License application for ragweed allergy immunotherapy tablet accepted for review by FDA
Copenhagen, 2013-05-08 14:32 CEST (GLOBE NEWSWIRE) --
Today, ALK’s partner for North America, Merck (known as MSD outside the USA and Canada), announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its ragweed allergy immunotherapy tablet (AIT) for review. Merck submitted the BLA, for a tablet against ragweed allergy, to the FDA in March 2013.
The application to the FDA is based on results from an extensive clinical development programme. Data from the clinical trials have demonstrated that treatment with ragweed AIT reduces patients’ allergy symptoms and their concomitant use of symptom-relieving medication and that the treatment is well tolerated. 20-30 million North Americans are estimated to suffer from seasonal ragweed allergy.
In March, the FDA accepted the BLA for grass AIT for review. Grass AIT is marketed by ALK in Europe as GRAZAX®.
“The FDA is now reviewing two registration applications for allergy immunotherapy tablets against the most common pollen allergies in North America: ragweed and grass. This is a significant step forward in ALK’s efforts to globalise allergy immunotherapy and help the many allergy sufferers in need of better treatment options,” says Jens Bager, President and CEO, ALK.
ALK’s partnership with Merck covers the development, registration and commercialisation of a portfolio of allergy immunotherapy tablets in North America.
Merck has also issued a news release, which follows in full, and which can also be found on the Merck corporate website: www.merck.com. This announcement does not change ALK’s outlook for the financial year 2013.
President and CEO
For further information please contact:
Jens Bager, President and CEO, tel. +45 4574 7576
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Press: Martin Barlebo, tel. +45 4574 7901, mobile +45 2064 1143
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 (MSD outside the USA and Canada) and Torii to commercialise allergy immunotherapy tablets in North America and Japan, respectively. The company is headquartered in Hørsholm, 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 tablets (AITs) 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.