Regulatory Filings • Nov 20, 2014
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Download Source FileCopenhagen, 2014-11-20 11:55 CET (GLOBE NEWSWIRE) --
ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that a registration
application for the house dust mite sublingual allergy immunotherapy tablet has
been submitted in Europe. House dust mites are the most common cause of
respiratory allergic disease, affecting an estimated 35 million adult Europeans
of whom more than 3 million are poorly controlled with current standard
pharmacotherapy.
Today, ALK's regulatory filing for the house dust mite (HDM) sublingual allergy
immunotherapy (SLIT) tablet has been accepted for review by the European health
authorities via the Decentralised Procedure with Germany as the Reference
Member State.
“The filing is a landmark event as the HDM SLIT-tablet is ALK's most important
product candidate and the first of its kind in Europe. House dust mites are the
most common cause of respiratory allergic disease. The condition appears early
in life, it is present all year round, and involves both allergic rhinitis and
allergic asthma. Our ambition is that patients, who are in poor control of
their disease despite the use of symptom-relieving medication, are relieved
from the burden of this chronic disease," says Jens Bager, President and CEO of
ALK.
The regulatory review process is expected to take around 12 months, which means
that, subject to approval, the first launches could possibly take place in
2016.
The European market
House dust mite allergy is estimated to affect 35 million adult Europeans, of
whom more than 3 million are poorly controlled and experience persistent
moderate to severe symptoms despite the use of symptom-relieving medication1,2.
An additional 1 million children and adolescents are estimated to be in the
same situation1,2,3. ALK estimates that roughly 50% of these patients live in
countries where they have no or very limited access to allergy immunotherapy
treatment. For the sufferers and society as a whole, the impact of respiratory
allergic disease is significant. Almost 70% of patients with allergic rhinitis
feel that their condition limits their way of life and 43% of patients
suffering from allergic rhinitis and allergic asthma have difficulties
sleeping4.
Supporting clinical data
ALK’s regulatory filing is supported by a clinical development programme
involving approximately 3,000 patients. Data from the clinical trials
demonstrated efficacy in both HDM allergic asthma and HDM allergic rhinitis.
The pivotal Phase III MITRA trial in HDM allergic asthma demonstrated that the
tablet significantly reduced patients’ risks of moderate or severe asthma
exacerbations. Measured as a hazard ratio, patients treated with the 12 SQ-HDM
dose experienced a 34% reduction in the risk of suffering moderate or severe
asthma exacerbations compared with placebo treated patients during reduction of
inhaled corticosteroids. This included a 36% reduction in the patients' risk of
experiencing nocturnal awakenings and/or increased daytime symptoms due to
their asthma5.
The pivotal Phase III MERIT trial in HDM allergic rhinitis involved patients
who were highly symptomatic despite regular use of pharmacotherapy. The trial
demonstrated that the tablet significantly reduced patients' rhinitis symptoms
and medication use. Patients treated with the 12 SQ-HDM dose experienced a 22%
reduction in the median combined symptom and medication score compared with the
placebo group. This effect represents an additional benefit on top of the
effect provided by pharmacotherapy since all treatment groups had free access
to guideline-recommended pharmacotherapy during the entire trial. Moreover, the
treatment reduced the patients’ risk of experiencing days with rhinitis
exacerbations by 50% (defined as a day impacted by severe allergic rhinitis
symptoms)6.
Both the MITRA and MERIT trials demonstrated that the treatment was well
tolerated.
Global development programme
The HDM SLIT-tablet is also in late-stage clinical development in North America
and Japan. The joint development activities in Europe, North America and Japan
form the largest clinical development programme in the history of allergy
immunotherapy.
In North America, ALK’s partner Merck & Co., Inc. (known as MSD outside the USA
and Canada) is currently conducting a Phase III clinical trial to investigate
the safety and efficacy of the HDM SLIT-tablet in the treatment of HDM allergic
rhinitis. The trial is expected to be completed in 2015 and is intended to form
the basis for a registration application.
In Japan, ALK’s partner Torii Pharmaceutical Co., Ltd. is currently preparing
to submit a registration application within the next 3-5 months for the HDM
SLIT-tablet. The application is based on Japanese Phase III data that
demonstrated efficacy in HDM allergic rhinitis. Subject to approval, the HDM
SLIT-tablet could reach the market in Japan in 2016.
ALK intends to conduct further clinical trials with the HDM SLIT-tablet to
allow access to China and other emerging markets. Additional clinical
development in the coming years is expected to also include trials to support
paediatric use and the prevention of allergic asthma. Once completed, the
programme is expected to have involved more than 8,000 patients.
ALK estimates that close to 200 million people are affected by house dust mite
respiratory allergic disease in Europe, North America, Japan and China. A
proportion of these patients are facing moderate to severe symptoms which are
poorly controlled with current standard pharmacotherapy and there is an unmet
medical need for additional treatment options.
This announcement does not impact ALK’s financial guidance for 2014.
ALK-Abelló A/S
For further information please contact:
Jens Bager, President and CEO, tel. +45 4574 7576
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Press: Martin Barlebo, tel. +45 4574 7901, mobile +45 2064 1143
About ALK
ALK is a research-driven global pharmaceutical company focusing on allergy
prevention, diagnosis and treatment. ALK is the world leader in allergy
immunotherapy – a unique treatment of the underlying cause of allergy. The
company has approximately 1,800 employees with subsidiaries, production
facilities and distributors worldwide. ALK has entered into partnership
agreements with Merck and Torii to commercialise sublingual allergy
immunotherapy tablets in North America and Japan, respectively. The company is
headquartered in Hørsholm, Denmark, and listed on NASDAQ Copenhagen. Find more
information at www.alk.net.
References:
http://www.efanet.org/wp-content/documents/EFABookonRespiratoryAllergiesFINAL.pd
f
5. Data on file ALK: MITRA (MT-04) Integrated Clinical Trial Report
6. Data on file ALK: MERIT (MT-06) Integrated Clinical Trial Report
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