ALK-Abelló

Regulatory Filings • Mar 1, 2017

Copenhagen, 2017-03-01 23:02 CET (GLOBE NEWSWIRE) --

ALK (ALKB:DC / 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.

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

For further information please 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

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 www.alk.net.