MedImmune Submits Marketing Authorisation Appli...

NIJMEGEN, The Netherlands, January 6 /PRNewswire/ --

    MedImmune, the global biologics unit of AstraZeneca, announced today that
it has submitted a Marketing Authorisation Application (MAA) for its nasal
spray live attenuated influenza vaccine (LAIV), which is now being reviewed
by the European Medicines Agency (EMEA). The proposed indication in the MAA
is for prevention of seasonal influenza.



    The MAA submission for LAIV is based on data from 73 global clinical and
U.S. post-marketing studies of more than 141,000 subjects ranging in age from
7 weeks to 97 years and conducted in 38 countries. Study objectives have
included clinical safety and tolerability, clinical efficacy and
effectiveness, and immunogenicity.



    "Influenza creates a heavy medical and economic burden on Europe and
throughout the world, and we are hopeful that the future availability and
product characteristics of this novel nasal spray influenza vaccine will
contribute to an increase in vaccination rates and reduce the spread of
influenza around the world," said Alex Zukiwski, M.D., executive vice
president, clinical affairs and chief medical officer. "MedImmune is pleased
to submit this application for approval of our nasal spray influenza vaccine
in Europe."



About LAIV

    Each dose of LAIV is formulated to contain three live attenuated
influenza virus strains, which are weakened as to not cause illness: Two Type
A influenza strains (A/H1N1 and A/H3N2) and one Type B strain. The vaccine
strains are selected annually by the World Health Organization (WHO) based on
anticipated circulating influenza strains for the upcoming season. The
vaccine is sprayed into the nose, rather than by injection as with other
licensed influenza vaccines, where it induces protective immunity.



    In the U.S., LAIV is marketed under the trade name FluMist(R) (Influenza
Virus Vaccine Live, Intranasal). It was approved by the U.S. Food and Drug
Administration in 2003. The vaccine included in the MAA has not been
registered in the European Union (EU) and is not available outside of the
United States.



About Influenza

    Influenza is the most common vaccine-preventable disease in the developed
world. According to WHO estimates, seasonal influenza results in three to
five million cases of severe illness and up to half a million deaths globally
each year, primarily among the elderly. Rates of infection are highest among
children, with school-aged children significantly contributing to spread of
disease to their families, communities and high-risk individuals.



    Influenza also has socioeconomic consequences related to both direct and
indirect health care costs, including hospitalizations, work absence and loss
of work productivity when either a caregiver or child is sick with influenza.



    In the EU, current guidelines recommend annual influenza vaccination for
the elderly as well as those with underlying medical conditions such as
chronic heart or lung disease. However, vaccination rates in the recommended
groups throughout Europe are estimated to be only 35 percent (Ryan, Vaccine,
August 2006).



    To date, six EU countries (Finland, Austria, Estonia, Latvia, Slovakia
and Slovenia) recommend routinely vaccinating young children against
influenza with varying age limits. EU and Member State policymakers continue
to evaluate data on the impact of influenza in children to best inform the
potential expansion of recommendations.



About MedImmune

    MedImmune is a leading innovation-focused biotechnology company whose
mission is to provide better medicines to patients, new medical options for
physicians and rewarding careers to employees. Dedicated to advancing science
and medicine to help people live better lives, the company is focused on
infection, oncology, respiratory disease and inflammation,
cardiovascular/gastrointestinal disease and neuroscience. Headquartered in
Gaithersburg, Maryland, MedImmune has approximately 3,000 employees worldwide
and is the wholly owned biologics business for AstraZeneca PLC (LSE: AZN.L,
NYSE: AZN). For more information, visit MedImmune's website at
http://www.medimmune.com.