HAL Allergy Includes First Patient in Phase II PURETHAL® Mites Study

Included the first patient in its PHASE II dose range finding study. This multi-centre, randomized, double-blind, placebo-controlled study in patients with persistent allergic

LEIDEN, The Netherlands I October 31, 2011 I HAL Allergy B.V. today announced that it has included the first patient in its PHASE II dose range finding study. This multi-centre, randomized, double-blind, placebo-controlled study in patients with persistent allergic rhinitis/rhinoconjunctivitis will characterize the dose-response relationship of PURETHAL® Mites in order to support the optimal dose in terms of clinical efficacy and safety. The study has been initiated in September 2011 in 5 European countries.

PURETHAL® Mites is currently on the market in Germany and several other European countries on a named patient basis. Due to changes in the regulatory landscape immunotherapy products containing common allergens (such as house dust mite) can remain on the market but require a development program that is designed to obtain full marketing authorization. The approval and start of this study are important steps to obtain final licensure for the use of PURETHAL® Mites in the treatment of immediate type allergic disorders (IgE-mediated), such as allergic rhinitis and allergic conjunctivitis induced by house dust mite allergy. It follows the submission of a marketing authorization application (November 2010) for PURETHAL® Mites at the Paul-Ehrlich-Institute, the regulatory authority in Germany.

The design of the study complies with the current state of the art guidelines on the clinical development of products for specific immunotherapy for the treatment of allergic diseases and the German Regulation on Therapy Allergens.

"The initiation of this trial is an important milestone for HAL Allergy's clinical development plan. It also stresses our commitment to meet today's requirements for gaining registration for specific immunotherapy products," says Harry Flore, CEO of HAL Allergy.

About Allergic Rhinitis

Allergic rhinitis is a common chronic inflammatory disease of the upper airways characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion. The prevalence is estimated to be as high as 25% in developed countries. The disease has an impact on the quality of life of patients and is associated with considerable direct and indirect costs. The most recent estimate of the annual costs of allergic rhinitis range from $2 to 5 billion in the USA (2003 values).

About PURETHAL® Mites

PURETHAL® Mites is a modified aluminum hydroxide-adsorbed extract of house dust mites for subcutaneous use. The product is in commercial use and is primarily prescribed for patients suffering from severe allergic respiratory diseases inadequately controlled despite the use of symptomatic treatments.

About HAL Allergy

The HAL Allergy Group (http://www.hal-allergy.com) was established in 1959 and is a main European manufacturer of allergy vaccines and diagnostics. The Group's products are distributed via subsidiaries in Germany, Spain, Italy, Poland, Austria and the Benelux as well as a network of distribution partners around Europe. Currently HAL Allergy employs over 280 people throughout Europe with more than 160 situated in the Netherlands HQ. The German subsidiary in Düsseldorf, in operation since 1977 and one of the top three players in the largest allergy market, employs 60 people and is the main sales and marketing operation for the HAL Allergy Group.

SOURCE: HAL Allergy Group

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