ALK-Abelló

Regulatory Filings • Feb 16, 2017

Copenhagen, 2017-02-16 08:27 CET (GLOBE NEWSWIRE) --

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the European
regulatory filing for its ragweed sublingual allergy immunotherapy (SLIT)
tablet has been accepted for review by the relevant health authorities via the
Decentralised Procedure, with Germany as the Reference Member State. The
proposed indication is for the treatment of adult patients (18-65 years) with
ragweed allergic rhinitis and/or conjunctivitis, despite use of
symptom-relieving medication.

The data used in the filing are primarily drawn from the North American
development programme which resulted in successful registrations in both Canada
and the USA. In all, the programme involved 2,517 participants across five
clinical trials that were conducted in North America, Hungary, Ukraine and
Russia.

Carsten Hellmann, President and CEO of ALK, said: “Today’s news represents
another step forward in globalising our SLIT-tablet portfolio. Subject to
approval, the introduction of the ragweed SLIT-tablet will be a useful addition
to our European product range. In particular, strengthening our expansion
markets in eastern Europe, where ragweed allergy is most common.”

Ragweed has been spreading in Europe since it first gained a foothold in the
mid-1900s and, as it has spread, allergy to ragweed pollen has becoming
increasingly common. Ragweed sensitisation varies greatly by country but is
most significant in Eastern Europe. For example, in Hungary, it is estimated
that more than 40% of the population is affected, whereas in Finland the figure
is estimated to be just 2%.

In ragweed-affected areas, the threat on public health caused by ragweed
appears to be enhanced due to the combined impact of air pollution and global
warming, resulting in a higher allergenicity as a consequence of both an
extended pollen season and a higher pollen load. Importantly, the threshold for
eliciting clinical symptoms has been reported to be lower for the ragweed
pollen when compared with other pollens. As with other respiratory allergies,
such as house dust mite and grass pollen, ragweed-allergic patients often also
have asthma.

The European regulatory review process is anticipated to take approximately 12
months so that, subject to approval, the first market introductions could take
place from late 2018.

                             ALK-Abelló A/S

For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525

About the ragweed SLIT-tablet
ALK’s ragweed SLIT-tablet was initially developed for the North American
markets as part of the now terminated partnership between ALK and MSD (known as
Merck in the USA and Canada). Following a successful clinical development
programme and subsequent regulatory approvals, the product was launched in the
USA and Canada in 2014 under the brand name RAGWITEK®.

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.