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ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet, ACARIZAX®, has been approved in Canada.
The New Drug Submission (NDS) for ACARIZAX® was filed with Health Canada in May 2016. ACARIZAX® is indicated as allergy immunotherapy for the treatment of moderate to severe house dust mite-induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age confirmed by a positive skin prick test and/or in vitro testing for D. farinae or D. pteronyssinus IgE antibodies.
Henrik Jacobi, ALK’s Executive Vice President, Research and Development, said: “This new approval expands ALK’s SLIT-tablet range in Canada, which now covers grass, ragweed and, the most common of all respiratory allergies, house dust mite. We continue to develop our organisation and launch readiness in North America ahead of the introduction of the HDM SLIT-tablet.”
ACARIZAX® is currently approved in 18 countries worldwide and launched in nine. Registration reviews are underway in a further eight countries with further submissions planned.
ALK-Abelló A/S
For further information please contact:
Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
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.
http://www.globenewswire.com/NewsRoom/AttachmentNg/36640687-4854-400a-b165-434b0e60920f
