ALK’s partner, Merck, submits a BLA to the FDA for a marketing authorisation for grass AIT (GRAZAX® in Europe)
ALK’s partner, Merck, submits a BLA to the FDA for a marketing authorisation
for grass AIT (GRAZAX® in Europe)
Copenhagen, 2013-02-01 13:00 CET (GLOBE NEWSWIRE) -- ALK's partner, Merck
(known as MSD outside the USA and Canada) has submitted a Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA) for a
marketing authorisation for grass allergy immunotherapy tablet (AIT) – a
disease-modifying AIT against grass pollen allergy. The product is marketed as
GRAZAX® in Europe. The partnership with Merck covers the development,
registration and commercialisation of a portfolio of AITs in North America.
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 grass AIT reduces patients’ allergy symptoms and their need for
symptom-relieving medication and provides a sustained long-term effect after
completion of treatment.
“Merck’s submission is an important milestone in ALK’s efforts to globalise
allergy immunotherapy and to help the millions of allergy sufferers who need
treatment,” says Jens Bager, President & CEO, ALK.
It is estimated that some 30 million children and adults in North America
suffer from allergy to grass pollen. Many patients’ disease and allergy
symptoms are not well-controlled and there is a significant unmet need for
better treatment. The current allergy immunotherapy practice builds primarily
on treatment with a special form of injections manufactured by the treating
physicians on the basis of active allergen extracts. No registered allergy
immunotherapy products are currently available in the USA.
ALK intends to communicate on the registration process with the U.S. health
authorities when the FDA completes its initial screening of the application and
on any other material developments during the process.
President & 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.