ALK Announces FDA Approval for its House Dust Mite Sublingual Allergy Immunotherapy Tablet (ACARIZAX® in Europe)

Hørsholm, Denmark (ots/PRNewswire) -

ALK (ALKB:DC (http://alk-b.co/) / OMX: ALK B / AKABY / AKBLF)
today announced that the US Food and Drug Administration (FDA) has
approved the Biologics License Application (BLA) for its house dust
mite (HDM) sublingual allergy immunotherapy (SLIT) tablet.

(Logo: http://photos.prnewswire.com/prnh/20160420/357628LOGO )

The HDM SLIT-tablet is an allergen extract and, in the USA, it is
indicated as immunotherapy for house dust mite (HDM)-induced allergic
rhinitis, with or without conjunctivitis, confirmed by in vitro
testing for IgE antibodies to Dermatophagoides farinae or
Dermatophagoides pteronyssinus house dust mites, or skin testing to
licensed house dust mite allergen extracts. The HDM SLIT-tablet is
approved for use in adults 18 through 65 years of age. The HDM
SLIT-tablet is marketed in Europe and Australia under the brand name
ACARIZAX® and in Japan as MITICURE[TM].

The BLA for the HDM SLIT-tablet was originally submitted by MSD
(known as Merck in the USA and Canada) in February 2016 under a
partnership agreement with ALK. Since then, the partnership has ended
and all North American rights to the SLIT-tablet portfolio have been
repatriated to ALK following a six-month, managed handover between
the two companies.

Carsten Hellmann, President and CEO of ALK, said: "The approval of
the HDM SLIT-tablet marks the beginning of a new era for ALK in the
USA as we now take full control of the SLIT-tablet portfolio and
integrate it into our existing US business. The coming months will
see a scaling up of our US organisation so that we can market the
already launched GRASTEK® and RAGWITEK®, and build our competences
and launch readiness ahead of the introduction of the HDM SLIT-tablet
in the USA."

ALK's SLIT-tablets against grass pollen allergy (GRASTEK®) and
ragweed pollen allergy (RAGWITEK®) were both approved by the FDA in
2014.

The approval of the HDM SLIT-tablet is not expected to have an
impact on ALK's 2017 financial outlook.

ALK-Abelló A/S

About the HDM SLIT-tablet

In the USA, ALK's HDM SLIT-tablet is approved as an allergen
extract indicated as immunotherapy for house dust mite (HDM)-induced
allergic rhinitis, with or without conjunctivitis, confirmed by in
vitro testing for IgE antibodies to Dermatophagoides farinae or
Dermatophagoides pteronyssinus house dust mites, or skin testing to
licensed house dust mite allergen extracts. The HDM SLIT-tablet is
approved for use in adults 18 through 65 years of age. In Europe,
where it is sold as ACARIZAX®, the product has been approved in 14
countries. It is also approved in Japan where it is licensed by ALK
to Torii and marketed under the trade name MITICURE[TM] and in
Australia where it is licensed by ALK to Seqirus. The product is also
being developed for a number of other markets around the world
including Canada, Russia, South-East Asia, Turkey, the Middle East
and New Zealand. Altogether, clinical development activities for the
HDM SLIT-tablet have involved more than 6,000 patients worldwide.

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
http://www.alk.net.

ots Originaltext: ALK
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Carsten Hellmann
President & CEO
tel. +45 4574 7576 Investor Relations: Per Plotnikof
tel. +45 4574 7527
mobile +45 2261 2525 Media: Jeppe Ilkjær
tel. +45 7877 4532
mobile +45 3050 2014

Original-Content von: ALK, übermittelt durch news aktuell