HAL Allergy submits marketing authorization applications
HAL Allergy today announced that it has filed marketing authorization applications (MAA) for PURETHAL® Mites and SUBLIVAC® 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® Grasses, PURETHAL® Trees,
and VENOMENHAL®. 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."
About HAL Allergy
The HAL Allergy Group (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
170 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.
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