Allergy Thera. Regulatory News (AGY)

8 Apr 2009 07:00



FOR IMMEDIATE RELEASE

Allergy Therapeutics plc

Distribution Agreement for Pollinex® R in Canada

Exclusive Negotiation Period for Pollinex Quattro in Canada

WORTHING AND OAKVILLE - 8 April 2009 - Allergy Therapeutics plc ("Allergy Therapeutics"), announces that it has signed an exclusive distribution agreement with Nycomed Canada Inc ("Nycomed") for Pollinex® R, an allergy vaccine for the treatment of allergic rhinitis due to ragweed pollen. Nycomed becomes the exclusive distributor and marketer of the product in Canada.

Additionally, the companies have agreed on an exclusive Negotiation Period for rights to Pollinex® Quattro in Canada for the treatment of grass, ragweed and tree allergies. Pollinex® Quattro is a modern, adjuvanted vaccine and has a unique short dosing course of four injections. Nycomed will support Allergy Therapeutics in their efforts to submit the dossier for Pollinex® Quattro Grass in the first half of 2009. Allergy Therapeutics will work on the submission of Pollinex® Quattro Ragweed in the second half of 2009. Completion of clinical development and submission of Pollinex® Quattro Tree is subject to final agreement.

This agreement follows the submission on the 3rd of March of the Pollinex® Quattro Grass dossier for regulatory approval in the European Union and the announcement last year of the successful completion of Phase III studies for both Pollinex® Quattro Grass and Pollinex® Quattro Ragweed. These two studies are the largest controlled allergy vaccine studies ever conducted. In both studies the primary efficacy endpoint was met and Pollinex® Quattro demonstrated significant clinical benefits in efficacy, safety and patient compliance.

Keith Carter, Chief Executive of Allergy Therapeutics, said:

"Allergy Therapeutics is delighted to have signed an exclusive distribution agreement with one of the global leaders in pharmaceuticals. This is an important development for us particularly given Nycomed's knowledge of respiratory disease and its sales and marketing strength in Canada. Without doubt, Nycomed is a very attractive partner for Pollinex® R and potential future allergy vaccine products in Canada."

Joost van der Mark, Vice President, Business Development, Nycomed said:

"Nycomed is very pleased to add Pollinex® R, to its portfolio of products that can help Canadians who struggle with allergies. This agreement with Allergy Therapeutics reinforces that Nycomed is a company committed to developing relationships with business partners that can make a meaningful difference to Canadians."

For further information

About Pollinex® R

Pollinex® R is a therapeutic vaccine approved for the treatment of allergic conditions caused by Ragweed pollen. It is the predecessor product to Pollinex® Quattro and has been used since the 1980s to treat tens of thousands of Canadians with ragweed allergies.

About Pollinex® Quattro

Pollinex® Quattro is a four injection therapeutic vaccine which is being developed for the treatment of allergic conditions which offers same season relief in as little as three weeks after treatment. It is a family of specific standardised vaccines representing a potentially extensive franchise for Allergy Therapeutics and is a novel entrant in the multibillion dollar global allergy market. It is currently available in Europe on a named patient basis.

Pollinex® Quattro vaccines contain three distinct technologies which act synergistically. Natural allergens are chemically modified to improve safety and allow for delivery of higher doses. These are combined with a depot technology to provide prolonged activity 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 and has been extensively tested in Pollinex® Quattro and other late stage and registered vaccines including GlaxoSmithKline's Fendrix® and Cervarix®.

Evidence of the safety and efficacy of Pollinex® Quattro has been established through clinical trials in North America and Europe. Furthermore, substantial exposure data in more than 130,000 patients is available from the sale of 'named patient' products in Europe.

About Seasonal Allergic Rhino-conjunctivitis

Seasonal allergic rhino-conjunctivitis is commonly referred to as hayfever when it is caused by pollen. It is a widespread condition that usually occurs during the pollen season. It is characterized by sneezing, rhinorrhea, nasal congestion and pruritus of the nose, eyes or throat. It is a type I hypersensitivity response in which allergen binds to immunoglobulin E on the surface of mast cells. This response leads to the release of histamine, prostaglandins and leukotrienes, which cause the inflammation, itching and redness.

Datamonitor has estimated that prevalence rates for allergic rhino-conjunctivitis of 15 per cent to 25 per cent are to be found in Europe with grass identified as the most significant allergen. IMS estimates that sales in 2006 of allergic rhino-conjunctivitis therapies were in excess of ten (10) billion USD in the seven major global markets.

About Allergy Vaccination

Allergy vaccination or immunotherapy is an effective way of modifying or avoiding disease by influencing the immune system. It is essentially a reinforcement of the body's own defence mechanisms and is similar to preventative vaccination against infectious disease; an area of medicine that has met with spectacular success. In allergy vaccination the mechanism is regarded as a correction of the immune system towards a more normal, non-allergic, response.

Allergy vaccination attacks the underlying cause of the problem and provides a patient benefit which is usually long lasting. The World Health Organisation recognises allergy vaccination as the only treatment to target the immunological cause of allergy with the ability to modify disease progression (to more severe allergy and to asthma), decreasing symptoms in the short term and offering long term anti-inflammatory benefits which prevent the development of persistent disease. Allergy vaccination, therefore, has the potential of offering patients a cure for their disease.

About Allergy Therapeutics

Allergy Therapeutics plc is a London Stock Exchange (AIM) listed, integrated specialist pharmaceutical company focused on allergy vaccination. It has a growing, profitable core business achieving sales of allergy vaccines of £31 million in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. The Company is expanding its infrastructure with operations also in the United Kingdom, Poland, the Czech Republic, Slovakia and Austria.

About Nycomed

Nycomed Canada Inc. is a Canadian company belonging to the Nycomed Group, a privately owned, global, market-driven pharmaceutical company. Ranked by sales, the Nycomed Group is among the 28 largest pharmaceutical companies in the world. Nycomed Canada Inc. is based in Oakville, Ontario with more than 220 employees across the country. Through its innovative products and dedicated people, Nycomed Canada Inc. is committed to improving the health of Canadians by providing brand name, science-based medicines that matter. For more information, please visit www.nycomed.ca.