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MedImmune Submits Refrigerator-Stable Formulation of FluMist(R) to FDA for Approval in Healthy Individuals 5 to 49 Years of Age

Posted on: Monday, 19 September 2005, 12:00 CDT

GAITHERSBURG, Md., Sept. 19 /PRNewswire-FirstCall/ -- MedImmune, Inc. announced today that it submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for approval to use CAIV-T (cold adapted influenza vaccine, trivalent) in preventing influenza in healthy individuals 5 to 49 years of age. CAIV-T is MedImmune's investigational, refrigerator-stable formulation of FluMist (Influenza Vaccine Live, Intranasal), a frozen vaccine approved to prevent influenza in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. Included in the sBLA are data from a recently completed pivotal Phase 3 study comparing the immunogenicity of FluMist and CAIV-T, as well as additional preclinical and clinical data supporting the comparability of the two formulations.

"Converting from the frozen formulation of FluMist to the new refrigerator-stable formulation is a key component in our strategy to advance our attenuated, live intranasal influenza vaccine technology," said Edward M. Connor, M.D., executive vice president and chief medical officer. "A refrigerator-stable formulation would allow us to significantly expand access to FluMist to many more physicians' offices, clinics and pharmacies than can currently be reached with the frozen formulation."

As a part of its intranasal influenza vaccine development plans, MedImmune submitted an application in August 2005 to the FDA for its new state-of-the- art bulk vaccine manufacturing facility in Speke, England. This facility will have a capacity of up to 15 million bulk doses per month, or approximately 90 million doses per influenza manufacturing season. Construction and validation were substantially completed in spring 2005. Until regulatory approval of this new bulk facility is obtained, MedImmune will continue bulk production of FluMist in a nearby leased facility. The company's existing blend/fill/finish vaccine production facility in Pennsylvania has undergone improvements and modifications to increase finished product capacity to approximately 35 million doses per influenza season. Any decision to further increase blend/fill/finish capacity will be driven by future product demand.

Commenting on the company's next steps in its influenza strategy, Dr. Connor added, "We remain on track to complete our pivotal trial comparing the safety and relative efficacy of the refrigerator-stable formulation of FluMist to inactivated influenza vaccine in the fourth quarter of this year, and to submit these data to the FDA in the first half of 2006 requesting an expanded label including children from 6 months through 59 months of age. Our goal is to hopefully relaunch FluMist with a refrigerator-stable formulation and an expanded indicated population for the 2007-2008 influenza season."

MedImmune's current pivotal Phase 3 trial for CAIV-T is designed to compare its safety and relative efficacy to that of the injectable influenza vaccine. This study has been conducted at approximately 250 sites in 16 countries in the Northern Hemisphere, and includes approximately 8,500 children 6 months through 59 months of age. To date, more than 22 clinical trials including 40,000 participants have been conducted to demonstrate CAIV- T's safety and efficacy. The Phase 3 study included in the FDA submission announced today was conducted in 26 sites in the United States, and included 980 participants. Children between the ages of 5 and 8 years of age (n=414) received two doses of vaccine, while participants 9 years of age and older (n= 566) received one dose of vaccine. Immunogenicity was evaluated by measuring antibody levels in blood (specifically, serum HAI antibodies) to each of the three influenza strains contained in the vaccines. Study results indicated that CAIV-T and FluMist showed equivalent post-vaccination HAI antibody titers for all three vaccine strains.

About FluMist

FluMist is 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. Like any vaccine, FluMist does not protect 100 percent of individuals vaccinated. In studies of people between the ages of 5 and 49 years, runny nose was the most commonly reported side effect. Other common side effects included various cold-like symptoms, such as headache, cough, sore throat, tiredness/weakness, irritability, and muscle aches.

FluMist should not be used, under any circumstances, in anyone with an allergy to any part of the vaccine, including eggs; in children and adolescents receiving aspirin therapy; in people who have a history of Guillain-Barre syndrome; and in people with known or suspected immune system problems. Pregnant women and people with certain medical conditions, asthma, or reactive airways disease should not get FluMist.

Please see the Prescribing Information at http://www.flumist.com/pdf/prescribinginfo.pdf, visit http://www.flumist.com/, or call 1-877-633-4411 for additional information.

About MedImmune, Inc.

MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. 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 approximately 2,000 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" regarding the results of clinical trials and regulatory submissions for CAIV-T. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change current expectations and could cause actual outcomes and results to differ materially from current expectations. In addition to risks and uncertainties disclosed in MedImmune's filings with the U.S. Securities and Exchange Commission, MedImmune can provide no assurance that CAIV-T will be commercially successful. In addition, no assurance exists that development efforts for CAIV-T will succeed, that CAIV-T will receive required regulatory approval or that, even if regulatory approval is received, CAIV-T will be commercially successful. MedImmune undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise except as may be required by applicable law or regulation.

MedImmune, Inc.

CONTACT: Media: Jamie Lacey, +1-301-398-4035 or Clarencia Stephen,+1-301-398-4073, or Investors: John Filler, +1-301-398-4086, all of MedImmune,Inc.

Web site: http://www.medimmune.com/http://www.flumist.com/

Source: PRNewswire-FirstCall

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