ALK-Abelló

Regulatory Filings • Sep 27, 2017

Copenhagen, 2017-09-27 09:00 CEST (GLOBE NEWSWIRE) --

-- CEDARCURE™ is the first SLIT-tablet to be approved for both adult and
paediatric use in Japan
-- Joins the already launched MITICURE™ (ACARIZAX® in Europe) in Torii’s
allergy portfolio, effectively completing the coverage of allergies in
Japan
-- ALK entitled to receive royalties on sales of CEDARCURE™
-- ALK’s financial guidance for 2017 remains unchanged

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that Japan’s
Ministry of Health, Labour and Welfare has approved the New Drug Application
submitted by its partner Torii Pharmaceutical Co., Ltd., for the Japanese cedar
sublingual allergy immunotherapy (SLIT) tablet, which will be branded
CEDARCURE™.

CEDARCURE™ is based on the same SLIT-tablet technology used in ALK’s grass,
ragweed and house dust mite SLIT-tablets, and was developed by Torii with
support from ALK specifically for the Japanese market, where Japanese cedar
pollen is a major allergen.

Japan is the world’s second largest market for allergy medicine after the USA.
Around 25% of Japan’s population suffer from allergic rhinitis (AR), with
around 70% of AR sufferers having a specific allergy to Japanese cedar pollen.
Japanese cedar allergy can affect people of all ages but recent research shows
that the typical age of onset is falling.

CEDARCURE™ has been approved for hyposensitisation therapy (allergy
immunotherapy) for the treatment of Japanese cedar pollinosis (allergic
rhinitis) in adults and children, and is the first SLIT-tablet to be approved
for both adult and paediatric use in Japan.

Carsten Hellmann, ALK’s President and CEO says: “This approval marks the
culmination of several years of successful R&D collaboration between ALK and
Torii, a partnership that we anticipate will bring many more years of
commercial return. It also means another successful approval for the
SLIT-tablet technology that underpins our global range of standardised,
registered allergy immunotherapy treatments, adding Japanese cedar to a range
that includes grass, ragweed and house dust mite treatments, with a tree tablet
to be added in the foreseeable future.”

ALK’s partnership with Torii was announced in 2011, and covers the development,
registration and commercialisation of CEDARCURE™ as well as ALK’s house dust
mite SLIT-tablet, ACARIZAX®, which was approved for adult use in Japan in 2015
and launched under the Torii brand name of MITICURE™. In March 2017, Torii also
submitted a paediatric registration application for MITICURE™ based on positive
Phase III clinical data.

A launch date for CEDARCURE™ will be announced by Torii after price and
reimbursement have been agreed upon with the National Health Insurance.

ALK is entitled to receive royalties on the sales of CEDARCURE™ which will be
booked as partner revenue from International markets. This announcement does
not change ALK’s 2017 financial outlook.

                             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

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.

About Torii Pharmaceutical Co., Ltd.
Established in 1921, Torii Pharmaceutical Co., Ltd., manufactures and markets
pharmaceutical products in four main therapeutic areas: renal diseases and
haemodialysis, skin diseases, HIV, and allergy. The company has approximately
1,000 employees, is headquartered in Tokyo and is listed on the Tokyo Stock
Exchange (TSE:4551). Read more at www.torii.co.jp.