FORM 6-K
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
Report of Foreign
Issuer
Pursuant to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of
1934
For November 2008
Commission File
Number: 001-11960
AstraZeneca PLC
15 Stanhope Gate, London W1K 1LN, England
Indicate by check mark whether the
registrant files or will file annual reports under cover of Form 20-F or Form
40-F.
Form 20-F X
Form
40-F __
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule
101(b)(1):
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule
101(b)(7): ______
Indicate by check mark whether the
registrant by furnishing the information contained in this Form is also thereby
furnishing the information to the Commission pursuant to Rule 12g3-2(b) under
the Securities Exchange Act of 1934.
Yes __ No
X
If “Yes” is marked, indicate below the
file number assigned to the Registrant in connection with Rule
12g3-2(b): 82-_____________
AstraZeneca PLC
INDEX TO EXHIBITS
|
1.
|
Press release entitled, “John
Patterson to retire from AstraZeneca”, dated 4 November
2008.
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2.
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Press release entitled, “Crestor
demonstrates dramatic CV risk reduction in a large statin outcomes study”,
dated 10 November 2008.
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3.
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Press release entitled, “Seroquel
XR and Seroquel approved in Europe for new indications for the
treatment of bipolar disorder“, dated 13 November
2008.
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4.
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Press release entitled,
“AstraZeneca enters agreement for authorized generic Pulmicort Respules”,
dated 19 November 2008.
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5.
|
Press release entitled, “FDA
responds to AstraZeneca’s citizen petition – FDA also grants approval for
a generic version of Pulmicort Respules”, dated 19 November
2008.
|
|
6.
|
Press release
entitled, “Phase III studies show that Vandetanib (ZACTIMA) brings
clinical benefits to patients with lung cancer”, dated 19 November
2008.
|
|
7.
|
Press release
entitled, “AstraZeneca granted temporary restraining order in Pulmicort
Respules patent litigation”, dated 20 November
2008.
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|
8.
|
Press release
entitled, “AstraZeneca provides update on agreement with Abraxis
Bioscience for co-promotion of Abraxane in the US”, dated 25 November
2008.
|
|
9.
|
Press release
entitled, “AstraZeneca settles US Pulmicort patent litigation with Teva”,
dated 26 November 2008.
|
|
10.
|
Press release
entitled, “MedImmune receives FDA complete response letter on
Motavizumab”, dated 28 November
2008.
|
|
11.
|
Press release
entitled, “Transparency Directive – Voting Rights and Capital”, dated 28
November 2008.
|
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the Registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly
authorized.
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AstraZeneca
PLC |
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Date: 3 December
2008
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By: |
/s/ Justin
Hoskins |
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Name: |
Justin
Hoskins
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Title: |
Deputy Company
Secretary
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Item 1
JOHN
PATTERSON TO RETIRE FROM ASTRAZENECA
AstraZeneca today
announced that John Patterson, Executive Director, Development will retire from
the company in March 2009.
Anders Ekblom is
appointed to the role of Executive Vice President, Development with effect from
1 January 2009, when he will also join AstraZeneca’s Senior Executive
Team. He is currently Vice President and Head of Global Clinical
Development at AstraZeneca.
Anders will assume
full management responsibility for the Development organisation at the end of
January when John steps down from his operational position. John will
retire from the Board of AstraZeneca PLC on 31 March 2009.
AstraZeneca Chief
Executive Officer, David Brennan commented: “John has made an important and
lasting contribution to the business over the course of his career with AZ.
Under his leadership, the productivity and efficiency of AstraZeneca’s drug
development has improved significantly; we now have the largest pipeline in our
history and a clear focus on what is required to deliver it.
“I’m delighted to
welcome Anders to our Senior Executive Team. He brings strong leadership and
valuable experience to the role, having worked in both Discovery and
Development, most recently leading substantial improvements in Clinical
Development.”
NOTES
TO EDITORS
John
Patterson CBE
John joined ICI
Pharmaceuticals in 1975 and for five years was responsible for the clinical
development of breast cancer treatment, tamoxifen. He took various leadership
roles in Clinical Research in the UK, Germany and the US before being appointed
Medical Director. His subsequent roles have included head of Europe and then the
International Sales and Marketing Organisation (ISMO) for Zeneca. At the
formation of AstraZeneca he became Executive Vice President, Product Strategy
& Licensing and, later, Business Development. In December 2004 John was
appointed to the main AstraZeneca Board as Executive Director responsible for
Development.
John is a Fellow of
the Royal College of Physicians and the Academy for Medical Science. He is a
Director of the British Pharmaceutical Group and a non-executive director at
Cobham PLC. He is a former President of the Association of the British
Pharmaceutical Industry.
Anders
Ekblom
Anders joined Astra
in 1993 from the Karolinska Institutet and Karolinska Hospital in Stockholm,
where he was a senior lecturer and Director for the Perianesthetic
Unit. His previous roles at AstraZeneca have included: Vice President
of Strategy, Portfolio and Alliances; Head of Respiratory and Inflammation; Head
of Pain Control. Most recently he has been responsible for Global
Clinical Development, the largest
single function in
R&D, operating across drug development and life cycle
management. In this role he has led initiatives to increase the
quality and speed of clinical development, while reducing cost, improving
productivity and cutting cycle times.
Anders is a Director
of the board of Albireo Ltd. He is an Associate Professor of
Physiology at the Karolinska Institutet, a medical doctor board certified in
Anesthesiology and Intensive Care, and a doctor of dental surgery.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information visit www.astrazeneca.com
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4
November 2008
-
ENDS -
Item 2
CRESTOR
DEMONSTRATES DRAMATIC CV RISK REDUCTION IN A LARGE STATIN OUTCOMES
STUDY
New data from the
JUPITER study demonstrated that CRESTOR (rosuvastatin calcium) 20 mg
significantly reduced major cardiovascular (CV) events (defined in this study as
the combined risk of myocardial infarction, stroke, arterial revascularization,
hospitalization for unstable angina, or death from CV causes) by a dramatic 44%
compared to placebo (p<0.001) among men and women with elevated hsCRP but low
to normal cholesterol levels.
Results also showed
that for patients in the trial taking rosuvastatin:
|
§
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the combined
risk of heart attack, stroke or CV death was reduced by nearly half (47%,
p<0.001).
|
|
§
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risk of heart
attack was cut by more than half (54%,
p<0.001).
|
|
§
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risk of stroke
was cut by nearly half (48%,
p=0.002).
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§
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total
mortality was significantly reduced by 20%
(p=0.02).
|
These results were
accompanied by a median LDL-C reduction of 50% (p<0.001) resulting in an
on-treatment median LDL-C of 55 mg/dL.
On the basis of the
data, if the results are projected over a period of 5 years, 25 patients would
need to be treated to prevent one major cardiovascular event
(NNT=25).
The JUPITER results
will be presented today at the American Heart Association Scientific Sessions
and were simultaneously published online by the New England Journal of
Medicine.
"These results
provide new information about Crestor’s effects on CV risk. The
JUPITER trial confirmed that CRESTOR dramatically reduces LDL-C cholesterol
levels and has now demonstrated a nearly 50% reduction in the risk of heart
attack and stroke in a population of patients who had elevated hsCRP but low to
normal cholesterol levels,” said Howard Hutchinson, Chief Medical Officer for
AstraZeneca. "As is appropriate, the medical community, regulators, and
guideline committees will now carefully consider these data and any implications
for treating patients."
As previously
guided, AstraZeneca expects to file a regulatory submission including the
JUPITER data in the first half of 2009 and if approved, will begin promotional
activities within the approved labelling.
Rosuvastatin is not
indicated for the prevention of cardiovascular events. Rosuvastatin should be
used according to the prescribing information, which contains recommendations
for initiating and titrating therapy according to the individual patient
profile. In most countries, the usual recommended starting dose of rosuvastatin
is 10 mg.
Rosuvastatin 20 mg
was well tolerated in nearly 9,000 patients during the course of the study.
There was no difference between treatment groups for major adverse events,
including cancer or myopathy. There was a small increase in physician reported
diabetes consistent with data from other large placebo controlled statin
trials.
About
JUPITER:
JUPITER
(Justification for the Use of statins in Primary prevention: an Intervention
Trial Evaluating Rosuvastatin) was a long-term, randomized, double-blind,
placebo-controlled, large-scale study of 17,802 patients designed to determine
if rosuvastatin 20 mg decreases the risk of heart attack, stroke and other major
cardiovascular events in patients with low to normal LDL-C but at increased
cardiovascular risk as identified by elevated high-sensitivity C-reactive
protein (hsCRP) and age. The majority of patients had at least one other risk
factor including hypertension, low HDL-C, family history of premature coronary
heart disease (CHD) or smoking. hsCRP is a recognized marker of inflammation
which is associated with an increased risk of atherosclerotic cardiovascular
events.
JUPITER is a part of
AstraZeneca’s extensive GALAXY clinical trials programme, designed to address
important unanswered questions in statin research. Currently, more than 69,000
patients have been recruited from 55 countries worldwide to participate in the
GALAXY Programme.
About
CRESTOR (ROSUVASTATIN):
Studies have
previously shown that CRESTOR was the most effective statin at lowering LDL-C,
had a significant effect on raising HDL-C and slowed the progression of
atherosclerosis, an underlying cause of cardiovascular disease.
CRESTOR has now
received regulatory approval in over 95 countries. Nearly 15 million patients
have been prescribed CRESTOR worldwide. Data from clinical trials and real world
use shows that the safety profile for CRESTOR is in line with other marketed
statins.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information visit www.astrazeneca.com
- Ends
-
|
Neil
McCrae
|
+44 207 304
5045 (24 hours)
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Chris
Sampson
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+44 20 7304
5130 (24 hours)
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| Investor
Enquiries UK: |
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Jonathan
Hunt
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+44 207 304
5087
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mob: +44 7775
704032
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Mina
Blair
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+44 20 7304
5084
|
mob: +44 7718
581021
|
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
654364
|
| Investor
Enquiries US: |
|
|
Ed
Seage
|
+1 302 886
4065
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mob: +1 302
373 1361
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|
Jorgen
Winroth
|
+1 212 579
0506
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mob: +1 917
612 4043
|
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
10 November
2008
Item 3
SEROQUEL
XR and SEROQUEL approved in Europe for new indications for the treatment of
bipolar disorder
AstraZeneca today
announced that the once-daily formulation SEROQUEL XR (quetiapine fumarate
extended release tablets) and SEROQUEL (quetiapine fumarate) have been approved
under the European Mutual Recognition Procedure (MRP) for new indications in
bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for the treatment
of major depressive episodes in bipolar disorder. Additionally, SEROQUEL XR has
been licensed for moderate to severe manic episodes in bipolar
disorder.
This follows the
October 2008 approval of SEROQUEL XR in similar indications by the US Food and
Drug Administration (FDA). As a result of these new indications for adult
patients, SEROQUEL (both formulations) is currently the only atypical
antipsychotic approved to treat the spectrum of mood episodes associated with
bipolar disorder and the only licensed treatment for bipolar depression in the
EU. The mechanism of action of SEROQUEL, which involves both
antipsychotic and antidepressant activities, may help explain its unique
efficacy across the spectrum of mood episodes associated with bipolar
disorder.
AstraZeneca will
move forward with obtaining local approvals with the 17 Member States that take
part in the Mutual Recognition Procedure.
About
bipolar disorder
Bipolar disorder is
a common and serious mental illness that causes dramatic and severe mood swings.
Bipolar I disorder is the classic form of the disease, characterised by
recurrent episodes of mania and depression. Bipolar II disorder involves one or
more periods of major depression with at least one episode of mild to moderate
mania (hypomania), but never full mania. It is estimated that the
worldwide prevalence of bipolar disorder is 3-5%. Up to half of all
individuals with bipolar disorder make at least one suicide attempt in their
lifetime, and approximately 10–15% complete suicide. Currently,
there is no licensed treatment for bipolar depression in the EU, making this
approval a significant step forward for clinicians and
patients.
About
SEROQUEL XR and SEROQUEL
SEROQUEL XR has been approved in 43
countries for schizophrenia (including all 17 countries in the Mutual
Recognition Procedure), 12 countries for bipolar mania, in 7 countries for
bipolar depression, in 3 markets for bipolar maintenance, in 1 market for Major
Depressive Disorder (MDD), and in 1 market for Generalised Anxiety Disorder
(GAD).
A filing for SEROQUEL XR seeking
approval for the treatment of MDD was made in the US in February this year with the EU
filing in June. In October 2008, SEROQUEL XR became the first atypical
antipsychotic to be filed with the EMEA in Europe seeking approval for the treatment of
GAD. A similar filing was made to the FDA in May 2008. These applications remain
under review by the regulatory authorities.
Launched in 1997, it
is estimated that SEROQUEL has been prescribed to more than 22 million patients
worldwide*. It is approved in 92 countries for the treatment of schizophrenia,
in 88 countries for
the treatment of bipolar mania, and in 30 countries including the US for the
treatment of bipolar depression.
*Estimates based on IMS APLD and
Prescription data.
MRP countries
AstraZeneca will move forward with
obtaining local approvals for bipolar indications in the following EU Member
States: Austria, Belgium, Cyprus (XR only), Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Malta (XR only), Portugal, Poland (XR only), Spain and Sweden.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more information please
visit: www.astrazeneca.com
Media
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Sampson +44 207 304 5130 (24 hours)
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+1 301 252 7518
13
November 2008
– ENDS –
Item 4
ASTRAZENECA
ENTERS AGREEMENT FOR AUTHORIZED GENERIC PULMICORT RESPULES
AstraZeneca
today announced that it has entered into a supply and distribution agreement
with Par Pharmaceutical to distribute an authorized generic version of
budesonide inhalation suspension in the United States in response to the launch
‘at risk’ of a generic version of this product by Teva. Currently,
the authorized generic product will be distributed in the 0.25 mg/2 mL and 0.5
mg/2 mL dosage strengths. Par Pharmaceutical began shipping the
product today.
Additionally,
AstraZeneca has filed a Temporary Restraining Order (TRO), seeking to stop Teva
from launching its purported generic version of AstraZeneca’s PULMICORT RESPULES
‘at-risk’, until the ongoing patent infringement case between the parties has
been adjudicated. In October, AstraZeneca filed a preliminary
injunction order with the court. We await the court’s decision on
these motions.
The ongoing patent
infringement litigation brought by AstraZeneca against Teva for patent
infringement will also continue, with the court case to commence on 12 January
2009.
AstraZeneca’s
branded version of budesonide inhalation suspension, PULMICORT RESPULES, will
continue to be available in the United States.
Despite
the launch of generic competition to PULMICORT RESPULES, the company remains on
track to achieve its full year targets, although it is now likely that earnings
per share will be near the bottom of the $4.90 to $5.05 range communicated with
the third quarter financial results. This assumes that core EPS will be
negatively impacted by approximately $0.16 per share as a result of lost sales
contribution, one time charges associated with stock write-offs and provisions
against inventory in the pipeline, and an immediate impairment of the
PULMICORT-related intangible assets recognised in March 2008 under the terms of
the Merck arrangements.
As
a reminder, the company’s full-year guidance reflects actual results achieved in
the first nine months, combined with guidance for the fourth quarter based on
the original assumptions for currency, being fourth quarter 2007 average
exchange rates.
AstraZeneca
has full confidence in the strength of its intellectual property rights
protecting PULMICORT RESPULES and will continue to defend those
rights.
PULMICORT
RESPULES patients and their families should always consult with their health
care professional if they have concerns about their
medication. Patients should never disrupt or change their PULMICORT
RESPULES dosing without first consulting their health care
professional.
About
Pulmicort Respules
PULMICORT
RESPULES is a preventive, maintenance asthma medicine indicated for use in
children 12 months to 8 years of age in the United
States. Full-year US sales
for PULMICORT in 2007 totalled $964 million, about 90 percent of which is
accounted
for by PULMICORT RESPULES. Patents covering
PULMICORT RESPULES expire in 2018 with paediatric exclusivity extending to
2019.
About
AstraZeneca
AstraZeneca
is a major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information
visit www.astrazeneca.com
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Neil
McCrae
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Chris
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| Investor
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Karl
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| Investor
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Ed
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Jorgen
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Peter Vozzo
(MedImmune)
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mob: +1 301
252 7518
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19
November 2008
-
ENDS -
Item 5
FDA
RESPONDS TO ASTRAZENECA'S CITIZEN PETITION -- FDA ALSO GRANTS APPROVAL FOR A
GENERIC VERSION OF PULMICORT RESPULES
On
18 November 2008, the US FDA responded to AstraZeneca's Citizen Petition
surrounding the company's concern about the approval of any generic version of
PULMICORT RESPULES® (budesonide inhalation suspension). While the FDA
agreed with some of the company's concerns, other arguments in the Citizen
Petition were denied.
AstraZeneca
disagrees with several elements of the FDA's decision and is considering its
options to respond.
Simultaneously,
the FDA has granted approval for a generic version of AstraZeneca's PULMICORT
RESPULES. The ongoing litigation brought by AstraZeneca against Teva
for patent infringement continues, with the court case to commence on 12 January
2009.
AstraZeneca
has full confidence in the strength of its intellectual property rights
protecting PULMICORT RESPULES and will continue to vigorously defend and enforce
its intellectual property.
Patents
covering PULMICORT RESPULES expire in 2018 with pediatric exclusivity extending
to 2019.
About
Pulmicort Respules
PULMICORT RESPULES is a preventive, maintenance
asthma medicine indicated for use in children 12 months to 8 years of age in the
United States. Full-year US sales for PULMICORT in 2007 totalled $964
million, about 90 percent of which is accounted for by PULMICORT
RESPULES.
|
Neil
McCrae
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+44 207 304
5045 (24 hours)
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Chris
Sampson
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+44 20 7304
5130 (24 hours)
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| Investor
Enquiries UK: |
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Jonathan
Hunt
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+44 207 304
5087
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mob: +44 7775
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Mina
Blair
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+44 20 7304
5084
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mob: +44 7718
581021
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Karl
Hard
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+44 207 304
5322
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mob: +44 7789
654364
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| Investor
Enquiries US: |
|
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Ed
Seage
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+1 302 886
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mob: +1 302
373 1361
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|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
19
November 2008
- Ends -
Item 6
PHASE
III STUDIES SHOW THAT VANDETANIB (ZACTIMA) BRINGS CLINICAL BENEFITS TO PATIENTS
WITH LUNG CANCER
AstraZeneca
today announced results from three Phase III studies of ZACTIMA (vandetanib) in
combination with chemotherapy agents docetaxel (ZODIAC) and pemetrexed (ZEAL)
and as monotherapy (ZEST) in non-small cell lung cancer (NSCLC).
Results
from the ZODIAC and ZEAL studies showed advantages for vandetanib in combination
with chemotherapy, compared to chemotherapy alone. The addition of
vandetanib to chemotherapy prolonged Progression Free Survival (PFS), the
primary endpoint, which achieved statistical significance in the larger ZODIAC
study, but not in the smaller ZEAL study.
Clinical
benefits were seen in secondary endpoints. Both studies showed that adding
vandetanib to chemotherapy significantly improved Objective Response Rate (ORR),
which is a measurement of tumour shrinkage. Additionally, positive
trends in prolongation of Overall Survival (OS) were seen, although these did
not reach statistical significance.
Importantly,
the studies also showed that adding vandetanib to chemotherapy controlled the
symptoms of lung cancer better than chemotherapy alone, allowing patients to
maintain their quality of life for significantly longer.
ZODIAC
is a randomised, double-blind, placebo-controlled Phase III study evaluating the
combination of vandetanib 100mg with docetaxel versus docetaxel alone. The study
enrolled 1391 patients previously treated with one prior anti-cancer therapy for
advanced NSCLC.
ZEAL
is a randomised, double-blind, placebo-controlled Phase III study evaluating the
combination of vandetanib 100mg with pemetrexed versus pemetrexed alone. The
study enrolled 534 patients previously treated with one prior anti-cancer
therapy for advanced NSCLC.
ZEST,
a randomised, double-blind, Phase III study evaluating the efficacy of
vandetanib 300mg versus erlotinib 150mg, did not meet the primary objective of
demonstrating a statistically significant prolongation of PFS for vandetanib.
However, vandetanib and erlotinib showed equivalent efficacy for PFS and OS in a
pre-planned non-inferiority analysis. The study enrolled 1240 patients with
locally advanced or metastatic NSCLC after failure of at least one prior
anti-cancer therapy.
The
observed safety profile in these three Phase III studies was consistent with
previous studies with vandetanib in NSCLC. The most common adverse events
associated with vandetanib included rash, diarrhoea and
hypertension.
John
Patterson, Executive Director, Development, AstraZeneca commented: “Non-small
cell lung cancer is a truly debilitating disease. These studies have shown that
vandetanib can offer clinical benefit to patients with lung cancer by extending
the time a patient can live with their cancer under control, while managing
symptoms and maintaining quality of life better than chemotherapy
alone.”
AstraZeneca
plans to file a regulatory submission in the first half of 2009 following
discussion with regulatory agencies. Full results from ZODIAC, ZEAL and ZEST
will be presented at a forthcoming international medical congress.
Vandetanib
is also currently being investigated in another Phase III monotherapy study in
NSCLC (ZEPHYR) and in a number of other cancers, including thyroid
cancer.
NOTES
TO EDITORS
About
vandetanib
Vandetanib has a
unique profile that fights cancer through two clinically proven mechanisms – by
blocking the development of tumour blood supply (anti-angiogenesis or
anti-VEGFR), and by blocking the growth and survival of the tumour itself
(anti-EGFR). Vandetanib
also inhibits RET-tyrosine kinase activity, an important growth driver in
certain types of thyroid
cancer.
About
the Phase III studies
ZODIAC
(ZACTIMA
in cOmbination
with Docetaxel
In
non-smAll
cell lung Cancer)
is a Phase III randomised, double-blind, placebo-controlled study evaluating the
combination of vandetanib 100mg once daily plus docetaxel versus docetaxel alone
in patients with locally advanced or metastatic NSCLC, treated with one prior
anti-cancer therapy. It enrolled 1391 patients at 250 centres
throughout Europe, North America, South America and Asia Pacific.
ZEAL
(ZACTIMA Efficacy with
Alimta in
Lung cancer)
is a randomised, double-blind, placebo-controlled Phase III study
evaluating the combination of vandetanib 100mg with pemetrexed versus pemetrexed
alone in patients with locally advanced or metastatic NSCLC, treated with one
prior anti-cancer therapy. It enrolled 534 patients at approximately 160 centres
across 23 countries.
ZEST
(ZACTIMA Efficacy
Study versus
Tarceva) is a
Phase III randomised, double-blind, multi-centre study to assess the efficacy of
vandetanib 300mg versus erlotinib in patients with locally advanced or
metastatic NSCLC after failure of at least one prior anti-cancer therapy. It
enrolled 1240 patients at approximately 171 centres across 22
countries.
ZEPHYR
(ZACTIMA
Efficacy
trial for NSCLC Patients
with HistorY
of EGFR-TKI and chemo-Resistance) is a Phase III,
randomised, double-blind, parallel-group, multi-centre study evaluating the
efficacy of ZACTIMA 300mg plus best supportive care versus best supportive care
in patients with locally advanced or metastatic (stage IIIB-IV) NSCLC after
prior therapy with an EGFR inhibitor. The study is running in
approximately 170 centres across 23 countries.
About
lung cancer
Over
1.35 million new cases of lung cancer are diagnosed every year and nearly 1.2
million people die as a result of this devastating disease – more than breast,
colon and prostate cancer combined. Non-small cell lung cancer accounts for
around 85% of all lung cancers. If lung cancer is detected at early stages,
before it has spread to other organs or lymph nodes, around half of patients can
survive for five years or more. However, few lung cancers are found at this
early stage and it is normally diagnosed at the advanced stage, when five-year
survival falls to approximately 15%.
About AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca,
visit www.astrazeneca.com
|
Neil
McCrae
|
+44 207 304
5045 (24 hours)
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|
Chris
Sampson
|
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5130 (24 hours)
|
| Investor
Enquiries UK: |
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Jorgen
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Peter Vozzo
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19
November 2008
-
ENDS -
Item 7
AstraZeneca
granted Temporary Restraining Order in PULMICORT RESPULES patent
litigation
On
19 November 2008, AstraZeneca was granted a Temporary Restraining Order (TRO) by
the United States District Court for the District of New Jersey, halting sales
of Teva’s budesonide inhalation suspension product, a generic version of
AstraZeneca’s PULMICORT RESPULES treatment.
The
TRO freezes supply of Teva’s product to prevent any future sales and requires
Teva to send a letter to its customers, along with a copy of the TRO, requesting
that they comply with the terms of the Court’s Order. As part of the
same ruling, AstraZeneca and its partner Par Pharmaceuticals are to suspend
distribution of AstraZeneca’s own authorised generic and send a similar letter
to customers who purchased that product.
The
marketing and distribution of branded PULMICORT RESPULES is
unaffected.
The
TRO remains in force until further order of the Court. A preliminary
injunction hearing in this matter is scheduled to begin on Tuesday 25 November.
The full court case is due to commence on 12 January 2009. AstraZeneca has full
confidence in the strength of the patents protecting PULMICORT RESPULES and will
continue to defend them vigorously.
AstraZeneca
confirms that it continues to expect Core earnings per share in the range of
$4.90 to $5.05 for the full year 2008. Actual performance within this range is
dependent upon the performance of the business for the remainder of the year and
further developments in the PULMICORT situation, including the outcome of the
preliminary injunction hearing on 25 November 2008.
As
a reminder, the company's full year guidance reflects actual results for the
first nine months, combined with guidance for the fourth quarter based on the
original assumptions for currency, being fourth quarter 2007 average exchange
rates.
About
Pulmicort Respules
PULMICORT RESPULES
is a preventive, maintenance asthma medicine indicated for use in children 12
months to 8 years of age in the United States. Full-year US sales
for PULMICORT in 2007 totalled $964 million, about 90 percent of which is
accounted for by PULMICORT RESPULES. Patents covering
PULMICORT RESPULES expire in 2018 with paediatric exclusivity extending to
2019.
About
AstraZeneca
AstraZeneca
is a major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information
visit www.astrazeneca.com
|
Neil
McCrae
|
+44 207 304
5045 (24 hours)
|
|
Chris
Sampson
|
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5130 (24 hours)
|
| Emily
Denney |
+1-302-885-3451 |
| Investor
Enquiries UK: |
|
|
Jonathan
Hunt
|
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|
mob: +44 7775
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|
Mina
Blair
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5084
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|
|
Karl
Hard
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5322
|
mob: +44 7789
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|
| Investor
Enquiries US: |
|
|
Ed
Seage
|
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mob: +1 302
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|
|
Jorgen
Winroth
|
+1 212 579
0506
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mob: +1 917
612 4043
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|
Peter Vozzo
(MedImmune)
|
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4358
|
mob: +1 301
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|
20
November 2008
- ENDS
-
Item 8
ASTRAZENECA
PROVIDES UPDATE ON AGREEMENT WITH
ABRAXIS
BIOSCIENCE FOR CO-PROMOTION OF ABRAXANE IN THE US
On
19 November 2008, AstraZeneca entered into an agreement with Abraxis BioScience,
LLC, under which, subject to the satisfaction of terms and conditions thereof,
Abraxis would re-acquire exclusive rights to market ABRAXANE in the United
States.
Under the
agreement, the board of Abraxis’ parent will consider ending the Co-Promotion
Agreement between 1 January and 5 January 2009, and if board approval is
procured, the end of the Co-Promotion Agreement will be effective on the date of
AstraZeneca’s timely receipt of notice of such board approval. If
board approval is obtained, Abraxis will pay AstraZeneca a $268 million fee on
31 March 2009. If board approval is not obtained, then the
Co-Promotion Agreement will continue with an amended commission to AstraZeneca
of 50%.
AstraZeneca
will continue to promote ABRAXANE until AstraZeneca receives timely confirmation
that the board of directors of Abraxis’ parent has approved ending the
Co-Promotion Agreement.
-
Ends -
25
November 2008
|
Neil
McCrae
|
+44 207 304
5045 (24 hours)
|
|
Chris
Sampson
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5130 (24 hours)
|
| Investor
Enquiries UK: |
|
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Jonathan
Hunt
|
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mob: +44 7775
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Mina
Blair
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5084
|
mob: +44 7718
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|
Karl
Hard
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mob: +44 7789
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| Investor
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|
|
Ed
Seage
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mob: +1 302
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|
Jorgen
Winroth
|
+1 212 579
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mob: +1 917
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|
Peter Vozzo
(MedImmune)
|
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mob: +1 301
252 7518
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About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For
more Information visit www.astrazeneca.com
Broadcast
quality footage is available to download from the Media section of our website
at:
http://br.thenewsmarket.com/Astrazeneca/br/Login/LoginPreRegistration.aspx
Journalists
will be required to register to access this feature.
Item 9
ASTRAZENECA
SETTLES US PULMICORT RESPULES PATENT LITIGATION WITH TEVA
AstraZeneca
today announced it has entered into a settlement agreement in its Pulmicort
Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a
wholly owned subsidiary of Teva Pharmaceuticals USA.
The
agreement settles the patent infringement litigation filed by AstraZeneca
following Teva’s submission to the United States Food & Drug Administration
of an Abbreviated New Drug Application for a generic version of Pulmicort
Respules. Under the settlement agreement, Teva concedes that the
patents asserted by AstraZeneca in the patent litigation are valid and
enforceable. Teva also concedes that its generic version of Pulmicort
Respules infringes AstraZeneca’s patents.
The
settlement agreement will allow Teva to commence sales of budesonide inhalation
suspension, a generic version of Pulmicort Respules, under an exclusive license
from AstraZeneca beginning 15 December 2009. AstraZeneca will receive a
significant undisclosed royalty on sales of Teva's product, with a marked step
down in payments if additional at-risk generic products enter the marketplace.
Teva also agrees to pay AstraZeneca an undisclosed sum in respect of damages
resulting from the unauthorised launch of its generic budesonide inhalation
suspension product on 18 November 2008. Except as described, the
terms of the settlement are confidential.
The
agreement releases Teva from all past US sales of its generic budesonide
inhalation suspension and provides that any product already shipped by Teva will
remain in the market to be further distributed and dispensed.
AstraZeneca
intends to continue to sell Pulmicort Respules, even after the licensed entry of
Teva’s product in December 2009. However, the separate agreement between
AstraZeneca and Par Pharmaceuticals to make available an authorized generic
version of Pulmicort Respules will be discontinued.
AstraZeneca
and Teva have filed a Consent Judgment with the US District Court for the
District of New Jersey reflecting the terms of the settlement agreement. With
the Court now having entered the Consent Judgment, the settlement agreement is
final, and the patent infringement litigation against Teva has been
dismissed.
With
this announcement AstraZeneca confirms that it continues to expect Core earnings
per share in the range of $4.90 to $5.05 for the full year 2008. Actual
performance within this range is dependent upon the performance of the business
for the remainder
of the year, including the potential negative impact on sales of Pulmicort
Respules from Teva’s generic product and the small amount of authorised generic
already in trade channels. AstraZeneca
will address the 2009 outlook for Pulmicort Respules as part of the full year
2009 guidance in January.
As
a reminder, the company’s full year guidance reflects actual results for the
first nine months, combined with guidance for the fourth quarter based on the
original assumptions for currency, being fourth quarter 2007 average exchange
rates.
“This
agreement provides increased certainty and stability in our business and a
clearer backdrop for our investment decisions while re-affirming the strength of
our intellectual property,” said David Brennan, Chief Executive Officer of
AstraZeneca.
AstraZeneca’s
Pulmicort Respules patent infringement litigation against Breath Limited remains
ongoing. In compliance with the Medicare Modernization Act of 2003,
AstraZeneca will file all of the above agreements with the United States Federal
Trade Commission and the United States Department of Justice.
AstraZeneca’s
patents protecting Pulmicort Respules have expiration dates that extend through
2018, with pediatric exclusivity through 2019.
About
Pulmicort Respules
PULMICORT RESPULES
is a preventive, maintenance asthma medicine indicated for use in children 12
months to 8 years of age in the United
States. Full-year
US sales for PULMICORT in 2007 totalled $964 million, about 90 percent of which
is accounted for by PULMICORT RESPULES.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com
|
Neil
McCrae
|
+44 207 304
5045 (24 hours)
|
|
Chris
Sampson
|
+44 20 7304
5130 (24 hours)
|
| Investor
Enquiries UK: |
|
|
Jonathan
Hunt
|
+44 207 304
5087
|
mob: +44 7775
704032
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|
Mina
Blair
|
+44 20 7304
5084
|
mob: +44 7718
581021
|
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
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|
| Investor
Enquiries US: |
|
|
Ed
Seage
|
+1 302 886
4065
|
mob: +1 302
373 1361
|
|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
-
Ends -
26
November 2008
Item 10
MEDIMMUNE
RECEIVES FDA COMPLETE RESPONSE LETTER ON MOTAVIZUMAB
AstraZeneca today announced that
MedImmune, its wholly owned biologics business, has received a Complete Response
Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for
additional information on motavizumab. The CRL is in connection with the
Biologics License Application (BLA) for motavizumab for the prevention of
serious respiratory syncytial virus (RSV) disease, which was submitted on 30
January 2008. Motavizumab is an investigational monoclonal antibody
(MAb).
MedImmune is confident that it can
respond to the outstanding questions and, based on the company’s current
understanding, does not foresee a need to conduct further trials. MedImmune will
continue discussions with the FDA reviewers and, subject to this dialogue, currently
expects to resubmit in the first half of 2009.
An update to AstraZeneca investors on
progress will be provided when appropriate.
About
AstraZeneca
AstraZeneca is a major international
healthcare business engaged in research, development, manufacturing and
marketing of prescription pharmaceuticals and supplier for healthcare
services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more information
about AstraZeneca, visit www.astrazeneca.com
About
MedImmune
MedImmune is a
leading innovation-focused biotechnology company whose mission is to provide
better medicines to patients, new medical options for physicians and rewarding
careers to employees. Dedicated to advancing science and medicine to
help people live better lives, the company is focused on infection, oncology,
respiratory disease and inflammation, cardiovascular/ gastrointestinal disease
and neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune
has approximately 3,000 employees worldwide and is the wholly owned biologics
business for AstraZeneca PLC. For more information, visit MedImmune's
website at www.medimmune.com.
|
Neil
McCrae
|
+44 207 304
5045 (24 hours)
|
| Sarah
Lindgreen |
+44 207 304
5033 (24 hours) |
|
Chris
Sampson
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+44 20 7304
5130 (24 hours)
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| Investor
Enquiries UK: |
|
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Jonathan
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mob: +44 7775
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Mina
Blair
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5084
|
mob: +44 7718
581021
|
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
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|
| Investor
Enquiries US: |
|
|
Ed
Seage
|
+1 302 886
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|
mob: +1 302
373 1361
|
|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
28 November
2008
-
Ends
Item 11
Transparency
Directive
Voting
Rights and Capital
The following
notification is made in accordance with the UK Financial Services Authority
Disclosure and Transparency Rule 5.6.1. On 28 November 2008 the
issued share capital of AstraZeneca PLC with voting rights is 1,447,095,729
ordinary shares of US$0.25. No shares are held in Treasury.
Therefore, the total number of voting rights in AstraZeneca PLC is
1,447,095,729.
The above figure for
the total number of voting rights may be used by shareholders as the denominator
for the calculations by which they will determine if they are required to notify
their interest in, or a change to their interest in, AstraZeneca PLC under the
FSA's Disclosure and Transparency Rules.
G
H R Musker
Company
Secretary
28
November 2008
