1 December 2010 -- Allergy Therapeutics, the specialist pharmaceutical company focused on allergy vaccination, announces that, in line with its stated plan, it has submitted 10 Marketing Authorisation Applications (‘MAAs’) to the Paul Ehrlich Institute, the Regulatory Authority for biological products in Germany. This achievement has been in response to the introduction of the Therapeutic Allergen Regulation (‘TAV’) which has changed the regulatory landscape in Germany. To date many products have been available in Germany on a ‘named patient’ basis, however, as a result of the TAV all immunotherapy products containing common allergens (grass, trees, house dust mites and insect venoms) will need Marketing Authorisations by 2017.
Since 2008, Allergy Therapeutics has reviewed its product portfolio and has been preparing MAAs for its top 10 products in the Pollinex Quattro, Tyrosin TU t.o.p. and Oralvac Compact ranges. This has been a major project that has required significant investment over the past two years and will result in the Company continuing to offer an attractive portfolio of products.
Manuel Llobet, Chief Executive of Allergy Therapeutics, said:
“The regulatory landscape in Germany, the largest immunotherapy market in Europe, has been undergoing a significant period of change. Our response has been a crucial project for Allergy Therapeutics and its completion is a major achievement. The regulatory changes should favour the Company as the market will become focused on evidence-based, approved, value-added immunotherapy products and Allergy Therapeutics is well-placed to deliver a range of such products.”
For further information
Manuel Llobet, Chief Executive
Tom Holdich, R&D Director +44 (0) 1903 845 820
Nomura Code Securities
Juliet Thompson/ Clare Terlouw +44 (0) 207 776 1200
Ben Brewerton / Susan Quigley +44 (0) 207 831 3113
About Pollinex® Quattro
Pollinex® Quattro is a four injection therapeutic vaccine which is being developed 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.
About Oralvac ® Compact
Oralvac, our sublingual product, was recently re-launched in a new and improved form as Oralvac® Compact. Oralvac® Compact’s dosing schedule allows for a more rapid and simpler escalation of dosage, making treatment more convenient for patients and doctors. Oralvac® Compact contains up to four allergens extracts from a wide range of pollens, mites, moulds and animal hair, taking only 1 hour to reach maintenance dose.
About Tyrosin TU t.o.p
Tyrosin T.U. t.o.p is our conventional subcutaneous immunotherapy which includes tyrosine as a depot component and is available in a wide range of selected standardised allergen extracts. The Company has pioneered the use tyrosine, a natural amino-acid, instead of aluminium in the design of slow-release depot formulations for allergy vaccines, increasing the safety profile and enhancing the efficacy-associated immunological changes.
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 £41 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, Switzerland, the Czech Republic, Slovakia, Austria and the Netherlands.
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