AstraZeneca Presents its Global Biologics Organisation, MedImmune, at 2007 Analyst and Investor R&D Day

AstraZeneca (AZN) today holds an R&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’s highly developed capabilities in antibody and vaccine discovery, development, production and commercialisation within the broader context of AstraZeneca’s R&D activities.

"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’s largest biologics pipelines and establishes us as a leader in biotechnology among our pharmaceutical peers.”

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’s biologics ambitions and vision and describe how MedImmune will be operationally independent but strategically aligned within the AstraZeneca group.

“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’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.

“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.”

Progress in the following key therapeutic areas will be covered at the meeting:

Infectious Diseases:
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.

While MedImmune’s respiratory syncytial virus (RSV) franchise has been anchored by the success of Synagis® (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 & 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.

Expanding on its product development experience with FluMist® (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.

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’s global platform to commercialise FluMist across the world.

Respiratory and Inflammatory Diseases:
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 (IL-5) receptor 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.

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.

Oncology:
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’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.

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’s lymphoma. MEDI-538 is a recombinant single-chain bispecific T-cell engager, or BiTE®, 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.

Commercialisation:
Supporting this strong pipeline is MedImmune'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.

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 — with a strong reliance on balancing operational independence with strategic collaboration — will enable us to deliver on the potential of one of the largest biologics pipelines in the industry.”



Media Enquiries:
Jamie Lacey +1 301 398 4035

Analyst & Investor Enquiries:
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Ed Seage +1 302 886 4065
Jorgen Winroth +1 212 579 0506
Peter Vozzo + 1 301 398 4358

Notes To Editors
Interviews with some of the presenters at the R&D day can be found at:
http://www.astrazeneca.com/biologics

Broadcast quality footage of AstraZeneca and MedImmune products, activities and facilities is available from the Broadcast Centre at:
http://www.thenewsmarket.com/astrazeneca

Presentations from today’s R&D day will be available to download at the start of the event at: http://www.astrazeneca.com/biologics

An up to date development pipeline can be downloaded from: http://www.astrazeneca.com/article/511390.aspx


ABOUT SYNAGIS
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.

Important Safety Information
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.

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.

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.

ABOUT FLUMIST
* FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two-to-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life-threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

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.

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

Most common adverse reactions (occurring 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.

ABOUT MEDIMMUNE
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’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’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.

MedImmune’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's application to expand the vaccine’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.*

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’s intellectual property. As a result, MedImmune receives milestone payments and royalties on HPV vaccines marketed by both pharmaceutical companies.

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.

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's website at http://www.medimmune.com.

ABOUT ASTRAZENECA
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'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.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
In order to utilise the 'Safe Harbor' 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.

TRADEMARKS
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.








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