Allergy Thera. Regulatory News (AGY)

5 Jan 2005 07:00

Allergy Therapeutics PLC05 January 2005 5th January 2004 Allergy Therapeutics announces Canadian collaboration and trading update Allergy Therapeutics plc (LSE:AGY), the specialty pharmaceuticals companyfocused on allergy vaccines, today announced it has granted exclusive rights tomarket Allergy Therapeutics' award-winning four-shot allergy vaccine Pollinex(R)Quattro in Canada to Allerpharma Inc, a privately-owned Canadian companyspecialising in allergy. The two companies will collaborate in the developmentof 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 toAllergy Therapeutics totalling £8million during the period of development andregistration of the products. Following registration Allergy Therapeutics willalso be entitled to royalty payments and will supply Allerpharma with theproducts. Simultaneously Allergy Therapeutics has entered into a broad collaboration withAllied Research International ('ARI'), a sister company of Allerpharma.Toronto-based ARI is a well-respected Contract Research Organisation, owned andmanaged by Dr. Piyush Patel, an internationally renowned allergist. ARIoperates an advanced and proven environmental exposure chamber for controlledallergen exposure, making it the ideal partner for the supportive pre-phase IIItrials. Under the terms of the collaboration ARI will conduct a number ofclinical trials (Phases I, II and III) with a view to achieving earlyregistration in the Canadian market of Pollinex(R) Quattro for the treatment ofallergy to Ragweed - the most common cause of seasonal allergicrhino-conjunctivitis in North America. In addition to Ragweed, vaccines for other allergens are also covered by theagreement and Allergy Therapeutics will use the data from all the studies tosupport 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) toconduct the pivotal phase III study for grass, which will initiate globallylater this year, following approval of an Investigational New Drug (IND)application by the US Food & Drugs Administration (FDA). PRA is one of theworld's leading clinical development organisations with more than 2,500employees worldwide. Trading update Allergy Therapeutics expects to announce its maiden interim results for the sixmonths ended 31 December 2004 in early March. The Company will report grosssales in line with market expectations and management projections, whilst costsand profits will be better than expected. Sales of Pollinex(R) Quattro, AllergyTherapeutics' 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 AllergyTherapeutics' sales are taken in the first half of the Company's financial yearand as a consequence the first half results give a better than normal indicationfor 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 beencostly to the company in terms of sales and profits. As from 1 January thisyear the rebate has reverted to 6% and this rebate will be calculated usingcurrent list prices, as opposed to prices as at October 2002 as was previouslythe case. The impact of these measures will be an improvement in net sales andprofits of over £1million in the current financial year, to 30 June 2005, andover £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 AIMin October. With regard to the Canadian agreement, Dr. Patel is a practicingallergist as well as an experienced drug developer and his enthusiasm forPollinex(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 ofour new vaccines. "In Germany, the reversion of the sales rebate to 6% is welcome news for allpharmaceutical companies operating there, but particularly so for smallerbusinesses such as Allergy Therapeutics with a large proportion of salesgenerated in that market. We look to the future with growing confidence." For further information: Allergy Therapeutics 01903 844720Keith Carter, Chief Executive Grandfield 020 7417 4170Samantha Robbins / Charles Cook KBC Peel Hunt 020 7418 8900Capel Irwin NOTES TO EDITORS About Allergy Therapeutics Allergy Therapeutics is a fully integrated, specialty pharmaceuticals businessfocused on the treatment and prevention of allergies. The Group was formed inJune 1998 following the MBI of the Bencard allergy vaccine business fromSmithKline Beecham (now part of GSK). The Group has a manufacturing, sales andmarketing and product development infrastructure dedicated to a portfolio ofmarketed products and a pipeline of development products, focused on achievingregistrations world-wide. The Group has a history of pioneering innovative short course allergy vaccinesby developing well-characterised modified allergens using tyrosine as a depotadjuvant. Allergy Therapeutics' short term development objective is to createallergy vaccines capable of use as a first line therapy for the treatment andcure of allergic diseases including allergic rhinitis, allergic conjunctivitisand allergic asthma. To achieve this, the Group has a pipeline of new vaccinesbased on the patented innovative adjuvant MPL(R) to which the Group has licensedcertain exclusive rights. Through its own sales force in Germany, Italy and Spain and indirectly in morethan 20 countries, including 8 countries through licensing agreements, the Groupcurrently sells and distributes four families of vaccine products, injected andsub-lingual, ranging from registered general seasonal pollen allergyvaccinations for common allergens (such as grass and trees) to patient-specific(named patient products) . The Group also sells a range of skin-prick diagnostictests. 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 theadvancement of clinical research. For over ten years, Allied ResearchInternational (ARI) has been providing services to the Pharmaceutical andBiotechnology industries. These services range from conducting complex singlesite Phase I / Bioequivalence /Bioavailability (BE/BA) studies or early Phase IIstudies, to being a site in multi-center Phase II and III studies. ARI has developed an Environmental Exposure Chamber (EEC) for studies thatrequire controlled allergen exposure. This is a unique solution to the need forlarge Phase II type studies for anti-allergic drugs. In the EEC up to 100subjects can be exposed to known controlled amounts of allergen therebysimulating a heavy pollen day in the season. www.allied-research.com About Allerpharma Allerpharma Inc. is a sister company of ARI, offering a complementary servicefor sales and marketing of products to treat allergies. The business is run byBipin Kothyari, who has over 15 years experience in pharmaceutical sales inCanada. His previous roles have included Director, Clinical Liaison at BristolMyers Squibb and senior positions at GlaxoSmithKline (Vaccine Business Unit) andat Dupont Pharma. About PRA International PRA International is one of the world's leading clinical developmentorganisations, with over 2,500 employees working from offices in North America,Europe, South America, Africa, Australia and Asia. PRA delivers services to itsclients through a unique approach called Project AssuranceSM, which representsthe Company's commitment to reliable service delivery, program-level therapeuticexpertise, 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