HAL Allergy Submits Marketing Authorization Applications to the Paul-Ehrlich-InstituteBy Hal Allergy Group, PRNE
Sunday, November 28, 2010
LEIDEN, The Netherlands, November 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."
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 Dusseldorf, 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.
For further information please contact: Harry Flore, CEO HAL Allergy group, Tel: +31(0)88-1959-000, E-mail:corporatecommunications at hal-allergy.nl; Peter Schulte, Marketing & Sales Manager Germany, Tel: +49(0)2-11/9-77-65-0, E-mail:info at hal-allergie.de
Tags: Hal Allergy Group, Leiden, Netherlands, November 29, The Netherlands