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
February
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, “AstraZeneca Biologics Division, MedImmune, submits Biologics
License Application to FDA for Motavizumab”, dated 4 February
2008.
|
| |
|
|
2.
|
Press
release
entitled, “AstraZeneca PLC appoints new Non-Executive Director”, dated 18
February 2008.
|
| |
|
|
3.
|
Press
release
entitled, “AstraZeneca to appeal judgment in Alabama Medical Pricing
Case”, dated 22 February 2008.
|
| |
|
|
4.
|
Press
release
entitled, “Transaction by Persons Discharging Managerial Responsibilities
Disclosure Rule DTR 3.1.4”, dated 27 February 2008.
|
| |
|
|
5.
|
Press
release
entitled, “Transaction by Persons Discharging Managerial Responsibilities
Disclosure Rule DTR 3.1.4”, dated 27 February 2008.
|
| |
|
|
6.
|
Press
release
entitled, “Transaction by Persons Discharging Managerial Responsibilities
Disclosure Rule DTR 3.1.4”, dated 27 February 2008.
|
| |
|
|
7.
|
Press
release
entitled, “AstraZeneca Provides Update on RECENTIN™ Clinical Development
Programme”, dated 27 February 2008.
|
| |
|
|
8.
|
Press
release
entitled, “AstraZeneca Provides an Update on the Status of its
Arrangements with Merck & Co., INC.”, dated 28 February
2008.
|
| |
|
|
9.
|
Press
release
entitled, “Transparency Directive Voting Rights and Capital”, dated 29
February 2008.
|
| |
|
|
10.
|
Press
release
entitled, “AstraZeneca Submits its sNDA for Seroquel XR™ for the Treatment
of Major Depressive Disorder”, dated 29 February
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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Date:
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03
March
2008
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|
By:
|
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| |
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|
Name:
|
Justin
Hoskins
|
| |
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Title:
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Deputy
Company
Secretary
|
Item
1
ASTRAZENECA
BIOLOGICS DIVISION, MEDIMMUNE, SUBMITS
BIOLOGICS
LICENSE APPLICATION TO FDA FOR
MOTAVIZUMAB
AstraZeneca
PLC announced today that its
biologics division, MedImmune, had submitted a Biologics License Application
(BLA) to the U.S. Food & Drug Administration (FDA) for motavizumab, an
investigational monoclonal antibody (MAb) derived from recombinant DNA
technology.
“We
expect that this submission will
lead to the first new medicine delivered by MedImmune since we acquired the
company in June 2007 and one of three new filings that we plan to make this
year. MedImmune has a well-established reputation in the prevention of RSV
through its existing product, Synagis. Motavizumab offers the opportunity
to
build on this knowledge and improve treatment for a young and vulnerable
patient
population,” said David Brennan, Chief Executive Officer,
AstraZeneca.
4
February 2008
Media
Enquiries:
Jamie
Lacey,
(MedImmune) +1 301 398 4035
Steve
Brown, +44 207 304 5033 (24 hours)
Edel
McCaffrey, +44 207 304 5034 (24 hours)
Investor
Enquiries:
Jonathan
Hunt, +44 207 304 5087
Ed
Seage, +1 302 886 4065
Karl
Hard, +44 207 304 5322
Jorgen
Winroth, +1 212 579 0506
Peter
Vozzo,
(MedImmune) +1 301 398 4358
-
Ends -
Item
2
AstraZeneca
PLC appoints new Non-Executive Director
AstraZeneca
today announced that
Jean-Philippe Courtois is to join the Board of Directors as a Non-Executive
Director with immediate effect. Jean-Philippe Courtois is currently
President of Microsoft International, a territory that spans 100 subsidiaries
operating in over 240 countries outside the United States and Canada, and
a
Senior Vice-President of Microsoft Corporation.
Louis
Schweitzer,
Chairman of AstraZeneca said: “We are very pleased that Jean-Philippe Courtois
has agreed to join us. His considerable experience in global sales
and marketing, including emerging markets, will be of great benefit to
the work
of the Board”.
No
disclosure
obligations arise under paragraph (1) to (6) of Listing Rule 9.6.13 of
the UK
Listing Authority’s Listing Rules in respect of the appointment of Jean-Philippe
Courtois.
18
February 2008
Media
Enquiries:
Steve
Brown, +44 207 304 5033 (24 hours)
Chris
Sampson, +44 20 7304 5130 (24 hours)
Neil
McCrae, +44 207 304 5045 (24 hours)
Investor
Enquiries:
Jonathan
Hunt, +44 207 304 5087
Ed
Seage, +1 302 886 4065
Karl
Hard, +44 207 304 5322
Jorgen
Winroth, +1 212 579 0506
Mina
Blair, +44 20 7304 5084
Peter
Vozzo,
(MedImmune) +1 301 398 4358
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.
-
Ends -
Item
3
ASTRAZENECA
TO APPEAL JUDGMENT IN ALABAMA
MEDICAL
PRICING CASE
AstraZeneca
today
announced it intends to seek reconsideration or reversal of a verdict in
the
Montgomery County Circuit Court awarding $40 million in compensatory damages
and
$175 million in punitive damages for alleged false and misleading reporting
of
prices for drugs reimbursed by the Alabama State Medicaid Agency in the
US.
The
company was
among 73 pharmaceutical manufacturers named in a lawsuit filed in 2005 by
the
Alabama Attorney General, alleging that misleading and false reported prices
had
caused Alabama Medicaid to reimburse pharmacists too much money on prescriptions
filed for Medicaid patients.
AstraZeneca
maintains that this lawsuit is legally and factually unfounded. The case
was
based on the misleading premise that the Alabama State Medicaid Agency did
not
understand how drug prices are established and reported. AstraZeneca also
believes serious errors occurred during the proceedings and that the verdict
should not be upheld.
AstraZeneca
believes
it has fully complied with the law, government guidelines and contracts that
govern Medicaid pricing. AstraZeneca currently provides medicines to Medicaid
programmes at the lowest price offered to its best business clients, as federal
law requires.
AstraZeneca
and the
State Medicaid programme share a common goal of helping people access the
medicines they need. To help patients who have difficulty affording their
medicines, AstraZeneca offers patient assistance programmes side by side
with
its medicines. In the last two years alone, Alabama patients have received
more
than $25.5 million in savings through the company’s prescription savings
programmes.
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.
22
February,
2008
Media
Enquiries:
Steve
Brown, +44 207 304 5033 (24 hours)
Chris
Sampson, +44 20 7304 5130 (24 hours)
Neil
McCrae, +44 207 304 5045 (24 hours)
Investor
Enquiries:
Jonathan
Hunt, +44 207 304 5087
Ed
Seage, +1 302 886 4065
Karl
Hard, +44 207 304 5322
Jorgen
Winroth, +1 212 579 0506
Mina
Blair, +44 20 7304 5084
Peter
Vozzo,
(MedImmune) +1 301 398 4358
-
Ends
-
Item
4
Transaction
by Persons Discharging Managerial Responsibilities
Disclosure
Rule DTR 3.1.4
We
hereby inform you
that the interest of David R. Brennan, a Director of the Company, in the
shares
of AstraZeneca PLC has changed as detailed below. Mr Brennan has
interests in both the Ordinary Shares and the American Depositary Shares
(ADSs)
of AstraZeneca PLC. One ADS equals one Ordinary Share.
On
25 February 2008,
Mr Brennan received an allocation of 16,810 Ordinary Shares under the previously
disclosed arrangements relating to his annual bonus for 2007 whereby he is
required to defer a portion of the bonus earned into shares for a period
of
three years. The shares were allocated at a price of 1999 pence per
share. Mr Brennan will become beneficially entitled to these shares
on 25 February 2011.
On
25 February 2008,
Mr Brennan received a scheduled distribution out of the AstraZeneca US Executive
Deferral Plan, a unitised stock fund established in 2000, in which Mr Brennan,
in common with other participating US executives, is deemed to have a notional
interest in ADSs calculated by reference to the fund value and the closing
price
of AstraZeneca ADSs. Following this scheduled distribution on 25
February 2008, Mr Brennan had a notional interest in 40,286 ADSs within the
AstraZeneca US Executive Deferral Plan by reference to the closing price
on 25
February 2008 of US$39.47.
Immediately
prior to
the above transactions, Mr Brennan had an interest in 217,618 Ordinary Shares
and 143,617 AstraZeneca ADSs. As a result of these transactions, Mr
Brennan’s interest is now 234,428 Ordinary Shares and 121,435 AstraZeneca ADSs,
including the notional interest in ADSs in the AstraZeneca US Executive Deferral
Plan referred to above. This interest represents approximately 0.024%
of the Company’s issued ordinary capital.
G
H R
Musker
Company
Secretary
27
February
2008
Item
5
Transaction
by Persons Discharging Managerial Responsibilities
Disclosure
Rule DTR 3.1.4
We
hereby inform you
that on 25 February 2008, the following individuals, who are all persons
discharging managerial responsibilities, acquired an interest in the USD0.25
Ordinary Shares of AstraZeneca PLC or, in the case of D Mott, L Tetrault
and A
Zook, over the Company’s American Depositary Shares (ADSs). One ADS
equals one Ordinary Share. The interest arises as a result of the
previously disclosed arrangements relating to the payment of annual bonuses
for
2007 whereby each individual is required to defer a portion of the bonus
earned
into shares for a period of three years. The shares are awarded under
the terms of the AstraZeneca Deferred Bonus Plan. The individuals
will become beneficially entitled to these shares on 25 February
2011.
|
Name
|
Number
of
shares allocated
|
Award
price
per share
|
|
B
Angelici
|
2,369
|
1999p
|
|
J
Lundberg
|
2,343
|
1999p
|
|
D
Mott
|
5,390
|
US$39.47
|
|
D
Smith
|
2,026
|
1999p
|
|
L
Tetrault
|
1,198
|
US$39.47
|
|
A
Zook
|
2,546
|
US$39.47
|
G
H R
Musker
Company
Secretary
27
February
2008
Item
6
Transaction
by Persons Discharging Managerial Responsibilities
Disclosure
Rule DTR 3.1.4
We
hereby inform you
that on 25 February 2008, the following Directors acquired an interest
in the
USD0.25 Ordinary Shares of AstraZeneca PLC. The interest arises as a
result of the previously disclosed arrangements relating to the payment
of
annual bonuses for 2007 whereby each individual is required to defer a
portion
of the bonus earned into shares for a period of three years. The
shares were allocated at a price of 1999 pence per share. The
individuals will become beneficially entitled to these shares on 25 February
2011.
|
Name
|
Number
of
shares
allocated
|
Total
interest
in shares
after
this
allocation
|
Percentage
of
shares
in
issue
|
|
S
Lowth
|
1,340
|
17,744
|
0.001%
|
|
J
S
Patterson
|
7,810
|
139,722
|
0.010%
|
G
H R
Musker
Company
Secretary
27
February
2008
Item
7
AstraZeneca
Provides Update On RECENTINTM Clinical Development
Programme
HORIZON
Colorectal Cancer Programme Continues Into Phase III;
BR24 Non-Small
Cell
Lung Cancer
Trial Will Not Progress
AstraZeneca
today
announced that its HORIZON III Phase II/III head-to-head study of RECENTINTM (cediranib,
AZD2171) with chemotherapy versus bevacizumab (Avastin™)
with chemotherapy in patients
with first line metastatic colorectal cancer (CRC) will be progressing
directly
into Phase III at 20mg. Patients will also continue to be recruited
at 20mg into the first line CRC HORIZON II study of RECENTIN with chemotherapy
versus chemotherapy alone.
The
HORIZON
Independent Data Monitoring Committee (IDMC) conducted a planned end of
Phase II
(EOP II) review of efficacy and tolerability data from HORIZON I, HORIZON
II and
HORIZON III. Data from HORIZON I, in second line colorectal cancer, would
not by
itself have contributed to a positive EOP II decision. However, when combined
with a review of data from HORIZON II and III by the IDMC, the IDMC confirmed
the HORIZON programme in 1st line
CRC could
continue and HORIZON II and III had met pre-defined EOP II
criteria.
AstraZeneca
today
also announced that the National Cancer Institute of Canada Clinical Trials
Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study
of
RECENTIN at 30mg in first line non-small cell lung cancer (NSCLC) will
not
continue into Phase III following the planned end of Phase II efficacy
and
tolerability analysis by the study’s Data Safety Monitoring
Committee. Although evidence of clinical activity was seen, there
appeared to be an imbalance in toxicity and therefore the study was considered
not to have met the pre-defined criteria for automatic continuation into
Phase
III.
AstraZeneca
is
working in close collaboration with the NCIC-CTG to understand the BR24
data
further.
In
addition to colorectal and non-small
cell lung cancer, the RECENTIN
development programme includes trials
in recurrent glioblastoma and a number of signal search studies in
other
tumours.
John
Patterson,
AstraZeneca’s Executive Director for Development, said: “Given there is such a
high unmet patient need for more effective treatments in cancer, we are
pleased
that the HORIZON colorectal cancer programme has met its pre-defined criteria
to
continue recruitment into Phase III. Due to the Phase II/III trial design,
HORIZON III is able to move directly into Phase III utilising all the Phase
II
data and this saves valuable time in assessing the potential benefit of
RECENTIN in the first line
metastatic colorectal cancer setting.
“AstraZeneca
supports the NCIC-CTG’s BR24 recommendation and is working with them to
understand the data more fully in NSCLC. As evidence of clinical activity
was
seen in BR24, AstraZenenca remains committed to investigating the potential
of
RECENTIN in lung cancer and reducing the incidence of serious adverse
events.”
RECENTINTM
is a trademark of
the AstraZeneca group of companies.
27th
February
2008
Notes
To
Editors:
About
the
National Cancer Institute of Canada Clinical Trials Group
The
National Cancer
Institute of Canada Clinical Trials Group (NCIC-CTG), funded by the
Canadian Cancer Society and based at Queen's University in Kingston, Ontario,
Canada, develops, conducts and analyses national and international trials
of
cancer therapy, including trials for new cancer drugs, cancer prevention
and
supportive care to improve quality of life for people with cancer. Since
its
inception in 1971, the NCIC-CTG has enrolled more than 40,000 patients
from
Canada and around the world in over 300 clinical trials.
BR24
Background
NSCLC
accounts for
approximately 80 percent of all cases of lung cancer. Lung cancer is the
most
common cancer in the world with 1.3 million new cases diagnosed every year
and
nearly 1.2 million people dying as a result of the disease
annually.
BR24
is a
collaboration between AstraZeneca and the NCIC-CTG, based at Queen’s University
in Kingston, Ontario. The study is a randomised, double-blind,
placebo-controlled Phase II/III investigation of RECENTIN plus paclitaxel
and
carboplatin versus the chemotherapy arm alone. In the Phase II part of
the
study, patients were recruited from countries including: Argentina, Australia,
Brazil, Canada, Romania and Singapore.
RECENTIN
and
Colorectal Cancer
Colorectal
cancer is
the third most commonly reported cancer worldwide, with around 945,000
new cases
and 492,000 deaths annually.
The
Horizon Study Programme is evaluating RECENTIN in patients with
first
line advanced colorectal cancer:
|
Study
|
Phase
|
|
Design
|
|
Population
|
|
Horizon
III
|
II/III
|
|
Double
blind,
randomised trial of cediranib in combination
with FOLFOX
compared to bevacizumab in combination
with
FOLFOX
|
|
Patients
with first line
metastatic colorectal cancer
|
|
Horizon
II
|
III
|
|
Double
blind,
randomised trial of cediranib plus standard
chemotherapy
compared to standard chemotherapy alone
|
|
Patients
with first line
metastatic colorectal cancer
|
|
Horizon
I
|
II
|
|
Double
blind,
randomised trial of cediranib in combination
with FOLFOX
compared to bevacizumab in combination with FOLFOX
|
|
Patients
with second line
metastatic colorectal cancer
|
RECENTIN:
a potent and selective
VEGF signalling inhibitor
RECENTIN
is a once-daily, orally
available, highly potent and selective VEGF signalling inhibitor that inhibits
all three VEGF receptors.
VEGF
signalling is a
key driver of angiogenesis – the formation of new blood vessels that tumours
need to grow and spread. RECENTIN inhibits this signal
by
binding to the intracellular domain of all three VEGF receptors, in particular
VEGFR-2, the predominant receptor through which VEGF exerts its effects
on
angiogenesis, preventing the growth of new blood vessels. This effectively
“starves” the tumour of the oxygen and nutrients it needs to grow.
Phase
I data
indicate that RECENTIN is
generally well tolerated, with the most common adverse events being diarrhoea,
fatigue, hoarseness, nausea, vomiting, headache, hypertension and hand
foot
syndrome.
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
further
information:
Media
Enquiries:
Neil
McCrae, +44 207 304
5045 (24 hours)
Steve
Brown, +44 207 304
5033 (24 hours)
Chris
Sampson, +44 207 304
5130 (24 hours)
Investor
Enquiries:
Jonathan
Hunt, +44 207 304 5087
Ed
Seage, +1 302 886 4065
Karl
Hard, +44 207 304 5322
Jorgen
Winroth, +1 212 579 0506
Mina
Blair, +44 20 7304 5084
Peter
Vozzo,
(MedImmune) +1 301 398 4358
–
ends
–
Item
8
ASTRAZENECA
PROVIDES AN UPDATE ON THE STATUS OF ITS
ARRANGEMENTS
WITH MERCK & CO., INC.
AstraZeneca
today
announced that, under the provisions of the agreements relating to the
restructuring of the AstraZeneca and Merck & Co. joint venture in the United
States, AstraZeneca has been informed that Merck has elected not to exercise
the
First Option related to the relinquishment of Merck’s rights over the products
not covered by the Partial Retirement (see paragraph below), other than Nexium™
and Prilosec™. As a result of this decision, contingent payments will
continue on the products Atacand™, Lexxel™, Plendil™ and Entocort™ until at
least 2010, at which time AstraZeneca may exercise this option at the 2008
Appraised Value of approximately $650 million. The Appraised Value
also includes rights to certain products that are still in clinical development
(AZD6140, AZD3355, AZD0328 and AZD2327). AstraZeneca made contingent
payments in respect of the products included in the First Option of $69 million
in 2007.
Other
aspects of the
scheduled termination arrangements will proceed as previously
disclosed:
| |
·
|
The
Partial
Retirement of Merck’s limited partnership interest, under which Merck’s
rights in respect of certain products will end. The products
covered by the Partial Retirement include Toprol-XL™, Pulmicort™,
Rhinocort™ and Symbicort™. AstraZeneca made contingent payments
in respect of these products amounting to $182 million in
2007. AstraZeneca will pay Merck approximately $4.27 billion in
respect of the Partial Retirement.
|
| |
|
|
| |
·
|
A
true-up of
the Advance Payment, which was triggered at the time of the merger
between
Astra and Zeneca, under which Merck relinquished all rights, including
contingent payment on future sales, to potential Astra products
with no
existing or pending US patents at the time of the merger, amounting
to a
payment by Merck to AstraZeneca of approximately $0.24 billion,
inclusive
of interest.
|
| |
|
|
| |
·
|
Settlement
of
the loan note receivable by AstraZeneca from Merck, in the amount
of $1.4
billion inclusive of accrued
interest.
|
The
combined effects
of these three items will be a net cash outflow from AstraZeneca to Merck
of
approximately $2.63 billion upon settlement during the first quarter
2008.
Under
the provision
of the agreements a Second Option exists whereby AstraZeneca has the option
to
repurchase Merck’s interests in Prilosec™ and Nexium™ in the US. This
option is exercisable by AstraZeneca in 2012 should AstraZeneca exercise
the
First Option in 2010. Exercise of the second option by AstraZeneca at
a later date is also provided for in 2017 or if combined sales of the two
products fall below a minimum amount provided, in each case, that the First
Option has been exercised. The exercise price for the Second Option
is the net present value of the future annual contingent payments on Prilosec™
and Nexium™ as determined by the average valuation of two appraisers (one
selected by each party) at the time of exercise, which is subject to a potential
true-up mechanism under certain conditions. AstraZeneca made
contingent payments in respect of US sales for Prilosec™ and Nexium™ amounting
to $931 million in 2007.
Further
details on
the accounting treatment of these events from an AstraZeneca perspective
will be
provided in conjunction with the Q1 2008 earnings announcement on 24 April,
2008.
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.
28th
February
2008
For
further
information:
Media
Enquiries:
Neil
McCrae, +44 207 304
5045 (24 hours)
Steve
Brown, +44 207 304
5033 (24 hours)
Chris
Sampson, +44 207 304
5130 (24 hours)
Investor
Enquiries:
Jonathan
Hunt, +44 207 304 5087
Ed
Seage, +1 302 886 4065
Karl
Hard, +44 207 304 5322
Jorgen
Winroth, +1 212 579 0506
Mina
Blair, +44 20 7304 5084
Peter
Vozzo,
(MedImmune) +1 301 398 4358
–
Ends
–
Item
9
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 29 February 2008 the
issued share capital of AstraZeneca PLC with voting rights is 1,457,014,156
ordinary shares of US$0.25. No shares are held in Treasury.
Therefore, the total number of voting rights in AstraZeneca PLC is
1,457,014,156.
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
29
February
2008
Item
10
AstraZeneca
Submits sNDA for SeroquelXR™
for the Treatment of Major Depressive Disorder
AstraZeneca
today
announced submission of a
supplemental New Drug Application (sNDA) to the U.S. Food and Drug
Administration (FDA) for once-daily SEROQUEL XR™
(quetiapine
fumarate) Extended-Release Tablets
to seek approval for the treatment of major depressive disorder (MDD) as
monotherapy, adjunct therapy, and maintenance therapy in adult
patients.
MDD
affects 15 million American adults -
between 5 and 8 percent of the population each year - and today it is often
treated with generic or branded antidepressants. Studies have shown that
at
least one-third of patients with MDD treated with antidepressants fail to
achieve a satisfactory response. The American Psychiatric Association
Practice Guidelines recommend switching to another class when two medications
from the same class have proven ineffective. AstraZeneca has
investigated the use of SEROQUEL XR, an atypical antipsychotic, in the treatment
of MDD, aiming to develop another potential treatment option, including
treatment for patients who have failed or had an inadequate response to another
antidepressant therapy.
The
MDD submission is based on seven
Phase III, placebo-controlled studies that assessed the efficacy and safety
of
once-daily treatment with SEROQUEL XR in patients diagnosed with MDD. Studies
1,
2, 3, and 4 were acute monotherapy studies involving 2,116 patients; Studies
6
and 7 were acute adjunct therapy studies (with ongoing antidepressant therapy)
involving 939 patients who had an inadequate response to an antidepressant
therapy; and Study 5 was a longer-term (up to 78 weeks) monotherapy maintenance
study involving 1,854 patients. The acute studies included in this
submission used the Montgomery-Åsberg Depression Rating Scale (MADRS) as the primary
assessment of
depression symptoms. In the longer term study (Study 5), the primary assessment
was time to a depressed event using criteria including MADRS. Doses of 50
mg,
150 mg and 300 mg of SEROQUEL XR were studied in the MDD programme. Across
the
whole programme, patients entering treatment in these seven clinical studies
were drawn from 27 countries – three-
quarters
of the patients were in North
America – a further 10 percent were in Western Europe, 6 percent in Eastern
Europe and the remainder were in Asia, South America,
South
Africa and Australia.
SEROQUEL XR™
is
approved
in the US and 18 further countries for the treatment of schizophrenia in
adult
patients and for maintenance treatment of schizophrenia in adult
patients. It was launched in the US in 2007 and last month
AstraZeneca announced the submission of two separate sNDAs to the
FDA for
SEROQUEL XR seeking
approval for the treatment of manic episodes associated with bipolar disorder
and the treatment of depressive episodes associated with bipolar disorder
–
these remain under review by the FDA. In addition to the submission for MDD,
the
clinical development programme and planned regulatory filings for Seroquel
XR
extend to generalised anxiety disorder (GAD).
Launched
in 1997,
SEROQUEL®
(quetiapine fumarate) is approved in 88 countries for the treatment of
schizophrenia, in 79 countries for the treatment of bipolar mania, and in
11
countries including the USA for the treatment of bipolar depression. Global sales of Seroquel for
2007 passed
the $4 billion mark for the first time, up 15 per cent on the previous
year.
About
Major
Depressive Disorder
Major
depressive
disorder is a serious medical illness affecting 15 million American adults,
or
approximately 5 to 8 percent of the adult population in a given year. Depression
occurs twice as frequently in women as in men. Unlike normal emotional
experiences of sadness, loss, or passing mood states, major depressive disorder
is persistent and can significantly interfere with an individual’s thoughts,
behaviour, mood, activity, and physical health. Among all medical illnesses,
major depressive disorder is the leading cause of disability in the U.S.
and
many other developed countries.
Symptoms
of major
depressive disorder characteristically represent a significant change from
how a
person functioned before the illness. The symptoms of depression include: persistently
sad or irritable mood; pronounced changes in sleep, appetite, and energy;
difficulty thinking, concentrating, and remembering; physical slowing or
agitation; lack of interest in or pleasure from activities that were once
enjoyed; feelings of guilt, worthlessness, hopelessness, and emptiness;
recurrent
thoughts
of death or
suicide; and persistent physical symptoms for two or more weeks that do not
respond to treatment, such as headaches, digestive disorders, and chronic
pain.
Symptomatically, a major depressive episode in MDD is similar to a depressive
episode of bipolar disorder with the major distinguishing feature between
the
disorders being the absence of manic or hypomanic symptoms in MDD. It has
been
reported that 69 per cent of patients with bipolar disorder were misdiagnosed,
with the most frequent misdiagnosis being MDD.
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 $29.55 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 FTSE4Good Index.
For
more information
about AstraZeneca, please visit: www.astrazeneca.com
29
February 2008
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Enquiries:
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(Wilmington,
US)
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Enquiries:
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Enquiries:
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Hunt, +44 207 304 5087
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Seage, +1 302 886 4065
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Hard, +44 207 304 5322
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Blair, +44 20 7304 5084
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Vozzo,
(MedImmune) +1 301 398 4358
-
Ends -