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	<title>MedImmune Social Media Press Room &#187; asthma</title>
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		<title>MedImmune to Present 4 Abstracts on RSV and Influenza at 47TH Annual IDSA Meeting</title>
		<link>http://pressroom.medimmune.com/press-releases/2009/10/30/medimmune-to-present-4-abstracts-on-rsv-and-influenza-at-47th-annual-idsa-meeting/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2009/10/30/medimmune-to-present-4-abstracts-on-rsv-and-influenza-at-47th-annual-idsa-meeting/#comments</comments>
		<pubDate>Fri, 30 Oct 2009 18:36:11 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[influenza]]></category>
		<category><![CDATA[asthma]]></category>
		<category><![CDATA[biologics]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[influenza vaccines]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[MedImmune]]></category>
		<category><![CDATA[monoclonal antibody]]></category>
		<category><![CDATA[NIC]]></category>
		<category><![CDATA[pipeline]]></category>
		<category><![CDATA[President]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>
		<category><![CDATA[RSV]]></category>
		<category><![CDATA[Technology]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=1225</guid>
		<description><![CDATA[PHILADELPHIA, P.A., October 30, 2009 – MedImmune announced today it will present four abstracts at the 47th Annual Meeting of Infectious Disease Society of America (IDSA) being held here October 29 through November 1, 2009. These abstracts advance the body of data surrounding respiratory syncytial virus (RSV) and influenza prevention, highlighting MedImmune&#8217;s leadership in pediatric [...]]]></description>
			<content:encoded><![CDATA[<p>PHILADELPHIA, P.A., October 30, 2009 – MedImmune announced today it will present four abstracts at the 47th Annual Meeting of Infectious Disease Society of America (IDSA) being held here October 29 through November 1, 2009. These abstracts advance the body of data surrounding respiratory syncytial virus (RSV) and influenza prevention, highlighting MedImmune&#8217;s leadership in pediatric health.</p>
<p>&#8220;MedImmune is dedicated to conducting ground-breaking research on the prevention of respiratory syncytial virus (RSV) and influenza in children,&#8221; said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. &#8220;We believe the data being presented at the conference may help advance innovative healthcare solutions for these important causes of respiratory infections in children.&#8221;</p>
<p>MedImmune abstracts to be presented at IDSA on RSV include:</p>
<ul>
<li>Prophylaxis Utilizing Nebulized Motavizumab, a Monoclonal Antibody Against Fusion Protein of Respiratory Syncytial Virus (RSV) Zhang J, et al. Poster Session: October 30, 2009; 12:30 – 2:00 PM; Poster Hall A / Poster # 608</li>
</ul>
<p>BACKGROUND: Respiratory syncytial virus (RSV) infection is the primary cause of pneumonia and bronchiolitis in young children, and also causes disease in older adults. This study evaluated the prophylactic use of nebulized motavizumab, an investigational anti-RSV humanized monoclonal antibody against RSV fusion protein, in cotton rats. The findings suggest that prophylaxis with nebulized motavizumab may inhibit RSV infection and spread in the lungs and may provide an alternative to the current intramuscular antibody delivery.</p>
<p>MedImmune abstracts to be presented at IDSA on influenza include:</p>
<ul>
<li>A Postmarketing Evaluation of the Frequency of Use and Safety of Live Attenuated Influenza Vaccine Use in Unapproved Children Less Than 59 Months of Age Tennis P, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1179</li>
</ul>
<p>BACKGROUND: In September 2007, the approval of live attenuated influenza vaccine (LAIV) was expanded for use in children between 24 and 59 months in age. The vaccine was not approved for use in children younger than 24 months, or for use in children with asthma or recurrent wheezing, or those with altered immunocompetence. This study evaluates the usage and safety of the vaccine in those patient populations younger than 59 months of age that were not in the approved indication. The study found that healthcare providers appear to be complying with the indications for the use of LAIV in children &lt;5 years, and no adverse safety outcomes were detected in the small number of children in unapproved groups who received the vaccine.</p>
<ul>
<li>Whole Genome Transcriptional Analysis of the Early Immune Responses Induced by Live Attenuated and Inactivated Influenza Vaccines in Young Children Zhu W, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1181</li>
</ul>
<p>BACKGROUND: This study examined the early genomic immune response to live attenuated and inactivated vaccines in previously unvaccinated children 12 to 35 months of age. Among LAIV recipients, an increase in interferon (a natural anti-viral immune protein) production was seen, which may partly explain previous clinical study observations of LAIV-induced protection against illness in the first 2 weeks after administration.</p>
<ul>
<li>Influenza-Associated Antibiotic Use in Children Receiving Live Attenuated Influenza Vaccine Compared With Inactivated Influenza Vaccine Belshe R, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1180</li>
</ul>
<p>BACKGROUND: Influenza illness in children commonly results in the unnecessary use of prescription antibiotics. This analysis evaluated the efficacy of live attenuated influenza vaccine (LAIV) and trivalent inactivated influenza vaccine (TIV) in preventing antibiotic use in children ranging from six months to 17 years in age. Overall, there was less influenza-associated antibiotic use in LAIV recipients due to a lower rate of culture-confirmed influenza with LAIV.</p>
<p align="center">###</p>
<p>Additional information about the 2009 IDSA conference can be found at <a href="http://www.idsociety.org/IDSA2009.htm">http://www.idsociety.org/IDSA2009.htm</a>.</p>
<p><strong>About FluMist®</strong></p>
<p>FluMist® (Influenza 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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.</p>
<p>Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit <a href="http://www.medimmune.com/pdf/products/flumist_pi.pdf">http://www.medimmune.com/pdf/products/flumist_pi.pdf</a> for additional information.</p>
<p><strong>About MedImmune, Inc. </strong></p>
<p>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, MedImmune aims 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&#8217;s website at <a href="http://www.medimmune.com/">www.medimmune.com</a>.</p>
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		<title>FluMist(R) Begins Shipping for 2009-2010 Influenza Season</title>
		<link>http://pressroom.medimmune.com/press-releases/2009/07/28/flumist-begins-shipping-for-2009-2010-influenza-season/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2009/07/28/flumist-begins-shipping-for-2009-2010-influenza-season/#comments</comments>
		<pubDate>Tue, 28 Jul 2009 11:51:12 +0000</pubDate>
		<dc:creator>Mike O'Brien</dc:creator>
				<category><![CDATA[Products]]></category>
		<category><![CDATA[asthma]]></category>
		<category><![CDATA[influenza]]></category>
		<category><![CDATA[pipeline]]></category>
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		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=1116</guid>
		<description><![CDATA[Supports CDC&#8217;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&#8217;s Professional Soccer GAITHERSBURG, Md., July 28 /PRNewswire/ &#8212; MedImmune announced today that it has begun shipping its seasonal influenza vaccine FluMist (Influenza Vaccine Live, Intranasal) to vaccine distributors who [...]]]></description>
			<content:encoded><![CDATA[<p>Supports CDC&#8217;s Annual Recommendations for Families to Seek Vaccination for  Seasonal Influenza as Soon as Vaccine is Available</p>
<p>MedImmune Announces Influenza Vaccination Awareness Campaign with Women&#8217;s Professional Soccer</p>
<p>GAITHERSBURG, Md., July 28 /PRNewswire/ &#8212; 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.</p>
<p>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.</p>
<p>The 2009-2010 influenza season is the first for full implementation of the recommendations by the CDC&#8217;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.</p>
<p>&#8220;MedImmune is committed to delivering our seasonal nasal spray influenza vaccine in the summer months in order to increase opportunities for vaccination,&#8221; said Alex Zukiwski, MD, MedImmune&#8217;s Executive Vice President, Clinical Research &amp; Chief Medical Officer. &#8220;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.&#8221;</p>
<p>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.</p>
<p>FluMist Becomes Sponsor of Women&#8217;s Professional Soccer</p>
<p>To help communicate the importance of seasonal flu vaccination efforts, MedImmune has teamed up with Women&#8217;s Professional Soccer (WPS) for &#8220;Don&#8217;t Play with the Flu&#8221;(TM) (<a href="http://www.dontplaywiththeflu.com/">www.dontplaywiththeflu.com</a>), 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&#8217;s premier women&#8217;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.</p>
<p>&#8220;Our &#8216;Don&#8217;t Play with the Flu&#8217; 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,&#8221; said Peter Greenleaf, MedImmune&#8217;s Senior Vice President, Commercial Operations, Corporate Development &amp; Strategy.  &#8220;We&#8217;re proud to partner with the WPS in its inaugural season to bring this fun, educational and interactive campaign to the families across America.&#8221;</p>
<p>Important Safety and Eligibility information for FluMist</p>
<p>Who may be eligible for FluMist  (Influenza Vaccine Live, Intranasal)?</p>
<p>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.</p>
<p>Who may not be able to get FluMist?</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>What are the most common side effects of FluMist?</p>
<p>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.</p>
<p>Please see the <a href="http://www.medimmune.com/pdf/products/flumist_pi.pdf" target="_blank">complete product information</a>.</p>
<p>For more information, please visit <a href="http://www.flumist.com/">www.FluMist.com</a>.</p>
<p>About MedImmune</p>
<p>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&#8217;s website at <a href="http://www.medimmune.com/">www.medimmune.com</a>.</p>
<p>SOURCE  MedImmune</p>
<p>CONTACT:  Karen Lancaster of MedImmune, +1-301-398-5864, <a href="mailto:lancasterk@medimmune.com">lancasterk@medimmune.com</a>/</p>
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		<title>HHS Awards MedImmune Contract to Manufacture Live Attenuated Nasal Spray Vaccine for Novel Influenza A (H1N1)</title>
		<link>http://pressroom.medimmune.com/press-releases/2009/06/01/hhs-awards-medimmune-contract-to-manufacture-live-attenuated-nasal-spray-vaccine-for-novel-influenza-a-h1n1/</link>
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		<pubDate>Mon, 01 Jun 2009 13:21:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[antibodies]]></category>
		<category><![CDATA[asthma]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[H1N1]]></category>
		<category><![CDATA[influenza]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[pipeline]]></category>
		<category><![CDATA[Technology]]></category>

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		<description><![CDATA[MedImmune Plans to Begin Shipping Seasonal Vaccine to Health Care Providers in August GAITHERSBURG, Md., June 1 /PRNewswire/ &#8212; MedImmune announced today that the U.S. Department of Health and Human Services (HHS) has awarded the company a contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations [...]]]></description>
			<content:encoded><![CDATA[<p>MedImmune Plans to Begin Shipping Seasonal Vaccine to Health Care Providers in August</p>
<p>GAITHERSBURG, Md., June 1 /PRNewswire/ &#8212; MedImmune announced today that the U.S. Department of Health and Human Services (HHS) has awarded the company a contract to manufacture monovalent (single-strain) live attenuated influenza vaccine for Novel Influenza A (H1N1) to vaccinate priority populations identified by HHS in the National Strategy for Pandemic Influenza. An initial order of $90 million of vaccine has been placed, with the potential for additional orders. This project has been funded in whole or in part with the Federal funds from HHS/ASPR/BARDA, under Contract No. HHSO100200900002I.</p>
<p>MedImmune scientists have identified several promising vaccine candidates against the Novel Influenza A (H1N1) strain, and are currently evaluating their growth properties and antigenicity (i.e., their ability to stimulate antibodies) for mass production as part of the vaccine manufacturing process.</p>
<p>&#8220;MedImmune is pleased to be able to contribute our scientific expertise in influenza vaccine development and manufacturing to help combat this unpredictable public health threat,&#8221; said Ben Machielse, Drs., executive vice president of operations, MedImmune. &#8220;We are confident that our vaccine technology has several attributes that may be useful in protecting people with limited exposure to influenza against the Novel Influenza A (H1N1) strain.&#8221;</p>
<p>MedImmune&#8217;s live attenuated influenza vaccine (LAIV) technology may be particularly well-suited for vaccinating against emerging influenza strains. LAIV is different from the injectable influenza vaccine (&#8220;flu shot&#8221;) in that it is a gentle mist sprayed into the nose, where the influenza virus usually enters the body. It contains live vaccine virus strains that are weakened so as not to cause the flu, but prompt the body to mount an immune response after the first dose. Because it is live and stimulates a broad range of immune responses, LAIV may offer some cross-protection against circulating flu strains that are &#8220;drifted&#8221; &#8211; meaning they are very closely-related but not perfectly matched to the flu strains in the vaccine.</p>
<p>As a needle-free nasal spray, LAIV is well suited to facilitate mass vaccination, and has been widely used for school-based vaccinations and to help protect active-duty military personnel.</p>
<p>While MedImmune is committed to supporting global efforts to help protect individuals against the Novel Influenza A (H1N1) virus, its vaccine technology is currently only licensed in the United States. MedImmune is willing to make additional vaccine available to other governments if any capacity remains after fulfilling obligations to the U.S. government, assuming that necessary regulatory approval can be obtained.</p>
<p>Seasonal FluMist(R) on Track to Begin Shipping in August</p>
<p>MedImmune believes that the best way to help protect all eligible age groups against seasonal influenza is to vaccinate prior to and during the back-to-school period. The CDC&#8217;s Advisory Committee on Immunization Practices (ACIP) recommends influenza vaccination for all age groups as soon as seasonal vaccine is available each year. MedImmune plans to begin shipping the first of approximately 10 million doses of seasonal FluMist(R) (Influenza Virus Vaccine Live, Intranasal) to health care providers in August. This early availability of vaccine significantly widens the window of opportunity to vaccinate more eligible individuals and improve seasonal influenza vaccination rates, as patients seeing their providers for routine office visits can be vaccinated without waiting for the rush of fall vaccination clinics.</p>
<p>About Seasonal FluMist</p>
<p>FluMist(R) (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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.</p>
<p>Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit <a href="http://www.flumist.com/prescribing-information.aspx">http://www.flumist.com/prescribing-information.aspx</a> for additional information.</p>
<p>About MedImmune</p>
<p>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&#8217;s website at <a href="http://www.medimmune.com">www.medimmune.com</a>.</p>
<p>The opinions expressed herein do not represent opinions or statements made or expressed by the U.S. Department of Health and Human Services.</p>
<p><a href="http://www.medimmune.com">http://www.medimmune.com</a></p>
<p>SOURCE MedImmune</p>
<p>CONTACT: Karen Lancaster of MedImmune, +1-301-398-5864</p>
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		<title>FluMist® Shows Acceptable Safety Profile in Immunocompromised Children, According to New Findings Presented at Pediatric Academic Societies Annual Meeting</title>
		<link>http://pressroom.medimmune.com/press-releases/2009/05/05/flumist-shows-acceptable-safety-profile-in-immunocompromised-children-according-to-new-findings-presented-at-pediatric-academic-societies-annual-meeting/</link>
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		<pubDate>Tue, 05 May 2009 04:00:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Breakthroughs / Scientific Advancements]]></category>
		<category><![CDATA[Products]]></category>
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		<description><![CDATA[Additional Studies Report on FluMist Efficacy in Children; Indicate How Pediatricians Might Increase Influenza Vaccination Rates GAITHERSBURG, MD, May 5, 2009 &#8212; Data presented suggest that FluMist&#174; (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 [...]]]></description>
			<content:encoded><![CDATA[<p align="center"><em>Additional Studies Report on FluMist Efficacy in Children; Indicate How Pediatricians Might Increase Influenza Vaccination Rates</em></p>
<p><strong>GAITHERSBURG</strong><strong>, MD</strong><strong>, May 5, 2009</strong> &mdash; Data presented suggest that FluMist&reg; (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.<strong> </strong></p>
<p> 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&#8217;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. </p>
<p>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.   <em>(Please see About FluMist for important safety and eligibility information later in this release</em>).</p>
<p>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 &mdash; 2009 flu seasons and the impact of respiratory illness in children on parent work absenteeism and productivity.   </p>
<p> 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. </p>
<p>Brief summaries of the ten (10) MedImmune-sponsored abstracts presented at PAS are provided below.</p>
<p><strong><u>LAIV Use in Children</u></strong></p>
<ul type="disc">
<li>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.* <em>(Belshe R, #5529.501)    </em></li>
<li>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.   <em>(Block, #5529.505)</em></li>
<li>Across eight randomized, controlled studies, LAIV reduced influenza-associated acute otitis media (AOM) &mdash; commonly referred to as an ear infection &mdash; 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.   <em>(Block S, #5529.504)</em></li>
<li>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)</li>
<li>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.(<em>Belshe R, 5529.502)</em></li>
</ul>
<p><em>       *LAIV is not approved for use in children under two years of age.  </em></p>
<p><strong><u>Influenza Vaccination Practices of U.S. Pediatricians</u></strong></p>
<ul>
<li>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:</li>
<li>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 <em>(Bhatt P, #5529.499)</em></li>
<li>Pediatricians may be able to vaccinate more children by offering flu vaccine to their patients before October and after December <em>(Bhatt P, #5529.500)</em></li>
<li>Pediatricians are supportive of vaccinating parents in their offices <em>(Toback S, # 5529.498)</em></li>
<li>Generally, pediatric offices have little influenza vaccine left-over at the end of the influenza season <em>(Block S, #5529.503)</em></li>
</ul>
<p><strong><u>Increased Employee Absenteeism Seen Among Adults from Homes Where Kids Had Influenza-like-Illness </u></strong></p>
<ul>
<li>A final MedImmune-sponsored study presented at PAS prospectively followed 2,298 households during the 2007-2008 influenza season. <em>(Rousculp M, #3866.255)   </em></li>
<li>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. </li>
<li>The study&#8217;s authors conclude that employers should evaluate opportunities to reduce influenza-like illnesses and other acute respiratory illnesses in both the employee and employee&#8217;s children in order to maximize employee productivity.</li>
</ul>
<p><strong>About FluMist</strong></p>
<p>FluMist&reg; (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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.</p>
<p>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.</p>
<p><strong>About MedImmune</strong></p>
<p>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&#8217;s website at www.medimmune.com.</p>
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		<title>MedImmune to Present Nine Abstracts on RSV and Influenza at 48th Annual ICAAC/46th Annual IDSA Meeting</title>
		<link>http://pressroom.medimmune.com/press-releases/2008/10/24/medimmune-to-present-nine-abstracts-on-rsv-and-influenza-at-48th-annual-icaac-46th-annual-idsa-meeting/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2008/10/24/medimmune-to-present-nine-abstracts-on-rsv-and-influenza-at-48th-annual-icaac-46th-annual-idsa-meeting/#comments</comments>
		<pubDate>Fri, 24 Oct 2008 04:00:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
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		<description><![CDATA[WASHINGTON, Oct. 24 /PRNewswire-USNewswire/ &#8212; MedImmune announced today it will present nine abstracts at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/46th Annual Meeting of Infectious Disease Society of America (IDSA). These abstracts advance the knowledge about respiratory syncytial virus (RSV) and influenza, providing valuable insight into infectious disease prevention and underscoring [...]]]></description>
			<content:encoded><![CDATA[<p> WASHINGTON, Oct. 24 /PRNewswire-USNewswire/ &#8212; MedImmune announced today it will present nine abstracts at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/46th Annual Meeting of Infectious Disease Society of America (IDSA). These abstracts advance the knowledge about respiratory syncytial virus (RSV) and influenza, providing valuable insight into infectious disease prevention and underscoring MedImmune&#8217;s leadership in this disease category.</p>
<p> &#8220;MedImmune is committed to conducting innovative infectious disease research to determine how best to prevent serious illness that can negatively impact pediatric health, especially during this time of year,&#8221; said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. &#8220;We believe the data being presented at this meeting will help lead to important new healthcare solutions, and our company is proud to advance our already robust research base to identify the best ways to help protect children.&#8221;
<p> MedImmune abstracts to be presented at ICAAC/IDSA on RSV include:
<ul>
<li>Respiratory Syncytial Virus Therapy Utilizing Intranasally Delivered Motavizumab, a Monoclonal Antibody Against the Viral Fusion Protein (#V-4145) B. Richter, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM </li>
</ul>
<p> BACKGROUND: A primary cause of pneumonia and bronchiolitis in young children is RSV infection. This preclinical study examined the therapeutic effect of topically administered motavizumab.
<ul>
<li>Therapeutic Addition of Motavizumab, a Monoclonal Antibody Against Respiratory Syncytial Virus, Modulates Epithelial Cell Responses to RSV Infection (#V-4146) S. Krishnan, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM </li>
</ul>
<p> BACKGROUND: RSV infection of epithelial cells leads to inflammatory host responses. This preclinical study tested whether motavizumab, a humanized monoclonal antibody against the RSV fusion (F) protein, could modulate epithelial cell immune responses to RSV. Lower and upper airway epithelial cells were infected with RSV and motavizumab or a control antibody was subsequently administered at various points post-infection to evaluate the therapeutic addition.
<ul>
<li>Total Healthcare Costs of Preterm Infants with Medically Attended Respiratory Syncytial Virus Lower Respiratory Infection (#K-1429 ) D. Stewart, Sunday, October 26, 2008, Hall C from 12:15 PM to 1:15 PM </li>
</ul>
<p> BACKGROUND: While RSV lower respiratory infection (LRI) is the most common cause of hospitalization among infants under one year of age, the total healthcare costs of medically attended RSV LRI for babies of this age group is unknown. This retrospective, propensity-matched cohort assessment sought to determine first-year healthcare costs by examining premature infants born over a five-year period who were insured by a national U.S. health plan, including a subgroup analysis of babies born between 33 and 36 weeks gestation.
<ul>
<li>In Vitro Mechanism of Action Studies of the RSV-Neutralizing Monoclonal Antibodies Palivizumab and Motavizumab (#V-4146) K. Huang, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM </li>
</ul>
<p> BACKGROUND: Synagis is the only licensed drug product available to help prevent lower respiratory tract RSV infection in premature infants, a leading cause of hospitalizations in this patient population. An affinity-optimized version of Synagis, motavizumab, has been subsequently developed. Since both Synagis and motavizumab bind the RSV fusion (F) protein, which plays a role in virus attachment and mediates the process of virus-cell fusion and cell-to-cell fusion, this study aimed to determine exactly how the drugs neutralize RSV. Four assays were used, which target four distinct steps during virus replication, to identify the mechanism.
<ul>
<li>In Vitro and In Vivo Characterization of a Motavizumab-Resistant RSV A Mutant (#V-4148) F. J. Palmer-Hill, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM </li>
</ul>
<p> BACKGROUND: This study investigated the growth characteristics &#8211; both in vitro and in vivo &#8211; of an RSV mutant that was created in the laboratory and is resistant to neutralization by motavizumab, an affinity-optimized MAb directed against the RSV fusion (F) protein. The F protein of the MAb differs from a wild type RSV F protein, so comparisons were made.
<ul>
<li>Characterization of Respiratory Syncytial Virus (RSV)Mutants Resistant to Antibody Neutralization with Novel Amino Acid Changes in the RSV Fusion Protein (#V-4149) N. K. Patel, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM </li>
</ul>
<p> BACKGROUND: Synagis is a MAb approved for the prevention of serious lower respiratory tract RSV infection in premature infants. Motavizumab was developed by affinity optimization of Synagis and is characterized by greater in vitro and in vivo neutralization activity against RSV. Previously, the selection of RSV mutants resistant to Synagis has been reported, characterized by amino acid changes in the RSV fusion (F) protein. This study sought to identify the selection and characterization of additional Synagis MAb-resistant mutants, as well as a novel motavizumab MAb-resistant mutant.
<p> MedImmune abstracts to be presented at ICAAC/IDSA on influenza include:
<ul>
<li>Influenza-like Illness and Employee Productivity &#8211; Results from the Child and Household Influenza-illness and Employee Function (CHIEF) (#K-4207) M. D. Rousculp, Tuesday, October 28, Room 150B from 2:450 PM to 3:00 PM </li>
</ul>
<p> BACKGROUND: This prospective cohort study of nearly 2,293 U.S. households evaluated the effect of employee and household member influenza-like illness on worker productivity. The households studied were employees from three large Fortune 500 companies. All households included in the study had at least one child. Households were surveyed monthly throughout the 2007-2008 influenza season to determine the impact of influenza-like illness on employees&#8217; work absenteeism and decreased productivity while on the job.
<ul>
<li>Impact of Early and Late Influenza Vaccine Availability on In-Office Vaccination Opportunities (#G1-1208) R. Judelsohn, Sunday October 26, Hall C from 11:15 AM to 12:15 PM </li>
</ul>
<p> BACKGROUND: The CDC now recommends all children from six months to 18 years of age receive an annual influenza vaccination; however, a key barrier to implementation is the inconvenience to parents and providers around scheduling additional office visits to administer the vaccination. This study examined how many more vaccination opportunities exist if influenza vaccination availability were expanded beyond the typical October-to-December timeframe.
<ul>
<li>Benefits Versus Risks of Live Attenuated Influenza Vaccine (LAIV) in Young Children (#G1-1204) G. Oster, Sunday October 26, Hall C from 11:15 AM to 12:15 PM </li>
</ul>
<p> BACKGROUND: In September 2007, approved use of LAIV in the U.S. was expanded to include children aged 24-59 months but with warning/precautions against use in younger children and children 24-59 months with a history of recurrent wheezing or asthma. Since some latter children may receive LAIV in clinical practice, its risks and benefits versus trivalent influenza vaccine (TIV) in this setting must be considered.
<p> Additional information about the 2008 ICAAC/IDSA conference can be found at <A HREF="http://www.icaacidsa2008.org/" target="_new">http://www.icaacidsa2008.org/</A>.
<p> <b>About Synagis</b><br/> Synagis(R) (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. The first dose of Synagis should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been used in more than one million children in the U.S. since its introduction in 1998.
<p> Synagis should not be used in patients with a history of severe prior reaction to Synagis or its components. 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. Another serious side effect, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin, has been reported.
<p> Most common side effects with Synagis may include upper respiratory tract infection, ear infection, fever, and runny nose. In children born with heart problems, Synagis was associated with reports of low blood oxygen levels and abnormal heart rhythms. Side effects, such as, skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) have also been reported.
<p> Please see accompanying full prescribing information at <A HREF="http://www.synagis.com" target="_new">http://www.synagis.com</A>.
<p> <b>About FluMist</b><br/> FluMist(R) (Influenza Virus Vaccine Live, Intranasal) 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.
<p> 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.
<p> 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.
<p> 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.
<p> 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.
<p> FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.
<p> Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit <A HREF="http://www.flumist.com/prescribing-information.aspx" target="_new">http://www.flumist.com/prescribing-information.aspx</A> for additional information.
<p> <b>About MedImmune</b><br/> 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&#8217;s website at <A HREF="http://www.medimmune.com" target="_new">http://www.medimmune.com</A>.
<p> <strong>Contacts</strong>:<br/> Media: Tor Constantino, 301-398-5801<br/> Investors: Peter Vozzo, 301-398-4358<br/> <A HREF="http://www.medimmune.com" target="_new">http://www.medimmune.com</A></p>
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		<title>FluMist(R) Now Available for the 2008-2009 Flu Season</title>
		<link>http://pressroom.medimmune.com/press-releases/2008/08/04/flumist-r-now-available-for-the-2008-2009-flu-season/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2008/08/04/flumist-r-now-available-for-the-2008-2009-flu-season/#comments</comments>
		<pubDate>Mon, 04 Aug 2008 12:05:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
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		<description><![CDATA[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/ &#8212; 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 [...]]]></description>
			<content:encoded><![CDATA[<p>Beginning Vaccinations in August Widens Window of Opportunity to Help Prevent Flu; Supports Newly Expanded Federal Influenza Vaccination Recommendations for</p>
<pre> All School-Age Children</pre>
<p> GAITHERSBURG, Md., Aug. 4 /PRNewswire/ &#8212; 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&#8217;s (CDC) Advisory Committee on Immunization Practices (ACIP) to be vaccinated annually against influenza.</p>
<p> (Photo: http://www.newscom.com/cgi-bin/prnh/20080804/NEM027 )</p>
<p> 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.</p>
<p> &#8220;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,&#8221; said Norman &#8220;Chip&#8221; Harbaugh, M.D., F.A.A.P. of the Children&#8217;s Medical Group of Atlanta. &#8220;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.&#8221;</p>
<p> Record Number of FluMist Doses Available &#8211; and in More Locations</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> About FluMist</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.</p>
<p> 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.</p>
<p> About MedImmune</p>
<p> 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&#8217;s website at www.medimmune.com .</p>
<pre> 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 </pre>
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		<title>Starting Flu Vaccination in August Could Help Protect Nearly 11 Million More Children During Scheduled Doctors&#8217; Visits</title>
		<link>http://pressroom.medimmune.com/press-releases/2008/05/05/starting-flu-vaccination-in-august-could-help-protect-nearly-11-million-more-children-during-scheduled-doctors-visits/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2008/05/05/starting-flu-vaccination-in-august-could-help-protect-nearly-11-million-more-children-during-scheduled-doctors-visits/#comments</comments>
		<pubDate>Mon, 05 May 2008 16:03:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
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		<description><![CDATA[HONOLULU, May 5 /PRNewswire/ &#8212; Research presented at the annual meeting of the Pediatric Academic Societies (PAS) shows that by starting flu vaccinations in August &#8212; ahead of the start of the typical flu vaccination season &#8212; healthcare providers could reach an additional 10.7 million children when these children are already in the doctor&#8217;s office. [...]]]></description>
			<content:encoded><![CDATA[<p> HONOLULU, May 5 /PRNewswire/ &#8212; Research presented at the annual meeting of the Pediatric Academic Societies (PAS) shows that by starting flu vaccinations in August &#8212; ahead of the start of the typical flu vaccination season &#8212; healthcare providers could reach an additional 10.7 million children when these children are already in the doctor&#8217;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&#8217; 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.</p>
<p> (Photo: http://www.newscom.com/cgi-bin/prnh/20080505/NEM076 )</p>
<p> In February, the Centers for Disease Control and Prevention&#8217;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.</p>
<p> &#8220;MedImmune is committed to doing all it can to support the ACIP&#8217;s expanded influenza vaccination recommendations and to work toward our common goal to vaccinate more children against the flu each year,&#8221; said John Trizzino, vice president, vaccines. &#8220;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.&#8221;</p>
<p> Earlier Influenza Vaccination Could Reach Nearly 11 Million More Children in Provider Offices</p>
<p> 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).</p>
<p> Flu Vaccination Rates in Pediatrician Offices Remain Low</p>
<p> Another study, presented by Praful U. Bhatt, M.D. of Lock Haven, PA, assessed influenza vaccination use in pediatricians&#8217; 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.</p>
<p> 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).</p>
<p> 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).</p>
<p> About FluMist</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.</p>
<p> 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.</p>
<p> About MedImmune</p>
<p> 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&#8217;s website at www.medimmune.com.</p>
<p> (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.</p>
<p> SOURCE MedImmune</p>
<p> CONTACT: Media: Karen Lancaster, +1-301-398-5864, or Investors: Peter Vozzo, +1-301-398-4358, both of MedImmune </p>
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		<title>Efficacy of FluMist(R) in Children Highlighted at Pediatric Academic Societies Meeting</title>
		<link>http://pressroom.medimmune.com/press-releases/2008/05/05/efficacy-of-flumist-r-in-children-highlighted-at-pediatric-academic-societies-meeting/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2008/05/05/efficacy-of-flumist-r-in-children-highlighted-at-pediatric-academic-societies-meeting/#comments</comments>
		<pubDate>Mon, 05 May 2008 14:31:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Products]]></category>
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		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[influenza]]></category>
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		<description><![CDATA[Up to Twelve-Month Efficacy Against Influenza Observed; Good Protection Demonstrated in Trial Evaluating the Benefit of the Recommended Two Doses for Previously Unvaccinated Children HONOLULU, May 5 /PRNewswire/ &#8212; Data from two new studies presented at the annual meeting of the Pediatric Academic Societies (PAS) demonstrate that FluMist(R) (Influenza Virus Vaccine Live, Intranasal) may offer [...]]]></description>
			<content:encoded><![CDATA[<p> Up to Twelve-Month Efficacy Against Influenza Observed; Good Protection Demonstrated in Trial Evaluating the Benefit of the Recommended Two Doses for Previously Unvaccinated Children </p>
<p> HONOLULU, May 5 /PRNewswire/ &#8212; Data from two new studies presented at the annual meeting of the Pediatric Academic Societies (PAS) demonstrate that FluMist(R) (Influenza Virus Vaccine Live, Intranasal) may offer children both durable protection against influenza, as well as significant protection for previously unvaccinated children who receive the recommended two-dose regimen approximately four weeks apart. In the efficacy trial evaluating one and two doses in previously unvaccinated children, protection was also observed among previously unvaccinated children who received only one dose of FluMist.</p>
<p> (Photo: http://www.newscom.com/cgi-bin/prnh/20080505/NEM076 )</p>
<p> &#8220;These data add to the growing body of evidence that FluMist offers good protection against influenza for children eligible to receive it,&#8221; commented Chris Ambrose, M.D., director, medical affairs. &#8220;We hope that this data will help support public health efforts to encourage parents to vaccinate their children each year as soon as vaccine is available and follow dosing recommendations to optimally protect children against this infectious disease.&#8221;</p>
<p> FluMist is different from the flu shot in that it uses live, attenuated &#8212; or weakened &#8212; viruses within the vaccine to help stimulate an immune response that is designed to closely resemble the body&#8217;s natural response to an influenza infection.</p>
<p> Efficacy of FluMist Among Previously Unvaccinated Children</p>
<p> In a study involving 3,200 previously unvaccinated children between the ages of six (1) and 36 months, the efficacy of one dose of FluMist was compared to the recommended two doses. The study showed that for children receiving one dose of FluMist, efficacy against matched strains was 58 percent, and efficacy increased to 74 percent for those receiving two doses. In the second season of the study, both groups received a single dose of FluMist (per recommendations) and no difference in efficacy was seen (efficacies of 65 percent and 74 percent, respectively). Runny nose/nasal congestion and cough were the most frequently reported events. No events were significantly increased in FluMist recipients; cough was significantly decreased. This double-blind, placebo controlled study, led by Drs. Bracco and Farhat of the Federal University of San Paulo, Brazil, was conducted at 35 sites in the Southern Hemisphere during the 2001 and 2002 influenza seasons.</p>
<p> Dr. Ambrose stated: &#8220;Previously unvaccinated children under nine years of age are recommended to receive two doses of influenza vaccine, but studies have shown that less than 50 percent of these children actually receive the second dose. Our trial shows clear evidence that receiving the second dose of FluMist provides more robust protection. However, we are also encouraged that there was still protection for those that received one dose.&#8221;</p>
<p> Duration of Influenza Protection Using Nasal Spray Flu Vaccine</p>
<p> In a second study, researchers at MedImmune examined data from four previous clinical trials of children between six months (1) and 18 years of age and found that children who were given FluMist had a comparable level of protection through 12 months after vaccination.</p>
<p> &#8220;The data on FluMist&#8217;s duration of protection provide comfort for providers and parents who wish to vaccinate children in late summer or early fall,&#8221; said Ambrose.</p>
<p> About FluMist</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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 degree F in children two to six years of age, and sore throat in adults.</p>
<p> FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.</p>
<p> 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.</p>
<p> About MedImmune</p>
<p> 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&#8217;s website at http://www.medimmune.com.</p>
<p> (1) Do not administer FluMist to children less than two years of age due</p>
<p> to an increased risk of hospitalization and wheezing observed in</p>
<p> clinical trials.</p>
<p> SOURCE MedImmune</p>
<p> CONTACT: Media, Karen Lancaster, +1-301-398-5864, or Investors, Peter Vozzo, +1-301-398-4358, both of MedImmune </p>
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		<title>Fourteen Abstracts Featuring MedImmune&#8217;s Influenza and RSV Therapeutic Areas to Be Presented at Pediatric Academic Societies Annual Meeting</title>
		<link>http://pressroom.medimmune.com/press-releases/2008/04/28/fourteen-abstracts-featuring-medimmune-s-influenza-and-rsv-therapeutic-areas-to-be-presented-at-pediatric-academic-societies-annual-meeting/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2008/04/28/fourteen-abstracts-featuring-medimmune-s-influenza-and-rsv-therapeutic-areas-to-be-presented-at-pediatric-academic-societies-annual-meeting/#comments</comments>
		<pubDate>Mon, 28 Apr 2008 17:02:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
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		<description><![CDATA[Results Provide Insights into Infectious Disease Prevention in Children GAITHERSBURG, Md., April 28 /PRNewswire/ &#8212; MedImmune today announced that researchers will present results from a host of studies in pediatric infectious disease, featuring FluMist(R) (Influenza Virus Vaccine Live, Intranasal) as well as Synagis(R) (palivizumab) and emerging RSV compounds motavizumab and MEDI-534, at the Pediatric Academic [...]]]></description>
			<content:encoded><![CDATA[<pre> Results Provide Insights into Infectious Disease Prevention in Children</pre>
<p> GAITHERSBURG, Md., April 28 /PRNewswire/ &#8212; MedImmune today announced that researchers will present results from a host of studies in pediatric infectious disease, featuring FluMist(R) (Influenza Virus Vaccine Live, Intranasal) as well as Synagis(R) (palivizumab) and emerging RSV compounds motavizumab and MEDI-534, at the Pediatric Academic Societies (PAS) Annual Meeting beginning later this week in Honolulu, HI.</p>
<p> &#8220;Our rich history in pediatric research is a pillar of our strength at MedImmune and we believe the collective data we share at PAS will help further the understanding of prevention around two important infectious diseases that impact the health of children,&#8221; said Alexander A. Zukiwski, M.D., senior vice president and chief medical officer. &#8220;Ongoing research from our portfolio of current and emerging biologics reflects our commitment to finding important new solutions for pediatric infectious disease prevention.&#8221;</p>
<pre> Influenza-Related Studies Studies including data on influenza or FluMist are as follows: </pre>
<p> Immunogenicity of Live Attenuated Influenza Vaccine (LAIV) Compared With Trivalent Inactivated Influenza Vaccine (TIV) in Children 12-35 Months of Age(1) (Harvey BM, et al)</p>
<pre> PRESENTATION TYPE Podium Presentation # 5628, Late Breaker Abstract Session II: General Pediatrics PUBLICATION # 5628.5 DATE Monday, May 5, 2008 TIME 4:00 - 4:15 PM LOCAL TIME LOCATION Room 323A </pre>
<p> (1) 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.</p>
<p> Shedding and Safety of Live Attenuated Influenza Vaccine in Healthy Subjects 6 to &lt;60 Months of Age(1) (Block SL, Reisinger KS)</p>
<pre> PRESENTATION TYPE Podium Presentation # 5628, Late Breaker Abstract Session II: General Pediatrics PUBLICATION # 5628.6 DATE Monday, May 5, 2008 TIME 4:15 - 4:30 PM LOCAL TIME LOCATION Room 323A </pre>
<p> Efficacy, Immunogenicity, and Safety of One Versus Two Doses of LAIV in Young Children (Bracco H, et al)</p>
<pre> PRESENTATION TYPE Podium Presentation, Session # 4320: Infectious Diseases I - Respiratory Viruses PUBLICATION #4320.6 DATE Sunday, May 4, 2008 TIME 10:30 - 10:45 AM LOCAL TIME LOCATION Room 313A </pre>
<p> Cost-Effectiveness of Live Attenuated Influenza Vaccine Versus Inactivated Influenza Vaccine Among Children Aged 24 to 59 Months (Luce B, et al)</p>
<pre> PRESENTATION TYPE Poster Presentation, Session # 4461: Infectious Diseases PUBLICATION #4461.8, Board # 208 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C Duration of Protection Provided by LAIV in Children (Ambrose CS, et al) PRESENTATION TYPE Poster Presentation, Session # 4461: Infectious Diseases PUBLICATION #4461.9, Board # 209 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C </pre>
<p> Real-Time Assessment of 2007-2008 Influenza Vaccine Coverage Among Practicing Pediatricians (Bhatt P, et al)</p>
<pre> PRESENTATION TYPE Poster Presentation, Session # 4461: Infectious Diseases PUBLICATION Publication #4461.6, Board #207 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C </pre>
<p> Efficacy of Live Attenuated Influenza Vaccine in Children: A Meta-Analysis of 9 Randomized Clinical Trials (Rhorer J, et al)</p>
<pre> PRESENTATION TYPE Poster Presentation, Session # 4461: Infectious Diseases PUBLICATION Publication #4461.11, Board #211 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C </pre>
<p> Early Availability of Influenza Vaccine Could Double In-Office Vaccination Opportunities (Ambrose CS, et al)</p>
<pre> PRESENTATION TYPE Poster Presentation, Session # 4461: Infectious Diseases PUBLICATION Publication #4461.10, Board #210 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C </pre>
<p> Genetic Sequences of Circulating 2004-2005 Influenza Strains and Serum Antibody Responses to LAIV vs. TIV in Young Children (Belshe RB, et al)</p>
<pre> PRESENTATION TYPE Poster Presentation, Session # 4461: Infectious Diseases PUBLICATION Publication #4461.2, Board #204 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C RSV-Related Studies</pre>
<p> A total of five studies related to MedImmune&#8217;s respiratory syncytial virus (RSV) marketed and investigational products are scheduled for presentation at the PAS meeting. Among these are two studies related to epidemiology and pharmacoeconomics of RSV, and one each related to Synagis(R) (palivizumab), motavizumab and MEDI-534. Results of these studies are scheduled to be presented as follows:</p>
<p> Seasonality of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Infection (LRI) and Apnea in Infants Presenting to the Emergency Department (ED) (Bonner A, et al)</p>
<pre> PRESENTATION TYPE Poster Presentation, Session # 4460: Infectious Diseases PUBLICATION Publication #4460.9, Board #190 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C Pediatricians' Clinical Judgment Accurately Predicts Risk for Increased RSV Hospitalization Among Preterm Infants 32-35 Weeks Gestational Age (Groothuis JR, et al) PRESENTATION TYPE Poster Presentation, Session # 4460: Infectious Diseases PUBLICATION Publication #4460.10, Board #191 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C </pre>
<p> Phase 1 study of MEDI-534, a Live Attenuated Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy 1-9 Year-Old RSV and PIV3 Seropositive Children (Gomez M, et al)</p>
<pre> PRESENTATION TYPE Poster Presentation, Session # 4460: Infectious Diseases PUBLICATION Publication #4460.4, Board #259 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C </pre>
<p> Lung Function in Healthy Late Preterm Infants Delivered at 33-36 Weeks of Gestation (Venigalla S, et al)</p>
<pre> PRESENTATION TYPE Podium Presentation, Session Title: Neonatal - Patient-Oriented Research I DATE Saturday, May 3, 2008 TIME 9:15 - 11:15 PM LOCAL TIME LOCATION Ballroom A </pre>
<p> Safety and Efficacy of motavizumab in the Prevention of RSV Disease in Healthy Infants (Chandran A, et al)</p>
<pre> POSTER # Poster Presentation, Session #4460: Infectious Diseases PUBLICATION Publication #4460.5, Board #186 DATE Sunday, May 4, 2008 TIME 11:00 AM - 3:00 PM LOCAL TIME LOCATION Halls A - C About FluMist</pre>
<p> FluMist(R) (Influenza Virus Vaccine Live, Intranasal) 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.</p>
<p> 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.</p>
<p> About Synagis</p>
<p> Synagis(R) (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. The first dose of Synagis should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been used in more than one million children in the U.S. since its introduction in 1998.</p>
<p> Very rare cases (&lt;1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (&lt;1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis is given, not just the first one. Also, rare but serious side effects can occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.</p>
<p> Other side effects with Synagis may include upper respiratory tract infection, ear infection, fever, and runny nose. In children born with heart problems, Synagis was associated with reports of low blood oxygen levels and abnormal heart rhythms. Synagis should not be used in patients with a history of a severe prior reaction to Synagis or its components. Side effects, such as, skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) can also occur.</p>
<p> Please see complete prescribing information at www.synagis.com.</p>
<p> About MedImmune</p>
<p> 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 cardiovascular/gastrointestinal disease, neuroscience, oncology, infection, respiratory disease and inflammation. 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&#8217;s website at www.medimmune.com.</p>
<pre> SOURCE MedImmune -0- 04/28/2008 /CONTACT: Media: Karen Lancaster, +1-301-398-5864 (influenza), or Tor Constantino, +1-301-398-8501 (RSV), or Investors: Peter Vozzo, +1-301-398-4358, all of MedImmune / /Web site: http://www.medimmune.com http://www.flumist.com/prescribing-information.aspx http://www.synagis.com / (AZN) CO: MedImmune; Pediatric Academic Societies Annual Meeting; PAS; AstraZeneca plc ST: Maryland, Hawaii IN: HEA MTC IDC SU: CHI JE-JT -- NEM099 -- 2883 04/28/2008 13:00 EDT http://www.prnewswire.com </pre>
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		<title>MedImmune Prepared to Support Implementation of Expanded ACIP Recommendations for Influenza Vaccinations</title>
		<link>http://pressroom.medimmune.com/press-releases/2008/02/27/medimmune-prepared-to-support-implementation-of-expanded-acip-recommendations-for-influenza-vaccinations/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2008/02/27/medimmune-prepared-to-support-implementation-of-expanded-acip-recommendations-for-influenza-vaccinations/#comments</comments>
		<pubDate>Wed, 27 Feb 2008 16:36:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
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		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[influenza]]></category>
		<category><![CDATA[influenza virus]]></category>
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		<description><![CDATA[- School-Based Vaccination Programs Using FluMist(R) May Serve as Model to Help Vaccinate Large Numbers of Eligible Children - GAITHERSBURG, MD, February 27, 2008 &#8212; MedImmune, the manufacturer of FluMist(R) (Influenza Virus Vaccine Live, Intranasal), today lauded the U.S. Centers for Disease Control and Prevention&#8217;s (CDC) Advisory Committee on Immunization Practices (ACIP) for its unanimous [...]]]></description>
			<content:encoded><![CDATA[<pre> - School-Based Vaccination Programs Using FluMist(R) May Serve as Model to Help Vaccinate Large Numbers of Eligible Children -</pre>
<p> GAITHERSBURG, MD, February 27, 2008 &#8212; MedImmune, the manufacturer of FluMist(R) (Influenza Virus Vaccine Live, Intranasal), today lauded the U.S. Centers for Disease Control and Prevention&#8217;s (CDC) Advisory Committee on Immunization Practices (ACIP) for its unanimous vote to expand recommendations for routine seasonal influenza vaccination to include all school-age children up to the age of 18 years as soon as feasible but no later than the 2009-2010 influenza season. To support this move by the ACIP, MedImmune is preparing to manufacture a record number of FluMist doses &#8212; about 12 million &#8212; for the upcoming flu season, with the intention of continuing to substantially increase production in subsequent seasons.</p>
<p> &#8220;MedImmune applauds the ACIP for expanding its recommendations and stands ready to support this move by nearly tripling its production of FluMist doses for the 2008-2009 flu season,&#8221; said Frank J. Malinoski, M.D., Ph.D., senior vice president of medical and scientific affairs.</p>
<p> &#8220;We also believe that positive experiences using FluMist in school-based programs point to the importance &#8212; and opportunity &#8212; of using non- traditional venues, in addition to traditional venues, to help achieve the goal of vaccinating a larger number of school-age children against the flu,&#8221; added Malinoski.</p>
<p> Research has shown statistically significant reductions in influenza like illness (ILI), child doctors&#8217; office visits, medication use and work/school absenteeism among households whose children attended schools/daycares with influenza vaccination programs, compared to those whose children attended schools/daycares without these programs(1)(2).</p>
<p> Since introduction of the nasal spray vaccine to the U.S. market in 2003, FluMist has been increasingly utilized in schools, public health centers, and other community-based programs to efficiently vaccinate a large number of people.</p>
<p> &#8220;Our experience has been that children are generally quite accepting of a vaccine that does not involve a needle,&#8221; Malinoski said. &#8220;Additionally, parents and health care providers may appreciate that FluMist works differently than the flu shot in that it uses live, attenuated &#8212; or weakened &#8212; vaccine viruses within the vaccine to help stimulate an immune response that closely resembles the body&#8217;s natural protective response to an influenza infection. This may also explain why we have observed some protection against mismatched strains in past seasons.&#8221;</p>
<p> While past clinical trial results are not indicative of future results, in multiple studies across several seasons FluMist demonstrated that it could help offer protection against mismatched influenza A strains(3).</p>
<pre> -- In a two-year, multicenter, randomized, double-blind placebo-controlled trial (conducted between 1996-1998) in children 24 months-71 months of age, FluMist provided comparable protection in a year with matched strains (95 percent protection -- year two) and a year with mismatched strains (87 percent protection -- year two). The mismatched strain that circulated during the studied season was A/Sydney (H3N2). -- In a head-to-head study conducted during the 2004-2005 influenza season that included over 4,000 children between two and five years of age, when looking specifically at strains that were mismatched, there were 54.2 percent fewer cases of flu in children who received FluMist versus those that received the flu shot (Attack rate 3.2 percent vs 7.1 percent, respectively). The mismatched strains that circulated during the studied season were A/California-like (H3N2), B/Florida and B/Victoria lineage strains. </pre>
<p> MedImmune strongly supports the CDC&#8217;s efforts to encourage vaccination against influenza throughout the season even if there is evidence that some circulating strains are not well-matched to the vaccine. According to the CDC, an influenza vaccination can provide enough protection to help prevent or lessen illness severity and help prevent flu-related complications.</p>
<p> About FluMist</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> 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.</p>
<p> FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.</p>
<p> Please see complete Prescribing Information for FluMist, call 1-877- FLUMIST (1-877-358-6478) or visit http://www.flumist.com for additional information.</p>
<p> Pricing and Insurance Coverage</p>
<p> FluMist is priced per-dose to be competitive with the flu shot. In addition, 94 percent of health insurance plans with immunization benefits provide coverage for FluMist, which is also available to eligible children at no cost through the federal Vaccines for Children (VFC) program.</p>
<p> About MedImmune</p>
<p> 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 cardiovascular/gastrointestinal disease, neuroscience, oncology, infection, respiratory disease and inflammation. 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&#8217;s website at www.medimmune.com.</p>
<pre> (1) King JC, et al. N Engl J Med. 2006;355:2523-2532. (2) Hurwitz ES, et al. JAMA. 2000;284:1677-1682. (3) In past studies, FluMist has not provided protection against different-lineage, mismatched B strains. </pre>
<p> Note to Editors: When reporting on the CDC advisory committee&#8217;s recommendation today, please recognize that the term &#8220;flu shot&#8221; is not the most accurate way to report or describe influenza vaccine options. Please consider the more accurate term &#8220;flu vaccine&#8221; to cover both FDA-approved vaccination options available to people ages 2-49; the nasal spray live attenuated vaccine and the traditional flu shot. This is particularly important today given the CDC&#8217;s focus on influenza vaccination of children. Please communicate this new information to copy and headline editors.</p>
<pre> CONTACTS: Media: Karen Lancaster, 301-398-5864 Investors: Peter Vozzo, 301-398-4358 FLU08-030 </pre>
<pre> SOURCE MedImmune -0- 02/27/2008 P /PRNewswire - Feb. 27/ /Web site: http://www.medimmune.com http://www.flumist.com / (AZN) CO: MedImmune; U.S. Centers for Disease Control and Prevention; CDC; ACIP ST: Maryland IN: MTC HEA EDU SU: PDT MAV JC-JA -- NEW091 -- 2420 02/27/2008 12:34 EST http://www.prnewswire.com </pre>
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