Allergy Thera. Regulatory News (AGY)

26 Jan 2007 10:00

Allergy Therapeutics PLC26 January 2007 26 January 2007 Allergy Therapeutics plc Opening of Noon and Freeman Buildings Significant manufacturing investment leading to creation of 80 jobs Allergy Therapeutics (AIM: AGY) today formally opened its new productionfacility at its Worthing, United Kingdom site. The new building has been namedThe Noon Building while Allergy Therapeutics' existing building has been renamedThe Freeman Building, The buildings have been named in honour of Dr Leonard Noonand Dr John Freeman, the generally recognised "Fathers" of immunotherapy, whowhile working at St Mary's Hospital in London were the first to use allergyvaccines (published June 1911 in The Lancet). In acknowledgment of thepioneering nature of this work Allergy Therapeutics will be making a ResearchGrant to St Mary's Hospital. Allergy vaccination is now used on a global basis with millions of patientsevery year receiving a treatment that works on the underlying cause of thedisease and offers the potential of a cure rather than mere symptomatictreatment. The Noon Building is the cornerstone of an ongoing investment by AllergyTherapeutics to provide world class manufacturing on a global basis fromWorthing. The building houses a state of the art production line for thecompany's Pollinex(R) Quattro allergy vaccine which is currently supplied on anamed patient basis in Europe. Pollinex Quattro is also in Phase III clinicaldevelopment in the first ever Phase III global allergy vaccine trial. Theinvestment is in anticipation of the increased demand expected for PollinexQuattro once approval by the Food and Drug Administration allows for the vaccineto be marketed in the United States. This investment is one of the largest ever in allergy vaccine manufacturing andone of the largest in recent years within the pharmaceutical industry in theUnited Kingdom. It is expected that the expansion of Allergy Therapeutics'manufacturing capabilities in Worthing has resulted in the creation of over 80jobs over a three year period. Attending the opening are fifty leading allergists from around the worldincluding those from Europe, North America and Japan. Opening the building willbe Professor Tony Frew, the President of the European Academy of Allergology andClinical Immunology. Also presenting is Dr Bill Frankland who, at the age of94, is a London based practicing allergist and a former student of Dr Freeman. Keith Carter, Chief Executive of Allergy Therapeutics, said: "This new facility is a crucial step in our plan to make Pollinex Quattro theglobal leader in allergy vaccine. Work can now begin to modernise and expandthe production line in the existing building ahead of the full launch of ourvaccines. "Allergy Therapeutics' aim is to transform allergy treatments by continuousdevelopment of novel, patient friendly, highly-effective treatments for hayfever sufferers worldwide." Professor Tony Frew, President of the European Academy of Allergology andClinical Immunology, said: "Allergy is an increasingly important problem, right across Europe. Young peopleare particularly affected, but increasing numbers of adults are also sufferingwith hay fever, asthma, allergy to pets and other animals, as well as foodallergies such as peanut and fish allergy. We have good basic treatments forallergic symptoms, but we desperately need better ways to treat allergicconditions and get rid of the condition, rather than simply suppressing thesymptoms. Allergy Therapeutics is at the forefront of providing good tools forthe diagnosis of allergies, and developing better forms of vaccines to modifyand hopefully get rid of allergies. This work requires faith in the expertise ofthe scientists and hard work in developing and testing safe, effectivetreatments for these important conditions that affect so many children andadults of working age. Today's ceremony to mark the opening of the new buildingshere in Worthing is an outward and visible sign of the investment being made inthis area, and a very welcome boost to allergy research and development in theUK" For further information Allergy Therapeutics +44 (0) 1903 844 722Keith Carter, Chief Executive Financial Dynamics +44 (0) 207 831 3113David YatesBen Brewerton About Pollinex Quattro There are three programmes of subcutaneous immunotherapy in clinicaldevelopment; Pollinex Quattro Grass, Pollinex Quattro Ragweed & Pollinex QuattroTree, all of which are based on proprietary technologies. Collectively theseform the "Caution: Allergen" programme. Pollinex Quattro Ragweed is currentlyunder review by Health Canada. In addition, an oral vaccine development iscompleting its first phase II study. Pollinex Quattro vaccines contain three distinct technologies which actsynergistically. Natural allergens are chemically modified to improve safety andallow for delivery of higher doses. These are combined with a depot technologyto provide prolonged desensitization and further improved tolerability. Finally,the immune response is specifically enhanced and directed by an adjuvant,monophosphoryl lipid A (MPL). MPL is a Toll-Like 4 Receptor (TLR4) agonist andhas been extensively tested in Pollinex Quattro and other late stage andregistered vaccines including GlaxoSmithKline's Fendrix(R) and Cervarix(R) Pollinex Quattro is an ultra-short course vaccine requiring only four shots overthree weeks and incorporates the TLR4 agonist adjuvant MPL(R). In contrast,existing vaccine treatments typically require between 16 and 50 injections takenunder specialist supervision prior to the start of the hay fever season.Pollinex Quattro therefore has the potential to transform allergy treatment byproviding a safe, effective and highly convenient method of vaccination. TheCompany has three programmes of Pollinex Quattro allergy vaccines in clinicaldevelopment: Grass, Tree and Ragweed. Evidence of the safety and efficacy ofPollinex Quattro has been established through earlier clinical trials in Europe. Furthermore, substantial exposure data in more than 87,000 patients isavailable from the named patient programme in Europe. The market opportunity is considerable with the American Academy of Allergy,Asthma and Immunology estimating that 33 million allergy injections a year aregiven in the United States. Allergic rhinitis (hay fever) is a large andgrowing problem. Prevalence estimates vary on a country by country basis butrange from 14-29% of the total population*. Worldwide over 150m people areestimated to suffer from allergic rhinitis and the prevalence is increasing*.There is a substantial unmet medical need in a market currently worth anestimated US$12 billion per annum. *Decision Resources Allergic Rhinitis June 2005 About Allergy Therapeutics plc Allergy Therapeutics plc is a UK AIM-listed specialty pharmaceutical companyfocused on allergy vaccination. It has a profitable core business achievingsales of allergy vaccines of over £24m in Germany, Italy, Spain and other EUmarkets through its own sales and marketing infrastructure. This information is provided by RNS The company news service from the London Stock Exchange