A marketing authorisation for France was first granted in January 2016 and since then, ALK has been in dialogue with the authorities to secure market access for the product.
Copenhagen, 2017-11-30 12:27 CET (GLOBE NEWSWIRE) --
ALK-Abelló (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that it has reached a satisfactory agreement with health authorities in France for the pricing and reimbursement of its house dust mite sublingual allergy immunotherapy (SLIT) tablet, ACARIZAX®.
ACARIZAX® in France is indicated for both allergic rhinitis and allergic asthma in house dust mite-allergic adult patients whose condition is not well controlled by symptom-relieving medications, and also for the treatment of adolescent patients with house dust mite-induced allergic rhinitis. A marketing authorisation for France was first granted in January 2016 and since then, ALK has been in dialogue with the authorities to secure market access for the product.
Søren Niegel, ALK’s Executive Vice President of Commercial Operations and Product Supply, says: “France is the world’s largest market for sublingual allergy immunotherapy, and this agreement on pricing and reimbursement for ACARIZAX® is the final step before a commercial launch. We now look forward to making this innovative new treatment available to patients nationwide as soon as possible in 2018.”
ACARIZAX® first gained European approval for use in adults in 2015, when it also became the first SLIT-product to be approved for use in allergic asthma. In February 2017, clinical data from the ACARIZAX® clinical development programme led the Global Initiative for Asthma (GINA), for the first time, to add allergy immunotherapy as a treatment option in its Global Strategy for Asthma Management and Prevention. Today, ACARIZAX® is marketed in 12 countries around the world.
ALK-Abelló A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014
This information is information that ALK-Abelló A/S is obliged to make public pursuant to the EU Market Abuse Regulation.
About ALK
ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy – a treatment of the underlying cause of allergy. The company has approximately 2,300 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. Find more information at www.alk.net.
