Regulatory Filings • Mar 27, 2013
Regulatory Filings
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Company release No 11/2013
Page 1/4 ALK's partner for North America, Merck (known as MSD outside the USA and Canada), today announced that the Biologics License Application (BLA) for its investigational grass allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). The BLA, for a disease-modifying tablet against grass pollen allergy, was first submitted to the FDA in January 2013. The product is marketed as GRAZAX® in Europe.
Merck's application is based upon results from an extensive clinical development programme which demonstrates that treatment with grass AIT reduces patients' allergy symptoms and their need for symptom-relieving medication. The data also show that grass AIT provides a long-term effect for patients, which is sustained beyond the period of treatment.
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.
Jens Bager President & CEO
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 1,850 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.
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.
(908) 423-5042
Media Contacts: Pam Eisele Investor Contacts: Justin Holko
(908) 423-5088
Tracy Ogden (267) 305-2301
WHITEHOUSE STATION, N.J., March 27, 2013 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT.
The BLA for Merck's grass pollen AIT is supported by Phase III trials that evaluated the safety and efficacy of the investigational product, including a long-term, multi-season trial.
""We are pleased to have achieved this important milestone in the development of our investigational grass pollen AIT, which, if approved, would represent a potential new option for allergy specialists to offer appropriate allergic rhinitis patients," said Jeffrey A. Chodakewitz, M.D., senior vice president, Global Scientific Strategy, franchise head, Infectious Diseases and interim franchise head, Respiratory & Immunology, Merck Research Laboratories.
Merck's grass pollen (Phleum pratense) AIT is an investigational sublingual dissolvable tablet designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against targeted allergens. Merck has partnered with ALK-Abello to develop its grass pollen (Phleum pratense) AIT in North America.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2012 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
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