HAL Allergy submits marketing authorization applications to the Paul-Ehrlich-Institute
Leiden, the Netherlands, 29 November 2010 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.
