License application for investigational house dust mite SLIT-tablet accepted for review by FDA
April 13 2016 - 1:15AM
Today, ALK's (ALKB:DC / OMX: ALK B / AKABY / AKBLF) partner for
North America, MSD (known as Merck (NYSE: MRK) in the United States
and Canada), announced that the U.S. Food and Drug Administration
(FDA) has accepted the Biologics License Application (BLA) for its
house dust mite (HDM) sublingual allergy immunotherapy (SLIT)
tablet for review. MSD submitted the BLA, for a tablet against HDM
allergy, to the FDA in February 2016.
The application to the FDA is based on results from an extensive
clinical development programme that has involved approximately
4,400 patients in North America and Europe and has already seen the
product approved in 11 European countries, where it is known as
ACARIZAX(r). The product has also been launched in Japan, where it
is marketed by Torii under the brand name MITICURETM.
House dust mites are one of the most common causes of allergy,
likely affecting more than 200 million people worldwide. The
condition appears early in life and is present all year
round.
ALK's partnership with MSD covers the development, registration
and commercialisation of a portfolio of allergy immunotherapy
tablets in North America.
MSD has also issued a news release, which can be found on the
MSD corporate website: www.merck.com. This announcement does not
change ALK's outlook for the financial year 2016.
ALK-Abello A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45
2261 2525 Press: Jeppe Ilkjaer, tel. +45 7877 4532, mobile
+45 3050 2014
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 1,900 employees with subsidiaries, production
facilities and distributors worldwide. ALK has entered into
partnership agreements with MSD (known as Merck in the USA and
Canada), Torii, Abbott and Seqirus to commercialise sublingual
allergy immunotherapy tablets in North America, Japan, Russia,
Southeast Asia, Australia and New Zealand, respectively. The
company is headquartered in Hoersholm, Denmark, and listed on
NASDAQ Copenhagen. Find more information at www.alk.net.
About the partnership with MSD (known as Merck in the
USA and Canada) for North America ALK has entered into a
strategic partnership with MSD to develop, register and
commercialise a portfolio of sublingual allergy immunotherapy
tablets against grass pollen (GRASTEK(r)), ragweed
(RAGWITEK(r)) and house dust mite allergy in the USA, Canada and
Mexico. Under the agreement, ALK will receive up to DKK 1.6 billion
(USD 290 million) in milestone payments from MSD, of which,
approximately DKK 400 million has already been recognised in the
years 2007-15. In addition, ALK is entitled to royalty payments on
the net sales of the products on the North American market as well
as payments for product supply. MSD will be responsible for all
costs of clinical development, registration, marketing and sales of
the products on the North American markets. ALK will be responsible
for tablet production and supply.
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