10th Apr 2006 07:02
Allergy Therapeutics PLC10 April 2006 Allergy Therapeutics plc, "the Group" or "the Company" Placing of 19,000,000 new Ordinary Shares of 0.1p each at 100p per Share Allergy Therapeutics plc, the specialist pharmaceutical Company focused onallergy vaccination, today announces a Placing of £19 million. This additionalcapital will primarily fund the completion of the Company's development pipelineof innovative ultra-short course allergy vaccines, Pollinex(R) Quattro, throughto Registration. The Placing is conditional upon, inter alia, the approval of Shareholders. Acircular convening an EGM of the Company, which is expected to take place on 4May 2006, will be issued shortly. Highlights • Allergy Therapeutics to raise approximately £18.2 million (net of expenses) • Funds to be utilised primarily for the development through Phase III to Registration of the Company's lead product, Pollinex Quattro • Institutional shareholder base further widened with additional new shareholders joining the Register Allergy treatment is one of the largest therapeutic markets worldwide, withestimated annual sales of $11 billion. Current market needs are only partly metby the existing treatments. Allergy vaccines are the only treatment acknowledgedto address the underlying cause of the condition, not just the symptoms. AllergyTherapeutics' strategy is to establish a position as a market leading providerof novel therapies for the prevention and treatment of allergy, by providing acomprehensive range of innovative, patent protected, high value, allergyvaccines. The Company's development efforts are currently focused on its lead product,Pollinex(R) Quattro, a group of ultra-short course allergy vaccinations for thetreatment of allergies to grass, tree and ragweed pollens and Japanese Cedar.Pollinex Quattro has the potential to transform allergy treatment and is theonly ultra-short course allergy vaccine currently on the market. Commenting on the successful fund raising, Keith Carter, Chief Executive ofAllergy Therapeutics said: "This fund raising is a significant step forward for Allergy Therapeutics.Following the successful outcome to our pivotal study for Pollinex QuattroRagweed, the capital raised will help us to complete our Phase III programme forPollinex Quattro and will bring the Company closer to delivering the first andonly simple, four shot allergy vaccine therapy to patients worldwide. "We have been delighted by investor appetite for our new stock, which we believereflects our ongoing success and the strong prospects for Allergy Therapeutics." -ends- For further information please contact: Allergy Therapeutics plc 01903 845 820Keith Carter, Chief ExecutiveIan Postlethwaite, Finance Director Bell Pottinger Corporate and Financial 020 7861 3232Daniel de Belder / Emma Charlton Bridgewell Securities Limited 020 7003 3000Shaun Dobson / Nick Lovering About Allergy Therapeutics plc Allergy Therapeutics plc is a London Stock Exchange (AIM: AGY) listed specialistpharmaceutical company focused on allergy vaccination. It has a profitable corebusiness achieving sales of allergy vaccines of over £22 million through its ownEU sales and marketing infrastructure. Pollinex Quattro incorporates the innovative TLR4 agonist MPL, which acts as anefficient vaccine adjuvant. Allergy Therapeutics has certain exclusiveintellectual property rights to the use of MPL(R) in both injected and oralvaccines. Allergy Therapeutics manufactures its own vaccine products in a MHRA approved,sterile manufacturing facility in Worthing, United Kingdom. In January 2006 theCompany successfully underwent an audit by the MHRA. Expected Placing Timetable Extraordinary General Meeting 11 a.m. on 4 May 2006Admission of the Placing Shares to AIM 8 a.m. on 5 May 2006 Placing Statistics Placing Price 100 penceNumber of Placing Shares being placed on behalf of the Company 19,000,000Number of Ordinary Shares in issue following Admission 81,950,632Percentage of enlarged issued share capital subject to the Placing 23.2%Proceeds of the Placing available to the Company (net of expenses) £18.2 million Background to and reasons for the PlacingAllergy Therapeutics announces today that it is to raise £18.2 million (net ofexpenses), from a Placing of 19,000,000 ordinary shares of 0.1p each at aPlacing price per share of 100 pence. Allergy Therapeutics is a fully integrated, specialist pharmaceuticals businessfocused on the treatment and prevention of allergies. The Group has amanufacturing, sales and marketing, and product development infrastructure whichsupports a portfolio of marketed products and a development pipeline ofinnovative vaccines, and is focused on achieving Registrations of allergyvaccines worldwide. Allergy treatment is one of the largest therapeutic markets worldwide, withestimated annual sales of $11 billion. Allergy Therapeutics' strategy is toestablish a position as a market leading provider of novel therapies for theprevention and treatment of allergies by providing a comprehensive range ofinnovative, patent protected, high value, allergy vaccines. The Company's development efforts are currently focused on its leading product,Pollinex(R) Quattro, a group of ultra short course allergy vaccines for thetreatment of allergies to grass, tree and ragweed pollens and Japanese Cedar.These products use tyrosine as a depot in combination with the innovativepatented adjuvant MPL(R) to which the Group has certain licensed exclusiverights. Pollinex Quattro, the Group's four-shot a year allergy vaccine, is the onlyultra-short course allergy vaccine on the market and the funds raised at thisPlacing, supplemented by the Company's existing cash reserves and the operatingcash flows from the business, will be used primarily to fund the completion ofits development, through to Registration. On a 'named patient product' ('NPP') basis, Pollinex Quattro is already amarketed product in certain EU territories. Over 140,000 treatment sets havebeen sold to date and this represents a considerable body of evidence in supportof the product's development. In the financial year ending 31 December 2005,Pollinex Quattro generated sales of £7.2 million (2004: £5.1million) and saleshave continued to grow in the first half of the current financial year. Thisgrowth was achieved through a targeted approach to marketing in key areas. InGermany, which accounts for approximately 70% of the Group's sales, winning theprestigious MMW Arzneimittelpreis, an Award for pharmaceutical innovation, had,in the Directors' view, a positive effect on sales. Through its own sales force in Germany, Italy, Spain, the UK, Austria, CzechRepublic, Slovakia and Poland and indirectly in more than 20 additionalcountries (including 6 countries through licensing agreements), the Groupcurrently sells and distributes four families of allergy vaccine products,injected and sub-lingual. In addition to Pollinex Quattro, the Group has a rangeof non-MPL(R)-based short-course vaccines, registered in certain markets for themajor allergens of grass, tree and ragweed and sold under the TA Mix andPollinex brand names. The Group's portfolio is completed with Oralvac(R), asublingual product range and Venomil(R), a vaccine for allergies to bee and waspstings. A range of approximately 125 skin-prick allergy diagnostics is alsosold. With its established business and current infrastructure, the Directors believethat the Group has the basis to build a market leading allergy-focusedspecialist pharmaceutical business through product development, in-licensing ofproducts and, in the longer term, the acquisition of both products andbusinesses. Allergy Therapeutics' development objective is to create modern allergy vaccinescapable of use as a first line therapy in the treatment and cure of allergicdiseases including allergic rhinitis, allergic conjunctivitis and allergicasthma. The Board believes that Pollinex Quattro, which requires only fourinjections per year, has the potential to transform allergy treatment, byproviding a convenient, safe, effective and potentially curative method oftreating seasonal allergic rhino-conjunctivitis (hayfever). In mainstream pharmaceuticals, the products prescribed by physicians across theworld must have marketing authorisations, granted by national regulatoryauthorities such as the FDA (tasked with the regulation of human medication inthe United States of America) and the EMEA (the European Union equivalent). Thegranting of such authorisations is commonly referred to as 'Registration' andrequires rigorous proof of product quality, safety and efficacy through clinicaltrials culminating in pivotal 'Phase III' studies. Allergy vaccines have traditionally been made-to-order for individualprescription according to the specific allergen causing the patient symptoms.This has meant that, in general, allergy vaccines fall outside the normalregistration system and are sold as NPPs. As part of Allergy Therapeutics' aim of transforming allergy treatment bymodernising allergy vaccination, the Group has embarked on a programme ofclinical trials with the objective of gaining Registration in all the majormarkets worldwide for the Pollinex Quattro standardised products which aresuitable for a broad range of patients. The proceeds of the Placing willprimarily be applied to achieving this end and to put in place the additionalinternal and external resources this will require. Subject to regulatory approval, Allergy Therapeutics intends to initiate thepivotal Phase III clinical trial programme during 2006 and to run the trialsthroughout the 2007 pollen seasons. Three trials will be conducted, one for eachof the three most prevalent hayfever-causing allergens: grass, tree and ragweed.These studies will be multi-centre, multi-national and conducted in both NorthAmerica and Europe. So far as the Directors are aware, no other allergy vaccinesare being developed on this worldwide basis, which requires the highest standardof evidence of efficacy and safety. R204 development Allergy Therapeutics recently reported the successful outcome of its pivotal clinical efficacy and safety study, R204. This phase II/III data forms a crucial part of the development of the Pollinex Quattro product line, and is pivotal for the Registration of Pollinex Quattro Ragweed in Canada. It is estimated that more than 30 million people in North America suffer from allergies to ragweed. The main outcome of this study showed a statistically significant (pRelated Shares:
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