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MEDIMMUNE TO PRESENT ELEVEN ABSTRACTS ON INFLUENZA AND RESPIRATORY SYNCYTIAL VIRUS AT THE ANNUAL PEDIATRIC ACADEMIC SOCIETIES MEETING

Melissa Garcia — Mon, 02 May 2011 14:11:05 +0000

GAITHERSBURG, MD, May 1, 2011 – MedImmune announced today it will present 11 abstracts at the Pediatric Academic Societies (PAS) Meeting at the Colorado Convention Center in Denver, CO, April 30 – May 3, 2011. These abstracts advance the body of existing data and knowledge surrounding influenza and respiratory syncytial virus (RSV) prevention, highlighting MedImmune’s continued leadership in patient health.

MedImmune abstracts to be presented at PAS regarding influenza include:

Factors Associated with Increased Vaccination in 2009 H1N1 School-Located Influenza Vaccination Programs. Ambrose CS, et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 468

The Impact of School-Located Influenza Vaccination Programs on Student Absenteeism: A Review of the US Literature. Hull, HF, et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 473

An Integrated, Multistudy Analysis of The Safety of Ann Arbor Strain Live Attenuated Influenza Vaccine in Children Aged 2–17 Years. Ambrose CS, et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 465

Evidence of Homosubtypic But Not Heterosubtypic Immunity in Children After Wild-Type Influenza Illness. Ambrose CS, et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 469

Factors Associated with Increased In-Office Influenza Vaccine Coverage and Two-Dose Compliance Among Practicing U.S. Pediatricians. Toback, SL, et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 467

Maternal Outcomes in Pregnant Women Receiving Live Attenuated Influenza Vaccine. Toback, SL, et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 466

MedImmune abstracts to be presented at PAS regarding RSV include:

RSV Prophylaxis: Chronologic Age, Number of Doses, and Timing of RSV Hospitalization. Griffin M., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 558

Safety Profile, Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) Vaccine in RSV/PIV3 Seronegative Children. Bernstein D., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 458

Burden of RSV Disease Among Infants 32-35 wGA in Outpatient Clinic Settings: The REPORT Study – Season One. Elhefni H., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 556

Hospitalizations Associated with Respiratory Syncytial Virus Among Infants 32-35 Weeks Gestational Age: Season One of the REPORT Study. Elhefni H., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 557

Distribution of Respiratory Syncytial Virus (RSV) Subtypes A and B Among Infants Presenting to the Emergency Department (ED) with Lower Respiratory Tract Infection (LRI) or Apnea. Jafri H., et al. Poster Session: May 1, 2011 Time: 4:15 – 7:30 PM, Exhibit Hall F, Board: 559

Additional information about the 2011 PAS conference can be found at

http://www.pas-meeting.org/2011Denver/default.asp

About MedImmune

MedImmune, the global biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

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EUROPEAN COMMISSION APPROVES NASAL SPRAY VACCINE FLUENZ FOR THE PREVENTION OF SEASONAL INFLUENZA IN CHILDREN

Tor Constantino — Tue, 01 Feb 2011 15:03:09 +0000

AstraZeneca announced today that the European Commission (EC) has granted marketing authorisation to FLUENZ Influenza Vaccine (Live Attenuated, Nasal), a nasally administered live attenuated influenza vaccine (LAIV), for prevention of seasonal influenza for children 24 months to less than 18 years of age. This decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 22^nd October 2010 and is applicable to the 27 Member States and the 3 European Economic Area countries of the European Union.

“We are delighted that FLUENZ has received regulatory approval in Europe since influenza creates a significant medical and economic burden there and throughout the world. We hope that the availability of this nasal spray influenza vaccine with its novel mechanism of action will help reduce the spread of influenza,” said Alex Zukiwski, M.D., executive vice president and chief medical officer of MedImmune, the biologics unit of AstraZeneca.

It is expected that the FLUENZ vaccine will be initially available in select European markets for the 2012-13 influenza season.

The EC decision and CHMP positive opinion were reached after a review of data from 73 global clinical studies and US post-marketing studies of more than 141,000 subjects conducted in 38 countries. Study objectives included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

- ENDS -

NOTES TO EDITORS

About LAIV
Each dose of FLUENZ is formulated to contain three live attenuated influenza virus strains, which are weakened so as to not cause illness. 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 administered by spraying into the nose where it induces protective immunity. In several clinical studies it has demonstrated superior efficacy in children 24 months to less than 18 years of age compared to traditional inactivated influenza vaccines that are injected. The most common adverse events for LAIV include runny nose or nasal congestion. The live influenza virus strains used in LAIV are cold-adapted, temperature sensitive and attenuated.

In the US, FLUENZ is marketed by MedImmune under the trade name FluMist (Influenza Vaccine Live, Intranasal). FluMist was approved by the US Food and Drug Administration in 2003. The seasonal vaccine is currently approved in five countries including the US and Canada.

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.

Studies in several European countries have demonstrated that hospitalization rates associated with influenza are highest in young children including those without underlying medical problems (Weigl et al, 2002; Pitman et al, 2007; Gasparini et al, 2007; Lenglet et al, 2007; Jansen et al, 2007). Based on these accumulated data, many experts include young children among those at high risk for severe influenza disease and influenza-related complications (Heikkinen et al, 2006).

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

To date, seven EU countries (Finland, Austria, Estonia, Latvia, the state of Saxony in Germany, 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, the worldwide biologics unit for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $33.3 billion in 2010. For more information please visit: www.astrazeneca.com.

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EUROPEAN REGULATOR BACKS NASAL SPRAY VACCINE FLUENZ FOR THE PREVENTION OF SEASONAL INFLUENZA IN CHILDREN

Tor Constantino — Mon, 25 Oct 2010 15:16:27 +0000

London, October 22, 2010. AstraZeneca announced today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the marketing authorisation application for FLUENZInfluenza Vaccine (Live attenuated, nasal), its nasally administered live attenuated influenza vaccine (LAIV) for prevention of seasonal influenza. The CHMP issued its opinion for marketing this product in Europe for children 24 months to less than 18 years of age.

The Committee’s positive opinion is now referred for a final decision by the European Commission (EC). The EC, which makes the decision whether to approve a new drug candidate for use in the European Union, typically decides within a few months of the CHMP issuing its opinion.

“Influenza creates a significant 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 reduce the spread of influenza around the globe,” said Alex Zukiwski, M.D., MedImmune’s executive vice president and chief medical officer.

The positive opinion was reached after the CHMP reviewed data from 73 global clinical studies and US post-marketing studies of more than 141,000 subjects conducted in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

NOTES TO EDITORS

About LAIV
Each dose of Fluenz is formulated to contain three live attenuated influenza virus strains, which are weakened so as to not cause illness. 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 administered by spraying into the nose where it induces protective immunity. In several clinical studies it has demonstrated superior efficacy in children 24 months to less than 18 years of age compared to traditional inactivated influenza vaccines that are injected. The most common adverse events for LAIV are nasal congestion/rhinorrea, decreased appetite, headache, malaise and fever. The live influenza virus strains used in LAIV are cold-adapted, temperature sensitive and attenuated.

In the US, Fluenz is marketed by MedImmune under the trade name FluMist (Influenza Vaccine Live, Intranasal). FluMist was approved by the US Food and Drug Administration in 2003. The seasonal vaccine is currently approved in a further six countries including Canada.

Studies in several European countries have demonstrated that hospitalisation rates associated with influenza are highest in young children including those without underlying medical problems (Weigl et al, 2002; Pitman et al, 2007; Gasparini et al, 2007; Lenglet et al, 2007; Jansen et al, 2007). Based on these accumulated data, many experts include young children among those at high risk for severe influenza disease and influenza-related complications (Heikkinen et al, 2006).

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

About MedImmune

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com

FLUMIST® BEGINS SHIPPING FOR 2010-2011 INFLUENZA SEASON

Tor Constantino — Sat, 24 Jul 2010 00:12:15 +0000

Vaccine Includes 2009 H1N1 Pandemic Strain; Public Health Officials Encourage Influenza Immunization as Soon as Vaccine Becomes Available

GAITHERSBURG, MD, July 23, 2010 – MedImmune announced today that it has begun shipping FluMist^®(Influenza Vaccine Live, Intranasal) to influenza vaccine distributors who service health care providers throughout the United States.

MedImmune expects to provide approximately 15 million doses of its trivalent (three-strain) nasal spray flu vaccine for the 2010-2011 influenza season through a variety of private health care practices, public health departments, school-located vaccination programs, military bases, and other venues.

Earlier this year, the Advisory Committee on Immunization Practices (ACIP), a panel of immunization experts advising the U.S. Centers for Disease Control and Prevention (CDC) expanded the recommendations for annual influenza vaccination to include all people aged six months and older. Please refer to the specific prescribing information for each manufacturers’ influenza vaccines as not all vaccines are indicated for all ages.

The CDC also recommends that flu vaccine be administered to eligible recipients every year as soon as the vaccine becomes available. A MedImmune analysis looking at pediatric populations suggests that starting influenza vaccination in August and September — months earlier than the typical influenza vaccination season — may help reach an additional 10.5 million children at already-scheduled healthcare provider visits.

Global public health authorities have determined that this season’s vaccine will include the 2009 H1N1 pandemic strain among the three vaccine strains. Additionally, the ACIP voted in June 2010 to recommend that children younger than nine years who did not receive at least one dose of the H1N1 monovalent vaccine in the 2009-2010 season should receive two doses of the 2010-2011 trivalent seasonal vaccine.

“MedImmune is committed to supporting public health efforts to initiate seasonal influenza vaccination as early as possible each year, greatly widening the window of opportunity for vaccination,” said Alex Zukiwski, MD, MedImmune’s Executive Vice President, Clinical Research & Chief Medical Officer. “The public can be reassured that influenza vaccination with FluMist in the late summer helps protect against influenza throughout the influenza season, even into the late spring.”

FluMist is available in every state, except South Dakota, through the federally funded Vaccines for Children (VFC) program, which provides vaccines at no cost to eligible children. Based on a nationally-representative sample of private insurance claims from approximately 50 percent of US patients, FluMist accounted for 34 percent of seasonal influenza vaccinations given to children two through 18 years of age during the 2009-2010 season. FluMist is covered by approximately 99 percent of private health plans which offer immunization benefits.

FluMist is now available on the Vaccine for Adults contract allowing state and local immunization programs to access the vaccine at the public-sector price for community vaccination programs focused on young adults and immunization of first-responders and healthcare workers.

Important Safety and Eligibility Information for FluMist

Who may be eligible for FluMist^® (Influenza Vaccine Live, Intranasal)?

FluMist is a vaccine approved for the prevention of certain types of influenza disease in children, adolescents and adults 2-49 years of age. FluMist may not protect everyone who gets it. FluMist is for intranasal administration only.

Who may not be able to get FluMist?

FluMist is not right for everyone. FluMist must not be given to: people with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine; people with life-threatening reactions to previous influenza vaccinations; and children and adolescents receiving aspirin or aspirin-containing therapy. Children less than 24 months of age are not eligible for FluMist.

The following people may not be able to get FluMist or may be able to get it only in certain situations: people with asthma or active wheezing, or children less than five years of age with recurrent wheezing; people with a history of Guillain-Barré syndrome; people with a weakened immune system; people with long-term medical conditions including heart disease, kidney disease, and metabolic diseases, such as diabetes; and pregnant women.

If you or your child falls into one of these groups, their healthcare provider will decide if FluMist is right for you or your child.

What are the most common side effects of FluMist?

Most common side effects included runny nose or nasal congestion, sore throat, and fever. For a full list of side effects, please see section 6.1 in the following product information.

Please see the complete product information, including patient information at www.medimmune.com.

For more information, please visit www.FluMist.com.

About MedImmune

MedImmune, the worldwide biologics unit for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising drug candidates, MedImmune strives to deliver life-changing products, a rewarding career to our employees and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

‘Don’t Play With the Flu’(TM) Campaign to Coach Families on Playing Defense Against Seasonal Flu

Mike O'Brien — Thu, 20 Aug 2009 12:03:04 +0000

Soccer Champions Mia Hamm and Brandi Chastain Kick Off National Effort to Increase Seasonal Flu Vaccination Rates for Eligible Kids and Families

NEW YORK, Aug. 20 /PRNewswire/ — MedImmune, Women’s Professional Soccer (WPS) and the American Youth Soccer Organization (AYSO) today officially launched “Don’t Play with the Flu,”(TM) a national health awareness campaign that aims to highlight the importance of getting a seasonal influenza vaccination every year. “Don’t Play with the Flu” kicks off today in New York City with a one-of-a-kind soccer clinic led by soccer legends and moms Mia Hamm and Brandi Chastain.

The U.S. Centers for Disease Control and Prevention (CDC) advises that the single best way families can help prevent the seasonal flu is by getting a flu vaccine – every year – for those individuals who are eligible to receive it. The CDC recommends that children 6 months through 18 years of age be vaccinated annually against seasonal flu and that eligible individuals be immunized as soon as the seasonal vaccine becomes available, which can be as early as August and September.

“We know a vaccine is the best way to help protect ourselves from the flu, so my family and I get a seasonal flu vaccine as soon as we can every year,” said Mia Hamm, international soccer legend and proud mother of 2-year-old twins. “That way we can concentrate on all the other things we regularly do to stay healthy on and off the field and in our busy lives.”

The campaign reminds families of one key soccer term, G.O.A.L., when thinking about seasonal influenza prevention:

Get a seasonal flu vaccine every year for eligible family members.
Options are available. Talk to your healthcare provider about what type of flu vaccine – the shot or the nasal spray – is right for you and your family members.
Avoid germs and illness. Wash hands often, cover sneezes and coughs with a tissue or arm sleeve, avoid those who are sick, and keep yourself and family members home when sick.
Lead a healthy lifestyle with plenty of sleep, proper nutrition, frequent exercise and plenty of liquids.

“Along with all the things that parents know are important for helping keep their kids healthy – like washing hands and getting enough sleep – influenza vaccination should be at the top of the list. It’s a smart defense to help protect our kids – and our families – from seasonal flu,” said Anat R. Feingold, M.D., a pediatric infectious disease expert. “And because kids can spread the flu, including at school, it’s important that parents ask about an annual flu vaccine as soon as it is available. Back-to-school and sports physicals can be the perfect opportunity.”

According to the CDC, each year, as many as 60 million Americans get the flu, and the resulting complications cause more than 200,000 hospitalizations. Children between 2 and 17 years of age are twice as likely to get the flu as adults and commonly need medical care. Flu can also impact school, with one analysis showing students missed approximately 38 million school days due to seasonal flu in one year.

The campaign offers families information, resources, and updates through DontPlaywiththeFlu.com. Parents and kids can find interactive content, including a quiz about seasonal flu, educational information, and insights into the lives of soccer stars, moms and role models Hamm and Chastain. The campaign also aims to educate families about the importance of seasonal flu vaccination for eligible individuals through informational brochures at WPS stadiums, media events and soccer clinics in WPS franchise cities, and directly to AYSO members and families around the country.

“‘Don’t Play with the Flu’ reflects MedImmune’s commitment to supporting healthy families,” said Tony Zook, president of MedImmune. “We’re very pleased to partner with Women’s Professional Soccer, the American Youth Soccer Organization, and of course Mia Hamm and Brandi Chastain, to bring this important preventive health message to families across the country this flu season.”

As a part of the campaign, MedImmune has become a sponsor of WPS, the world’s premier women’s professional soccer league, and AYSO, a nationwide non-profit youth soccer organization that develops and delivers quality youth soccer programs to approximately 600,000 players. MedImmune is the presenting sponsor of the 2009 WPS Championship in Los Angeles this Saturday, Aug. 22, and will also present the “Defender of the Year” award at the WPS All-Star Game in St. Louis on Sunday, Aug. 30. MedImmune manufactures FluMist (Influenza Vaccine Live, Intranasal), the nasal spray flu vaccine against seasonal influenza for eligible individuals 2 – 49 years of age. See important safety and eligibility information below.

For more information about today’s event, including time and location, please contact Paddi Hurley, Fleishman-Hillard, 917-743-2290 or paddi.hurley@fleishman.com.

Important Safety and Eligibility information for FluMist

Who may be eligible for FluMist (Influenza Vaccine Live, Intranasal)?

Who may not be able to get FluMist?

The following people may not be able to get FluMist or may be able to get it only in certain situations: people with asthma or active wheezing, or children less than 5 years of age with recurrent wheezing; people with a history of Guillain-Barre syndrome; people with a weakened immune system; people with long-term medical conditions including heart disease, kidney disease, and metabolic diseases, such as diabetes; and pregnant women.

If a child falls into one of these groups, a healthcare provider can decide if FluMist is right for that child.

What are the most common side effects of FluMist?

Most common side effects included runny nose or nasal congestion, sore throat, and fever. For a full list of side effects, please see section 6.1 in the following product information.

Please see the complete product information. For more information, please visit www.FluMist.com.

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, we aim to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

About Women’s Professional Soccer

Women’s Professional Soccer (WPS) is the premier women’s soccer league in the world and the global standard by which women’s professional sports are measured. The Inaugural Season kicked off on March 29 and runs through August 30, 2009, with WPS teams based in the Bay Area, Boston, Chicago, Los Angeles, New Jersey/New York, St. Louis, and Washington, D.C. The league’s eighth and ninth franchises in Philadelphia and Atlanta will begin play in 2010. For more information, visit www.womensprosoccer.com.

About American Youth Soccer Organization

The American Youth Soccer Organization (AYSO) is the largest single-entity youth soccer association in the U.S. with nearly 600,000 players and 225,000 volunteers. AYSO develops and delivers quality youth soccer development programs in a fun, safe environment based on the Six Philosophies of Everyone Plays , Balanced Teams, Open Registration, Positive Coaching, Good Sportsmanship and Player Development. For questions about AYSO, please contact Sahar Milani at 310-727-5421 or SaharMilani@ayso.org.

SOURCE MedImmune
08/20/2009
/CONTACT: Karen Lancaster, MedImmune, +1-301-398-5864,
lancasterk@medimmune.com; Paddi Hurley, Fleishman-Hillard, +1-917-743-2290,
paddi.hurley@fleishman.com/
/Web Site: http://www.medimmune.com /
(AZN)

CO: MedImmune
ST: New York
IN: HEA MTC
SU: CHI

PR
– AQ64061 –
3361 08/20/2009 08:00 EDT http://www.prnewswire.com

FluMist(R) Begins Shipping for 2009-2010 Influenza Season

Mike O'Brien — Tue, 28 Jul 2009 11:51:12 +0000

Supports CDC’s Annual Recommendations for Families to Seek Vaccination for Seasonal Influenza as Soon as Vaccine is Available

MedImmune Announces Influenza Vaccination Awareness Campaign with Women’s Professional Soccer

GAITHERSBURG, Md., July 28 /PRNewswire/ — MedImmune announced today that it has begun shipping its seasonal influenza vaccine FluMist (Influenza Vaccine Live, Intranasal) to vaccine distributors who service health care providers throughout the United States. MedImmune expects approximately 10 million doses of its trivalent (three-strain) nasal spray flu vaccine will be available for the 2009-2010 influenza season through a variety of private health care practices, public health departments, school-based vaccination programs, military bases, and other locations.

The U.S. Centers for Disease Control and Prevention (CDC) and American Academy of Pediatrics advise that flu vaccine be administered every year as soon as it becomes available. A MedImmune analysis suggests that starting influenza vaccination in August instead of October may help reach an additional 11.5 million children at already-scheduled healthcare provider visits.

The 2009-2010 influenza season is the first for full implementation of the recommendations by the CDC’s Advisory Committee on Immunization Practices (ACIP) that children six months through the age of 18 years be vaccinated annually against influenza, meaning 30 million additional children 5 through 18 years of age now fall within influenza vaccination recommendations.

“MedImmune is committed to delivering our seasonal nasal spray influenza vaccine in the summer months in order to increase opportunities for vaccination,” said Alex Zukiwski, MD, MedImmune’s Executive Vice President, Clinical Research & Chief Medical Officer. “If more eligible children can be vaccinated against seasonal influenza while attending back-to-school checkups, sports physicals, and clinics early in the school year, the country will be better prepared for the flu season ahead.”

FluMist is available in every state through the federally funded Vaccines for Children (VFC) program, which provides vaccines at no cost to eligible children. FluMist is also covered by approximately 95 percent of private health plans which offer immunization benefits.

FluMist Becomes Sponsor of Women’s Professional Soccer

To help communicate the importance of seasonal flu vaccination efforts, MedImmune has teamed up with Women’s Professional Soccer (WPS) for “Don’t Play with the Flu”(TM) (www.dontplaywiththeflu.com), a national health awareness campaign with the goal of increasing seasonal flu vaccination rates among eligible kids and families across the country. As part of the multi-faceted campaign, FluMist has become an official sponsor of WPS, the world’s premier women’s professional soccer league, working with real-life soccer moms and the league to reach families during flu vaccination season, including back-to-school visits.

“Our ‘Don’t Play with the Flu’ efforts are directed toward parents to help them understand the importance of annual influenza vaccination and reminds them not to wait to put up a defense against the flu, particularly with seasonal vaccine becoming available during the summer,” said Peter Greenleaf, MedImmune’s Senior Vice President, Commercial Operations, Corporate Development & Strategy. “We’re proud to partner with the WPS in its inaugural season to bring this fun, educational and interactive campaign to the families across America.”

Important Safety and Eligibility information for FluMist

Who may be eligible for FluMist (Influenza Vaccine Live, Intranasal)?

Who may not be able to get FluMist?

If your child falls into one of these groups, be sure to tell your healthcare provider. They will decide if FluMist is right for your child.

What are the most common side effects of FluMist?

Most common side effects included runny nose or nasal congestion, sore throat, and fever. For a full list of side effects, please see section 6.1 in the following product information.

Please see the complete product information.

For more information, please visit www.FluMist.com.

About MedImmune

SOURCE MedImmune

CONTACT: Karen Lancaster of MedImmune, +1-301-398-5864, lancasterk@medimmune.com/

MedImmune Expands Access for Eligible Premature Infants to Receive Synagis(R) at No Cost

Tor Constantino — Mon, 29 Jun 2009 16:20:00 +0000

Company Increases Eligibility to Its Patient Assistance Program to 400 Percent of Federal Poverty; as Many as 75 Percent of U.S. Households May Now Qualify for This Program

GAITHERSBURG, Md., June 29 /PRNewswire/ — MedImmune today announced the expansion of the MedImmune Assistance Program for Synagis(R) (palivizumab) designed to provide the antibody at no cost to qualifying patients who lack health insurance and whose family household income falls within a certain range of the Federal Poverty Level (FPL) guidelines established by the U.S. Department of Health and Human Services (HHS). Synagis is a biologic medicine known as a monoclonal antibody administered monthly to high-risk infants to prevent serious lower respiratory tract infection caused by respiratory syncytial virus (RSV), a leading cause of viral respiratory infection among infants.

Effective July 1, 2009, patients with household income up to 400 percent of the FPL (e.g. a household of four with an income up to $88,200), and without healthcare coverage or medical insurance, may be eligible to receive Synagis at no cost. This marks a significant expansion over the program’s previous eligibility ceiling of 250 percent of the FPL (e.g. $55,125 for that same four-member household).

“MedImmune recognizes the rising cost of healthcare and the burden those expenses can have on working families who lack insurance through no fault of their own,” said Tony Zook, MedImmune President. “This expansion of the MedImmune Assistance Program makes it possible for as many as 75 percent of U.S. households without health insurance and with eligible infants to apply to receive the established preventive benefits of Synagis as prescribed by their doctor at no cost to the family.”

The MedImmune Assistance Program is administered as part of the Synagis Reimbursement Hotline and can be reached by calling 1-877-778-9010. A health care provider can review the patient’s eligibility with a program specialist.

In addition, MedImmune supports The Patient Access Network Foundation (PANF), which is an independent, non-profit 501(c)(3) organization dedicated to supporting the needs of insured patients who cannot afford the treatments they need due to out-of-pocket health care costs. More information about the help that’s available for RSV prevention and treatment can be found by visiting www.patientaccessnetwork.org.

About Synagis

Synagis(R) (palivizumab) is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in children at high risk. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season.

Synagis should not be used in patients with a history of a severe allergic reaction to Synagis or its ingredients. Cases of severe allergic reactions such as anaphylaxis and other types of hypersensitivity reactions have been reported with Synagis. These reactions may occur when any dose of Synagis is given, not just the first one. Very low platelet counts may occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.

Common side effects may include fever, cold-like symptoms (upper respiratory infection) including runny nose and ear infection, and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort). In children born with certain types of heart disease, other possible side effects include bluish color of the skin, lips or under fingernails and abnormal heart rhythms. These are not all the possible side effects of Synagis.

About RSV

Each year, up to 125,000 infants in the United States are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in U.S. infants. RSV is the most common respiratory infection in infancy or childhood. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk groups.

A recent study published in the New England Journal of Medicine found that RSV accounts for one of every 13 visits to a pediatrician, one of every 38 emergency room trips, and inpatient hospital stays for one out of every 334 children.

About MedImmune

SOURCE: MedImmune 06/29/2009

CONTACT: Tor Constantino of MedImmune, +1-301-398-5801,
constantinos@medimmune.com
Web Site: http://www.medimmune.com
(AZN)

FluMist® Shows Acceptable Safety Profile in Immunocompromised Children, According to New Findings Presented at Pediatric Academic Societies Annual Meeting

Tor Constantino — Tue, 05 May 2009 04:00:00 +0000

Additional Studies Report on FluMist Efficacy in Children; Indicate How Pediatricians Might Increase Influenza Vaccination Rates

GAITHERSBURG, MD, May 5, 2009 — Data presented suggest that FluMist® (Influenza Vaccine Live, Intranasal) has an acceptable safety profile among mild to moderately immunocompromised children with cancer. The immune systems of children with cancer can be weakened due to cancer treatments, making them vulnerable to influenza or other infections. The small multi-center, randomized, double-blind pilot study compared FluMist to placebo in 20 children, five to 17 years of age. The results, along with data from 10 other MedImmune-sponsored, influenza-related studies, were presented at the 2009 Pediatric Academic Societies (PAS) annual meeting in Baltimore, MD.

In our pilot study, immunocompromised children with cancer who received FluMist had no related serious adverse events, explained Pat Flynn M.D., director, clinical research, infectious diseases, St. Jude Children’s Research Hospital. We believe these data are promising and add to the extensive body of evidence supporting the overall safety of FluMist in the population for whom it is approved. A larger study will help us confirm the safe use of FluMist in immunocomprised patients. The value of this type of research is even more apparent today as we all consider how best to protect all of our patients against the threat of emerging, new influenza viruses.

FluMist, a live attenuated influenza vaccine (LAIV), is the only nasal spray influenza vaccine approved in the United States to help prevent influenza in eligible individuals ages two to 49 years of age. (Please see About FluMist for important safety and eligibility information later in this release).

Additional studies presented at PAS explored various aspects of FluMist, including its efficacy as a function of age from six months to 17 years of age*, results with only a single dose in previously unvaccinated children, and data regarding influenza-related ear infections. Research also evaluated the effect of FluMist against opposite-lineage influenza B strains. Other research focused on influenza vaccination practices of U.S. pediatricians during the 2007 — 2009 flu seasons and the impact of respiratory illness in children on parent work absenteeism and productivity.

In a time when influenza prevention is receiving so much attention, MedImmune is pleased to share a number of new studies and analyses with the medical community as we work together to help protect our children and families from influenza, said Chris Ambrose, M.D., senior director, medical affairs, MedImmune.

Brief summaries of the ten (10) MedImmune-sponsored abstracts presented at PAS are provided below.

LAIV Use in Children

In an abstract that reviewed data from multiple randomized, controlled studies among children six months to 17 years of age, LAIV efficacy against culture-confirmed influenza did not vary with age. Compared to placebo, LAIV had high efficacy and this efficacy did not vary among children 15 to 84 months of age. LAIV had higher efficacy in children six months to 17 years of age compared to the traditional injectable vaccine.* (Belshe R, #5529.501)
In an analysis of three randomized, double-blind studies, a single dose of LAIV in previously unvaccinated children two to six years of age provided significant protection against culture-confirmed influenza compared to placebo. These findings are significant because most children who are recommended to receive two doses of influenza vaccine only receive one dose. The efficacy of one LAIV dose was approximately 90 percent of the efficacy of two doses. Efficacy after revaccination in year two with a single dose was comparable whether the child received one or two doses in the previous year. (Block, #5529.505)
Across eight randomized, controlled studies, LAIV reduced influenza-associated acute otitis media (AOM) — commonly referred to as an ear infection — caused by influenza strains matched to the vaccine by 73 percent to 98 percent. These data suggest that FluMist has the potential to reduce the burden of AOM in young children with influenza. (Block S, #5529.504)
An analysis of LAIV efficacy against opposite-lineage influenza B strains, against which efficacy of all influenza vaccines has been believed to be low or zero, was conducted with data from six randomized, double-blind studies. In young children, LAIV may provide some efficacy against opposite-lineage influenza B strains, but this efficacy is lower than efficacy against influenza B strains of the same lineage as the vaccine. Based on these findings, study authors suggest that quadrivalent vaccines containing influenza B strains of both lineages should be considered. (Belshe R, #4357.473)
In an analysis of a previously conducted study that compared LAIV and injectable influenza vaccine in children six to 59 months of age* and found 51 percent fewer cases of influenza illness among LAIV recipients compared to injectable vaccine recipients, the amount of viral RNA recovered from subjects with breakthrough influenza illness was analyzed. No statistically significant differences were seen, and analysis of infectious virus by cell culture will gather additional data.(Belshe R, 5529.502)

*LAIV is not approved for use in children under two years of age.

Influenza Vaccination Practices of U.S. Pediatricians

Four additional MedImmune-sponsored studies evaluated influenza vaccination practices among U.S. pediatricians, based on a prospective, observational study of pediatric offices during the 2007-2009 flu seasons. The principal conclusions of the studies included the following:
Pediatric influenza vaccination rates in pediatric offices may have increased in 2008-09 compared to the previous year, and LAIV represented approximately one-third of the vaccinations given to children two to 18 years of age during the 2008-2009 season (Bhatt P, #5529.499)
Pediatricians may be able to vaccinate more children by offering flu vaccine to their patients before October and after December (Bhatt P, #5529.500)
Pediatricians are supportive of vaccinating parents in their offices (Toback S, # 5529.498)
Generally, pediatric offices have little influenza vaccine left-over at the end of the influenza season (Block S, #5529.503)

Increased Employee Absenteeism Seen Among Adults from Homes Where Kids Had Influenza-like-Illness

A final MedImmune-sponsored study presented at PAS prospectively followed 2,298 households during the 2007-2008 influenza season. (Rousculp M, #3866.255)
The research found that employed adults had increased work absenteeism in homes where children had influenza-like illnesses, as well as other acute respiratory illnesses.
The study’s authors conclude that employers should evaluate opportunities to reduce influenza-like illnesses and other acute respiratory illnesses in both the employee and employee’s children in order to maximize employee productivity.

About FluMist

FluMist® (Influenza Virus Vaccine Live, Intranasal) is a vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in children two to six years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.flumist.com/prescribing-information.aspx for additional information.

About MedImmune

FluMist(R) Now Available for the 2008-2009 Flu Season

Tor Constantino — Mon, 04 Aug 2008 12:05:00 +0000

Beginning Vaccinations in August Widens Window of Opportunity to Help Prevent Flu; Supports Newly Expanded Federal Influenza Vaccination Recommendations for

 All School-Age Children

GAITHERSBURG, Md., Aug. 4 /PRNewswire/ — MedImmune announced today that it began shipping FluMist(R) (Influenza Virus Vaccine Live, Intranasal) on July 31 for the 2008-2009 influenza season. Early and wide availability of FluMist is a key component in maximizing opportunities to vaccinate an additional 30 million children and teenagers through the age of 18 years who are now recommended by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) to be vaccinated annually against influenza.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080804/NEM027 )

The CDC also advises that flu vaccine be administered every year as soon as it becomes available. Results of a recent analysis reported by MedImmune at the annual meeting of the Pediatric Academic Societies (PAS) revealed that starting vaccination against influenza in August may help reach an additional 10.7 million children while they are at healthcare provider offices for already-scheduled visits.

“To meet the goal of vaccinating every school-age child and teenager against the flu, vaccination practices must shift to include opportunities across a longer period of time,” said Norman “Chip” Harbaugh, M.D., F.A.A.P. of the Children’s Medical Group of Atlanta. “Early availability of FluMist gives providers the ability to reach more eligible children through back-to-school check-ups, sports physicals and annual well-child visits with a vaccine that has been shown to provide protection throughout the entire flu season.”

Record Number of FluMist Doses Available – and in More Locations

MedImmune will make FluMist more widely available than ever before, with plans to produce approximately 12 million doses for the 2008-2009 season. In addition to ongoing shipments to healthcare provider offices and clinics, FluMist will also be available this influenza season at select retail pharmacies and supermarkets. Please visit www.flumist.com for information about availability of FluMist in local areas.

FluMist will also be available in nearly 200 school-based vaccination programs and university health centers. Additionally, the U.S. Department of Defense (DoD) has awarded MedImmune a contract for FluMist for the fourth consecutive year to help vaccinate eligible active duty military personnel and their families.

FluMist is available in every state through the federally funded Vaccines for Children (VFC) program, which provides vaccines at no cost to eligible children. FluMist is also covered by approximately 94 percent of private health plans which offer immunization benefits.

About FluMist

FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life-threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.medimmune.com/pdf/products/flumist_pi.pdf for additional information.

About MedImmune

MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN) and is the worldwide biologics business for the AstraZeneca Group. The company has approximately 3,000 employees worldwide and is headquartered in Gaithersburg, Maryland. 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 infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. For more information, visit MedImmune’s website at www.medimmune.com .

 SOURCE MedImmune -0- 08/04/2008 /NOTE TO EDITORS: In your coverage of influenza prevention, please recognize that the term "flu shot" is not an accurate way to report or describe influenza vaccinations. Please consider the more general term "flu vaccine" to cover both options available to people ages 2-49: the nasal spray influenza vaccine and the traditional flu shot. Please communicate this information to copy and headline editors. Images of FluMist are available upon request by contacting Karen Lancaster at 301-398-5864 or lancasterk@medimmune.com/ /CONTACT: Media, Karen Lancaster, +1-301-398-5864, or Investors, Peter Vozzo, +1-301-398-4358, both of MedImmune/ /Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20080804/NEM027 AP Archive: http://photoarchive.ap.org AP PhotoExpress Network: PRN10 PRN Photo Desk, photodesk@prnewswire.com/ /Web site: http://www.medimmune.com http://www.flumist.com http://www.flumist.com/prescribing-information.aspx / (AZN) CO: MedImmune; AstraZeneca plc; U.S. Centers for Disease Control and Prevention; CDC ST: Maryland IN: MTC HEA IDC SU: CHI LB-EE -- NEM027 -- 3728 08/04/2008 08:00 EDT http://www.prnewswire.com

Starting Flu Vaccination in August Could Help Protect Nearly 11 Million More Children During Scheduled Doctors’ Visits

Tor Constantino — Mon, 05 May 2008 16:03:00 +0000

HONOLULU, May 5 /PRNewswire/ — Research presented at the annual meeting of the Pediatric Academic Societies (PAS) shows that by starting flu vaccinations in August — ahead of the start of the typical flu vaccination season — healthcare providers could reach an additional 10.7 million children when these children are already in the doctor’s office. The potential impact of early vaccination was underscored by another study that found that less than 20 percent of school-aged children between five and 18 years of age were vaccinated in their pediatricians’ offices during the past influenza season. This study also showed that, on average, only about 40 percent of those children recommended to receive two doses of influenza vaccine actually received the second dose.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080505/NEM076 )

In February, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand flu vaccination recommendations to include all children six months through 18 years of age. Previously, the recommendations were for vaccination of children from six months to 59 months of age. The new guidelines add approximately 30 million children to the recommended pediatric population to be vaccinated annually against influenza.

“MedImmune is committed to doing all it can to support the ACIP’s expanded influenza vaccination recommendations and to work toward our common goal to vaccinate more children against the flu each year,” said John Trizzino, vice president, vaccines. “The data presented at the PAS meeting highlight the need to use every possible opportunity to improve vaccination rates and compliance, including vaccinating children when they visit their healthcare providers for back-to-school check-ups and sports physicals. We are focused on delivering FluMist(R) (Influenza Virus Vaccine Live, Intranasal) into the marketplace this year beginning in August.”

Earlier Influenza Vaccination Could Reach Nearly 11 Million More Children in Provider Offices

To examine the potential impact of early influenza vaccination, MedImmune researchers analyzed the Medical Expenditure Panel Survey (MEPS), a federally funded survey of families, individuals, and medical providers that collects data on health services utilized by Americans. They compared the number of children who had at least one healthcare provider visit between October 1 and December 31 (the traditional influenza vaccination period) to the number of children who had at least one visit between August 1 and December 31. The analysis found that by extending the flu vaccination season into August, an additional 6.6 million children would have vaccination opportunity during a well visit and 10.7 million children would have an opportunity to get a flu vaccine during an already-existing provider visit (well or sick).

Flu Vaccination Rates in Pediatrician Offices Remain Low

Another study, presented by Praful U. Bhatt, M.D. of Lock Haven, PA, assessed influenza vaccination use in pediatricians’ offices. Researchers selected a nationally representative sample of 44 pediatric practices in advance of the 2007-2008 influenza season. In these offices, the mean influenza vaccination rates were 37 percent in six to 23 month olds (1), 24 percent in 24 to 59 month olds, 19 percent in five to eight year olds, and 12 percent in nine to 17 year olds through February 29, 2008.

Additionally, the study looked at compliance with the recommendation that children younger than nine years of age who have not been previously vaccinated receive two doses of influenza vaccine at least four weeks apart. Compliance rates for receiving the second dose were 55 percent (six to 23 months) (1), 43 percent (24 to 59 months) and 25 percent (five to eight years of age).

The study also found that vaccination and compliance rates were higher in practices that administered influenza vaccine for more months during the vaccination season (starting earlier and ending later).

About FluMist

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life-threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.flumist.com/prescribing-information.aspx for additional information.

About MedImmune

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 infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease, and neuroscience. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune’s website at www.medimmune.com.

(1) Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing observed in clinical trials.

SOURCE MedImmune

CONTACT: Media: Karen Lancaster, +1-301-398-5864, or Investors: Peter Vozzo, +1-301-398-4358, both of MedImmune