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ALK Announces FDA Approval For Merck's Grass Sublingual Allergy Immunotherapy Tablet GRASTEK(r) (GRAZAX(r))

COPENHAGEN, Denmark, April 14, 2014 (GLOBE NEWSWIRE) -- ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the US Food and Drug Administration (FDA) has approved the Biologic License Application (BLA) for Merck's grass sublingual allergy immunotherapy (SLIT) tablet GRASTEK (r).

GRASTEK (r) is the US trade name of the grass SLIT-tablet which is licensed to Merck (known as MSD outside the USA and Canada) for North America by ALK, and marketed in Europe under the brand name GRAZAX (r).

GRASTEK (r) is an allergen extract. In the USA, GRASTEK (r) is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK (r) is approved for use in persons 5 through 65 years of age. GRASTEK (r) is not indicated for the immediate relief of allergic symptoms.

Jens Bager, President and CEO of ALK, said: "With the FDA approval of GRASTEK (r)/GRAZAX (r), US patients who suffer from moderate to severe grass allergy will now gain access to effective, convenient and well documented allergy treatment."

He continued: "Merck is now able to launch the first of ALK's tablets in the USA - the world's largest pharmaceutical market. This is another major step on our journey towards commercialising our portfolio of SLIT-tablets globally."

ALK's partnership with Merck covers the development, registration and commercialisation of a portfolio of sublingual allergy immunotherapy tablets in North America. GRASTEK (r) is the first of these products to be approved by the FDA and, following today's approval, Merck is expected to move ahead with its launch plans.

The FDA is currently also reviewing Merck's BLA for a SLIT-tablet against ragweed allergy (RAGWITEK(tm)). Following a positive recommendation from the FDA's Advisory Committee in January, a decision by the FDA is expected in Q2 2014.

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