterial infection. As a result, the immune system mounts a cell-mediated immune response (TH1) and synthesises IgG specific to the challenging material, which in combination with the allergoid creates a rapidly efficacious product. The clinical experience with MPL(R) is extensive, demonstrating the adjuvant to be safe, well-tolerated and effective for human use. This information is provided by RNS The company news service from the London Stock Exchange xchange MSCQKBKPKBDBOBK
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