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


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:
Jonathan Hunt +44 (0) 207 304 5087
Karl Hard +44 (0) 207 304 5322
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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Attachments

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