Agreement & Trading Update

Allergy Therapeutics PLC 05 January 2005 5th January 2004 Allergy Therapeutics announces Canadian collaboration and trading update Allergy Therapeutics plc (LSE:AGY), the specialty pharmaceuticals company focused on allergy vaccines, today announced it has granted exclusive rights to market Allergy Therapeutics' award-winning four-shot allergy vaccine Pollinex(R) Quattro in Canada to Allerpharma Inc, a privately-owned Canadian company specialising in allergy. The two companies will collaborate in the development of Pollinex(R) Quattro vaccines for allergy to Ragweed, grass and tree pollen and to house dust mite. In anticipation of the registration of Pollinex(R) Quattro, Allerpharma will also have the rights to sell Allergy Therapeutics' existing registered Ragweed allergy vaccine, Pollinex(R) R, in Canada. Under the terms of the agreement Allerpharma will make milestone payments to Allergy Therapeutics totalling £8million during the period of development and registration of the products. Following registration Allergy Therapeutics will also be entitled to royalty payments and will supply Allerpharma with the products. Simultaneously Allergy Therapeutics has entered into a broad collaboration with Allied Research International ('ARI'), a sister company of Allerpharma. Toronto-based ARI is a well-respected Contract Research Organisation, owned and managed by Dr. Piyush Patel, an internationally renowned allergist. ARI operates an advanced and proven environmental exposure chamber for controlled allergen exposure, making it the ideal partner for the supportive pre-phase III trials. Under the terms of the collaboration ARI will conduct a number of clinical trials (Phases I, II and III) with a view to achieving early registration in the Canadian market of Pollinex(R) Quattro for the treatment of allergy to Ragweed - the most common cause of seasonal allergic rhino-conjunctivitis in North America. In addition to Ragweed, vaccines for other allergens are also covered by the agreement and Allergy Therapeutics will use the data from all the studies to support its programme of world-wide registrations for Pollinex Quattro, including the US and European markets. Phase III Clinical Trials Allergy Therapeutics has also selected PRA International Inc. (NASDAQ:PRAI) to conduct the pivotal phase III study for grass, which will initiate globally later this year, following approval of an Investigational New Drug (IND) application by the US Food & Drugs Administration (FDA). PRA is one of the world's leading clinical development organisations with more than 2,500 employees worldwide. Trading update Allergy Therapeutics expects to announce its maiden interim results for the six months ended 31 December 2004 in early March. The Company will report gross sales in line with market expectations and management projections, whilst costs and profits will be better than expected. Sales of Pollinex(R) Quattro, Allergy Therapeutics' award-winning four-shot allergy vaccine, show growth of nearly 40% over the same period last year. Owing to the seasonality of the allergy market, some 70% of Allergy Therapeutics' sales are taken in the first half of the Company's financial year and as a consequence the first half results give a better than normal indication for full year performance. German statutory sales rebate At present, nearly 70% of Allergy Therapeutics' sales are generated in Germany, so the increase of the compulsory rebate from 6% to 16% in January 2004 has been costly to the company in terms of sales and profits. As from 1 January this year the rebate has reverted to 6% and this rebate will be calculated using current list prices, as opposed to prices as at October 2002 as was previously the case. The impact of these measures will be an improvement in net sales and profits of over £1million in the current financial year, to 30 June 2005, and over £2.5million in a 12 month period at current sales levels. Commenting on these developments Keith Carter, CEO of Allergy Therapeutics, said: "We are very pleased to be able to report on our progress since listing on AIM in October. With regard to the Canadian agreement, Dr. Patel is a practicing allergist as well as an experienced drug developer and his enthusiasm for Pollinex(R) Quattro is further validation of our development plans. The Canadian market is the 8th largest in the world and therefore the milestone payments Allergy Therapeutics will receive reflect the commercial potential of our new vaccines. "In Germany, the reversion of the sales rebate to 6% is welcome news for all pharmaceutical companies operating there, but particularly so for smaller businesses such as Allergy Therapeutics with a large proportion of sales generated in that market. We look to the future with growing confidence." For further information: Allergy Therapeutics 01903 844720 Keith Carter, Chief Executive Grandfield 020 7417 4170 Samantha Robbins / Charles Cook KBC Peel Hunt 020 7418 8900 Capel Irwin NOTES TO EDITORS About Allergy Therapeutics Allergy Therapeutics is a fully integrated, specialty pharmaceuticals business focused on the treatment and prevention of allergies. The Group was formed in June 1998 following the MBI of the Bencard allergy vaccine business from SmithKline Beecham (now part of GSK). The Group has a manufacturing, sales and marketing and product development infrastructure dedicated to a portfolio of marketed products and a pipeline of development products, focused on achieving registrations world-wide. The Group has a history of pioneering innovative short course allergy vaccines by developing well-characterised modified allergens using tyrosine as a depot adjuvant. Allergy Therapeutics' short term development objective is to create allergy vaccines capable of use as a first line therapy for the treatment and cure of allergic diseases including allergic rhinitis, allergic conjunctivitis and allergic asthma. To achieve this, the Group has a pipeline of new vaccines based on the patented innovative adjuvant MPL(R) to which the Group has licensed certain exclusive rights. Through its own sales force in Germany, Italy and Spain and indirectly in more than 20 countries, including 8 countries through licensing agreements, the Group currently sells and distributes four families of vaccine products, injected and sub-lingual, ranging from registered general seasonal pollen allergy vaccinations for common allergens (such as grass and trees) to patient-specific (named patient products) . The Group also sells a range of skin-prick diagnostic tests. www.allergytherapeutics.com About Allied Research International Allied Research International Inc. (formerly known as Allied Clinical Research) is a dynamic group of scientific and medical professionals dedicated to the advancement of clinical research. For over ten years, Allied Research International (ARI) has been providing services to the Pharmaceutical and Biotechnology industries. These services range from conducting complex single site Phase I / Bioequivalence /Bioavailability (BE/BA) studies or early Phase II studies, to being a site in multi-center Phase II and III studies. ARI has developed an Environmental Exposure Chamber (EEC) for studies that require controlled allergen exposure. This is a unique solution to the need for large Phase II type studies for anti-allergic drugs. In the EEC up to 100 subjects can be exposed to known controlled amounts of allergen thereby simulating a heavy pollen day in the season. www.allied-research.com About Allerpharma Allerpharma Inc. is a sister company of ARI, offering a complementary service for sales and marketing of products to treat allergies. The business is run by Bipin Kothyari, who has over 15 years experience in pharmaceutical sales in Canada. His previous roles have included Director, Clinical Liaison at Bristol Myers Squibb and senior positions at GlaxoSmithKline (Vaccine Business Unit) and at Dupont Pharma. About PRA International PRA International is one of the world's leading clinical development organisations, with over 2,500 employees working from offices in North America, Europe, South America, Africa, Australia and Asia. PRA delivers services to its clients through a unique approach called Project AssuranceSM, which represents the Company's commitment to reliable service delivery, program-level therapeutic expertise, easy, global access to knowledge and involved senior management. www.prainternational.com This information is provided by RNS The company news service from the London Stock Exchange
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