ALK's partner in North America, Merck, reports Phase III data on investigational grass sublingual allergy immunotherapy tablet
Copenhagen, Nov. 9, 2013 (GLOBE NEWSWIRE) -- ALK's (ALKB:DC / OMX: ALK B / AKABY / AKBLF) partner for North America, Merck (NYSE: MRK) reported that data from a pivotal Phase III clinical trial with its investigational grass sublingual allergy immunotherapy (AIT) tablet were presented at the 2013 annual meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Baltimore, USA during 7-11 November.
Merck has issued a news release concerning the findings from the clinical trial. The release can be found on http://www.mercknewsroom.com
The trial met its primary endpoint and the results showed that the use of grass AIT tablets significantly reduced the total combined score that measured nasal and eye symptoms and use of rescue allergy medicines, compared to placebo, in grass-allergic patients. Initiated in 2011, the trial, which included approximately 1,500 North American patients, is the largest trial of grass AIT tablets to date.
In January 2013, Merck submitted a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for the disease-modifying grass AIT tablet and the regulatory review is currently ongoing. The product is marketed as GRAZAX(r) in Europe.
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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 1,800 employees with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Merck and Torii to commercialise allergy immunotherapy tablets in North America and Japan, respectively. The company is headquartered in Hoersholm, Denmark, and listed on NASDAQ OMX Copenhagen. Find more information at www.alk.net.
About the partnership with Merck in North America
ALK has entered into a strategic partnership with Merck to develop, register and commercialise a portfolio of allergy immunotherapy (AIT) tablets against grass pollen, ragweed 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 Merck, of which approximately DKK 300 million has already been recognised in the years 2007-12. 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. Merck 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.