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	<title>MedImmune Social Media Press Room &#187; respiratory diseases</title>
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		<title>MedImmune Presents New Data Demonstrating Increased Risk for Medically Attended RSV in Late-Preterm Infants</title>
		<link>http://pressroom.medimmune.com/press-releases/2009/05/05/medimmune-presents-new-data-demonstrating-increased-risk-for-medically-attended-rsv-in-late-preterm-infants/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2009/05/05/medimmune-presents-new-data-demonstrating-increased-risk-for-medically-attended-rsv-in-late-preterm-infants/#comments</comments>
		<pubDate>Tue, 05 May 2009 16:31:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>

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		<description><![CDATA[Results Showing Burden of RSV Disease Presented at Pediatric Academic Societies&#8217; Annual Meeting BALTIMORE, May 5 /PRNewswire/ &#8212; MedImmune today announced results from a recent study it sponsored, performed by the Kaiser Permanente Division of Research in Oakland, CA, assessing risk factors for respiratory syncytial virus (RSV) infection requiring medical treatment in infants born at [...]]]></description>
			<content:encoded><![CDATA[<p>Results Showing Burden of RSV Disease Presented at Pediatric Academic Societies&#8217; Annual Meeting</p>
<p>BALTIMORE, May 5 /PRNewswire/ &#8212; MedImmune today announced results from a recent study it sponsored, performed by the Kaiser Permanente Division of Research in Oakland, CA, assessing risk factors for respiratory syncytial virus (RSV) infection requiring medical treatment in infants born at 33 weeks gestational age [GA]&#8211;&gt;Baltimore, Maryland</p>
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		<title>MedImmune Awards Five Fellowship Research Grants to Advance Viral Respitory Disease Research</title>
		<link>http://pressroom.medimmune.com/press-releases/2009/05/04/medimmune-awards-five-fellowship-research-grants-to-advance-viral-respitory-disease-research/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2009/05/04/medimmune-awards-five-fellowship-research-grants-to-advance-viral-respitory-disease-research/#comments</comments>
		<pubDate>Mon, 04 May 2009 04:00:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Awards]]></category>
		<category><![CDATA[Company News]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=6</guid>
		<description><![CDATA[- For Sixth Consecutive Year, MedImmune Commits $175,000 &#8211; Baltimore, MD — May 4, 2009 — MedImmune has awarded grants to five pediatric fellows to assist their conduct of original research in the field of viral respiratory diseases. The fellowship research grants, which underscore the company&#8217;s dedication to advancing research in pediatric health, were presented [...]]]></description>
			<content:encoded><![CDATA[<p align="center"><strong>- For Sixth Consecutive Year, MedImmune Commits $175,000 &#8211;</strong></p>
<p><strong>Baltimore</strong><strong>, MD — May 4, 2009</strong> — MedImmune has awarded grants to five pediatric fellows to assist their conduct of original research in the field of viral respiratory diseases. The fellowship research grants, which underscore the company&#8217;s dedication to advancing research in pediatric health, were presented for the sixth consecutive year through MedImmune&#8217;s Fellowship Research Grant Program. This year&#8217;s recipients, awarded $35,000 each, were acknowledged on Sunday, May 3, 2009 at a reception at the Pediatric Academic Societies Annual Meeting in Baltimore.</p>
<p>We are honored to contribute to important research that is essential to better understanding very common and potentially severe pediatric infectious diseases, such as respiratory syncytial virus, or RSV, and influenza, said Doris A. Makari, M.D., senior director, medical affairs. Research continues to be the cornerstone of viral respiratory health advancements, which is why we remain dedicated to sponsoring promising studies like those of the five recipients being honored this year.</p>
<p align="left">All grant candidates are required to be full-time fellows conducting original research as their primary focus in an American Board of Pediatrics-accredited fellowship program. The selection was made by an independent committee comprised of external pediatric reviewers from across the United States.</p>
<p>The 2009 Pediatric Fellowship Program grant recipients are:</p>
<ul>
<li><strong>Jennifer Esbenshade, M.D.</strong><br />
Pediatric Infectious Diseases Fellow, Vanderbilt Children&#8217;s Hospital  <br />
Project Title: <em>Surveillance of Influenza Shedding in Healthcare Workers in a Pediatric Intensive Care Unit</em></li>
<li><strong>Dana Lynn Esham, M.D.</strong><br />
Pediatric Allergy Immunology Fellow, University of Texas Medical Branch<br />
Project Title: <em>Role of Metapneumovirus G Protein in Modulating Innate Immune Responses</em></li>
<li><strong>Carla Garcia, M.D.</strong> Pediatric Infectious Diseases Fellow, University of Texas at Southwestern Medical Center<br />
Project Title: <em>Rhinovirus and Respiratory Syncytial Virus in Children:   Clinical and Immune Differences</em></li>
<li><strong>Alejandro Jordan-Villegas, M.D.</strong> Pediatric Infectious Diseases Fellow, University of Texas at Southwestern Medical Center<br />
Project Title: <em>Immunopathogenesis of RSV and Streptococcus pneumoniae interactions</em></li>
<li><strong>Maria Marchenko, M.D.</strong><br />
Pediatric Critical Care Fellow, Women and Children&#8217;s Hospital of Buffalo<br />
Project Title: <em>The effects of Isoflurane Inhalation on RSV Infection in Mice</em></li>
</ul>
<p>MedImmune&#8217;s Fellowship Research Grant Program is one example of the company&#8217;s broader, ongoing commitment to research and pediatric health. To date, MedImmune has invested hundreds of millions of dollars in research funds over the last 20 years to develop new and next-generation medicines against respiratory viruses, such as respiratory syncytial virus (RSV) and influenza.</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 <a href="http://www.medimmune.com">www.medimmune.com</a>.</p>
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		<title>Depth of MedImmune&#8217;s Respiratory Disease Research Program Highlighted at Annual Meeting of the American Thoracic Society</title>
		<link>http://pressroom.medimmune.com/press-releases/2008/05/15/depth-of-medimmune-s-respiratory-disease-research-program-highlighted-at-annual-meeting-of-the-american-thoracic-society/</link>
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		<pubDate>Thu, 15 May 2008 17:02:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
		<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[monoclonal antibody]]></category>
		<category><![CDATA[neuroscience]]></category>
		<category><![CDATA[respiratory diseases]]></category>

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		<description><![CDATA[GAITHERSBURG, Md., May 15 /PRNewswire/ &#8212; MedImmune today announced that researchers will present eight abstracts from its respiratory disease program at the Annual Meeting of the American Thoracic Society, from May 18 to 20, 2008 in Toronto, Canada. Presentations are designed to showcase MedImmune&#8217;s biologics capabilities. &#8220;MedImmune is committed to finding innovative solutions that may [...]]]></description>
			<content:encoded><![CDATA[<p> GAITHERSBURG, Md., May 15 /PRNewswire/ &#8212; MedImmune today announced that researchers will present eight abstracts from its respiratory disease program at the Annual Meeting of the American Thoracic Society, from May 18 to 20, 2008 in Toronto, Canada. Presentations are designed to showcase MedImmune&#8217;s biologics capabilities.</p>
<p> &#8220;MedImmune is committed to finding innovative solutions that may one day help patients struggling with respiratory diseases,&#8221; said Tony Coyle, vice president, head, autoimmunity inflammation and respiratory disease research. &#8220;We are pleased to present a plethora of promising data that could potentially address diseases such as asthma and chronic obstructive pulmonary disease.&#8221;</p>
<pre> MedImmune research scheduled to be presented includes: -- Regulation of Lung Inflammation in Animal Models (Poster Session: IL-33, the Ligand for T1/ST2, Induces Airway Hyperresponsiveness Via a Mast Cell but Not T Cell Dependent Mechanism, publication page A63) - Sunday, May 18 from 8:15 a.m.- 4:15 p.m., Metro Toronto Convention Centre, Area E. -- Viral Infection and Wheezing (Poster Session: Evidence for T-Lymphocyte Independent Antibody Responses in Primary RSV Infection, publication page A190)-Sunday, May 18 from 8:15 a.m. - 4:15 p.m., Metro Toronto Convention Centre, Area A. -- Chitins: Flying High (Symposium: Hyperresponsiveness and Inflammation in a Murine Model of Asthma, publication page A501)- Monday, May 19 at 2:45 p.m., Ontario, Fairmont Royal York Hotel. -- New Insights and Developing Controversies in Clinical Asthma (Poster Session: Safety Profile, Pharmacokinetics and Biologic Activity of a Single IV Dose of the Anti IL-5 Receptor Alpha Antibody MEDI-563 in Patients with Mild Asthma, publication page A569)-Tuesday, May 20 from 8:15 a.m.- 11:00 a.m., Metro Toronto Convention Centre, Room 205A. -- Eosinophils, Mast Cells and Neutrophils as Modulators of Immunity and Injury -- Poster Session: In Vitro Characterization of MEDI-563, a Humanized Anti-IL-5Ralpha Monoclonal Antibody in Phase1 Clinical Trial, publication page A602 -- Poster Session: MEDI-563, a Humanized Anti-Human IL-5R alpha Antibody Binds to Lung Tissue Eosinophils in Asthmatic Patients, publication page A602 -- Poster Session: A Monoclonal Anti-IL-5 Receptor (IL-5R) alpha Antibody with Enhanced ADCC Selectively and Efficaciously Depletes Tissue Eosinophils in IL-5 Transgenic Mice, publication page A603 </pre>
<p> The preceding presentations will occur on Tuesday, May 20 from 8:15 a.m. &#8211; 4:15 p.m., Metro Toronto Convention Centre, Area B.</p>
<pre> -- Monocytes and Macrophages in Inflammation, Immunity and Injury (Poster Session: Role for Alveolar Macrophages in Limiting Primary RSV Immunopathology, publication page A623) - Tuesday, May 20 from 8:15 a.m. - 4:15 p.m., Metro Toronto Convention Centre, Area B. </pre>
<p> About MedImmune<br/><br/> 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>
<p> SOURCE MedImmune </p>
<p> CONTACT: Media: Sidoney Atse, +1-301-398-5990, or Investors: Peter Vozzo, +1-301-398-4358, both of MedImmune </p>
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		<title>RSV Drug Starts Phase Ia Clinical Trials</title>
		<link>http://pressroom.medimmune.com/press-releases/2007/07/16/rsv-drug-starts-phase-ia-clinical-trials/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2007/07/16/rsv-drug-starts-phase-ia-clinical-trials/#comments</comments>
		<pubDate>Mon, 16 Jul 2007 04:00:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Products]]></category>
		<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>

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		<description><![CDATA[MELBOURNE, Australia and GAITHERSBURG, Md., July 16 /PRNewswire/&#8211; Biota Holdings Limited (ASX: BTA) and MedImmune Inc. today announced the start of a Phase Ia clinical trial for their respiratory syncytial virus (RSV) antiviral drug, BTA9881, with the goal of providing a treatment for RSV-infected infants and adults. Developed from original research by Biota, the drug [...]]]></description>
			<content:encoded><![CDATA[<p> MELBOURNE, Australia and GAITHERSBURG, Md., July 16 /PRNewswire/&#8211; Biota Holdings Limited (ASX: BTA) and MedImmune Inc. today announced the start of a Phase Ia clinical trial for their respiratory syncytial virus (RSV) antiviral drug, BTA9881, with the goal of providing a treatment for RSV-infected infants and adults. Developed from original research by Biota, the drug was licensed to MedImmune on December 14, 2005.</p>
<p> The trial is an oral, single dose escalating, double-blinded, placebo- controlled study in 72 healthy adult volunteers. The primary objective of the trial is to assess the safety and tolerability of BTA9881, with a secondary objective to determine its pharmacokinetic properties in adults. It is being conducted with acceptance by an Independent Ethics Committee (IEC) for the clinical trial center and by notification to the Australian Therapeutic Goods Administration. Results of the study are expected by the end of 2007.</p>
<p> &#8220;We are pleased to begin the clinical testing stage of this promising anti-RSV target,&#8221; said Genevieve Losonsky, M.D., Vice President of Clinical Development, Infectious Diseases at MedImmune.</p>
<p> Under the terms of the licensing agreement, MedImmune is to provide Biota with a $3 million U.S. payment upon the initiation of the trial.</p>
<p> Biota CEO Peter Cook stated, &#8220;We have been working very closely with MedImmune over the last 18 months and are delighted to have progressed BTA9881 to clinical trial stage. Biota now has three products in clinic. We have consistently focused on the delivery of milestones to generate value for our shareholders and to progress our products closer to market.&#8221;
<p> BTA9881 is a small molecule fusion inhibitor, designed to specifically inhibit the process by which RSV infects a cell. The drug will be used to stop replication of RSV in an infected patient with the aim of clearing the infection or reducing the clinical impact of the disease.</p>
<p> About respiratory syncytial virus</p>
<p> Respiratory syncytial virus (RSV) infects people of all ages, but particularly infants, causing similar symptoms to influenza. In the northern hemisphere, the RSV season usually starts in the fall and runs through the spring.</p>
<p> The virus is highly contagious, infecting virtually all infants under the age of two and re-infection is common. For example approximately 50 percent of children will experience two RSV infections by the age of two.</p>
<p> RSV is the most common cause of bronchiolitis and pneumonia in infants and, according to the World Health Organisation (WHO), is the single most important cause of severe lower respiratory infections in infants and young children. The Centers for Disease Control and Prevention (CDC) state that 25 to 40 percent of young children will have signs of bronchiolitis and pneumonia during their first RSV infection and 0.5 to 2 percent will require hospitalization. In particular, RSV can cause severe or life-threatening illness in infants who are born prematurely or those with chronic lung or heart disease.</p>
<p> RSV can also have serious consequences in the elderly, and patients with chronic lung or heart disease or with compromised immune systems.</p>
<p> About clinical trials</p>
<p> There are three phases of clinical trials before a new drug can be marketed. The respective phases are:</p>
<p> Phase I</p>
<p> The new medicine is tested in a small group (20-100) of healthy volunteers, often in a hospital setting, to determine its safety profile, including the safe dose range. Pharmacokinetic studies examine how the drug is absorbed, distributed, metabolized and excreted, as well as the duration of its action. There can be a number of Phase I studies and can take from six months to one year to fully complete.</p>
<p> Phase II</p>
<p> Placebo-controlled trials involve approximately 100 to 500 volunteer patients who have the disease being studied. The goal of this phase is to establish if the new medicine effectively treats the disease. There can be a number of such studies before the full completion of Phase II.</p>
<p> Phase III</p>
<p> The new medicine is tested in placebo-controlled trials with much larger numbers of volunteer patients to generate statistically significant safety and efficacy data, across a variety of age and ethnic groups and other population variables.</p>
<p> About Biota</p>
<p> Biota is a leading antiviral drug development company based in Melbourne, Australia, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza.</p>
<p> Biota research breakthroughs have included a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease, licensed to MedImmune Inc. and novel nucleoside analogues designed to treat hepatitis C virus (HCV) infections, licensed to Boehringer Ingelheim. Biota has clinical trials underway with its lead compound for human rhinovirus (HRV) infection in patients with compromised respiration or immune systems. In addition, Biota has key partnerships with Daiichi-Sankyo for the development of second generation influenza antivirals and with Inverness Medical to market Biota developed FLU OIA influenza diagnostics.</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 the areas of infectious diseases, cancer and inflammatory diseases. With approximately 3,000 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s Web site at http://www.medimmune.com.</p>
<p> Relenza(TM) is a registered trademark of the GlaxoSmithKline group of companies.</p>
<p> BioStar (R) OIA(R) FLU and BioStar (R) OIA(R) FLU A/B are registered trademarks of Inverness Medical.</p>
<p> *Further information available at http://www.biota.com.au.</p>
<p> SOURCE MedImmune Inc. and Biota Holdings Limited </p>
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		<title>MedImmune and Pediatric Infectious Diseases Society Present 2007 Career Development Award and Viral Respiratory Disease Fellowship</title>
		<link>http://pressroom.medimmune.com/press-releases/2007/05/07/medimmune-and-pediatric-infectious-diseases-society-present-2007-career-development-award-and-viral-respiratory-disease-fellowship/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2007/05/07/medimmune-and-pediatric-infectious-diseases-society-present-2007-career-development-award-and-viral-respiratory-disease-fellowship/#comments</comments>
		<pubDate>Mon, 07 May 2007 13:32:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Awards]]></category>
		<category><![CDATA[asthma]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>

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		<description><![CDATA[TORONTO, May 7 /PRNewswire-FirstCall/ &#8212; The Pediatric Infectious Diseases Society (PIDS), supported by grants from MedImmune, Inc. (Nasdaq: MEDI), will present the third annual MedImmune Career Development Award in Pediatric Infectious Disease to Jin-Young Han, M.D., Ph.D., from the University of Minnesota and the second annual Viral Respiratory Disease Fellowship to Niranjan Bhat, M.D. from [...]]]></description>
			<content:encoded><![CDATA[<p> TORONTO, May 7 /PRNewswire-FirstCall/ &#8212; The Pediatric Infectious Diseases Society (PIDS), supported by grants from MedImmune, Inc. (Nasdaq: MEDI), will present the third annual MedImmune Career Development Award in Pediatric Infectious Disease to Jin-Young Han, M.D., Ph.D., from the University of Minnesota and the second annual Viral Respiratory Disease Fellowship to Niranjan Bhat, M.D. from Johns Hopkins University. The awardees, chosen by an independent PIDS committee, will be formally acknowledged tonight at a PIDS Dinner and Awards Banquet being held in conjunction with the annual meeting of the Pediatric Academic Societies in Toronto, Canada.</p>
<p> &#8220;We are very proud to continue our support of the research community by sponsoring these two awards,&#8221; said Frank J. Malinoski, M.D., Ph.D., senior vice president, medical and scientific affairs at MedImmune. &#8220;It is vital that our efforts to fight pediatric infectious disease include support for investments in research by the medical community in its quest to develop new breakthroughs in pediatric research.&#8221;</p>
<p> The MedImmune Career Development Award in Pediatric Infectious Disease was established to support the development of outstanding physician-scientists as independent laboratory investigators performing research in the field of pediatric infectious disease. The award includes a $50,000 per year grant for up to three years. This year&#8217;s recipient, Dr. Han, hopes that through his project, titled Induction of Apoptosis in T-cells by HSV-2, he will be able to begin to understand how herpes simplex virus type 2 (HSV-2) evades the host&#8217;s immune system. &#8220;This will be a critical step toward the development of better therapeutic approaches to genital and neonatal herpes,&#8221; said Dr. Han.</p>
<p> The Viral Respiratory Disease Fellowship was established to stimulate and support clinical research related to viral respiratory diseases. The fellowship includes a $45,000 per year grant for up to two years. Dr. Bhat, this year&#8217;s recipient, will examine whether human rhinovirus (hRV) infection is specifically associated with acute wheezing in asthmatic children, and will evaluate the role of critical immune mediators that have been linked theoretically to hRV-induced wheezing through his project titled Mechanisms of Human Rhinovirus-Induced Asthma Exacerbations. &#8220;I am honored by the vote of confidence this fellowship award gives to my potential to make a meaningful contribution to improve the health of this vulnerable patient population,&#8221; said Dr. Bhat.</p>
<p> The MedImmune and PIDS awards partnership is just one example of the company&#8217;s broader, ongoing commitment to research and pediatric health. To date, MedImmune has invested more than $2 billion in research funds to develop new and next-generation medicines against respiratory viruses such as respiratory syncytial virus (RSV) and influenza.</p>
<p> About MedImmune, Inc.</p>
<p> MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of pediatric infectious diseases, cancer and inflammatory diseases. With more than 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com .</p>
<p> About the Pediatric Infectious Diseases Society</p>
<p> The Pediatric Infectious Diseases Society (PIDS) is organized exclusively for scientific and educational purposes and not for profit. Its purpose is to enhance the health of infants, children, and adolescents by promoting excellence in diagnosis, management and prevention of infectious diseases through clinical care, education, research and advocacy.</p>
<p> Notice to Investors and Stockholders of MedImmune</p>
<p> This release is neither an offer to purchase nor a solicitation of an offer to sell shares of MedImmune. MedImmune stockholders are urged to read the relevant tender offer documents from AstraZeneca PLC which have been filed on May 3, 2007 because they will contain important information that stockholders should consider before making any decision regarding tendering their shares. AstraZeneca has filed tender offer materials with the U.S. Securities and Exchange Commission, and MedImmune has also filed a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the offer. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other offer documents) and the Solicitation/Recommendation Statement contain important information, which should be read carefully before any decision is made with respect to the tender offer. The Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, are available for free at the U.S. Securities and Exchange Commission&#8217;s web site at http://www.sec.gov , at AstraZeneca&#8217;s website at http://www.astrazeneca.com or at MedImmune&#8217;s website at http://www.medimmune.com .</p>
<p> SOURCE MedImmune, Inc. <br/><br/> CONTACT: Media, Kate Barrett of MedImmune, Inc., +1-301-398-4320 </p>
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		<title>MedImmune Reconfirms 2009 Financial Targets of $2 Billion in Revenues and $2.00 in Earnings Per Diluted Share, Excluding Share-Based Compensation Expense, at 2006 Analyst Day</title>
		<link>http://pressroom.medimmune.com/press-releases/2006/12/06/medimmune-reconfirms-2009-financial-targets-of-2-billion-in-revenues-and-2-00-in-earnings-per-diluted-share-excluding-share-based-compensation-expense-at-2006-analyst-day/</link>
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		<pubDate>Wed, 06 Dec 2006 11:01:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
		<category><![CDATA[antibodies]]></category>
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		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[influenza vaccines]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[pipeline]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[reverse genetics]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=122</guid>
		<description><![CDATA[GAITHERSBURG, Md., Dec. 6 /PRNewswire-FirstCall/ &#8212; Highlighting its proven strengths in discovering, developing and commercializing multiple innovative products in several disease categories, MedImmune, Inc. (Nasdaq: MEDI) today will provide an overview of its opportunities for long-term growth at its 2006 Analyst Day. MedImmune executives plan to discuss the company&#8217;s technological and scientific capabilities and goals [...]]]></description>
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<p> GAITHERSBURG, Md., Dec. 6 /PRNewswire-FirstCall/ &#8212; Highlighting its proven strengths in discovering, developing and commercializing multiple innovative products in several disease categories, MedImmune, Inc. (Nasdaq: MEDI) today will provide an overview of its opportunities for long-term growth at its 2006 Analyst Day. MedImmune executives plan to discuss the company&#8217;s technological and scientific capabilities and goals focused on driving the company&#8217;s financial results in 2009 to approximately $2 billion in revenue and $2.00 in earnings per diluted share (EPS), excluding share-based compensation expense. At today&#8217;s meeting, MedImmune is reconfirming its 2006 guidance of $1.3 billion in revenues and an EPS range of $0.17 to $0.22, excluding share-based compensation expense. The event, which will run from 9:00 a.m. to 4:30 p.m. eastern time, will be webcast via the company&#8217;s website at http://www.medimmune.com.</p>
<p> David M. Mott, chief executive officer and president, stated, &#8220;Having completed a significant multi-year investment in every aspect of the business &#8212; from the commercial organization to operations to our robust pipeline &#8212; we are poised to return to a pattern of robust financial growth as we approach the middle of our five-year plan. As an established leader in pediatric respiratory diseases, MedImmune expects continued growth from its largest currently marketed product, Synagis(R) (palivizumab), and is ready to implement a first-rate launch of refrigerated FluMist(R) (Influenza Virus Vaccine Live, Intranasal) in 2007 and of Numax(R) in 2008, assuming timely approval by the U.S. Food &#038; Drug Administration (FDA). We also expect royalties from our human papillomavirus vaccine technology to drive substantial growth over the next several years. Finally, we have a firm belief in our potential to deliver innovative products to patients from the largest pipeline in the company&#8217;s history thanks to our world-class management team and the dedication of our scientific, medical, manufacturing, commercial, and business experts.&#8221;</p>
<pre> Key Highlights * RSV Franchise: MedImmune is the industry leader in the development of innovative pediatric products targeting RSV. With its currently marketed Synagis, the potential future market introduction of Numax and several other RSV-targeted products in development, the company believes that its franchise is stronger than ever and related worldwide sales are expected to grow by a compounded average rate of approximately 10 percent from 2006 to 2009. -- Synagis: During 2006, MedImmune made a number of changes and enhancements to its U.S. sales and marketing organization focused on improving effectiveness and efficiency. The company believes these changes are driving improvements in the business. MedImmune's distribution partner outside the U.S., Abbott International, continues to make excellent progress building the worldwide Synagis brand. For the 2006-2007 RSV season, worldwide sales of Synagis are expected to grow by approximately 10 percent. As previously stated, worldwide sales of Synagis in calendar year 2006 are expected to be approximately even with calendar year 2005, reflecting a stronger second half of 2006. -- Numax: MedImmune will discuss the current data profile for Numax, the company's next-generation anti-RSV MAb, including the recently announced results of its pivotal Phase 3 clinical trial results in which Numax was compared directly to Synagis. In this study, Numax demonstrated a 26-percent relative reduction versus Synagis in RSV hospitalizations among high risk infants showing non-inferiority of Numax compared to Synagis. The trial also showed a 50-percent relative reduction in the incidence of outpatient medically attended lower respiratory infections caused by RSV. "MedImmune believes that the current data profile for Numax establishes the value of the product in advancing RSV prevention," commented Edward M. Connor, M.D., executive vice president and chief medical officer. "The results from our head-to-head Phase 3 study indicate that Numax may have the potential to further strengthen MedImmune's RSV franchise by offering high-risk infants additional protection against RSV disease." * Influenza franchise: MedImmune will describe its current plans to launch the refrigerated formulation of FluMist with an expanded label in 2007. The company is currently waiting for the FDA to complete its review of two previously submitted supplemental biologics license applications (sBLAs) focused on: 1) allowing the company to manufacture a more convenient formulation (moving from the current frozen formulation to a refrigerated formulation), and 2) expanding the approved usage from the current population of healthy individuals 5 to 49 years of age to include children as young as one year of age who do not have a history of wheezing or asthma. "We are actively preparing for our launch of our new live, attenuated, thimerosal-free intranasal vaccine," said Mark Twyman, vice president and general manager, vaccines. "Our immediate goal is to help reduce the serious burden of influenza disease among school-aged children with a well-tolerated and effective vaccine that is also less painful to receive than the traditional shot. Beyond that, we are confident in future growth opportunities for FluMist and our influenza vaccine franchise through additional label and geographical expansion, the implementation of cell-culture manufacturing, pandemic vaccine production and the out-licensing of intellectual property to other vaccine manufacturers around the use of reverse genetics technologies." * Pipeline: MedImmune is advancing the largest pipeline in its history, with about 45 programs at various stages of development and commercialization in three key areas of therapeutic focus: infectious disease, cancer and inflammatory disease. "We continue to build on our core scientific strengths in antibodies and vaccines by incorporating cutting-edge technologies and implementing best practices to maximize the efficiency and quality of research and development efforts," stated James F. Young, Ph.D., president, research and development. "Key components of our approach include integrating translational science methods, evolving governance practices, and instituting scalable processes and infrastructure to support and sustain MedImmune's rapid growth. Ultimately, our goal is to discover and develop innovative products that fulfill our mission of 'advancing science to improve human health' while delivering sustainable long-term growth for the company." * Manufacturing and Process Development: MedImmune continues to demonstrate its strengths in biological process development and manufacturing across multiple technologies and products. It is an industry leader in protein engineering, cell-culture production, vaccine manufacturing and technological enhancements, such as the virus-like particle technology that helped lead to the development of vaccines to prevent cervical cancer caused by human papillomavirus. "Since we began commercially producing Synagis in 1999, MedImmune has become a world leader in high-yield cell culture process development," stated Bernardus N.M. Machielse, Drs., executive vice president, operations. "Today, we are poised to use this expertise to support development of cell-culture based influenza vaccines as part of our commitment to helping protect U.S. citizens in the event of an influenza pandemic. We are also preparing for broad-scale increases in commercial production by expanding our cell-culture manufacturing facilities in Frederick, Maryland, in support of our maturing pipeline." * Management: During 2006, MedImmune has substantially enhanced the strength and depth of its management ranks. Most recently the company expanded the leadership in its development organization with the elevation of three new vice presidents and augmented its medical affairs leadership with an additional vice president. "Over the last year, we have been pleased to promote several highly qualified internal leaders in our operations, clinical and development areas, while supplementing our existing strengths with world-class professionals in product portfolio management, infectious disease medicine, government contracting, and sales and marketing," said Mr. Mott. "As such, we have built an extraordinarily talented team of senior leaders at MedImmune that are working together to provide better medicines to patients, new medical options for physicians, rewarding careers to employees and increased value to shareholders." * Financial Guidance: MedImmune is providing an update to its previously issued guidance for 2006, 2007 and 2009. MedImmune's guidance below excludes share-based compensation expense for all periods mentioned. In the aggregate, MedImmune expects that the impact of share-based compensation expense before taxes will be approximately $32 million in 2006; $31 million to $33 million in 2007; and $55 million to $60 million in 2009. The associated impact to diluted EPS will be approximately $0.10 for 2006, $0.09 to $0.10 for 2007, and $0.16 to $0.18 for 2009. -- 2006: MedImmune expects total revenue in 2006 to be approximately $1.3 billion and its 2006 diluted EPS to be in the range of $0.17 to $0.22. MedImmune also anticipates that, as a percentage of product sales, in 2006: gross margins will be approximately 73 percent; R&#038;D will be approximately 38 percent; and SG&#038;A will range from 40 to 42 percent. MedImmune also expects that in 2006 its tax rate will be approximately 42 percent of pretax income; net other income will be approximately 10 percent of product sales; and that it will end the year with approximately 247 million diluted shares. -- 2007: MedImmune anticipates that total revenue for 2007 will grow to approximately $1.5 billion and that diluted EPS will be in the range of $0.90 to $0.95. MedImmune also anticipates that, as a percentage of product sales, in 2007: gross margins will be about 74 percent; R&#038;D will be in the range of 28 to 30 percent; and SG&#038;A will be about 35 percent. MedImmune also expects that in 2007 its tax rate will be approximately 36 percent of pretax income; its net other income will be approximately 3 to 4 percent of product sales; and that it will end the year with approximately 245 million diluted shares. -- 2009: MedImmune anticipates that total revenue for 2009 will grow to approximately $2 billion and that diluted EPS will be approximately $2.00. MedImmune also anticipates that, as a percentage of product sales, in 2009: gross margins will be in the range of 76 to 78 percent; R&#038;D will be in the range of 27 to 29 percent; and SG&#038;A will be about 25 percent. MedImmune also expects that in 2009 its tax rate will be approximately 36 percent of pretax income; its net other income will be approximately 2 to 3 percent of product sales; and that it will end the year with approximately 245 million diluted shares. </pre>
<p> &#8220;The years 2004 through 2006 marked a period of substantial investment in our business. MedImmune is now poised to enter a new period of robust financial growth with revenues increasing at a compound annual rate in excess of 15 percent through 2009, margins expanding significantly, and earnings growing approximately ten-fold,&#8221; said Mr. Mott.</p>
<p> Guidance and objectives provided by the company are projections and are based upon numerous assumptions, many of which MedImmune cannot control and that may not develop as MedImmune expects. For a discussion of the risks associated with these forward-looking statements, see the Disclosure Notice below.</p>
<p> DISCLOSURE NOTICE AND FORWARD LOOKING STATEMENTS</p>
<p> This announcement contains forward-looking statements regarding MedImmune&#8217;s future financial performance and business prospects. Those statements involve substantial risks and uncertainties and contain statements with words such as &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;intend,&#8221; &#8220;project&#8221; or other terms of similar meaning. Those statements reflect management&#8217;s current beliefs and are based on numerous assumptions, which MedImmune cannot control and which may not develop as MedImmune expects for reasons set forth in MedImmune&#8217;s Annual Report on Form 10-K for the year ended December 31, 2005, its subsequent quarterly reports on Form 10-Q, its current reports on Form 8-K filed for events occurring in 2006 and other public disclosures and filings with the U.S. Securities and Exchange Commission. Consequently, actual results may differ materially from those projected in the forward-looking statements.</p>
<p> MedImmune is also developing several products for potential future marketing and the overall success of these development efforts is important for the company&#8217;s long-term prospects. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.</p>
<p> This press release can be found on MedImmune&#8217;s website at http://www.medimmune.com in the box marked &#8220;News&#8221; or with the archived press releases on the Investor Summary page.</p>
<p> Live Webcast</p>
<p> MedImmune is offering a live webcast of its Analyst &#038; Investor Day, which will start today, Wednesday, December 6, 2006 at 9:00 a.m. eastern time. The live webcast may be accessed in the investor section of MedImmune&#8217;s website, http://www.medimmune.com. A replay of the webcast will also be available via the MedImmune website until January 3, 2007.</p>
<p> About FluMist</p>
<p> FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines, including FluMist. Like any vaccine, FluMist does not protect 100 percent of individuals vaccinated. In studies of people between the ages of 5 and 49 years, runny nose was the most commonly reported side effect. Other common side effects included various cold-like symptoms, such as headache, cough, sore throat, tiredness/weakness, irritability, and muscle aches.</p>
<p> FluMist should not be used, under any circumstances, in anyone with an allergy to any part of the vaccine, including eggs; in children and adolescents receiving aspirin therapy; in people who have a history of Guillain-Barre syndrome; and in people with known or suspected immune system problems. Pregnant women and people with certain medical conditions, asthma, or reactive airways disease should not get FluMist.</p>
<p> Please see the Prescribing Information at http://www.flumist.com/pdf/prescribinginfo.pdf, visit http://www.flumist.com, or call 1-877-633-4411 for additional information.</p>
<p> About Synagis</p>
<p> Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease and is administered by intramuscular injection. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). Synagis has been used in over 900,000 children since introduction in 1998. The first dose of Synagis should be administered prior to commencement of the RSV season. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.</p>
<p> Very rare cases of anaphylaxis (less than one case per 100,000 patients) and rare hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis.</p>
<p> In clinical trials, the most common adverse events occurring at least 1 percent more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seen in children with CHD.</p>
<p> For full prescribing information for Synagis, see the company&#8217;s website at http://www.medimmune.com/pdf/products/synagis_pi.pdf.</p>
<p> About MedImmune, Inc.</p>
<p> MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious disease, cancer and inflammatory diseases. With more than 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com.</p>
<p> SOURCE MedImmune, Inc. <br/><br/> CONTACT: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo, +1-301-398-4358, or Beatrice Pierre, +1-301-398-4905, all of MedImmune </p>
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		<title>MedImmune Reports Financial Results for 2006 Third Quarter and Nine-Month Period</title>
		<link>http://pressroom.medimmune.com/press-releases/2006/10/26/medimmune-reports-financial-results-for-2006-third-quarter-and-nine-month-period/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2006/10/26/medimmune-reports-financial-results-for-2006-third-quarter-and-nine-month-period/#comments</comments>
		<pubDate>Thu, 26 Oct 2006 11:02:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
		<category><![CDATA[monoclonal antibody]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=130</guid>
		<description><![CDATA[Recent Highlights Total revenues increased 15 percent for the 2006 third quarter Worldwide sales of Synagis(R) increased 11 percent in the 2006 third quarter Sales of FluMist(R) for the 2006 third quarter increased 52 percent to $16 million Began shipping FluMist in July as the first influenza vaccine available for 2006-2007 season; all FluMist lots [...]]]></description>
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<p> Recent Highlights
<ul>
<li> Total revenues increased 15 percent for the 2006 third quarter
<li> Worldwide sales of Synagis(R) increased 11 percent in the 2006 third quarter
<li> Sales of FluMist(R) for the 2006 third quarter increased 52 percent to $16 million
<li> Began shipping FluMist in July as the first influenza vaccine available for 2006-2007 season; all FluMist lots available for purchase by mid-September
<li> Royalty revenues received related to Merck&#8217;s HPV vaccine
<li> New collaboration formed with Infinity Pharmaceuticals to develop small molecule cancer therapeutics
<li> Decision made to not proceed with Phase 3 study for Abegrin(R) in metastatic melanoma
<li> Label-expanding sBLA for CAIV-T submitted to FDA in July 2006 </ul>
</p>
<p> GAITHERSBURG, Md., Oct. 26 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that total revenues grew 15 percent to $177 million in the 2006 third quarter from $154 million in the 2005 third quarter. The revenue growth was fueled by an 11-percent increase in worldwide sales of Synagis (palivizumab) to $112 million; a 52-percent increase in sales of FluMist (Influenza Vaccine Virus Live, Intranasal) to $16 million; and approximately $7 million in royalty and milestone revenues associated with European approval and U.S. sales of Merck&#8217;s human papillomavirus (HPV) vaccine.</p>
<p> &#8220;I am pleased to see the initial rewards of the intensive work we undertook earlier this year to refresh our commercial organization and return our revenues to a pattern of growth,&#8221; said David M. Mott, MedImmune&#8217;s president and chief executive officer. &#8220;While the true test of our commercial progress will be in the balance of the RSV season, I am cautiously optimistic at this point given the improvements tracked by product sales for both Synagis and FluMist thus far in their respective seasons. On the development front, we continue to manage our portfolio rigorously by adding innovative new programs, like those recently in-licensed from Infinity Pharmaceuticals, as well as by stringently prioritizing our development programs to focus our resources on those that have the greatest chance of becoming medically meaningful products.&#8221;</p>
<p> MedImmune reported a net loss for the 2006 third-quarter of $56 million, or $0.23 per share, including share-based compensation expense and as calculated in accordance with generally accepted accounting principles (GAAP). Excluding share-based compensation expense, MedImmune&#8217;s net loss was $73 million, or $0.30 per share, compared to a net loss of $64 million, or $0.26 per share in the 2005 third quarter. MedImmune&#8217;s net loss for the 2005 third quarter included approximately $5 million of acquired in-process research and development (IPR&#038;D). Excluding the IPR&#038;D, MedImmune&#8217;s net loss for the 2005 third quarter would have been $61 million or $0.25 per share.</p>
<p> For the first nine months of 2006, MedImmune reported revenues of $748 million versus $752 million for the first nine months of 2005. On a GAAP basis, MedImmune reported a net loss of $72 million, or $0.29 per share, for the first nine months of 2006. Excluding share-based compensation expense, MedImmune&#8217;s net loss for the 2006 nine-month period was $80 million, or $0.33 per share, compared to net earnings of $6 million, or $0.02 per diluted share in the first nine months of 2005. MedImmune&#8217;s net loss for the first nine months of 2005 included approximately $7 million of acquired IPR&#038;D and technology transfer and transition expenses. Excluding these charges, MedImmune&#8217;s net earnings in the first nine months of 2005 would have been $10 million or $0.04 per diluted share.</p>
<p> MedImmune&#8217;s financial results for both the 2006 third quarter and nine- month period were affected by the previously announced agreement with Infinity Pharmaceuticals, primarily due to the upfront license fees totaling $70 million.</p>
<p> Product Sales</p>
<p> In the 2006 third quarter, total product sales grew nine percent to $159 million from $146 million in the 2005 third quarter due primarily to increases in the company&#8217;s two products that prevent seasonal respiratory diseases: Synagis, which is a monoclonal antibody that prevents respiratory syncytial virus (RSV); and FluMist, which is a nasally delivered vaccine to prevent influenza. Worldwide sales of Synagis grew to $112 million in the 2006 third quarter from $101 million in the 2005 third quarter, while sales of FluMist increased to $16 million in the 2006 quarter from $10 million in the 2005 quarter.</p>
<p> Commenting on Synagis sales, Peter Greenleaf, MedImmune&#8217;s senior vice president of sales and marketing, said: &#8220;Throughout the third quarter, we focused our commercial efforts on: completing the expansion and training of our pediatric infectious disease sales force; expanding our payor and distributor relationships to ensure access for the appropriate patients; and working closely with physicians and nurses to better identify and track appropriate patients. While early indicators of the progress we are making are favorable, we will know more as we progress through the fourth quarter and into the heart of the RSV season.&#8221;</p>
<p> Turning to FluMist, Greenleaf commented: &#8220;We are very pleased with the progress we are making this season with FluMist. Through last week, we had sold approximately 1.7 million doses of FluMist, which compares very favorably with the 1.3 million doses we sold for the entire season last year. We are particularly proud that we were the first manufacturer to have vaccine available to the market in July, and that we had FDA approval of all of our manufactured lots by mid-September. Our goal for the future is to consistently deliver product to the market beginning in July every year, to provide for back-to-school immunizations.&#8221;</p>
<p> For the first nine months of 2006, MedImmune&#8217;s product sales of $716 million included $608 million of worldwide sales of Synagis. Total product sales in the first nine months of 2005 were $739 million, including $624 million in worldwide sales of Synagis. For the nine-month periods, sales of FluMist were $18 million in 2006 and $13 million in 2005.</p>
<p> Margin and Operating Expense Analysis</p>
<p> On January 1, 2006, MedImmune adopted the new accounting standard (Statement of Financial Accounting Standards No. 123R) that requires the company to recognize costs associated with share-based compensation arrangements, including stock options. Share-based compensation expense, before taxes, was approximately $8 million in the 2006 third quarter and $24 million for the 2006 nine-month period. These costs are reflected in cost of goods sold, research and development (R&#038;D) and selling, general and administrative expenses (SG&#038;A). To aid investors in understanding the underlying components of our business, MedImmune has separately identified the share-based compensation expense in the following discussion.</p>
<p> Gross Margins</p>
<p> Gross margins on product sales were 66 percent in the 2006 third quarter compared to 67 percent in the 2005 third quarter. Excluding the impact of FluMist (as well as shared-based compensation expense) gross margins were 73 percent in the 2006 third quarter and 72 percent in the 2005 third quarter. Gross margins on product sales for the nine months ended September 30 were 73 percent in both 2006 and 2005. Excluding the impact of FluMist (as well as share-based compensation expense), gross margins were 76 percent in 2006 compared to 75 percent in 2005. The increase in the proportion of lower-margin sales of FluMist exerted downward pressure on overall gross margins for the 2006 third quarter and first nine months of 2006.</p>
<p> Research and Development</p>
<p> R&#038;D expenses were $162 million in the 2006 third quarter. Excluding the impact of share-based compensation expense, R&#038;D expenses were $160 million in the 2006 third quarter compared to $119 million in the 2005 third quarter. R&#038;D expenses for the first nine months of 2006 were $344 million. Excluding the impact of share-based compensation expense, R&#038;D expenses for the 2006 period were $336 million compared to $266 million in the 2005 period. The increase in R&#038;D expenses was primarily due to the impact of the $70 million upfront fees associated with the collaboration agreement with Infinity Pharmaceuticals. For the third quarter comparison, the 2005 quarter included expenses associated with the pivotal Phase 3 clinical trial for CAIV-T that was unblinded in December 2005.</p>
<p> Selling, General and Administrative</p>
<p> SG&#038;A expenses were $88 million in the 2006 third quarter. Excluding the impact of share-based compensation expense, SG&#038;A expenses were $83 million in the 2006 third quarter compared to $81 million in the 2005 third quarter. This increase is largely due to increased personnel costs due to the expansion of the pediatric sales organization and the marketing and sales management team in the first half of 2006, commissions on earlier FluMist sales, and higher legal and other professional services fees, partially offset by the absence of co-promotion expense to Abbott that totaled $8 million in the 2005 third quarter.</p>
<p> For the first nine months of 2006, SG&#038;A expenses were $382 million. Excluding the impact of share-based compensation expense, SG&#038;A expenses for the 2006 period were $366 million compared to $300 million in 2005. This increase was due to about $46 million of amortization expense associated with the August 2005 acquisition of full promotion rights to Synagis, increased personnel costs and higher legal and other professional services fees.</p>
<p> Taxes</p>
<p> The effective tax rate was 55 percent for the 2006 third quarter. Excluding the impact of share-based compensation expense, the effective tax rate was 37 percent in the 2006 third quarter compared to 29 percent in the 2005 third quarter. For the first nine months of 2006, the effective tax rate was 53 percent. Excluding the impact of share-based compensation expense, the effective tax rate was 37 percent for the 2006 nine month period compared to 65 percent reported in the comparable 2005 period.</p>
<p> Other Results</p>
<p> Cash and marketable securities at September 30, 2006 were $1.5 billion, which equals the balance at December 31, 2005 and is down from $2.3 billion at June 30, 2006. The decrease from the end of the 2006 second quarter is primarily due to the repayment of approximately $490 million of 1 percent convertible senior notes that were tendered in July and the fact that the end of the third quarter is typically the seasonal low point for cash balances prior to the beginning of the Synagis and FluMist seasons.</p>
<p> 2006 Guidance</p>
<p> As a convenience to investors, MedImmune is providing an update to its previously issued guidance for 2006. Today, MedImmune has increased its diluted earnings per share (EPS) guidance to a range of $0.17 to $0.22, excluding share based compensation expense. The increase in EPS guidance is largely due to the gain on sale of MedImmune Ventures&#8217; investment in Avidia, which was acquired by Amgen earlier this week. As previously stated, MedImmune continues to believe that total revenues for 2006 will grow about four percent to approximately $1.3 billion.</p>
<p> In the aggregate, MedImmune now expects that the 2006 impact of share- based compensation expense will be approximately $32 million, or $0.10 per diluted share. The following additional guidance is provided excluding the impact of share-based compensation expense.</p>
<p>
<ul>
<li> MedImmune continues to expect gross margins to be about 73 percent of product sales for the full-year 2006.
<li> Due to the impact of the recently announced collaboration with Infinity Pharmaceuticals, MedImmune believes R&#038;D expense in 2006 will be approximately $450 million, or about 36 percent of product sales.
<li> MedImmune continues to believe that SG&#038;A as a percentage of product sales will be about 40 percent.
<li> The company&#8217;s effective tax rate is now expected to be approximately 40 percent. </ul>
</p>
<p> Guidance and objectives provided by the company are projections and are based upon numerous assumptions, many of which MedImmune cannot control and that may not develop as MedImmune expects. For a discussion of the risks associated with these forward-looking statements, see the Disclosure Notice below.</p>
<p> DISCLOSURE NOTICE AND FORWARD LOOKING STATEMENTS</p>
<p> This announcement contains historical financial information as of and for the nine-month and three-month periods ended September 30, 2006 and September 30, 2005 that is unaudited (except for the balance sheet information as of December 31, 2005), and MedImmune assumes no obligation to update this information based on new information or future performance except as may be specifically required by applicable law or regulation.</p>
<p> This announcement also contains forward-looking statements regarding MedImmune&#8217;s future financial performance and business prospects. Those statements involve substantial risks and uncertainties and are present in the section captioned &#8220;Looking Ahead in 2006,&#8221; as well as other sections containing statements with words such as &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;intend,&#8221; &#8220;project&#8221; or other terms of similar meaning. Those statements reflect management&#8217;s current beliefs and are based on numerous assumptions, which MedImmune cannot control and which may not develop as MedImmune expects for reasons set forth in MedImmune&#8217;s Annual Report on Form 10-K for the year ended December 31, 2005, its subsequent quarterly reports on Form 10-Q, its current reports on Form 8-K filed for events occurring in 2006 and other public disclosures and filings with the U.S. Securities and Exchange Commission. Consequently, actual results may differ materially from those projected in the forward-looking statements.</p>
<p> MedImmune is developing several products for potential future marketing and the overall success of these development efforts is important for the company&#8217;s long-term prospects. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.</p>
<p> This press release, including the reconciliation of certain historical data presented in this release to their most comparable GAAP measures, can be found on MedImmune&#8217;s website at http://www.medimmune.com in the box marked &#8220;News&#8221; or with the archived press releases on the Investor Summary page.</p>
<p> Conference Call &#038; Webcast</p>
<p> MedImmune is offering a live webcast of a discussion by MedImmune management of its earnings and other business results on Thursday, October 26, 2006 at 8:00 a.m. eastern time. The live webcast may be accessed in the investor section of MedImmune&#8217;s website, www.medimmune.com. A replay of the webcast will also be available via the MedImmune website until November 2, 2006. An audio replay of the webcast will be available beginning at 10:00 a.m. eastern time on October 26, 2006 and ending at midnight November 2, 2006 by calling (888) 286-8010. The passcode for the audio replay is 40637580.</p>
<p> About MedImmune, Inc.</p>
<p> MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious disease, cancer and inflammatory diseases. With more than 2,400 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at www.medimmune.com.</p>
<pre> MedImmune, Inc. Consolidated Statements of Operations (in millions, except per share data)  Three Months Ended Nine Months Ended September 30, September 30, 2006 2005 2006 2005  (Unaudited) (Unaudited) Revenues: Product sales $158.6 $146.0 $716.4 $739.4 Other revenue 18.6 7.6 31.7 12.5 177.2 153.6 748.1 751.9 Costs and expenses: Cost of sales 53.5 48.7 190.6 196.5 Research and development 162.0 118.6 343.6 265.8 Selling, general and administrative (1) 88.2 81.1 382.1 299.5 Other operating expenses 2.2 3.8 13.7 9.3 Acquired in-process research and development (IPR&#038;D) - 4.7 - 4.7 Technology transfer and transition expenses - 0.5 - 1.9 305.9 257.4 930.0 777.7 Operating income (loss) (128.7) (103.8) (181.9) (25.8) Interest income, net 13.0 12.8 38.2 43.2 Gain (loss) on investment activities (8.2) 0.4 (8.1) (0.5) Earnings (loss) before income taxes (123.9) (90.6) (151.8) 16.9 Provision (benefit) for income taxes (68.1) (26.5) (79.8) 11.1 Net earnings (loss) $(55.8) $(64.1) $(72.0) $5.8 Basic earnings (loss) per share $(0.23) $(0.26) $(0.29) $0.02 Shares used in computing basic earnings (loss) per share 239.3 245.9 244.3 247.1 Diluted earnings (loss) per share $(0.23) $(0.26) $(0.29) $0.02 Shares used in computing diluted earnings (loss) per share 239.3 245.9 244.3 249.4 (1) In August 2005, the company acquired full promotion rights in the U.S. for Synagis, effective July 1, 2006. In connection with this transaction, the company recorded an intangible asset of $360.4 million which represents the fair value of the exclusive promotion rights, determined as the aggregate value of the probable additional payments to be made as a result of the amended terms of the agreement in excess of the value of the co-promotion services to be rendered, as determined under the previous agreement. Amortization expense of $4.5 million and $50.0 million was recognized during the third quarter of 2006 and nine months ended September 30, 2006, respectively, compared to $3.9 million during both the third quarter of 2005 and nine months ended September 30, 2005, and is included in selling, general and administrative expense in the consolidated statements of operations. MedImmune, Inc. Reconciliation of GAAP Results to Adjusted Results (in millions, except per share data) </pre>
<p> Presented in the following table is a reconciliation of reported net earnings (loss) under GAAP to net earnings (loss) excluding the impact of employee share-based compensation expense.</p>
<pre> Three Months Ended Nine Months Ended September 30, September 30, 2006 2005 2006 2005 Item: Net earnings (loss), as reported (1) $(55.8) $(64.1) $(72.0) $5.8 Share-based compensation expense (2) Cost of sales (3) 0.3 - 0.7 - Research and development 2.4 - 7.6 - Selling, general and administrative 4.9 - 15.9 - Acquired in-process research and development - 4.7 - 4.7 Technology transfer and transition expense - 0.5 - 1.9  7.6 5.2 24.2 6.6 Income taxes - deductible share-based compensation expense (4) (1.6) (1.9) (5.0) (2.4) Income taxes - impact on effective tax rate (5) (23.0) - (27.2) - Net earnings (loss), as adjusted $(72.8) $(60.8) $(80.0) $10.0 Basic earnings (loss) per share, as reported (0.23) (0.26) (0.29) 0.02 Diluted earnings (loss) per share, as reported (0.23) (0.26) (0.29) 0.02 Basic earnings (loss) per share, as adjusted (0.30) (0.25) (0.33) 0.04 Diluted earnings (loss) per share, as adjusted (0.30) (0.25) (0.33) 0.04 Shares used to compute earnings per share: Basic, as reported 239.3 245.9 244.3 247.1 Diluted, as reported 239.3 245.9 244.3 249.4 Basic, as adjusted 239.3 245.9 244.3 247.1 Diluted, as adjusted 239.3 245.9 244.3 249.4 (1) Prepared in accordance with accounting principles generally accepted in the United States. (2) Represents the addback of the noncash employee share-based compensation expense. Share-based compensation is comprised of incentive stock options, nonqualified stock options and the discount on stock purchased by employees. (3) Share-based compensation capitalized in inventory was $0.4 million in the three months ended September 30, 2006 and $1.5 million in the nine months ended September 30, 2006. (4) The company recognizes a tax benefit for nonqualified stock option expense. If incentive stock options are exercised and sold or stock purchased by employees through the employee stock purchase plan is sold within one year, becoming non-qualifying dispositions, the company will be allowed to recognize tax deductions at that time. Until that time, the company must assume that no tax deduction is allowed. (5) The company's effective tax rate is impacted by the exclusion of share-based compensation expense, a portion of which is nondeductible. MedImmune, Inc. Condensed Consolidated Balance Sheets (1) (in millions) September 30, December 31, 2006 2005  (Unaudited) (Audited) Assets: Cash and marketable securities $1,472.6 $1,471.9 Trade and contract receivables, net 129.4 284.3 Inventory, net 102.4 69.4 Deferred taxes, net 392.3 186.6 Property and equipment, net 457.0 381.4 Intangible assets, net (2) 269.1 323.5 Other assets 100.9 62.9 $2,923.7 $2,780.0 Liabilities and shareholders' equity: Accounts payable  $38.5 $37.0 Accrued expenses  182.5 335.1 Other liabilities (2) 261.1 331.2 Debt (3)(4)  1,165.8 506.2 Shareholders' equity 1,275.8 1,570.5 $2,923.7 $2,780.0 Common shares outstanding 239.3 247.0 (1) Certain prior period amounts have been reclassified to conform to current presentation. (2) In August 2005, the company acquired full promotion rights in the U.S. for Synagis, effective July 1, 2006. In connection with this transaction, the company recorded an intangible asset of $360.4 million which represents the fair value of the exclusive promotion rights, determined as the aggregate value of the probable additional payments to be made as a result of the amended terms of the agreement in excess of the value of the co-promotion services to be rendered, as determined under the previous agreement. In addition, certain of the additional payments under the agreement totaling $240.5 million as of September 30, 2006 that the company deems probable have been aggregated and recorded as liabilities in the consolidated balance sheet. (3) In June 2006, the company issued $1.15 billion in convertible senior notes (the "Notes") for total proceeds of $1.13 billion, net of debt issuance costs. In connection with the issuance of the Notes, the company entered into separate convertible note hedge transactions and separate warrant transactions with respect to its common stock to reduce the potential dilution upon conversion of the Notes for a net cost of $139.6 million. Concurrently with the sale of the Notes, the company used $148 million of the net proceeds to repurchase approximately 5.4 million shares of its common stock in privately negotiated transactions. (4) On July 10, 2006, holders of the company's 1% convertible senior notes exercised their put options requiring the company to redeem the notes for cash at 100% of the principal amount of the notes, plus accrued and unpaid interest. On July 17, 2006, the company paid $492.1 million to redeem the notes, including $489.6 million in aggregate principal amount and $2.5 million in accrued and unpaid interest. The remaining $10.4 million aggregate principal amount was not redeemed. </pre>
<p> SOURCE MedImmune, Inc. <br/><br/> CONTACT: Investors, Peter Vozzo, +1-301-398-4358, or Media, Jamie Lacey, +1-301-398-4035 </p>
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		<title>MedImmune Reports 2006 Second-Quarter and Six-Month Financial Results</title>
		<link>http://pressroom.medimmune.com/press-releases/2006/07/20/medimmune-reports-2006-second-quarter-and-six-month-financial-results/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2006/07/20/medimmune-reports-2006-second-quarter-and-six-month-financial-results/#comments</comments>
		<pubDate>Thu, 20 Jul 2006 11:02:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
		<category><![CDATA[influenza vaccines]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[pipeline]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[reverse genetics]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=142</guid>
		<description><![CDATA[Recent Highlight &#8211; Reverse genetics technology approved for use in development of influenza vaccines &#8211; Clinical study initiated with vaccine candidate against an H5N1 influenza virus with the National Institutes of Health (NIH) &#8211; Research agreement entered into for pediatric respiratory diseases with the NIH &#8211; $170 million contract awarded by U.S. Department of Health [...]]]></description>
			<content:encoded><![CDATA[<p><b></b>
<p> Recent Highlight<br/><br/> &#8211; Reverse genetics technology approved for use in development of influenza vaccines<br/><br/> &#8211; Clinical study initiated with vaccine candidate against an H5N1 influenza virus with the National Institutes of Health (NIH)<br/><br/> &#8211; Research agreement entered into for pediatric respiratory diseases with the NIH<br/><br/> &#8211; $170 million contract awarded by U.S. Department of Health and Human Services to develop cell culture-based influenza vaccines<br/><br/> &#8211; MedImmune to receive royalties and milestone revenues from newly approved vaccine to prevent cervical cancer<br/><br/> &#8211; Initial $500 million stock repurchase program fully utilized; new $500 million stock buyback program authorized in May; $282 million of common stock repurchased during the 2006 second quarter, including $148 million repurchased concurrent with the issuance of $1.15 billion in convertible senior notes in June<br/><br/> &#8211; Full transition completed in June of promotional responsibility for Synagis(R) in U.S. from Abbott Laboratories<br/><br/> </p>
<p> GAITHERSBURG, Md., July 20 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today 2006 second-quarter revenues of $73 million and a net loss of $63 million, or $0.26 per share, including share-based compensation expense and as calculated in accordance with generally accepted accounting principles (GAAP). Excluding share-based compensation expense, MedImmune&#8217;s net loss was $66 million, or $0.27 per share. In the 2005 second quarter, MedImmune reported revenues of $88 million, and a net loss of $44 million, or $0.18 per share. MedImmune&#8217;s second-quarter results reflect the seasonal impact of two of its four marketed products, Synagis (palivizumab) and FluMist(R) (Influenza Virus Vaccine Live, Intranasal), both of which are prescribed to help prevent serious respiratory viruses that most commonly occur in the fall and winter months.</p>
<p> &#8220;We continue to make solid progress in building our business for the near and long term,&#8221; stated David M. Mott, MedImmune&#8217;s president and chief executive officer. &#8220;Two recent approvals from the U.S. Food and Drug Administration (FDA) exemplify our current momentum, which we believe bodes well for our future. On June 30, the FDA approved our reverse genetics technology for use in making influenza vaccines. Earlier in June, the FDA approved the first vaccine to prevent cervical cancer, for which we will receive royalties and milestone revenues based on our intellectual property rights related to this technology. Additionally, we continue to make progress advancing the rest of our pipeline that now includes approximately 40 products and product candidates in various stages of development, including 14 candidates in the clinic. Further, we expect to submit up to five investigational new drug applications by the end of the year.&#8221;</p>
<p> For the first six months of 2006, MedImmune reported revenues of $571 million versus $598 million in revenues for the first six months of 2005. The company reported a net loss of $16 million, or $0.07 per share, including share-based compensation expense and as calculated in accordance with GAAP for the first six months of 2006. Excluding share-based compensation expense, MedImmune&#8217;s net loss for the 2006 six-month period was $7 million, or $0.03 per share, compared to net earnings of $70 million, or $0.28 per diluted share in the first six months of 2005.</p>
<p> Product Sales</p>
<p> In the 2006 second quarter, MedImmune reported total product sales of $66 million, including $33 million in worldwide sales of Synagis and $25 million in sales of Ethyol(R) (amifostine). This compares to $85 million in total product sales in the 2005 second quarter, which included $51 million in worldwide sales of Synagis and $23 million in sales of Ethyol. In the 2006 second quarter, sales of Synagis to the company&#8217;s international distributor, Abbott International (AI), grew to $10 million from $7 million in 2005, while U.S. sales of $24 million for the 2006 quarter were down from the $43 million reported in the 2005 quarter.</p>
<p> &#8220;As we prepare for the 2006-2007 season, we are focused on returning Synagis to a pattern of growth, as well as the potential launch of CAIV-T in 2007 and the introduction of Numax(R) in 2008,&#8221; commented Mott. &#8220;As part of our preparations, we have taken significant steps to bolster our commercial operations since the beginning of 2006. Specifically, we have added seven new vice presidents and senior vice presidents with substantial industry experience to key leadership positions; we have realigned every functional area within the commercial organization; and we have completed the anticipated 125-person expansion of our infectious disease sales organization, which now includes 425 pediatric-focused specialty sales professionals.&#8221;</p>
<p> For the first six months of 2006, MedImmune&#8217;s product sales of $558 million included $496 million of worldwide sales of Synagis, $458 million of which came from U.S. sales and $38 million from sales to AI. Total product sales in the comparable 2005 period were $593 million including $523 million in worldwide sales of Synagis, of which $483 million were domestic sales and $40 million were from sales to AI. For the six-month periods, sales of Ethyol totaled $45 million in both 2006 and 2005.</p>
<p> Margin and Operating Expense Analysis</p>
<p> On January 1, 2006, MedImmune adopted the new accounting standard (Statement of Financial Accounting Standards No. 123R) that requires the company to recognize costs associated with share-based compensation arrangements, including stock options. These costs are reflected in inventory, cost of goods sold, research and development (R&#038;D) and selling, general and administrative expenses (SG&#038;A). To aid investors in understanding the underlying components of our business, MedImmune has separately identified the share-based compensation expense in the following discussion.</p>
<p> Gross Margins and Other Operating Expenses</p>
<p> Gross margins on product sales were 79 percent in the 2006 second quarter and 67 percent in the 2005 second quarter. The impact of FluMist on overall gross margins for the second quarter of 2006 was largely neutral, while last years&#8217; second-quarter gross margin would have been 71 percent excluding FluMist. The remaining increase in gross margin was due to declining royalties and manufacturing efficiencies for Ethyol combined with an end-of-season reduction in sales allowances for Synagis.</p>
<p> Other operating expenses were $9 million for the second quarter of 2006 compared to $3 million last year, and $12 million for the first six months of 2006 compared to $6 million for the first six months of 2005. The increase of $6 million in both periods was due to manufacturing process validation costs associated with CAIV-T (cold adapted influenza vaccine, trivalent), the company&#8217;s refrigerator-stable formulation of its live, attenuated influenza vaccine.</p>
<p> Research and Development (R&#038;D)</p>
<p> R&#038;D expenses were $94 million in the 2006 second quarter. Excluding the impact of share-based compensation expense, R&#038;D expenses were $92 million in the 2006 second quarter compared to $79 million in the 2005 second quarter.</p>
<p> R&#038;D expenses for the six months ended June 30 were $182 million in 2006. Excluding the impact of share-based compensation expense, R&#038;D expenses for the six months ended June 30 were $176 million in 2006 compared to $147 million in 2005. The increase in R&#038;D expenses is primarily due to a higher level of activity from new and ongoing collaboration agreements, as well as preclinical research and process development activities.</p>
<p> Selling, General and Administrative (SG&#038;A)</p>
<p> SG&#038;A expenses were $82 million in the 2006 second quarter. Excluding the impact of share-based compensation expense, SG&#038;A expenses were $77 million in the 2006 second quarter, up from $61 million in the 2005 second quarter. The year-over-year increase is largely due to the impact of the 2005 and first- half 2006 additions to the sales organization, plus approximately $2 million of amortization expense related to the reacquisition of domestic promotion right to Synagis.</p>
<p> SG&#038;A expenses were $294 million for the six months ended June 30, 2006. Excluding the impact of share-based compensation expense, SG&#038;A expenses for the six months ended June 30 were $283 million in 2006, up from $218 million in for the first half of 2005. Contributing to the year-over-year increase was amortization expense of $45 million and the impact of the additions to the sales organization. Effective July 1, normal co-promotion expense to Abbott, which was $95 million for the first six months of 2006, was discontinued. However, the amortization costs of the buyout will continue until we cease actively marketing Synagis, which is expected to occur sometime during the 2008-2009 season when we expect to start marketing Numax, if and when it is approved by the FDA.</p>
<p> Taxes</p>
<p> The effective tax rate was 44 percent for the second quarter and 42 percent for the six months ended June 30, 2006. Excluding the impact of share- based compensation expense, the effective tax rate was 37 percent in the 2006 second quarter and 36 percent for the first six months of 2006, compared to 35 percent reported in the comparable 2005 periods, reflecting the current absence of certain federal tax credits associated with research and development activities and increased state taxes.</p>
<p> Share-based compensation expense before taxes approximated $7 million in the 2006 second quarter and $17 million for the six months ended June 30, 2006, and was allocated to cost of goods sold, R&#038;D expense and SG&#038;A expense.</p>
<p> Other Results</p>
<p> Cash and marketable securities at June 30, 2006 were $2.3 billion as compared to $1.5 billion at December 31, 2005. The increase is primarily due to net proceeds from the June 2006 issuance of convertible senior notes. The recent financing transaction combined a net share settlement feature that requires the principal amount of the notes, or $1.15 billion, to be repaid in cash, with only the conversion premium, if any, to be paid in common stock. Additionally, the conversion premium was effectively increased to 75 percent, or $47.67, through concurrent hedging transactions that cost $140 million. Finally, MedImmune also made a simultaneous repurchase of $148 million of common stock, bringing the total share repurchase for the quarter to $282 million, or approximately 10 million shares. The 2006 convertible senior notes were issued in part to pay off the convertible notes issued in 2003, $490 million of which were redeemed on July 17, 2006. The remaining proceeds are intended to be used for general corporate purposes, including additional share repurchases, as well as potential acquisition and in-licensing activities.</p>
<p> Looking Ahead in 2006</p>
<p> MedImmune is confirming its previously stated annual guidance for 2006 issued on April 20, 2006. The company&#8217;s guidance is provided as a convenience to investors. Guidance and objectives provided by the company are projections and are based upon numerous assumptions, many of which MedImmune cannot control and that may not develop as MedImmune expects. For a discussion of the risks associated with these forward-looking statements, see the Disclosure Notice below.</p>
<p> DISCLOSURE NOTICE AND FORWARD LOOKING STATEMENTS</p>
<p> This announcement contains historical financial information as of and for the six-month and three-month periods ended June 30, 2006 and June 30, 2005 that is unaudited (except for the balance sheet information as of December 31, 2005), and MedImmune assumes no obligation to update this information based on new information or future performance except as may be specifically required by applicable law or regulation.</p>
<p> This announcement also contains forward-looking statements regarding MedImmune&#8217;s future financial performance and business prospects. Those statements involve substantial risks and uncertainties and are present in the section captioned &#8220;Looking Ahead in 2006,&#8221; as well as other sections containing statements with words such as &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;intend,&#8221; &#8220;project&#8221; or other terms of similar meaning. Those statements reflect management&#8217;s current beliefs and are based on numerous assumptions, which MedImmune cannot control and which may not develop as MedImmune expects for reasons set forth in MedImmune&#8217;s Annual Report on Form 10-K for the year ended December 31, 2005, its subsequent quarterly reports on Form 10-Q, its current reports on Form 8-K filed for events occurring in 2006 and other public disclosures and filings with the U.S. Securities and Exchange Commission. Consequently, actual results may differ materially from those projected in the forward-looking statements.</p>
<p> MedImmune is developing several products for potential future marketing and the overall success of these development efforts is important for the company&#8217;s long-term prospects. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.</p>
<p> This press release, including the reconciliation of certain historical data presented in this release to their most comparable GAAP measures, can be found on MedImmune&#8217;s website at http://www.medimmune.com in the box marked &#8220;News&#8221; or with the archived press releases on the Investor Summary page.</p>
<p> Conference Call &#038; Webcast</p>
<p> MedImmune is offering a live webcast of a discussion by MedImmune management of its earnings and other business results on Thursday, July 20, 2006 at 8:00 a.m. eastern time. The live webcast may be accessed in the investor section of MedImmune&#8217;s website, http://www.medimmune.com. A replay of the webcast will also be available via the MedImmune website until July 27, 2006. An audio replay of the webcast will be available beginning at 10:00 a.m. eastern time on July 20, 2006 and ending at midnight July 27, 2006 by calling (888) 286-8010. The passcode for the audio replay is 90522336.</p>
<p> About MedImmune, Inc.</p>
<p> MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious disease, cancer and inflammatory diseases. With more than 2,300 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com.</p>
<pre> MedImmune, Inc. Consolidated Statements of Operations (in millions, except per share data) (unaudited) Three Months Ended Six Months Ended  June 30, June 30, 2006 2005 2006 2005 Revenues: Product sales $66.2 $84.7 $557.8 $593.4 Other revenue 6.7 3.8 13.1 4.9 72.9 88.5 570.9 598.3 Costs and expenses: Cost of sales 14.0 28.0 137.1 147.8 Research and development 93.7 78.8 181.6 147.2 Selling, general and administrative (1) 82.0 60.9 293.9 218.4 Other operating expenses 8.8 2.9 11.5 5.5 Technology transfer and transition expenses -- 0.5 -- 1.4  198.5 171.1 624.1 520.3 Operating income (125.6) (82.6) (53.2) 78.0 Interest income, net 12.2 15.7 25.2 30.4 Gain (loss) on investment activities 0.9 (1.2) 0.1 (0.9) Earnings (loss) before income taxes (112.5) (68.1) (27.9) 107.5 Provision (benefit) for income taxes (49.3) (23.9) (11.7) 37.6 Net earnings (loss) $(63.2) $(44.2) $(16.2) $69.9 Basic earnings (loss) per share $(0.26) $(0.18) $(0.07) $0.28 Shares used in computing basic earnings (loss) per share 245.9 247.4 246.9 247.7 Diluted earnings (loss) per share (2) $(0.26) $(0.18) $(0.07) $0.28 Shares used in computing diluted earnings (loss) per share 245.9 247.4 246.9 257.0 (1) In August 2005, the company acquired full promotion rights in the U.S. for Synagis, effective July 1, 2006. In connection with this transaction, the company recorded an intangible asset of $360.4 million which represents the fair value of the exclusive promotion rights, determined as the aggregate value of the probable additional payments to be made as a result of the amended terms of the agreement in excess of the value of the co-promotion services to be rendered, as determined under the previous agreement. Amortization expense of $2.3 million and $45.5 million was recognized during the second quarter of 2006 and six months ended June 30, 2006, respectively, and is included in selling, general and administrative expense in the consolidated statements of operations. (2) Earnings used in computing diluted earnings per share, after assumed conversion of the 1% convertible senior notes, was $71.0 million for the six months ended June 30, 2005. These notes were anti-dilutive for all other periods. MedImmune, Inc. Reconciliation of GAAP Results to Adjusted Results (in millions, except per share data) Presented in the following table is a reconciliation of reported net earnings (loss) under GAAP to net earnings (loss) excluding the impact of employee share-based compensation expense.  Three Months Ended Six Months Ended June 30, June 30,  2006 2005 2006 2005 (Unaudited) (Unaudited) Item: Net earnings (loss), as reported (1) $(63.2) $(44.2) $(16.2) $69.9 Share-based compensation expense (2) Cost of sales (3) - - 0.4 - Research and development 1.5 - 5.2 - Selling, general and administrative 5.4 - 11.0 -  6.9 - 16.6 - Income taxes - deductible share-based compensation expense (4) (1.3) - (3.4) - Income taxes - impact on effective tax rate (5) (8.7) - (4.2) - Net earnings (loss), as adjusted $(66.3) $(44.2) $(7.2) $69.9 Basic earnings (loss) per share, as reported (0.26) (0.18) (0.07) 0.28 Diluted earnings (loss) per share, as reported (0.26) (0.18) (0.07) 0.28 Basic earnings (loss) per share, as adjusted (0.27) (0.18) (0.03) 0.28 Diluted earnings (loss) per share, as adjusted (0.27) (0.18) (0.03) 0.28 Shares used to compute earnings per share: Basic, as reported 245.9 247.4 246.9 247.7 Diluted, as reported 245.9 247.4 246.9 257.0 Basic, as adjusted 245.9 247.4 246.9 247.7 Diluted, as adjusted 245.9 247.4 246.9 257.0 (1) Prepared in accordance with accounting principles generally accepted in the United States. (2) Represents the addback of the noncash employee share-based compensation expense. Share-based compensation is comprised of incentive stock options, nonqualified stock options and the discount on stock purchased by employees. (3) Share-based compensation capitalized in inventory was $0.5 million in the three months ended June 30, 2006 and $1.1 million in the six months ended June 30, 2006. (4) The company recognizes a tax benefit for nonqualified stock option expense. If incentive stock options are exercised and sold or stock purchased by employees through the employee stock purchase plan is sold within one year, becoming non-qualifying dispositions, the company will be allowed to recognize tax deductions at that time. Until that time, the company must assume that no tax deduction is allowed. (5) The company's effective tax rate is impacted by the exclusion of share-based compensation expense, a portion of which is nondeductible. MedImmune, Inc. Condensed Consolidated Balance Sheets (1) (in millions)  June 30, December 31, 2006 2005 (unaudited) (audited) Assets: Cash and marketable securities $2,252.3 $1,471.9 Trade and contract receivables, net 18.4 284.3 Inventory, net  96.8 69.4 Deferred taxes, net 329.0 186.6 Property and equipment, net 419.5 381.4 Intangible assets, net (2) 273.7 323.5 Other assets 85.6 62.9  $3,475.3 $2,780.0 Liabilities and shareholders' equity: Accounts payable $33.3 $37.0 Accrued expenses 205.5 335.1 Other liabilities (2) 260.7 331.2 Debt (3)(4)  1,655.7 506.2 Shareholders' equity 1,320.1 1,570.5  $3,475.3 $2,780.0 Common shares outstanding 239.4 247.0 (1) Certain prior period amounts have been reclassified to conform to current presentation. (2) In August 2005, the company acquired full promotion rights in the U.S. for Synagis, effective July 1, 2006. In connection with this transaction, the company recorded an intangible asset of $360.4 million which represents the fair value of the exclusive promotion rights, determined as the aggregate value of the probable additional payments to be made as a result of the amended terms of the agreement in excess of the value of the co-promotion services to be rendered, as determined under the previous agreement. In addition, certain of the additional payments under the agreement totaling $240.5 million as of June 30, 2006 that the company deems probable have been aggregated and recorded as liabilities in the consolidated balance sheet. (3) In June 2006, we issued $1.15 billion in convertible senior notes (the "Notes") for total proceeds of $1.13 billion, net of debt issuance costs. In connection with the issuance of the Notes, we entered into separate convertible note hedge transactions and separate warrant transactions with respect to our common stock to reduce the potential dilution upon conversion of the Notes for a net cost of $139.6 million. Concurrently with the sale of the Notes, we used $148 million of the net proceeds to repurchase approximately 5.4 million shares of our common stock in privately negotiated transactions. (4) On July 10, 2006, holders of the company's 1% convertible senior notes exercised their put options requiring the company to redeem the notes for cash at 100% of the principal amount of the notes, plus accrued and unpaid interest. On July 17, 2006, the company paid $492.1 million to redeem the notes, including $489.6 million in aggregate principal amount and $2.5 million in accrued and unpaid interest. The remaining $10.4 million aggregate principal amount was not redeemed. </pre>
<p> SOURCE MedImmune, Inc. <br/><br/> CONTACT: Investors: Peter Vozzo, +1-301-398-4358, or Media: Jamie Lacey, +1-301-398-4035, both for MedImmune, Inc. </p>
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		<title>MedImmune Broadens Efforts to Develop Vaccines to Help Prevent RSV and Other Important Pediatric Respiratory Diseases</title>
		<link>http://pressroom.medimmune.com/press-releases/2006/06/29/medimmune-broadens-efforts-to-develop-vaccines-to-help-prevent-rsv-and-other-important-pediatric-respiratory-diseases/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2006/06/29/medimmune-broadens-efforts-to-develop-vaccines-to-help-prevent-rsv-and-other-important-pediatric-respiratory-diseases/#comments</comments>
		<pubDate>Thu, 29 Jun 2006 16:27:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[monoclonal antibody]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>
		<category><![CDATA[reverse genetics]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=145</guid>
		<description><![CDATA[- Company Enters Into Research Agreement with NIH to Investigate Different Vaccine Candidates - - MedImmune Also Initiates Second Phase 1 Study with MEDI-534, Its First Combination Intranasal Vaccine Candidate Targeting RSV and PIV-3 - GAITHERSBURG, Md., June 29 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that it has expanded its efforts to develop [...]]]></description>
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<pre> - Company Enters Into Research Agreement with NIH to Investigate Different Vaccine Candidates - - MedImmune Also Initiates Second Phase 1 Study with MEDI-534, Its First Combination Intranasal Vaccine Candidate Targeting RSV and PIV-3 - </pre>
<p> GAITHERSBURG, Md., June 29 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that it has expanded its efforts to develop live, attenuated intranasal vaccines against important viral pathogens that cause respiratory diseases. Two of these vaccine candidates will target leading causes of pediatric respiratory disease in the United States: human respiratory syncytial virus (RSV) and human parainfluenza virus type 3 (PIV- 3). To broaden its development options for potential vaccines against these and other pathogens, MedImmune has entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Additionally, MedImmune has started vaccinating patients in a second Phase 1 study with MEDI-534, the company&#8217;s own combination RSV/PIV-3 vaccine candidate.</p>
<p> &#8220;MedImmune is pursuing a multi-pronged approach to finding the quickest path to developing a successful human RSV/PIV-3 vaccine,&#8221; said Genevieve Losonsky, M.D., vice president, clinical development, infectious disease and vaccines. &#8220;The CRADA with the NIH allows us to combine our knowledge and resources with those of the researchers at the NIAID&#8217;s Laboratory of Infectious Diseases to potentially develop new and innovative approaches against these common pediatric respiratory viruses.&#8221;</p>
<p> Through the CRADA, MedImmune and NIAID researchers will work to develop live, attenuated intranasal vaccines designed to reduce the consequences of disease caused by RSV; PIV types 1, 2 and 3; and human metapneumovirus (hMPV). These viruses are responsible for more than half of all hospitalizations for pediatric respiratory tract disease and may cause bronchiolitis, pneumonia and/or croup.</p>
<p> Under the direction of Co-Chief Brian Murphy, M.D., NIAID&#8217;s Laboratory of Infectious Diseases (LID) has had a long-standing interest in developing intranasal vaccines for pediatric respiratory viruses. The NIAID component of the cooperative research agreement will be led by Peter L. Collins, Ph.D., LID senior investigator. Using a reverse genetics technology developed by Dr. Collins, researchers will initially focus on developing safe and effective vaccines for pediatric populations. A secondary goal is to evaluate multiple vaccines for other groups at risk for developing RSV disease, including the elderly. NIAID is expected to initiate a Phase 1 trial of a PIV-3 vaccine candidate later this year.</p>
<p> MedImmune also has continued to advance the development of its first live, attenuated intranasal RSV/PIV-3 vaccine candidate, MEDI-534. The company recently began enrolling healthy RSV- and PIV-3 sero-positive children between 1 and 9 years of age in a Phase 1 study. This trial is a double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety and tolerability of a single dose of the vaccine candidate. Children in the study will be randomized one-to-one to receive MEDI-534 or placebo. In MedImmune&#8217;s previous clinical trial with MEDI-534, the vaccine candidate was evaluated in healthy adults and found to have an acceptable safety profile.</p>
<p> RSV is a common respiratory infection that affects approximately one-half of all infants during the first year of life. Nearly all children in the U.S. are infected with RSV by age 2. The virus may also cause severe illness in other groups, such as the elderly, those with underlying respiratory or cardiac disease, and those with compromised immune systems (e.g., bone marrow transplant patients). PIV-3 is another commonly occurring respiratory virus of childhood, causing bronchitis, bronchiolitis, croup, cough, fever and pneumonia. These viruses may also lead to acute otitis media in children.</p>
<p> Currently, there are no licensed vaccines available to protect against RSV or PIV-3 in the United States. Synagis(R) (palivizumab), MedImmune&#8217;s currently marketed anti-RSV antibody, was approved by the U.S. Food and Drug Administration (FDA) in 1998. To date, Synagis has helped to protect more than 700,000 high-risk infants against RSV. Whereas Synagis is indicated for prevention of RSV in high-risk infants, MedImmune&#8217;s RSV vaccine candidates will likely be targeted at a broader pediatric population, including healthy full-term infants.</p>
<p> About Synagis</p>
<p> Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere during the winter months. Synagis is a humanized monoclonal antibody given by an intramuscular injection once a month during the RSV season. Synagis was approved in 1998 by the FDA; in 1999, by the European Medicines Evaluation Agency; and in 2002, by the Japanese Ministry of Health, Labor and Welfare. In 2003, the FDA expanded the U.S. label for Synagis for use in young children with hemodynamically significant congenital heart disease at risk of RSV disease. To date, Synagis has been approved in 62 countries, including the United States. In clinical trials, the most common adverse events occurring at least 1 percent more frequently in Synagis-treated patients were upper respiratory infection, otitis media, fever and rhinitis. Cynanosis and arrhythmia were seen in children with CHD. Very rare cases of anaphylaxis (less than 1 case per 100,000 patients) and rare hypersensitivity reactions have been reported. Synagis should not be used in patients with a history of a severe prior reaction to Synagis or its components. For full prescribing information for Synagis, see the company&#8217;s website at: http://www.medimmune.com/products/synagis/index.asp.</p>
<p> About MedImmune, Inc.</p>
<p> MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With more than 2,300 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com.</p>
<p> This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the research and development of potential vaccines targeting pediatric respiratory diseases. Such statements reflect management&#8217;s current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune&#8217;s filings with the U.S. Securities and Exchange Commission. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.</p>
<pre> SOURCE MedImmune, Inc. -0- 06/29/2006 /CONTACT: Media: Clarencia Stephen, +1-301-398-4073, Jamie Lacey, +1-301-398-4035; or Investors: Peter Vozzo, +1-301-398-4358, all of MedImmune, Inc./ /Web site: http://www.medimmune.com / (MEDI) CO: MedImmune, Inc.; National Institute of Allergy and Infectious Diseases NIAID; National Institutes of Health; NIH ST: Maryland IN: MTC HEA BIO SU: CHI TRI PT-MB -- DCTH032 -- 0686 06/29/2006 12:25 EDT http://www.prnewswire.com </pre>
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		<title>MedImmune Files Investigational New Drug Application for Nasally Delivered RSV/PIV-3 Vaccine</title>
		<link>http://pressroom.medimmune.com/press-releases/2005/01/20/medimmune-files-investigational-new-drug-application-for-nasally-delivered-rsv-piv-3-vaccine/</link>
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		<pubDate>Thu, 20 Jan 2005 17:20:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[respiratory diseases]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>
		<category><![CDATA[respiratory tract infection]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=455</guid>
		<description><![CDATA[GAITHERSBURG, Md., Jan. 20 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that is has filed an investigational new drug application (IND) to begin clinical studies of its respiratory syncytial virus (RSV) and parainfluenza virus type-3 (PIV-3) candidate vaccine. Data from preclinical studies indicate that the combination vaccine elicited protective immune responses to RSV and [...]]]></description>
			<content:encoded><![CDATA[<p> GAITHERSBURG, Md., Jan. 20 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that is has filed an investigational new drug application (IND) to begin clinical studies of its respiratory syncytial virus (RSV) and parainfluenza virus type-3 (PIV-3) candidate vaccine. Data from preclinical studies indicate that the combination vaccine elicited protective immune responses to RSV and PIV-3, two leading causes of pediatric respiratory disease.</p>
<p> Upon the U.S. Food and Drug Administration&#8217;s review and approval of the IND, MedImmune plans to initiate a Phase 1 clinical study for the RSV/PIV-3 candidate vaccine. The study will evaluate the safety, tolerability and immunogenicity of the vaccine in healthy adults who have had multiple years of exposure to wild type RSV and PIV-3.</p>
<p> RSV and PIV-3 are viruses that cause serious respiratory disease, particularly in young children, the elderly and immunocompromised individuals. RSV is the most common cause of lower respiratory tract infections in infants and children worldwide, typically occurring during the fall and winter months.</p>
<p>PIV-3 is the leading cause of croup, an acute lower respiratory disease most often observed in young children.</p>
<p> The RSV/PIV-3 candidate vaccine will leverage MedImmune&#8217;s novel intranasal vaccine technology. Upon approval, the vaccine would have the potential to provide a new, needle-free option to help protect against two respiratory diseases that are responsible for significant healthcare expenditures annually.</p>
<p> &#8220;We believe that a vaccine engineered to target both the RSV and PIV-3 viruses will significantly reduce respiratory disease burden in children,&#8221; said Richard Spaete, Ph.D., senior research director at MedImmune. &#8220;With more than 125,000 children hospitalized with RSV-related complications each year and thousands of children impacted by croup, the development of a safe and effective vaccine will be a significant public health milestone.&#8221;</p>
<p> Preclinical studies have shown that a combination of the bovine and human versions of PIV-3 used as the vector in this new approach could be successfully constructed as a carrier to induce a protective immune response against PIV-3 and RSV.</p>
<p> Preliminary data from one such preclinical study of RSV/PIV-3 were published in the October 2004 issue of Journal of Virology. Results of this study, entitled &#8220;Parainfluenza Virus Type-3 Expressing the Native or Soluble Fusion (F) Protein of Respiratory Syncytial Virus (RSV) Confers Protection from RSV Infection in African Green Monkeys,&#8221; helped fuel MedImmune&#8217;s efforts to develop a novel RSV/PIV-3 vaccine.</p>
<p> About MedImmune, Inc.</p>
<p> MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With approximately 1,900 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com.</p>
<p> This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the research and development of a potential RSV/PIV-3 combination vaccine product and a potential PIV-3/hMPV combination vaccine product. Such statements reflect management&#8217;s current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune&#8217;s filings with the U.S. Securities and Exchange Commission. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.</p>
<p> SOURCE MedImmune, Inc.</p>
<p>CONTACT:</br> Media: </br>Jamie Lacey</br> +1-301-398-4035</br>or</br> Investors: </br>Peter Vozzo</br> +1-301-398-4358 </br>or</br> John Filler</br> +1-301-398-4086</br>all of MedImmune, Inc.</p>
<p>Web site: http://www.medimmune.com</p>
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