ALK-Abelló

Regulatory Filings • Jun 30, 2011

Copenhagen, 2011-06-30 17:15 CEST (GLOBE NEWSWIRE) --

-- Merck has submitted a registration application (NDS) for Grass AIT[1]
)
in Canada releasing a milestone payment of USD 5 million to ALK. Full-year
EBITDA outlook is consequently adjusted upwards
.
-- Merck is initiating additional clinical study for Grass AIT in North
America.
The anticipated filing date in the USA is still under assessment.
-- The results of two Phase III studies on Ragweed AIT
anticipated to be available
in Q3 2011.

Grass AIT regulatory submission in Canada
Merck has informed ALK that it has submitted a registration application (NDS)
for the Grass Allergy Immunotherapy Tablet (AIT) in Canada. ALK expects Merck
to launch Grass AIT in Canada after regulatory approval of the NDS.

The submission to the Canadian authorities entitles ALK to a milestone payment
of USD 5 million from Merck. This payment was not previously included in ALK's
financial outlook for 2011 and consequently ALK now expects operating profit
(EBITDA) to amount to DKK 385 million (from previously DKK 360 million),
equivalent to an increase of 34% compared to last year.

Rupert Vessey, Senior Vice President and Head of Respiratory and Immunology at
Merck Research Laboratories commented: “Merck is pleased that a regulatory
filing has been made in Canada as this is the first regulatory filing in North
America for this innovative new class of drugs."

Update on Grass AIT in the USA
Merck will continue to work with the US health authorities, the Food and Drug
Administration (FDA) regarding the registration process for Grass AIT in the
USA; however, based on current feedback from the FDA, Merck is initiating an
additional clinical study with Grass AIT in order to provide as robust a
submission package as possible.

The new study is planned to be a North American Phase III, multicenter,
randomised, placebo-controlled, double-blind, parallel-group clinical trial
evaluating the efficacy of Grass AIT versus placebo in the treatment of grass
pollen-induced rhinoconjunctivitis in 1,500 subjects. Screening of subjects for
the study will be initiated in Q3 2011. Further information is posted at
www.clinicaltrials.gov. Merck anticipates that the study will be completed in
the fall of 2012.

The anticipated filing date for Grass AIT in the USA is still under assessment
by Merck and the FDA.

Jens Bager, President and CEO of ALK, says: "We are very pleased that Merck has
submitted a registration application for Grass AIT in Canada and that Merck is
initiating an additional clinical study in North America which will be the
largest study ever conducted with AIT. This demonstrates Merck's strong
commitment to introduce AIT in North America. ALK and Merck have a close and
committed partnership and intensive work is being carried out to ensure the
success of the AIT development programmes in North America.”

Results from ragweed AIT trials expected in Q3 2011
In Q3 2011, ALK expects to receive and disclose the outcome of two large Phase
III clinical trials to assess the safety and efficacy of the Ragweed AIT
tablet. ALK anticipates the results of the studies to be presented by Merck at
a medical congress later in 2011.

                             ALK-Abelló A/S

                               Jens Bager
                            President and CEO

Call tel. +45 20 64 11 43 to contact Jens Bager, President and CEO, Flemming
Pedersen, EVP and CFO or Henrik Jacobi, EVP Research & Development for further
information.

Investor Relations: Per Plotnikof, tel.+45 45 74 75 27, mobile +45 22 61 25 25

Press: Martin Barlebo, tel. +45 45 74 79 01, mobile +45 20 64 11 43

About ALK
ALK is a research-driven global pharmaceutical company focusing on allergy
prevention, diagnosis and treatment. ALK is the world leader in allergy
immunotherapy - a unique treatment of the underlying cause of allergy. The
company has approximately 1,700 employees with subsidiaries, production
facilities and distributors worldwide. ALK has entered into partnership
agreements with Merck and Torii Pharmaceutical Co. Ltd. to commercialise
allergy immunotherapy tablets in North America and Japan, respectively. The
company is headquartered in Hørsholm, Denmark, and listed on the NASDAQ OMX
Copenhagen A/S. Find more information at www.alk-abello.com.

About Grass AIT (GRAZAX®) development programme
The clinical development programme for Grass AIT is the largest development
programme ever carried out with an allergy immunotherapy product. In the USA
and Europe, a total of 15 randomised, double-blind, placebo-controlled clinical
studies of Grass AIT have been conducted including a total of 3,744 patients.
Grass AIT has been approved in the EU since 2006.

About the partnership with Merck
In January 2007 Schering-Plough (merged with Merck in November 2009) signed an
agreement with ALK to develop, register and commercialise a combined portfolio
of tablet based allergy vaccines (AIT) for grass, ragweed and house dust mite
allergy in North America. It is estimated that some 60 million people suffer
from allergy in North America alone, an estimated 25 million of whom have been
diagnosed as suffering from moderate to severe allergy. The majority of these
patients suffer from an allergy to grass, ragweed or house dust mites, and in
many cases the disease and allergy symptoms are not well-controlled. Thus there
is a significant unmet need for better treatment. At present, up to 3 million
Americans are being treated with a special form of injection based vaccine
preparations. The treating physicians prepare the named patient products after
having received the active allergen ingredients from, for instance, ALK. No
registered products for allergy immunotherapy are currently available in North
America.

[1] Marketed under the brand name of GRAZAX® by ALK in Europe