Last updated on April 16, 2014 at 14:14 EDT

HAL Allergy Completes Patient Enrolment for its Phase II Trial with SUBLIVAC® FIX Birch

November 6, 2012

LEIDEN, Netherlands, November 6, 2012 /PRNewswire/ –

HAL Allergy B.V. today announced that it has successfully completed patient enrollment
in its Phase II trial with SUBLIVAC(R) FIX Birch. This combined dose tolerability and dose
range finding study will characterize the dose-response relationship of SUBLIVAC(R) FIX
Birch in order to support the optimal dose in terms of clinical efficacy and safety.

The multi-centre, randomized, double-blind, placebo-controlled study in patients with
persistent allergic rhinitis / rhino conjunctivitis was initiated in July 2012 and will be
completed in March 2013. More than 250 patients were included in 21 clinical sites in the
Czech Republic, Poland and Germany. Completion of enrollment is an important milestone in
the clinical development program of SUBLIVAC(R) FIX Birch.

“Timely patient recruitment is often a major hurdle in clinical trials. We are very
proud that recruitment has been successful and appreciate the hard work of our
investigators and the clinical trial team to meet the tight recruitment deadlines that are
an integral part of studies with seasonal allergens. This reinforces our confidence in our
ambitious clinical development program 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).


SUBLIVAC(R) FIX Birch is an allergen extract of birch pollen for sublingual 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 medication.

About HAL Allergy

The HAL Allergy Group 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 270 people
throughout Europe with more than 160 situated in the Netherlands HQ. The German subsidiary
in Duesseldorf, 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: PR Newswire