GAITHERSBURG, Md., June 14 /PRNewswire-FirstCall/ -- MedImmune, Inc. announced today that it has been awarded a contract from the U.S. Department of Health and Human Services (HHS) to retrofit its U.S.-based vaccine manufacturing facilities to produce pandemic influenza vaccines using its proprietary live, attenuated, needle-free influenza vaccine technology. The total value of the fully funded base contract is approximately $55.1 million. Under the cost-sharing portion of the contract, MedImmune will contribute approximately $14 million to the retrofitting of its U.S.-based vaccine manufacturing facilities.
MedImmune's marketed seasonal influenza vaccine, FluMist(R) (Influenza Virus Vaccine Live, Intranasal), is currently manufactured, blended, filled, packaged, stored and distributed through a series of procedures at the company's operations in California, the United Kingdom, Pennsylvania, and Kentucky. As a result of this contract, MedImmune will modify and expand its equipment and processes at its U.S.-based facilities and provide warm-base manufacturing operations to help the government rapidly respond to vaccine manufacturing needs in the event of a pandemic.
"MedImmune is honored to have been chosen once again to collaborate with the federal government to help protect the American public in the event of an outbreak of pandemic influenza," said Alan S. Taggart, vice president, government project management. "This contract, which is the second HHS/MedImmune partnership announced within just over a year, further bolsters our commitment toward ensuring the nation's pandemic preparedness."
FluMist is currently indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines, including FluMist. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine.
Under no circumstances should FluMist be administered as an injection (i.e. parenterally). FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients.
In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness.
Please see the Prescribing Information for the currently available formulation of FluMist at http://www.flumist.com/pdf/prescribinginfo.pdf, visit http://www.flumist.com, or call 1-877-633-4411 for additional information.
On January 5, 2007, the U.S. Food and Drug Administration (FDA) approved MedImmune's supplemental Biologics Licensing Application (sBLA) for a refrigerated version of FluMist, which will be manufactured for the 2007-2008 influenza season. Prior versions required frozen storage. Due to the seasonal nature of influenza vaccine, full prescribing information for the refrigerated version does not yet contain complete details on vaccine strains to be included for next season's vaccine. However, preliminary prescribing information can be found at http://www.fda.gov/cber/label/inflmed010507LB.pdf.
About MedImmune, Inc.
MedImmune strives 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 the areas of infectious diseases, cancer and inflammatory diseases. With more than 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's website at http://www.medimmune.com.
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the research and development of potential influenza vaccines. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune's filings with the U.S. Securities and Exchange Commission. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success. In addition, the amount of funding actually available under a government contract may be affected by a number of factors including, but not limited to, the funds available to HHS for this purpose and the amounts actually expended by the company in performance of the contract. As such, there can be no assurance that the full amount of expected funding will be provided under the contract or that that the government will not terminate the contract early.