HAL Allergy files MAA for PURETHAL Mites and SUBLIVAC FIX products at Paul-Ehrlich-Institute

Nov 29 2010

HAL Allergy today announced that it has filed marketing authorization applications (MAA) for PURETHAL(R) Mites and SUBLIVAC(R) FIX Grasses, Trees, and Mites (incl. homologous group products) at the Paul-Ehrlich-Institute, the regulatory authority in Germany.

The applications were submitted in accordance with the German Regulation on Therapy Allergens. Under the enactment of this Regulation, named-patient products for the treatment of most prevalent allergies must have a marketing authorization. The MAA of products that were on the German market at the time the Regulation came into effect (November 14, 2008) have to be submitted by December 1, 2010 to the German authorities. The Regulation provides for a maximum transition period of seven years to complete the clinical data on safety and efficacy for final marketing authorizations.

HAL Allergy also confirms that the MAA for each of the indicated products include a Paediatric Investigation Plan (PIP) that has been approved by the European Medicines Agency (EMA). The applications therefore comply with EU Regulation (EC) No 1901/2006, which mandates that any MAA for a new medicinal product should include either the results of studies in compliance with an agreed PIP, or a decision on a waiver or on a deferral from the EMA.

Dr. Harry Flore, CEO of the HAL Allergy group said:

"The German immunotherapy market is the largest in Europe and also the main market for HAL Allergy. The MAA submission is an important step for us and underlines our ambition to strengthen our position in Germany. With the submission we commit ourselves to a state-of-the-art clinical trial program to support final licensure of our products. In this way, we will assure the continued delivery of our first-in-class allergy vaccine therapies to the German market and reinforce our corporate value to remain a reliable partner for physicians and their allergic patients."

Jean Lumovici, General Manager of HAL Allergie GmbH in Germany said:

"The filing of the MAA for our subcutaneous therapy for house dust mite (HDM) allergy and our sublingual therapies for grass and trees pollen and HDM allergies is a major milestone towards completion of our portfolio of products which are already registered in Germany, i.e., PURETHAL(R) Grasses, PURETHAL(R) Trees, and VENOMENHAL(R). Having a long and successful history as one of the main providers of allergy vaccines in Germany, HAL Allergie GmbH will continue offering a broad range of immunotherapy products that covers most inhalant allergies."