FAQs
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1.
What is Allergy Therapeutics plc (ATp)'s business?
Allergy Therapeutics is a fully integrated, specialty pharmaceuticals business currently focused on the treatment and prevention of allergies. The group was formed in June 1998 following a management buy-in ("MBI") of the Bencard allergy vaccine business from SmithKline Beecham.
The group has a manufacturing, sales and marketing and product development infrastructure supporting a portfolio of marketed products and a development pipeline of innovative vaccines, focused on achieving registrations world-wide.
The group's marketed products are focused on ultra short-course injected allergy vaccines sold under the Pollinex® Quattro and Pollinex® brand names and sublingual vaccines sold under the Oralvac® name.
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2.
What is the group structure?
THE GROUP'S OPERATIONS
Allergy Therapeutics has its corporate, product development and manufacturing base in Worthing, UK. The European subsidiaries are sales and marketing operations selling the group's products in their associated territories.
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3.
Is ATp profitable?
ATp's core business selling and marketing allergy vaccines is profitable. Operating Profit before R&D was £0.6 Million in the year ended 30 June 2008. The strategy of investing heavily in development of new, improved adjuvanted vaccines will mean that until Pollinex Quattro is launched the R&D spend will exceed profits, making the group as a whole loss-making in that period.
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4.
Why has ATp listed on AIM?
We chose AIM because it is a growing market for smaller, more dynamic companies such as ATp and the costs and documents of compliance are relatively light.
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5.
Who are your worldwide distributors?
Canada - Nycomed, The Netherlands - Artu Biologicals N.V., Portugal - Decomed Pharmaceutics S.A., South Korea - Shinkwang New Drug Co. Ltd., Switzerland - Teomed AG, Greece - Kite Hellas
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6.
What is the company's strategy?
Corporate objectives
The market is such that 15-40% of the population of the developed world are allergy sufferers; the numbers are growing at approximately 5% p.a An estimated 60m Americans, 60m EU citizens and 30m Japanese are allergic rhinitis sufferers - our potential market is in excess of 150m patients. Current treatments have estimated sales of US$ 400m at current selling prices.
Our aim is to become a major player in the allergy market by increasing the size of the allergy vaccine segment by making injectible allergy vaccines more broadly accepted by;
Becoming the recognised leader in allergy related therapeutics will be achieved through;
the transformation of allergy treatment by technological change
efficient own pan-EU sales and marketing infrastructure
appropriate partnering to commercialise in other markets
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7.
Can you outline ATp products?
The group's product families are characterised by the mode of delivery: injected or sublingual. There are three injected lines: the ultra short course (four shots) MPL®-containing Pollinex® Quattro; the short course (six shots) registered Pollinex® range; and the long course (twelve shots) products marketed under the Tyrosin TU brand. The sublingual line is marketed under the brand name Oralvac®. The group has registered products for the most common allergens, namely grasses and trees. Other products marketed (where permitted) are named patient specific products, where a wider variety of allergens are available and can be mixed (for example, birch, ragweed and plantain pollen extracts). The group has taken advantage of its familiarity with named patient product distribution and its infrastructure for processing and fulfilling orders for named patient prescriptions to sell, on a limited basis, Pollinex® Quattro prior to its registration.
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8.
Which products are currently under development?
The group is developing a range of ultra-short course MPL®-based subcutaneous allergy vaccines, administered as four injections before the start of the pollen season. The products are for the treatment of allergic rhino-conjunctivitis to specific, high-prevalence allergens. The objective of the products is to relieve the symptoms and reduce the dependence of the patient on symptomatic medication such as anti-histamines and steroids, by engendering a specific TH2 to TH1 switch. The group is in the advantageous position of having already conducted successful preliminary double-blind placebo controlled studies on these vaccines and, as a consequence, having marketed these products (Pollinex® Quattro) in certain European markets since 1999 as named patient products. With the benefit of these preliminary studies and the wealth of safety and efficacy data generated by the clinical use of the products (over 130,000 patients and 270,000 treatment sets have been sold to date), the directors believe that the probability of success with the Phase III registration studies are high. The group currently has ultra-short course allergy vaccines in various stages of full scale development leading to registration. These vaccines are for the four key allergens of grass, tree, ragweed and Japanese cedar. It is estimated that these allergy vaccines cover the needs of approximately two thirds of allergic rhino-conjunctivitis sufferers in the main pharmaceutical markets of Europe, the US and Japan. Large Phase III pivotal trials for registration of the grass and ragweed products in Europe and Canada have been completed and the directors expect that first registrations will be achieved in early 2010.
Short Course Sublingual Allergy Vaccines
Pre-clinical experiments with MPL® administered sub-lingually have demonstrated immune system stimulation and the induction of specific IgA and IgG. AT has now also conducted an initial proof of concept study in humans which has demonstrated clinical and immunological improvements indicating MPL may potentially have the same pattern of effect when given sub-lingually as when administered subcutaneously. The directors believe that highly efficacious sublingual allergy vaccines based on MPL® with allergen could be developed. Such ‘oral’ allergy vaccines would be self-administered in suitable form to deliver the vaccine to the oral cavity. By incorporating MPL®, the intention is to improve the efficacy of sublingual vaccines and simplify the dosing regimes. The added convenience of safe and easy home administration would make the product suitable for a wide group of patients. The group would envisage developing sublingual vaccines particularly against persistent allergy to allergens such as house dust mite.
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9.
What is the competitive environment for Allergy Therapeutics plc's (ATp) products?
Owing to the size of the commercial opportunity presented by the therapeutic area, some of the world's largest pharmaceutical companies are active in the allergy field. GSK, Aventis, AstraZeneca, Merck and Novartis, amongst others, all have interests in the symptomatic market. Many of the largest selling products in this sector are either off-patent or sold over the counter in increasingly important markets. Within the allergy vaccine niche there are no major pharmaceutical companies present, with the exception of Merck KGaA, parent of Allergopharma. In addition to ATp and Allergopharma, there are three allergy vaccine companies operating multinationally: ALK-Abelló, Stallergènes and HAL. At the national level, there is a multiplicity of small players serving local markets. There is much similarity between all of these companies in terms of product offerings. Other than fast-melt tablet formulations of sublingual vaccines, where efficacy has proven difficult to establish, the Directors are not aware of any competitor having an innovative vaccine pipeline.
In the field of immune-system based treatments for allergy, such as those pursued by the group, the most notable development by a potential competitor is DNA Immunostimulatory Sequences combined with the major allergen of ragweed, Amb A1, being developed in the US by Dynavax.
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10.
Are there any restrictions on transfer of AIM securities of Allergy Therapeutics?
There are no restrictions on transfer of AIM securities of Allergy Therapeutics plc (AGY)
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