WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. announced today that the Company has entered into an exclusive agreement with CSL Biotherapies, a subsidiary of CSL Limited, to market and distribute AFLURIA® (Influenza Virus Vaccine), CSL's seasonal influenza (flu) vaccine, in the U.S., for the 2010/2011-2015/2016 flu seasons. CSL and Merck have been partners in vaccine development and marketing since 1980.
Under the terms of the agreement, Merck will assume responsibility for all aspects of commercialization of AFLURIA in the U.S. CSL will supply AFLURIA to Merck and will retain responsibility for marketing the vaccine outside the U.S. Specific financial details of the agreement were not disclosed.
AFLURIA was approved by the U.S. Food and Drug Administration (FDA) in September 2007. It is indicated for the active immunization of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. This indication is based on immune response elicited by AFLURIA, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with AFLURIA.
"Adult vaccines are an integral part of preventive healthcare and continue to be a strong focus for Merck," said Margaret G. McGlynn, president, Merck Vaccines and Infectious Diseases. "AFLURIA is an important addition to our robust adult vaccine portfolio and provides an opportunity for us to help address the public health need for flu vaccination in the U.S."
With the addition of seasonal flu vaccine, Merck will market eight of the 10 vaccines on the recommended immunization schedule for adults in the U.S.
CSL Biotherapies recently announced that the FDA licensed a new vaccine filling and packaging facility in Kankakee, Illinois. The facility includes a high-speed, single-dose vaccine syringe filling line and will primarily provide filling and packaging services for influenza vaccine supply to the U.S. market.
The flu is a contagious respiratory illness caused by influenza viruses. According to the U.S. Centers for Disease Control and Prevention, on average, 5 percent to 20 percent of the population gets the flu every year in the U.S. Everyone is at risk for the flu, but some people, such as older people and people with certain health conditions, are at high risk for serious flu complications. In the U.S., annual epidemics of influenza occur typically during the late fall through early spring seasons.
Important safety information about AFLURIA
AFLURIA should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of AFLURIA, or to anyone who has had a life-threatening reaction to previous influenza vaccination.
The most common injection-site adverse reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches.
Immunocompromised persons may have a diminished immune response to AFLURIA. If Guillain-Barre syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.
In four clinical studies, 343 subjects 65 years of age and older received AFLURIA. Hemagglutination-inhibiting (HI) antibody responses in geriatric subjects were lower after administration of AFLURIA in comparison to younger adult subjects. Adverse event rates were generally similar in frequency to those reported in subjects 18 years of age to less than 65 years of age, although some differences were observed.
Vaccination with AFLURIA may not protect all individuals.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.