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	<title>MedImmune Social Media Press Room &#187; lupus</title>
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		<title>MEDIMMUNE HIGHLIGHTS INFLAMMATORY DISEASE PORTFOLIO AT 73RD ANNUAL MEETING OF THE AMERICAN COLLEGE OF RHEUMATOLOGY</title>
		<link>http://pressroom.medimmune.com/press-releases/2009/10/15/medimmune-highlights-inflammatory-disease-portfolio-at-73rd-annual-meeting-of-the-american-college-of-rheumatology/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2009/10/15/medimmune-highlights-inflammatory-disease-portfolio-at-73rd-annual-meeting-of-the-american-college-of-rheumatology/#comments</comments>
		<pubDate>Thu, 15 Oct 2009 19:36:47 +0000</pubDate>
		<dc:creator>Perla Copernik</dc:creator>
				<category><![CDATA[Breakthroughs / Scientific Advancements]]></category>
		<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[rheumatoid-arthritis]]></category>
		<category><![CDATA[scleroderma]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=1164</guid>
		<description><![CDATA[GAITHERSBURG, MD, October 15, 2009 – MedImmune today announced that researchers will present data on several inflammatory disease programs at the annual meeting of the American College of Rheumatology, from October 17 to 21, 2009 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania. &#8220;Through our research into novel disease pathways involved in autoimmune disorders, we [...]]]></description>
			<content:encoded><![CDATA[<div><span lang="EN"><span lang="EN"></p>
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<p dir="ltr" align="left">GAITHERSBURG, MD, October 15, 2009 – MedImmune today announced that researchers will present data on several inflammatory disease programs at the annual meeting of the American College of Rheumatology, from October 17 to 21, 2009 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania.</p>
<p></span><span lang="EN-GB"></p>
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<p></span><span lang="EN"></p>
<p dir="ltr" align="left">&#8220;Through our research into novel disease pathways involved in autoimmune disorders, we continue to fulfill our mission of using scientific excellence to deliver life-changing medicines for patients with rheumatic diseases,&#8221; said Anthony Coyle, PhD., vice president, head of respiratory, inflammation, and autoimmune disease research. &#8220;Representing some of our most recent progress, we are pleased to share data relevant to the development of new therapies for conditions such as lupus, rheumatoid arthritis, and scleroderma.&#8221;</p>
<p dir="ltr" align="left">
<p dir="ltr" align="left">The schedule for MedImmune’s nine posters and two oral presentations at the meeting, starting on Sunday October 17, is as follows:</p>
<p><strong> </strong></p>
<p dir="ltr" align="left"><strong><br />
</strong></p>
<ul>
<p dir="ltr" align="left"><strong><br />
</strong></p>
<li><strong>Relationship Between Disease Activity and Type 1 Interferon- and Other Cytokine-Inducible Gene Expression in Blood in Dermatomyositis and Polymyositis</strong></li>
<p><strong> </strong></ul>
<ul>
<p dir="ltr" align="left"><strong><br />
</strong></p>
<li><strong>In Vitro and In Vivo Properties of MEDI-571, a Human Anti IL-17A Antibody in Development for the Treatment of Patients with Rheumatoid Arthritis</strong></li>
<p><strong> </strong></ul>
<p><strong><strong> </strong></strong></p>
<p dir="ltr" align="left"><strong><strong><br />
</strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><br />
</strong></strong></p>
<li><strong><strong>Utilising Assay Systems Relevant to IL-6 Mechanisms in Rheumatoid Arthritis to Demonstrate Efficacy of a Novel Human Anti-IL-6 Antibody, CAT6001</strong></strong></li>
<p><strong><strong> </strong></strong></ul>
<p><strong><strong><strong> </strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><br />
</strong></strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><strong><br />
</strong></strong></strong></p>
<li><strong><strong><strong>MEDI5117: A Human High Affinity Anti-IL-6 Monoclonal Antibody with Enhanced Serum Half-Life in Development for the Treatment of Inflammation and Rheumatological Diseases</strong></strong></strong></li>
<p><strong><strong><strong> </strong></strong></strong></ul>
<p><strong><strong><strong><strong> </strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><br />
</strong></strong></strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><strong><strong><br />
</strong></strong></strong></strong></p>
<li><strong><strong><strong><strong>Tissue Plasminogen Activator (tPA) Restores Normal Fibrinolysis / Coagulation Balance in Kidney and Reverses Clinical Score in Skin in a Murine Graft-Versus-Host Disease Model of Scleroderma: Proof of Concept for Therapeutic Fibrinolysis in Scleroderma</strong></strong></strong></strong></li>
<p><strong><strong><strong><strong> </strong></strong></strong></strong></ul>
<p><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></p>
<li><strong><strong><strong><strong><strong>Neutralization of Angiopoietin 2 Reduces Disease in Murine Arthritis and Augments Efficacy of Anti-TNF Treatment</strong></strong></strong></strong></strong></li>
<p><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></ul>
<p><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></p>
<li><strong><strong><strong><strong><strong><strong>Critical Requirement of RAGE for Development of Lung Fibrosis in An Experimental Model of Systemic Sclerosis</strong></strong></strong></strong></strong></strong></li>
<p><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></ul>
<p><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></p>
<li><strong><strong><strong><strong><strong><strong><strong>Depletion of Inducible Co-Stimulator (ICOS) Bearing T Cells Inhibits Expansion of T Follicular Helper Cells (TFH) and Prevents Disease in a Graft Versus Host Mouse Model of Scleroderma</strong></strong></strong></strong></strong></strong></strong></li>
<p><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></ul>
<p><strong><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></strong></p>
<li><strong><strong><strong><strong><strong><strong><strong><strong>Autoimmune-Driven Skin Fibrosis: The Critical Requirement for IFNAR1 in An Experimental Model of Systemic Sclerosis</strong></strong></strong></strong></strong></strong></strong></strong></li>
<p><strong><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></strong></ul>
<p><strong><strong><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<li><strong><strong><strong><strong><strong><strong><strong><strong><strong>Human S100 Proteins Differentially Regulate Pro-Inflammatory Cytokine Release and Cell Migration</strong></strong></strong></strong></strong></strong></strong></strong></strong></li>
<p><strong><strong><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></strong></strong></ul>
<p><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<ul>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<li><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong>CAM-3001; a Novel Human Monoclonal Antibody against GM-CSFR-á, in Subjects with Rheumatoid Arthritis (RA): Results of a Phi Study</strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></li>
<p><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></ul>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><br />
</strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<p><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong>About MedImmune</strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<p><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong> </strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<p dir="ltr" align="left"><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong>MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising 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.</strong></strong></strong></strong></strong></strong></strong></strong></strong></strong></p>
<p><strong><strong><strong><strong><strong><strong><strong><strong><strong><strong> </strong>(<em>Oral Presentation)</em><strong> </strong>– Gerd-R Burmester, M.D., Monday, October 19 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 1926</strong>– Bo Chen, Ph.D., Tuesday, October 20 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 1331</strong> – Tracy Delaney, M.Sc., Monday, October 19 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 1067</strong>– Gianluca Carlesso, Ph.D., Monday, October 19 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 1065</strong>–Tracy Delaney, M.Sc., Monday, October 19 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 1053</strong>– Brian Naiman, MS., Monday, October 19 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 666</strong> – Timothy Burwell, B.Sc., Monday, October 19 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 1062</strong>– Jacques Moisan, Ph.D., Sunday, October 18 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 401</strong>–Donna Finch, Ph.D., Sunday, October 18 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 45, Abstract: 587</strong></p>
<p dir="ltr" align="left">(<em>Oral Presentation</em>)–Steven Greeberg, Ph.D., Sunday, October 18 at 3:00 p.m. in Room 202 B</p>
<p><strong> </strong></p>
<p dir="ltr" align="left"><strong><br />
</strong></p>
<p><strong> </strong>– Matthew Sleeman, Ph.D., Sunday, October 18 from 9:00 a.m. &#8211; 11:00 a.m. in Hall D, Abstract: 8</p>
<p></span><span lang="DA">For more information, visit MedImmune’s website at </span><a href="http://www.medimmune.com/"><span lang="DA">www.medimmune.com</span></a><span lang="DA">.</span></span></div>
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		<title>AstraZeneca Presents its Global Biologics Organisation, MedImmune, at 2007 Analyst and Investor R&amp;D Day</title>
		<link>http://pressroom.medimmune.com/press-releases/2007/12/07/astrazeneca-presents-its-global-biologics-organisation-medimmune-at-2007-analyst-and-investor-r-d-day/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2007/12/07/astrazeneca-presents-its-global-biologics-organisation-medimmune-at-2007-analyst-and-investor-r-d-day/#comments</comments>
		<pubDate>Fri, 07 Dec 2007 04:00:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[antibodies]]></category>
		<category><![CDATA[asthma]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[influenza]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[neuroscience]]></category>
		<category><![CDATA[Oncology]]></category>
		<category><![CDATA[pipeline]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>
		<category><![CDATA[technologies]]></category>
		<category><![CDATA[Technology]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=50</guid>
		<description><![CDATA[AstraZeneca (AZN) today holds an R&#038;D day for analysts and investors at the headquarters of its global biologics organisation, MedImmune, in Gaithersburg, Maryland, USA, to present its recently expanded world-class biologics expertise. At the meeting, which will run from 9:00 AM to 3:00 PM EST, senior leaders from MedImmune will present the Company&#8217;s highly developed [...]]]></description>
			<content:encoded><![CDATA[<p>AstraZeneca (AZN) today holds an R&#038;D day for analysts and investors at the headquarters of its global biologics organisation, MedImmune, in Gaithersburg, Maryland, USA, to present its recently expanded world-class biologics expertise. At the meeting, which will run from 9:00 AM to 3:00 PM EST, senior leaders from MedImmune will present the Company&#8217;s highly developed capabilities in antibody and vaccine discovery, development, production and commercialisation within the broader context of AstraZeneca&#8217;s R&#038;D activities.</p>
<p> &#8220;Building a major international presence in the research, development and commercialisation of biologics to complement our small molecule capabilities is key to our sustained success, said David Brennan, Chief Executive Officer of AstraZeneca. The consolidation of all our biologics capabilities from AstraZeneca, Cambridge Antibody Technology (CAT) and MedImmune into one unit immediately creates one of the world&#8217;s largest biologics pipelines and establishes us as a leader in biotechnology among our pharmaceutical peers. </p>
<p>As part of the event, David Mott, President and Chief Executive Officer of the newly combined organisation that will continue to operate under the MedImmune name, will discuss AstraZeneca&#8217;s biologics ambitions and vision and describe how MedImmune will be operationally independent but strategically aligned within the AstraZeneca group.</p>
<p> In MedImmune, AstraZeneca has a world-class biologics organisation with end-to-end capabilities from discovery through commercialisation, said Mr. Mott. Since coming into AstraZeneca, we have strategically and operationally integrated the former Cambridge Antibody Technology group and other biologics activity within AstraZeneca. We have brought AstraZeneca&#8217;s two pre-existing biologics locations and approximately 300 more people under the MedImmune umbrella to address unmet therapeutic needs within the central nervous, gastrointestinal and cardiovascular systems, in addition to our historical focus on the areas of infectious disease, inflammatory disease and cancer. As a result, our biologics pipeline now has more than doubled in size to contain approximately 100 research projects and more than a dozen clinical product candidates. We also have a stronger and more diverse discovery engine with access to a wider range of cutting-edge technologies.</p>
<p> Thanks to these new capabilities, Mr Mott continued, we have also increased our productivity targets, including having at least three new drug candidates in pivotal trials by 2010 and, at steady state, targeting an average of six investigational new drug applications for submission per year. </p>
<p>Progress in the following key therapeutic areas will be covered at the meeting:</p>
<p><strong>Infectious Diseases:</strong> <br/> AstraZeneca believes that biologics will provide novel approaches for antivirals and antibacterials. In MedImmune, AstraZeneca has established a significant technology base in monoclonal antibodies (MAbs) and vaccines, which may contribute to important new solutions for the prevention and treatment of infectious diseases.</p>
<p>While MedImmune&#8217;s respiratory syncytial virus (RSV) franchise has been anchored by the success of Synagis&reg; (palivizumab), MedImmune is rapidly evolving its RSV-prevention efforts through significant clinical developments for its latest anti-RSV drug candidate, motavizumab. Today, MedImmune physicians will describe findings from a pivotal Phase III trial of motavizumab, which is expected to be filed under a biologics license application (BLA) to the U.S. Food &#038; Drug Administration (FDA) in early 2008. MedImmune presenters will also highlight additional RSV programmes, including RSV vaccine candidates and a next-generation anti-RSV MAb candidate that could follow motavizumab.</p>
<p>Expanding on its product development experience with FluMist&reg; (Influenza Virus Vaccine Live, Intranasal), MedImmune also will outline its efforts to bring a vaccine to market to help prevent pandemic influenza. MedImmune is currently engaged in dialogue with the U.S. government, the World Health Organisation and others around the world on how it can help prepare for a potential pandemic crisis. </p>
<p>MedImmune currently plans to file an application for FluMist with the European Agency for the Evaluation of Medicinal Products (EMEA) in 2008. The company intends to take maximum advantage of AstraZeneca&#8217;s global platform to commercialise FluMist across the world.</p>
<p><strong>Respiratory and Inflammatory Diseases:</strong><br/> Today, MedImmune scientists will describe multiple programmes currently underway to develop targeted treatments for a variety of respiratory and inflammatory diseases. An important area of focus for MedImmune is the potential control of asthma symptoms. MedImmune has a number of programmes evaluating this disease state including ongoing Phase I and II trials studying MAbs targeting the interleukin-5 receptor (IL-5R) and interleukin-9 (IL-9) respectively; and a planned Phase II trial studying a MAb targeting interleukin-13 (IL-13) in patients with severe asthma.</p>
<p>MedImmune will also highlight data from a Phase I study assessing the safety and efficacy of an anti-interferon-alpha treatment, which showed consistent evidence of clinical activity across multiple measures of disease in patients with mild-to-moderate systemic lupus erythematosus. Furthermore, a Phase I clinical trial for a MAb targeting the alpha subunit of the granulocyte-macrophage colony stimulating factor receptor (GM-CSFR) is underway. The study, designed to evaluate the safety and tolerability of single doses of this MAb in patients with rheumatoid arthritis, is the first clinical trial in which a MAb targeting this receptor is being investigated in this patient population. </p>
<p><strong>Oncology:</strong><br/> Traditionally a very strong growth area for biologics, MedImmune anticipates developing new cancer treatments using biological approaches with highly defined molecular targets for patient populations with unmet medical needs. Today MedImmune will describe numerous oncology trials that are underway and/or planned, including those for IPI-504, MedImmune&#8217;s partnered drug candidate designed to inhibit heat shock protein 90 (Hsp90). Hsp90 is an emerging cancer target, which is currently being evaluated as a potential treatment for three solid tumour indications. </p>
<p>MedImmune will also discuss new data from an ongoing Phase I clinical trial of MEDI-538 (also known as MT103) in patients with late-stage non-Hodgkin&#8217;s lymphoma. MEDI-538 is a recombinant single-chain bispecific T-cell engager, or BiTE&#61666;, molecule targeting the CD19 antigen. This candidate drug is the only BiTE molecule in clinical trials, and is currently in Phase I and II clinical development for the treatment of various B-cell malignancies. In addition, MedImmune will also discuss its anti-CD22 programme in Phase I development for certain leukemias and lymphomas. Also expected in the next 24 months are Phase I trials of biologics candidates targeting: PDGFR-alpha, IGF, EphA2, CD19 and CEA. </p>
<p><strong>Commercialisation:</strong><br/> Supporting this strong pipeline is MedImmune&#8217;s rich body of knowledge in biologics process and analytical development. In this area, MedImmune is led by a seasoned work force with experience in helping to select and optimise drug candidates from product inception through commercialisation. As part of this process, MedImmune investigates new pathways to disease and produces targeted, novel therapeutic interventions. In addition, MedImmune has integrated high-productivity antibody platforms, purification processes achieving some of the highest yields in the industry, and proven scale-up capabilities to meet the production demands of a diverse portfolio. Clinical production and analytical capability are focused on support for the rapidly advancing biologics portfolio at MedImmune. </p>
<p>Mr Brennan concluded, Through the acquisition of MedImmune, Inc. and the reorganisation of our existing biologics capabilities under the MedImmune brand, AstraZeneca has accelerated delivery of its biologics strategy while lowering its execution risk. I am confident that the business model we have created â€” with a strong reliance on balancing operational independence with strategic collaboration â€” will enable us to deliver on the potential of one of the largest biologics pipelines in the industry. </p>
<p><strong>Media Enquiries:</strong><br/> Jamie Lacey +1 301 398 4035 <br/><br/>
<p><strong>Analyst &#038; Investor Enquiries:</strong><br/> Jonathan Hunt +44 (0) 207 304 5087<br/> Karl Hard +44 (0) 207 304 5322<br/> Ed Seage +1 302 886 4065<br/> Jorgen Winroth +1 212 579 0506<br/> Peter Vozzo + 1 301 398 4358 <br/>
<p><strong>Notes To Editors</strong> <br/> Interviews with some of the presenters at the R&#038;D day can be found at: http://www.astrazeneca.com/biologics </p>
<p>Broadcast quality footage of AstraZeneca and MedImmune products, activities and facilities is available from the Broadcast Centre at: http://www.thenewsmarket.com/astrazeneca</p>
<p>Presentations from today&#8217;s R&#038;D day will be available to download at the start of the event at: http://www.astrazeneca.com/article/511711.aspx</p>
<p>An up to date development pipeline can be downloaded from: http://www.astrazeneca.com/article/511390.aspx</p>
<p><strong>ABOUT SYNAGIS</strong><br/> Synagis is the only MAb approved by the FDA to help prevent an infectious disease. Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. Synagis was approved for use in the United States in 1998, Europe in 1999, and Japan in 2002. Synagis is currently available in 62 countries. Abbott has exclusive rights to Synagis in markets outside the United States. MedImmune promotes Synagis in the United States. <br/> <strong>Important Safety Information </strong><br/> Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit http://www.medimmune.com/pdf/products/synagis_pi.pdf. <br/> Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in paediatric 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 more than one million children in the U.S. since its 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. <br/> Very rare cases (less than one per 100,000 patients) of anaphylaxis and rare (less than one per 1,000 patients) 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. In post-marketing reports, very rare cases (less than one case per 100,000 patients) of severe thrombocytopenia (platelet count less than 50,000/microliter) have been reported. 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. There have also been post-marketing reports of injection site reactions.</p>
<p><strong>ABOUT FLUMIST</strong></br> * FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two-to-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. </br> FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life-threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy. <br/> Do not administer FluMist to children less than 24 months of age due to an increased risk of hospitalisation and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing. <br/> If Guillain-BarrÃ© syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.<br /> Most common adverse reactions (occurring at greater than or equal to 10 percent in individuals receiving FluMist and at least five percent greater than in placebo) are runny nose or nasal congestion in recipients of all ages, fever greater than 100 degrees Fahrenheit in children two-to-six years of age, and sore throat in adults. FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only. Please see complete prescribing information at http://www.medimmune.com/pdf/products/flumist_pi.pdf.</p>
<p><strong>ABOUT MEDIMMUNE</strong><br/> As one of the few biotech companies in the world to have a track record of commercial success and profitability, MedImmune has demonstrated its ability to bring innovative vaccines and biologics speciality products to market through its 600-person commercial organisation in the United States. Over the last decade, MedImmune&#8217;s revenues have grown at a compound annual rate of 36 percent from under $50 million in 1996 to almost $1.5 billion in 2006, thanks primarily to MedImmune&#8217;s blockbuster product, Synagis, which is the first and only recombinantly produced MAb licensed by the FDA for prevention of an infectious disease. Approved now in more than 60 countries, Synagis is the standard of care for helping to prevent RSV disease in infants and young children at high-risk for RSV.</p>
<p>MedImmune&#8217;s vaccine franchise is anchored by FDA-approved FluMist, which represents the first licensed advance in flu vaccine technology in more than 60 years. The first nasal mist flu vaccine approved in the U.S., FluMist is part of a platform of technology around live, attenuated vaccines that have been developed at MedImmune. In 2007, the FDA approved MedImmune&#8217;s application to expand the vaccine&#8217;s label to include eligible children two to five years of age, as well as a new refrigerated formulation of FluMist. The vaccine was previously approved by the FDA for use in children and adults five to 49 years of age and was stored as a frozen formulation.* </p>
<p>MedImmune was also at the forefront of the work to develop a vaccine to prevent cervical cancer caused by human papilloma virus (HPV). The company partnered with GSK for the completion of the clinical development and the commercialisation of the vaccine. In early 2005 the agreement was amended to allow Merck, which has also been developing an HPV vaccine, to be granted a sublicense to MedImmune&#8217;s intellectual property. As a result, MedImmune receives milestone payments and royalties on HPV vaccines marketed by both pharmaceutical companies.</p>
<p>To complement its in-house discovery and research capabilities, MedImmune has been among the most active biotech strategic players, having executed almost 40 significant business development, licensing and acquisition-related transactions between 2004 and 2007.</p>
<p>MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicated to advancing science and medicine to help people live better lives and is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune&#8217;s website at http://www.medimmune.com. </p>
<p><strong>ABOUT ASTRAZENECA</strong><br/> AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world&#8217;s leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.</p>
<p><strong>CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS</strong><br/> In order to utilise the &#8216;Safe Harbor&#8217; provisions of the United States Private Securities Litigation Reform Act of 1995, AstraZeneca is providing the following cautionary statement. This Review contains forward-looking statements with respect to the research and development efforts within MedImmune, the biologics organization within AstraZeneca. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, the risk that research and development efforts will not yield new products that achieve commercial success; the loss or expiration of patents; difficulties in the manufacturing processes for biological products; the risk of delay to new product launches; and the difficulties of obtaining and maintaining governmental approvals for products. For a more complete list of risks associated with the AstraZeneca businesses, please refer to the AstraZeneca filings with the Securities and Exchange Commission. </p>
<p><strong>TRADEMARKS </strong><br /> MedImmune and Synagis are registered trademarks of MedImmune, Inc. and FluMist is a registered trademark of MedImmune Vaccines, Inc. Both MedImmune, Inc. and MedImmune Vaccines, Inc. are members of the AstraZeneca group of companies. BiTE is a registered trademark of Micromet, Inc. </p>
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		<title>MedImmune Publishes New Data in Nature Immunology Demonstrating The Role HMGB1 May Play in Systemic Autoimmune Diseases</title>
		<link>http://pressroom.medimmune.com/press-releases/2007/04/18/medimmune-publishes-new-data-in-nature-immunology-demonstrating-the-role-hmgb1-may-play-in-systemic-autoimmune-diseases/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2007/04/18/medimmune-publishes-new-data-in-nature-immunology-demonstrating-the-role-hmgb1-may-play-in-systemic-autoimmune-diseases/#comments</comments>
		<pubDate>Wed, 18 Apr 2007 21:02:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Breakthroughs / Scientific Advancements]]></category>
		<category><![CDATA[lupus]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=96</guid>
		<description><![CDATA[- Preclinical Data Support Rationale for Targeting Pro-Inflammatory Protein - GAITHERSBURG, Md., April 18 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) today announced the publication of preclinical study data demonstrating a role for high mobility group box protein-1 (HMGB1), a nuclear DNA-binding protein, in the pathology of systemic autoimmune diseases such as systemic lupus erythematosus (SLE [...]]]></description>
			<content:encoded><![CDATA[<p>- Preclinical Data Support Rationale for Targeting Pro-Inflammatory Protein -</p>
<p>GAITHERSBURG, Md., April 18 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) today announced the publication of preclinical study data demonstrating a role for high mobility group box protein-1 (HMGB1), a nuclear DNA-binding protein, in the pathology of systemic autoimmune diseases such as systemic lupus erythematosus (SLE or lupus) and rheumatoid arthritis. Data to be published in the May 2007 issue of Nature Immunology show that HMGB1 is an essential component of DNA-immune complexes that stimulate immune cells to produce potent inflammatory proteins. The data supplement earlier preclinical evidence that HMGB1 may be an important factor in the sequence of events that result in severe tissue damage following injury or during chronic inflammation. The data also suggest that a blocking antibody to HMGB1 may provide protection in chronic inflammatory diseases.</p>
<p>&#8220;MedImmune is committed to developing innovative treatments for inflammatory diseases, and among our key areas of focus are the disease pathology of lupus and the role of B cells in autoimmunity,&#8221; said Anthony J. Coyle, vice president, research and development, and head, inflammation and autoimmunity research. &#8220;These data, applicable to several programs within our pipeline, demonstrate a novel mechanism by which HMGB1 mediates B cell activation and may contribute to the pathogenesis of autoimmune disorders.&#8221;</p>
<p>HMGB1&#8242;s potential role in chronic inflammatory diseases is the focus of ongoing preclinical research conducted by MedImmune in collaboration with its partner, Critical Therapeutics, Inc. The Nature Immunology article, titled &#8220;Toll-like receptor 9-dependent activation by DNA containing immune complexes is mediated by HMGB1 and RAGE,&#8221; contains data showing that HMGB1 is a key component of DNA-immune complexes that stimulate activation of B cells and plasmacytoid dendritic cells (pDCs) via the toll-like receptor 9 pathway (TLR9). Both B cells and pDCs are associated with immune system disorders such as lupus. The data also suggest that HMGB1 DNA-immune complexes augment production of inflammatory proteins by interacting with the receptor for advanced glycation end products (RAGE).</p>
<p>About HMGB1</p>
<p>HMGB1, a pro-inflammatory protein secreted by different cell types, is part of the body&#8217;s response to trauma and infection. HMGB1 is expressed at high levels beginning 12 to 72 hours after an injury, which is about the time inflammation-associated tissue damage begins. Because of the timing and duration of expression of HMGB1, it may be an important factor in the sequence of events that result in severe tissue damage following injury or during chronic inflammation.</p>
<p>About Lupus</p>
<p>According to the Lupus Foundation of America, approximately 1.5 million Americans may suffer from some form of lupus, a chronic inflammatory disease that causes the body to attack its own tissues and organs, including the skin, joints, blood and kidneys. Treatments for lupus include anti-inflammatory drugs, antimalarials, corticosteroids and drugs approved for other purposes, such as immunosuppressive agents given to cancer patients undergoing chemotherapy or medicines developed to treat patients with arthritis. Lupus occurs about 10 times more frequently in adult females than adult males, and is two to three times more common among African Americans, Hispanics, Asians and Native Americans.</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 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at www.medimmune.com.</p>
<p>This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the research and development of antibodies targeting HMGB1. Such statements reflect management&#8217;s current views and are based on certain assumptions about the success of this program. 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 SEC. MedImmune is developing HMGB1-related product candidates for potential future marketing. 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 were received, such products would ultimately achieve commercial success.</p>
<p>SOURCE MedImmune, Inc.</p>
<p>CONTACT: Media, Kate Barrett, +1-301-398-4320, or Investors, Beatrice Pierre, +1-301-398-4905, both of MedImmune, Inc.</p>
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		<title>MedImmune Promotes Three Leaders in Key Scientific &amp; Medical Roles</title>
		<link>http://pressroom.medimmune.com/press-releases/2007/04/02/medimmune-promotes-three-leaders-in-key-scientific-medical-roles/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2007/04/02/medimmune-promotes-three-leaders-in-key-scientific-medical-roles/#comments</comments>
		<pubDate>Mon, 02 Apr 2007 12:32:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
		<category><![CDATA[HR / Leadership]]></category>
		<category><![CDATA[asthma]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[pipeline]]></category>
		<category><![CDATA[R&D]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=101</guid>
		<description><![CDATA[&#8211; Experts Recognized for their Expanded Strategic Contributions in Driving Pipeline Progress GAITHERSBURG, Md., April 2 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) today announced that it has promoted three senior leaders within its research and development (R&#38;D) and medical organizations. The new executive appointments include Iksung Cho, vice president, biostatistics; Anthony J. Coyle, Ph.D., vice [...]]]></description>
			<content:encoded><![CDATA[<p>&#8211; Experts Recognized for their Expanded Strategic Contributions in Driving Pipeline Progress</p>
<p>GAITHERSBURG, Md., April 2 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) today announced that it has promoted three senior leaders within its research and development (R&amp;D) and medical organizations. The new executive appointments include Iksung Cho, vice president, biostatistics; Anthony J. Coyle, Ph.D., vice president, R&amp;D, and head, inflammation and autoimmunity research; and Barbara White, M.D., vice president, clinical development, inflammatory disease.</p>
<p>&#8220;As MedImmune drives progress through its pipeline, the company relies on a growing number of senior leaders to contribute their expertise strategically,&#8221; said David M. Mott, chief executive officer and president. &#8220;Iksung&#8217;s statistical contributions have been critical in ensuring that we have solid Phase 3 pivotal data in support of our near-to-market infectious disease product candidates. Similarly, Anthony and Barbara have used their depth of experience and knowledge to advance important programs within our growing inflammatory disease portfolio.&#8221;</p>
<p>In his new role as vice president, biostatistics, Iksung Cho manages a team of nearly 20 statisticians who conduct activities such as clinical trial design and analysis for MedImmune&#8217;s research, development, clinical, regulatory and manufacturing organizations. He joined Aviron in 1997 as the primary statistician for the company&#8217;s influenza vaccine program. MedImmune completed the acquisition of Aviron in 2002. Previously, Mr. Cho had worked at Merck Research Laboratories within the vaccines development group. He holds masters of science degrees in mathematics and statistics from Virginia Polytechnic Institute &amp; State University and has completed additional graduate-level coursework at Virginia Polytechnic &amp; State University and Temple University. Mr. Cho is also the co-author of approximately 30 manuscripts or abstracts on vaccines and statistics.</p>
<p>As vice president, research and development, and head, inflammation and autoimmunity research, Anthony J. Coyle, Ph.D., oversees MedImmune&#8217;s preclinical research in disease areas such as asthma, lupus, rheumatoid arthritis and sepsis. Prior to joining MedImmune as a senior director in 2005, Dr. Coyle served as director, inflammation biology, at Millennium Pharmaceuticals in Cambridge, Massachusetts. In addition, he worked as a research scientist in the immunology department at the Glaxo Institute for Molecular Biology in Geneva, Switzerland. He also has more than six years of experience as a post-doctoral research assistant in immunology and pharmacology at Institut Pasteur in Paris and the National Jewish Center of Immunology in Denver. Dr. Coyle is a member of the American Thoracic Society and has published more than 120 scientific papers. He earned his bachelor of science and doctoral degrees in pharmacology from Kings College of the University of London.</p>
<p>Barbara White, M.D., now serves as vice president, clinical development, inflammatory disease. She joined MedImmune in January 2006 as senior director, and was appointed head of the inflammatory disease group in clinical development in November 2006. Prior to joining MedImmune, Dr. White was a director of medical affairs, inflammation therapeutic area, at Amgen where her activities included leading non-registration internal and external clinical research programs. Prior to 2003, Dr. White served as professor of medicine in the division of rheumatology, department of medicine, at the University of Maryland School of Medicine. She was formerly associate chief of staff of the research service at the Baltimore Veteran Administration (VA) Medical Center, one of the largest VA-based research programs in the country, where her research focused on immune-mediated mechanisms of lung fibrosis in scleroderma. Dr. White also previously served as co-director of the Johns Hopkins University and University of Maryland Scleroderma Center. She has been active in the American College of Rheumatology, serving as chair of the research committee and as a member of the board of directors, and has served as an ad hoc member of the FDA Arthritis Advisory Committee. She has served on the editorial boards of Arthritis &amp; Rheumatism and Arthritis Care and Research and has been a reviewer for numerous journals and grant review panels. Dr. White received her medical degree from the University of Pennsylvania School of Medicine and is board certified in Internal Medicine, Rheumatology and Allergy/Clinical Immunology. She completed her postdoctoral studies in basic cellular immunology at the National Institutes of Health.</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.</p>
<p>CONTACT: Media, Kate Barrett, +1-301-398-4320, or Investors, Beatrice Pierre, +1-301-398-4905, both of MedImmune, Inc.</p>
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		<title>MedImmune Expands Anti-Interferon-Alpha Program by Initiating Phase 1 Trial in Patients With Psoriasis</title>
		<link>http://pressroom.medimmune.com/press-releases/2007/03/23/medimmune-expands-anti-interferon-alpha-program-by-initiating-phase-1-trial-in-patients-with-psoriasis/</link>
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		<pubDate>Fri, 23 Mar 2007 16:02:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[antibodies]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[monoclonal antibody]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=104</guid>
		<description><![CDATA[GAITHERSBURG, Md., March 23 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) today announced that it has initiated a Phase 1 trial with its monoclonal antibody (MAb) targeting interferon-alpha, known as MEDI-545, in patients with psoriasis. Signaling an expanded focus on the role of interferons in inflammatory diseases, the psoriasis trial marks a second clinical study underway [...]]]></description>
			<content:encoded><![CDATA[<p> GAITHERSBURG, Md., March 23 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) today announced that it has initiated a Phase 1 trial with its monoclonal antibody (MAb) targeting interferon-alpha, known as MEDI-545, in patients with psoriasis. Signaling an expanded focus on the role of interferons in inflammatory diseases, the psoriasis trial marks a second clinical study underway with MEDI-545, which is also being evaluated in an ongoing Phase 1 trial in patients with systemic lupus erythematosus (SLE or lupus).</p>
<p> &#8220;MedImmune is committed to developing innovative new treatments for patients who suffer from debilitating inflammatory diseases,&#8221; said Barbara White, M.D., senior director, clinical development, inflammatory diseases. &#8220;It is exciting to expand our evaluation of MEDI-545 to patients with psoriasis. We are encouraged by the progress of MEDI-545 to date, and hope to further our understanding about the role of type 1 interferons in the pathology of immunological diseases like psoriasis and lupus.&#8221;</p>
<p> A growing body of preclinical data suggests that type-1 interferons are involved in a range of chronic inflammatory diseases. Elevated type-1 interferon mRNA levels have been found in preclinical models of psoriasis, and inhibition of type 1 interferon in these models has been shown to block the development of psoriasis. Preclinical study results have also demonstrated that interferon-alpha-induced genes and proteins are over-expressed in the skin in animal models of psoriasis.</p>
<p> Designed to evaluate safety and tolerability, MedImmune&#8217;s Phase 1 dose- escalation trial will be conducted at three sites in North America. Patients will be dosed once and subsequently evaluated for a period of 126 days, including blood and skin analysis at regular intervals.</p>
<p> MedImmune is advancing its anti-interferon-alpha program on several other fronts. The company&#8217;s ongoing Phase 1 study in lupus patients will be the subject of a poster presentation at the 8th International Lupus Consortium, to be held May 24-26 in Shanghai. The single-dose study was initiated by MedImmune in April 2006, based on preclinical research conducted in collaboration with its partner, Medarex, Inc. In addition to preclinical data suggesting that elevated levels of interferon alpha may be associated with lupus disease activity, preclinical study results also indicated that MEDI-545 may suppress the abnormal immune activity associated with lupus by binding to multiple interferon-alpha subtypes seen in the serum of lupus patients.</p>
<p> Additionally, MedImmune recently filed an application with the U.S. Food and Drug Administration (FDA) for MEDI-545 to be granted orphan drug status in a third indication, idiopathic inflammatory myositis. An area of unmet medical need, idiopathic inflammatory myositis is an immunological disease that involves chronic muscle inflammation, pain and weakness.</p>
<p> About Psoriasis</p>
<p> Psoriasis is an immunological disease affecting as many as 7.5 million Americans, according to the National Institutes of Health (NIH). Plaque psoriasis, the most common type of psoriasis, is characterized by the formation of lesions, or inflamed patches of skin. The severity of psoriasis can range from a small number of lesions to more severe cases involving moderate to large areas of skin. Psoriasis occurs nearly equally in men and women and can develop at any age, commonly appearing between ages 15 and 35. Approximately 10 to 30 percent of people with psoriasis will develop psoriatic arthritis, according to the National Psoriasis Foundation. In psoriatic arthritis, the joints and the soft tissue around them become inflamed and stiff, affecting the fingers and toes and possibly involving the neck, lower back, knees and ankles. In severe cases, psoriatic arthritis can be disabling and cause irreversible damage to joints.</p>
<p> About Lupus</p>
<p> Approximately 350,000 individuals in the United States are affected with lupus, a chronic inflammatory disease that causes the body to attack its own tissues and organs, including the skin, joints, blood and kidneys. Treatments for lupus include anti-inflammatory drugs, antimalarials, corticosteroids and drugs approved for other purposes, such as immunosuppressive agents given to cancer patients undergoing chemotherapy or medicines developed to treat arthritis patients. Lupus occurs about 10 times more frequently in adult females than adult males, and is two to three times more common among African Americans, Hispanics, Asians and Native Americans.</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> This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the research and development of antibodies targeting interferon-alpha. Such statements reflect management&#8217;s current views and are based on certain assumptions about the success of this program. 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 SEC. MedImmune is developing interferon-alpha-related product candidates for potential future marketing. 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 were received, such products would ultimately achieve commercial success.</p>
<p> SOURCE MedImmune, Inc. <br/><br/> CONTACT: Media: Kate Barrett, +1-301-398-4320, or Investors: Beatrice Pierre, +1-301-398-4905, both of MedImmune, Inc. </p>
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		<title>MedImmune Leases Human Genome Sciences Facility to Expand Cell Culture Influenza Vaccine Manufacturing Capabilities</title>
		<link>http://pressroom.medimmune.com/press-releases/2007/03/16/medimmune-leases-human-genome-sciences-facility-to-expand-cell-culture-influenza-vaccine-manufacturing-capabilities/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2007/03/16/medimmune-leases-human-genome-sciences-facility-to-expand-cell-culture-influenza-vaccine-manufacturing-capabilities/#comments</comments>
		<pubDate>Fri, 16 Mar 2007 12:02:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[asthma]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[influenza vaccines]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[pipeline]]></category>

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		<description><![CDATA[GAITHERSBURG, Md., March 16, 2007 /PRNewswire-FirstCall via COMTEX News Network/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) and Human Genome Sciences, Inc. (HGS) announced today that they have signed an agreement under which MedImmune will lease a portion of an HGS facility located in Rockville, MD, for the development and manufacturing of clinical trial material for cell [...]]]></description>
			<content:encoded><![CDATA[<p>GAITHERSBURG, Md., March 16, 2007 /PRNewswire-FirstCall via COMTEX News Network/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) and Human Genome Sciences, Inc. (HGS) announced today that they have signed an agreement under which MedImmune will lease a portion of an HGS facility located in Rockville, MD, for the development and manufacturing of clinical trial material for cell culture-based seasonal and pandemic influenza vaccine. The expanded capability will support MedImmune&#8217;s commitment to pandemic influenza vaccine development per a five-year, approximately $170 million contract awarded last year by the U.S. Department of Health and Human Services (HHS).(1) The financial terms were not disclosed.
<p>&#8220;While we are currently expanding our biologics manufacturing facility in Frederick, MD, which will increase our capacity to produce pandemic vaccine as well as other products in our pipeline, the immediate availability of the existing Human Genome Sciences facility allows us to expedite certain development steps toward expanding our capacity to produce cell culture-based influenza vaccines,&#8221; stated Alan Taggart, MedImmune&#8217;s vice president of government project management. &#8220;This should be particularly useful as we prepare to initiate our clinical trials of cell culture influenza vaccine under our HHS contract commitment.&#8221; </p>
<p>MedImmune currently develops, manufactures and markets FluMist(R) (Influenza Virus Vaccine Live, Intranasal), a live, attenuated, needle-free seasonal influenza vaccine. The company is also working with the National Institute of Health&#8217;s National Institute of Allergy and Infectious Diseases (NIAID) to apply MedImmune&#8217;s proprietary technology to develop pandemic influenza vaccines. </p>
<p>&#8220;HGS and MedImmune work together in a number of ways to advance the interests of the biotechnology industry in Maryland and the Greater Washington region, and we are pleased to extend use of this state-of-the-art facility to MedImmune &#8212; particularly for such an important national purpose,&#8221; said Curran Simpson, HGS senior vice president of operations. &#8220;Our priority focus at HGS is to advance our lead products toward commercialization as rapidly as possible. To that end, we have taken a number of steps to strengthen our financial position and reduce net cash burn, including a facilities consolidation program. This lease is one outcome of that effort.&#8221; </p>
<p>Currently, all U.S.-approved influenza vaccines are made in chicken eggs; however, using chicken eggs as the production medium limits scalability in manufacturing and increases the potential risk of manufacturing delays or supply shortages. A severe outbreak of avian influenza could kill the flocks that produce the eggs needed for vaccine production. To address these concerns, MedImmune will be applying advanced cell culture-based manufacturing methods to produce influenza vaccines eliminating the need for chicken eggs. The success of this technology will reduce production times and substantially increase MedImmune&#8217;s U.S.-based manufacturing capacity to provide influenza vaccine to the U.S. population. After adding the cell culture-based production capability for its influenza vaccine, MedImmune anticipates having the capacity to produce 300 million monovalent bulk doses of a pandemic vaccine annually by 2012. </p>
<p>About FluMist </p>
<p>FluMist is currently indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines, including FluMist. As with any vaccine, FluMist does not protect 100 percent of individuals vaccinated and may not protect against viral strains not contained in the vaccine. </p>
<p>Under no circumstances should FluMist be administered as an injection (i.e. parenterally). FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-BarrA(C) syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients. </p>
<p>In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness. </p>
<p>For information for indications and usage, dosage and administration, and safety information, please see the current 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 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 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com. </p>
<p>About Human Genome Sciences </p>
<p>The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company&#8217;s primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon(R) for hepatitis C, and LymphoStat-B(R) for lupus. Phase 3 clinical trials of both compounds are now underway. For more information, visit the HGS web site at http://www.hgsi.com. HGS, Human Genome Sciences, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc. </p>
<p>MedImmune Forward-Looking Statement </p>
<p>This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the development of potential influenza vaccines using a cell culture base. 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 vaccines will receive required regulatory clearance or that, even if such regulatory clearance is received, such vaccines will ultimately achieve commercial success. There can be no assurance that even if such a vaccine is commercially available, that it will protect against a particular influenza strain or prevent a pandemic. </p>
<pre> (1) This project has been funded in whole or in part with Federal funds from the Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, under Contract No. HHS0100200600010C. </pre>
<p>SOURCE MedImmune, Inc. </p>
<p>media <br />Jamie Lacey<br />1-301-398-4035<br />or <br />investors<br />Beatrice Pierre<br />1-301-398-4905<br /> both of MedImmune, Inc.<br />or<br /> media<br />Jerry Parrott<br />1-301-315-2777 <br />or<br /> investors<br /> Kate de Santis<br />1-301-251-6003<br /> both of Human Genome Sciences<br /> http://www.medimmune.com </p>
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		<title>MedImmune In-Licenses Novel Inflammatory Disease Target</title>
		<link>http://pressroom.medimmune.com/press-releases/2006/12/28/medimmune-in-licenses-novel-inflammatory-disease-target/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2006/12/28/medimmune-in-licenses-novel-inflammatory-disease-target/#comments</comments>
		<pubDate>Thu, 28 Dec 2006 12:07:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Products]]></category>
		<category><![CDATA[antibodies]]></category>
		<category><![CDATA[asthma]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[monoclonal antibody]]></category>
		<category><![CDATA[pipeline]]></category>

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		<description><![CDATA[GAITHERSBURG, Md., Dec. 28 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that it intends to develop a monoclonal antibody (MAb) targeting pathways within the CD28 receptor family for treatment of certain inflammatory diseases under a recently signed license agreement with Japan Tobacco, Inc. (JT). MedImmune&#8217;s initial efforts will focus on developing the current lead [...]]]></description>
			<content:encoded><![CDATA[<p> GAITHERSBURG, Md., Dec. 28 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that it intends to develop a monoclonal antibody (MAb) targeting pathways within the CD28 receptor family for treatment of certain inflammatory diseases under a recently signed license agreement with Japan Tobacco, Inc. (JT). MedImmune&#8217;s initial efforts will focus on developing the current lead antibody, which aims to inhibit a receptor believed to play a key role in controlling adaptive immune responses, called inducible-costimulator (ICOS), and thereby regulate T-cell dependent activation of B cells. Inappropriate activation of T cells resulting in B-cell activation is implicated in a variety of autoimmune disorders.</p>
<p> &#8220;The addition of this novel target to MedImmune&#8217;s inflammatory disease pipeline underscores our commitment to developing innovative therapies for the treatment of unmet medical needs, such as systemic lupus erythematosus (SLE or lupus), Sjogrens syndrome and rheumatoid arthritis,&#8221; said Anthony J. Coyle, Ph.D., MedImmune senior director, research, and head, inflammation biology. &#8220;As we work to develop the anti-ICOS MAb as a potential treatment for such immune system disorders, we also hope to continue to collect scientific knowledge related to the role of signaling pathways in regulating immune response outcomes.&#8221;</p>
<p> Under the terms of the agreement, JT will receive an undisclosed upfront payment, milestone payments and royalties on any future marketed products. JT retains exclusive development and marketing rights for the current lead antibody in Japan. MedImmune has exclusive development and marketing rights to this antibody for the rest of world and certain rights worldwide for other antibodies developed as a result of the agreement.</p>
<p> About Anti-ICOS MAbs</p>
<p> Preclinical study results indicate that ICOS is only expressed on a subset of T cells and is essential for T-cell dependent B-cell activation. In addition, ICOS is required for IL-17 secretion from activated T cells. IL-17 is a T-cell derived cytokine that is implicated in the development of various inflammatory diseases, including rheumatoid arthritis. In preclinical studies, ICOS-inhibition with MAbs was shown to be effective in models of rheumatoid arthritis, asthma, multiple sclerosis and lupus.</p>
<p> About Japan Tobacco</p>
<p> Japan Tobacco Inc. is the world&#8217;s third largest international manufacturer of tobacco products. Since its privatization in 1985, JT has actively diversified its operations into pharmaceuticals and foods. JT entered into the pharmaceutical business in 1987 and established the Central Pharmaceutical Research Institute in 1993. JT is currently engaged in the research and development of new drugs in various areas such as glucose and lipid metabolism, anti-virus, immune disorders and inflammation, and bone metabolism. The company&#8217;s net sales were 4.637 trillion yen in the fiscal year that ended March 31, 2006.</p>
<p> About MedImmune</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 2,500 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 &#8220;forward-looking statements&#8221; regarding the development of inflammatory disease product candidates by MedImmune, Inc. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change current expectations and could cause actual outcomes and results to differ materially from current expectations. In addition, MedImmune can provide no assurance that these products will be commercially successful. In addition to risks and uncertainties disclosed in MedImmune&#8217;s filings with the U.S. Securities and Exchange Commission, no assurance exists that development efforts for these products will succeed, that these products will receive required regulatory approval or that, even if regulatory approval is received, they will be commercially successful. MedImmune undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise except as may be required by applicable law or regulation.</p>
<p> SOURCE:<br />MedImmune, Inc.</p>
<p>CONTACT:<br />Media -<br /> Jamie Lacey<br />+1-301-398-4035</p>
<p>Investors -<br />Peter Vozzo<br /> +1-301-398-4358<br />both of MedImmune, Inc.</p>
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		<title>MedImmune Named One of Maryland&#8217;s Fastest Growing Technology Companies in Deloitte Technology Fast 50 Program</title>
		<link>http://pressroom.medimmune.com/press-releases/2006/09/29/medimmune-named-one-of-maryland-s-fastest-growing-technology-companies-in-deloitte-technology-fast-50-program-2/</link>
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		<pubDate>Fri, 29 Sep 2006 14:32:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[influenza virus]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[monoclonal antibody]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>

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		<description><![CDATA[&#8211; 10th Consecutive Year for MedImmune on the Fast 50 List - GAITHERSBURG, Md., Sept. 29 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. has been named to Deloitte&#8217;s Maryland Technology Fast 50 program for the tenth consecutive year. The Technology Fast 50 is a ranking of the fastest growing technology companies in the area by Deloitte &#038; Touche [...]]]></description>
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<p> &#8211; 10th Consecutive Year for MedImmune on the Fast 50 List -</p>
<p> GAITHERSBURG, Md., Sept. 29 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. has been named to Deloitte&#8217;s Maryland Technology Fast 50 program for the tenth consecutive year. The Technology Fast 50 is a ranking of the fastest growing technology companies in the area by Deloitte &#038; Touche LLP. Rankings are based on the percentage growth over five years from 2001-2005.</p>
<p> &#8220;We are pleased to be recognized again by Deloitte &#038; Touche as one of the area&#8217;s fastest growing technology companies,&#8221; said Lota S. Zoth, MedImmune&#8217;s chief financial officer. &#8220;Our continued inclusion in the Fast 50 program reflects the fact that MedImmune has doubled its revenues over the last five years, reaching $1.2 billion in 2005. Our goal is to continue to grow our business by aggressively investing in research and development activities. Toward this end, during 2005 we completed several late-stage clinical trials, started clinical testing on three new promising compounds, and expanded our product portfolio with almost a dozen new targets.</p>
<p> &#8220;MedImmune&#8217;s fast-paced growth continues in 2006,&#8221; Zoth said. &#8220;We submitted data to the FDA to expand our label indication for FluMist(R) (Influenza Virus Vaccine Live, Intranasal); we entered into an agreement with Infinity Pharmaceuticals to develop cancer drugs focused on two of the most attractive targeted therapy opportunities in cancer research today; we completed a Phase 3 study with our next-generation monoclonal antibody to prevent respiratory syncytial virus (RSV); and we initiated clinical testing with several new compounds, including those targeting lupus, RSV, parainfluenza virus type 3, B-cell lymphomas, and avian influenza viruses. We also received a $170-million contract from the U.S. Health and Human Services Department to expedite development of cell culture-based production of our flu vaccine, and earlier this month we broke ground on the first phase of a planned 700,000 square-foot expansion of our cell culture manufacturing facility in Frederick, Maryland.&#8221;</p>
<p> &#8220;To rank on Deloitte&#8217;s Technology Fast 50, companies must have phenomenal revenue growth over five years,&#8221; said Andrew Harrs, Deloitte&#8217;s Southeast regional managing partner for the Technology, Media and Telecommunications Industry Practice. &#8220;MedImmune has proven to be one of the fast-growth success stories in Maryland, and we applaud their dedication to making their vision a reality.&#8221;</p>
<p> The Maryland Technology Fast 50 program is presented by Deloitte and sponsored by Wilmer Cutler Pickering Hale and Dorr, NASDAQ and UK Trade &#038; Investment. Media sponsors include PR Newswire and Washington SmartCEO magazine.</p>
<p> To qualify for the Technology Fast 50, companies must have had operating revenues of at least $50,000 in 2001 and $5,000,000 in 2005, be headquartered in North America, and be a company that owns proprietary technology that contributes to a significant portion of the company&#8217;s operating revenues; or devotes a significant proportion of revenues to the research and development of technology.</p>
<p> Winners of the 16 regional Technology Fast 50 programs in the United States and Canada are automatically entered in Deloitte&#8217;s Technology Fast 500 program, which ranks North America&#8217;s top 500 fastest growing technology, media, telecommunications and life sciences companies. For more information on the Technology Fast 50 or Technology Fast 500 programs, visit http://www.fast500.com.</p>
<p> About MedImmune</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 2,400 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com.</p>
<p> About Deloitte</p>
<p> Deloitte refers to one or more of Deloitte Touche Tohmatsu, a Swiss Verein, its member firms and their respective subsidiaries and affiliates. As a Swiss Verein (association), neither Deloitte Touche Tohmatsu nor any of its member firms has any liability for each other&#8217;s acts or omissions. Each of the member firms is a separate and independent legal entity operating under the names &#8220;Deloitte,&#8221; &#8220;Deloitte &#038; Touche,&#8221; &#8220;Deloitte Touche Tohmatsu&#8221; or other related names. Services are provided by the member firms or their subsidiaries or affiliates and not by the Deloitte Touche Tohmatsu Verein.</p>
<p> Deloitte &#038; Touche USA LLP is the U.S. member firm of Deloitte Touche Tohmatsu. In the U.S., services are provided by the subsidiaries of Deloitte &#038; Touche USA LLP (Deloitte &#038; Touche LLP, Deloitte Consulting LLP, Deloitte Financial Advisory Services LLP, Deloitte Tax LLP and their subsidiaries), and not by Deloitte &#038; Touche USA LLP.</p>
<p> This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. 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 the company&#8217;s filings with the U.S. Securities and Exchange Commission. The company is developing several products for potential future marketing. 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 were received, such products would ultimately achieve commercial success.</p>
<p> SOURCE MedImmune, Inc. <br/><br/> CONTACT: Media: Kate Barrett, +1-301-398-4320, Investors: Peter Vozzo, +1-301-398-4358, both of MedImmune, Inc. </p>
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		<title>MedImmune Reports Financial Results for First Quarter 2006</title>
		<link>http://pressroom.medimmune.com/press-releases/2006/04/20/medimmune-reports-financial-results-for-first-quarter-2006/</link>
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		<pubDate>Thu, 20 Apr 2006 11:03:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Company News]]></category>
		<category><![CDATA[clinical trials]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[pipeline]]></category>
		<category><![CDATA[respiratory syncytial virus]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=160</guid>
		<description><![CDATA[Recent highlights Phase 3 study to begin in 2006 with Abegrin(TM) in metastatic melanoma patients Preclinical and clinical data with Abegrin presented at the annual meeting of the American Association for Cancer Research and the Canadian Melanoma Conference Dosing initiated in Phase 1 study with MEDI-545 in lupus patients Human papillomavirus vaccine licensed to GlaxoSmithKline [...]]]></description>
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<ul> Recent highlights
<li> Phase 3 study to begin in 2006 with Abegrin(TM) in metastatic melanoma patients
<li> Preclinical and clinical data with Abegrin presented at the annual meeting of the American Association for Cancer Research and the Canadian Melanoma Conference
<li> Dosing initiated in Phase 1 study with MEDI-545 in lupus patients
<li> Human papillomavirus vaccine licensed to GlaxoSmithKline (Cervarix(R)) submitted for marketing approval to European regulatory agency </ul>
</p>
<p> GAITHERSBURG, Md., April 20 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that total revenues for the 2006 first quarter were $498 million compared to $510 million in the 2005 first quarter.</p>
<p> &#8220;While we continue to make excellent progress toward achieving our long-term objectives of $2 billion in revenues and $2.00 in earnings per share in 2009, before share-based compensation expense, our recent sales results have been disappointing,&#8221; stated David M. Mott, president and chief executive officer. &#8220;As described on our year-end earnings call in February, several factors impacted U.S. sales of Synagis(R) (palivizumab) at the outset of the 2005-2006 respiratory syncytial virus (RSV) season from which we had hoped to be able to recover as the season progressed. Unfortunately, the effect of these factors &#8212; including changes in payer guidelines, disruptions in our distribution network, and the one-time effects of Hurricanes Rita and Katrina &#8212; have taken a more significant toll on seasonal sales of Synagis than previously expected. We have made a number of changes to our marketing and sales organization and our Synagis distribution network and are in the process of completing a significant expansion of our sales team in connection with the previously announced buyout of Abbott&#8217;s U.S. co-promotion rights for Synagis following the 2005-2006 RSV season. Following a difficult 2005-2006 RSV season, we expect worldwide reported Synagis sales to resume a pattern of high single-digit growth rates in the second half of this year.&#8221;</p>
<p> The company&#8217;s net earnings for the 2006 first quarter were $47 million, or $0.18 per diluted share, including share-based compensation expense and as calculated in accordance with generally accepted accounting principles (GAAP). Excluding share-based compensation expense, net earnings were $59 million, or $0.23 per diluted share, compared to $114 million, or $0.45 per diluted share, reported in the 2005 first quarter. The 2006 first quarter results reflect the impact of the company&#8217;s increased investment in its long-term business plan.</p>
<p> Mott continued, &#8220;With just under a third of product sales being reinvested in research and development, we are making tremendous progress toward building the long-term value of our business. In 2006, we expect to have two product candidates in registration, approximately 15 additional product candidates in clinical testing, including two in Phase 3 trials and at least three Investigational New Drug applications. We have one of the most robust pipelines in the biotechnology industry. We expect this pipeline will deliver meaningful returns on our current investment in the 2007-to-2009 timeframe.&#8221;</p>
<p> Product Sales</p>
<p> Total product sales for the 2006 first quarter were $492 million compared to $509 million in the 2005 first quarter. Worldwide sales of Synagis were $463 million in the 2006 first quarter compared to $472 million in the first quarter last year. Sales of Synagis to our international distributor, Abbott International (AI), were $29 million in the 2006 first quarter compared to $32 million in the 2005 first quarter, reflecting the timing of orders from AI. In the U.S., sales of Synagis were $434 million in the 2006 quarter, compared to $440 million in the first quarter of 2005. The factors that contributed to a slower than expected start to the 2005-2006 RSV season in the U.S., as stated above, continued to affect U.S. sales in the 2006 first quarter.</p>
<p> Worldwide sales of Ethyol(R) (amifostine) were $20 million in the 2006 first quarter compared to $23 million in the first quarter last year. The company believes that the decrease in sales is primarily due to the continued challenge presented by alternative therapies in the marketplace.</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 expense associated with share-based compensation arrangements, including stock options. This expense is 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 on product sales were 75 percent in the 2006 first quarter and 76 percent in the 2005 first quarter. The impact of seasonally low sales volumes for FluMist continues to exert downward pressure on overall gross margins. Excluding the impact of FluMist, first-quarter gross margins were 77 percent in both the 2006 and 2005 periods. Share-based compensation expense did not significantly impact gross margins in the 2006 first quarter.</p>
<p> Research and development expenses were $88 million in the 2006 first quarter. Excluding the impact of share-based compensation expense, R&#038;D expenses were $84 million in the 2006 first quarter compared to $69 million in the 2005 first quarter. This increase in R&#038;D expenses is primarily due to a higher level of activity from new and ongoing collaboration agreements, preclinical research and process development activities, and clinical trials for product candidates, including Numax(TM).</p>
<p> Selling, general and administrative expenses were $212 million in the 2006 first quarter. Excluding the impact of share-based compensation expense, SG&#038;A expenses were $206 million, or 42 percent of product sales, in the 2006 first quarter, up from $158 million, or 31 percent of product sales, in the 2005 first quarter. SG&#038;A expense in the first quarter of 2006 included amortization expense of $43 million, or 9 percent of product sales, related to the reacquisition of domestic promotion rights to Synagis, and $90 million, or 18 percent of product sales, of co-promotion expense. Recurring SG&#038;A expenses of $73 million or 15 percent of product sales, included in the annualized impact of 2005 additions to the pediatric sales organization.</p>
<p> The effective tax rate for the 2006 first quarter was 44 percent. Excluding the impact of share-based compensation expense, the effective tax rate was 37 percent compared to 35 percent reported in the 2005 first quarter, 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 $10 million in the 2006 first quarter, and was allocated to inventory, cost of goods sold, R&#038;D expense and SG&#038;A expense. The after-tax impact of share-based compensation expense was approximately $12 million. The total number of stock options granted in the 2006 first quarter was 3.4 million, compared to 4.0 million in the 2005 first quarter.</p>
<p> Other Results</p>
<p> Cash and marketable securities at March 31, 2006 were $1.6 billion as compared to $1.5 billion at December 31, 2005. The increase is primarily due to cash generated by operations during the quarter offset by continued investment in property, plant and equipment.</p>
<p> 2006 Guidance</p>
<p> As a convenience to investors, MedImmune is providing an update to its previously issued guidance for 2006. MedImmune now expects that total revenues for 2006 will grow about 4 percent to approximately $1.3 billion. Following lower than expected sales of Synagis in the first half of 2006, MedImmune believes that worldwide sales of Synagis will resume their pattern of growth in the second half of the year such that worldwide sales of Synagis for the full calendar year will be about even with 2005.</p>
<p> In the aggregate, MedImmune now expects the 2006 impact of share-based compensation expense to be approximately $37 million, or $0.11 per diluted share, and to be allocated in roughly the same proportion as in the first quarter. The following guidance is provided excluding the impact of share-based compensation expense.</p>
<p>
<ul>
<li> Gross margins are expected to be about 73 percent of product sales for the full-year 2006.
<li> R&#038;D expense in 2006 is expected to be approximately $375 million, or about 31 percent of product sales.
<li> SG&#038;A as a percentage of product sales is expected to be about 40 percent. SG&#038;A is expected to include approximately seven percentage points attributable to amortization of the repurchase of Synagis co- promotion rights from Abbott and approximately eight percentage points attributable to co-promotion expense. Co-promotion expenses are expected to cease mid-year 2006, and will be only partially offset by approximately $25 million in annualized selling expense due to the addition of 125 new sales representatives.
<li> The company&#8217;s effective tax rate is expected to be approximately 37 percent. </ul>
</p>
<p> MedImmune expects 2006 earnings per diluted share will range from $0.30 to $0.35 before share-based compensation expense, and $0.19 to $0.24, including share-based compensation.</p>
<p> DISCLOSURE NOTICE AND FORWARD LOOKING STATEMENTS</p>
<p> This announcement contains historical financial information as of and for the three-month periods ended March 31, 2006 and March 31, 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;2006 Guidance,&#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 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, 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, April 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 April 27, 2006. An audio replay of the webcast will be available beginning at 10:00 a.m. eastern time on April 20, 2006 and ending at midnight April 27, 2006 by calling (888) 286-8010. The passcode for the audio replay is 84848704.</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 2,200 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com.</p>
<pre> Cervarix(R) is a registered trademark of GlaxoSmithKline. MedImmune, Inc. Consolidated Statements of Operations (in millions, except per share data) (unaudited) Three Months Ended March 31, 2006 2005 Revenues: Product sales $491.6 $508.7 Other revenue 6.4 1.1 Total revenues 498.0 509.8 Costs and expenses: Cost of sales 123.1 119.8 Research and development 87.9 69.3 Selling, general and administrative (1) 211.9 157.5 Other operating expenses 2.7 2.6 Total expenses 425.6 349.2 Operating income 72.4 160.6 Interest income, net 13.0 14.7 Gain (loss) on investment activities (0.8) 0.3 Earnings before income taxes 84.6 175.6 Provision for income taxes 37.6 61.5 Net earnings $ 47.0 $114.1 Basic earnings per share $ 0.19 $ 0.46 Shares used in computing basic earnings per share 247.9 248.1 Diluted earnings per share (2) $ 0.18 $ 0.45 Shares used in computing diluted earnings per share (2) 260.0 257.2 (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 $43.1 million was recognized during the first quarter of 2006, and is included in selling, general &#038; administrative expense in the consolidated statements of operations. (2) In accordance with EITF No. 04-8, "The Effect of Contingently Convertible Debt on Diluted Earnings per Share," which became effective during 2004, the company's 1% Convertible Senior Notes, which represent 7.3 million potential shares of common stock, are now included in diluted earnings per share using the if-converted method, regardless of whether the market price trigger has been met, unless the effect is anti-dilutive. Earnings used in computing diluted earnings per share, after assumed conversion of convertible notes, was $47.5 million and $114.7 million for the three months ended March 31, 2006 and 2005, respectively. 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 under accounting principles generally accepted in the U.S. (GAAP) to net earnings excluding the impact of employee stock-based compensation expense. Three Months Ended March 31, 2006 2005 (Unaudited) Item: Net earnings, as reported (1) $ 47.0 $114.1 Share-based compensation expense (2) Cost of sales 0.4 - Research and development 3.7 - Selling, general and administrative 5.6 - 9.7 - Income taxes - deductible portion (3) (1.7) - 8.0 - Income taxes - nondeductible portion (3) 4.1 - Net earnings, as adjusted $ 59.1 $114.1 Basic earnings per share, as reported 0.19 0.46 Diluted earnings per share, as reported 0.18 0.45 Basic earnings per share, as adjusted 0.24 0.46 Diluted earnings per share, as adjusted 0.23 0.45 Shares used to compute earnings per share: Basic, as reported 247.9 248.1 Diluted, as reported 260.0 257.2 Basic, as adjusted 247.9 248.1 Diluted, as adjusted 259.7 257.2 (1) Prepared in accordance with accounting principles generally accepted in the United States (GAAP). (2) Represents the addback of the noncash employee share-based compensation expense. (3) Share-based compensation expense is comprised of incentive stock options, non-qualified stock options and the discount on stock purchased by employees. 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. Separately identified in this table for the quarter is the tax deduction allowed for non-qualified stock option expense and the nondeductible portion attributable to incentive stock options and the discounted employee stock purchase plan. MedImmune, Inc. Condensed Consolidated Balance Sheets (1) (in millions)  March 31, December 31, 2006 2005 (unaudited) (audited) Assets: Cash and marketable securities $1,637.7 $1,471.9 Trade and contract receivables, net 283.9 284.3 Inventory, net 70.5 69.4 Deferred taxes, net 162.1 186.6 Property and equipment, net 399.4 381.4 Intangible assets, net (2) 278.2 323.5 Other assets 59.1 62.9 $2,890.9 $2,780.0 Liabilities and shareholders' equity: Accounts payable $ 36.8 $ 37.0 Accrued expenses 403.9 335.1 Other liabilities (2) 276.2 331.2 Debt 505.9 506.2 Shareholders' equity 1,668.1 1,570.5 $2,890.9 $2,780.0 Common shares outstanding 248.7 247.0 (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(R), 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 $252.5 million that the company deems probable have been aggregated and recorded as liabilities in the consolidated balance sheet. </pre>
<p> SOURCE MedImmune, Inc. CONTACT: Investors &#8211; Peter Vozzo, +1-301-398-4358, or Media &#8211; Jamie Lacey, +1-301-398-4035, both of MedImmune, Inc. </p>
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		<title>MedImmune Begins Dosing of Lupus Patients in Phase 1 Clinical Trial</title>
		<link>http://pressroom.medimmune.com/press-releases/2006/04/13/medimmune-begins-dosing-of-lupus-patients-in-phase-1-clinical-trial/</link>
		<comments>http://pressroom.medimmune.com/press-releases/2006/04/13/medimmune-begins-dosing-of-lupus-patients-in-phase-1-clinical-trial/#comments</comments>
		<pubDate>Thu, 13 Apr 2006 18:05:00 +0000</pubDate>
		<dc:creator>Tor Constantino</dc:creator>
				<category><![CDATA[Research & Development]]></category>
		<category><![CDATA[antibodies]]></category>
		<category><![CDATA[lupus]]></category>
		<category><![CDATA[monoclonal antibody]]></category>

		<guid isPermaLink="false">http://pressroom.medimmune.com/?p=161</guid>
		<description><![CDATA[&#8211; Company Advances Anti-Inflammatory Clinical Program with Antibody Targeting Interferon-Alpha - GAITHERSBURG, Md., April 13 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that it has begun dosing lupus patients in a Phase 1 clinical trial to evaluate the safety and tolerability of MEDI-545, its monoclonal antibody (MAb) targeting interferon-alpha. The MAb is being developed [...]]]></description>
			<content:encoded><![CDATA[<p> &#8211; Company Advances Anti-Inflammatory Clinical Program with Antibody Targeting Interferon-Alpha -</p>
<p> GAITHERSBURG, Md., April 13 /PRNewswire-FirstCall/ &#8212; MedImmune, Inc. (Nasdaq: MEDI) announced today that it has begun dosing lupus patients in a Phase 1 clinical trial to evaluate the safety and tolerability of MEDI-545, its monoclonal antibody (MAb) targeting interferon-alpha. The MAb is being developed for the potential treatment of patients with systemic lupus erythematosus (SLE or lupus).</p>
<p> &#8220;Moving forward with our clinical program for MEDI-545 in lupus patients is an exciting next step in our plan to develop new treatments for patients suffering from inflammatory diseases,&#8221; said Stanley Pillemer, M.D., MedImmune&#8217;s senior director, clinical development, inflammatory disease. &#8220;With this Phase 1 program, we look to further increase our knowledge about the role of interferons in lupus disease activity, with the hope of developing a new medical option for patients suffering from this debilitating disease.&#8221;</p>
<p> MedImmune&#8217;s Lupus Interferon Skin Activity (LISA) study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study involving a single intravenous dose of the anti-interferon-alpha antibody in patients who have mild SLE with lupus rash or skin lesions. Forty-five individuals will be enrolled at approximately 20 centers in North America.</p>
<p> MedImmune&#8217;s development of MAbs targeting interferon-alpha stems from a collaboration agreement entered into with Medarex, Inc. in 2004 to focus on two specific antibodies, one of which was MDX-1103 (now known as MEDI-545). Under the terms of the agreement, MedImmune is responsible for all ongoing clinical development activities.</p>
<p> &#8220;We are pleased that the development of this product candidate continues to advance toward potentially helping patients fight the effects of a serious condition,&#8221; said Donald L. Drakeman, president and CEO of Medarex.</p>
<p> About MEDI-545 (Anti-IFN-alpha MAb)</p>
<p> MEDI-545 is a fully human monoclonal antibody (MAb) targeting interferon- alpha. Published preclinical data indicate that levels of interferon-alpha are elevated in many patients with active systemic lupus erythematosus (SLE or lupus) and other autoimmune disorders, and may be associated with disease activity. Preclinical data from animal models suggest that MEDI-545 may suppress the abnormal immune activity associated with lupus by binding to multiple interferon-alpha subtypes seen in the serum of lupus patients.</p>
<p> About Lupus</p>
<p> Approximately 350,000 individuals in the United States are affected with SLE, a chronic inflammatory disease that causes the body to attack its own tissues and organs, including the skin, joints, blood and kidneys. Treatments for lupus include anti-inflammatory drugs, antimalarials, corticosteroids and drugs approved for other purposes, such as immunosuppressive agents given to cancer patients undergoing chemotherapy or medicines developed to treat arthritis patients. Lupus occurs about 10 times more frequently in adult females than adult males, and is two to three times more common among African Americans, Hispanics, Asians and Native Americans.</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 2,200 employees worldwide, MedImmune is headquartered in Gaithersburg, Maryland. For more information, visit the company&#8217;s website at http://www.medimmune.com.</p>
<p> This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the research and development of antibodies targeting interferon-alpha. Such statements reflect management&#8217;s current views and are based on certain assumptions about the success of this program. 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 SEC. MedImmune is developing interferon-alpha-related product candidates for potential future marketing. 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 were received, such products would 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> SOURCE MedImmune, Inc. <br/><br/> CONTACT: Investors: Peter Vozzo, +1-301-398-4358; Media: Kate Barrett, +1-301-398-4320 or Jamie Lacey, +1-301-398-4035, all of MedImmune, Inc. </p>
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