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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 May 2009
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, “Publication of Annual Report”, dated 7 May
2009.
2.
Press release
entitled, “AstraZeneca announces top line results from pivotal phase III
study for BRILINTA”, dated 11 May 2009.
3.
Press release
entitled, “Transaction by Persons Discharging Managerial Responsibilities
Disclosure Rule DTR 3.1.4”, dated 20 May 2009.
4.
Press release
entitled, “Court grants AstraZeneca preliminary injunction against Apotex
in PULMICORT RESPULES patent litigation”, dated 21 May
2009.
5.
Press release
entitled, “Transaction by Persons Discharging Managerial Responsibilities
Disclosure Rule DTR 3.1.4”, dated 27 May 2009.
6.
Press release
entitled, “AstraZeneca regulatory update on SEROQUEL XR for the treatment
of major depressive disorder”, dated 29 May 2009.
7.
Press release
entitled, “Transparency Directive Voting Rights and Capital”, dated 29 May
2009.
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.
AstraZeneca
PLC
Date: 2 June
2009
By:
/s/ Justin
Hoskins
Name:
Justin
Hoskins
Title:
Deputy
Company Secretary
Item 1
PUBLICATION
OF ANNUAL REPORT
AstraZeneca PLC
announced today that copies of resolutions passed at its Annual General
Meeting on 30 April 2009, other than resolutions concerning ordinary
business, have been filed with the UK Listing Authority in accordance
with Rule 9.6.3 of the Listing Rules and will be available for viewing at the
UKLA document viewing facility at 25 The North Colonnade, Canary Wharf, London
E14 5HS. A copy of the resolutions can also be obtained by writing to
the Company Secretary, AstraZeneca PLC, 15 Stanhope Gate, London W1K
1LN.
A C N
Kemp
Company
Secretary
7 May
2009
Item
2
ASTRAZENECA
ANNOUNCES TOP LINE RESULTS FROM
PIVOTAL
PHASE III STUDY FOR BRILINTA
AstraZeneca
today announced top line results from the phase III trial, PLATO (A Study of
Platelet
Inhibition and Patient Outcomes),
which demonstrate that BRILINTA (ticagrelor), the investigational oral
antiplatelet treatment for acute coronary syndromes (ACS), has achieved a
statistically significant primary efficacy endpoint versus clopidogrel, in the
prevention of cardiovascular (CV) events in patients with ACS. The primary
efficacy measure was time to first occurrence of any event from the composite of
myocardial infarction, stroke, and CV death.
In PLATO, the
overall safety profile for BRILINTA was in line with the safety data observed in
the phase II studies. Given the size of the PLATO trial, further analysis of the
entire database, secondary variables, and subgroups is ongoing. AstraZeneca and
the PLATO Executive Committee’s aim is to submit the PLATO data to a
peer-reviewed medical journal and present at the European Society of Cardiology
(ESC) annual meeting in August 2009.
It is estimated
that one in three ACS patients will die, have a recurrent heart attack (also
known as myocardial infarction), or be readmitted to hospital within six months
of their first cardiovascular event so preventing reoccurrence is vital in ACS
patient treatment.
PLATO was a
head-to-head outcomes study of BRILINTA versus clopidogrel to establish whether
BRILINTA could achieve meaningful cardiovascular and safety endpoints in ACS
patients. The study involved 18,624 ACS patients in 43 countries and
was designed to provide a comprehensive analysis of efficacy, safety and
tolerability of BRILINTA. The
PLATO study was led by the Executive Committee co-chairs, Professor Lars
Wallentin, Sweden (Uppsala Clinical Research Center) and Professor Robert
Harrington, USA (Duke Clinical Research Institute).
The submission of
BRILINTA to regulatory authorities remains on schedule for the fourth quarter of
2009.
Notes
to Editors:
BRILINTA is the
first reversibly binding oral adenosine diphosphate (ADP) receptor antagonist
and is chemically distinct from thienopyridines like clopidogrel. It selectively
inhibits P2Y12,
a key target receptor for ADP. ADP receptor blockade inhibits the action of
platelets in the blood, reducing recurrent thrombotic events.
AstraZeneca has
proposed the name BRILINTA. If approved by the FDA and the EMEA, it will serve
as the trade name for ticagrelor/AZD6140.
BRILINTA is a
trademark of the AstraZeneca group of companies.
The study design of
PLATO was published in the April 2009 edition of the American Heart Journal
(James, S. et al. in Am. Heart J. 2009; 157: 599-605).
BRILINTA Phase II
studies include DISPERSE and DISPERSE2. DISPERSE was published by Husted, S. et
al. in Eur. Heart J. 2006; 27: 1038–1047. DISPERSE2 was published by Cannon,
C.P. et al in J. Am Coll. Cardiol. 2007; 50: 1844-1851 and by Storey, R.F. et al
in J. Am. Coll. Cardiol. 2007; 50: 1852-1856
About
AstraZeneca
AstraZeneca is a major international
healthcare business engaged in the research, development, manufacturing and
marketing of meaningful prescription medicines and supplier for healthcare
services. AstraZeneca is one of the world's leading pharmaceutical companies
with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infectious disease
medicines. For more information about AstraZeneca, please visit:
www.astrazeneca.com
Media
Enquiries UK:
Chris
Sampson
+44 20 7304
5130 (24 hours)
Neil
McCrae
+44 20 7304
5045 (24 hours)
Sarah
Lindgreen
+44 20 7304
5033 (24 hours)
Media
Enquiries US:
Michele
Pelkowski
+1 302 885
4055
mob: +1 610
812 3716
Investor
Enquiries UK:
Jonathan
Hunt
+44 207 304
5087
mob: +44 7775
704032
Karl
Hard
+44 207 304
5322
mob: +44 7789
654364
James
Mead
+44 1625
515290
mob: +44 7825
530018
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
11
May 2009
-
ENDS -
Item 3
Transaction
by Persons Discharging Managerial Responsibilities
Disclosure
Rule DTR 3.1.4
We
hereby inform you that on 19 May 2009, the interest of David Brennan, a person
discharging managerial responsibilities, in AstraZeneca PLC Ordinary Shares of
$0.25 each, changed as detailed below. The change in interest relates
to the vesting of a previously announced award made in May 2006 under the
AstraZeneca Performance Share Plan, whereby, following the application of
performance measures specified at the time of grant, David Brennan has now
become beneficially entitled to a percentage of the shares originally
awarded. In accordance with the plan rules, the unvested part of the
award has immediately and irrevocably lapsed. In addition, sufficient
vested shares were withheld to cover certain tax obligations arising on the
vesting.
Name
Number
of
Shares
Awarded
Vesting
Percentage
Number
of
Shares
Lapsed
Number
of
Shares
Vested
Number
of
Shares
Withheld
Net
Number of
Shares
David
Brennan
19,092
89%
2,100
16,992
6,967
10,025
Mr
Brennan has interests in both the Ordinary Shares and the American Depositary
Shares (ADSs) of AstraZeneca PLC. One ADS equals one Ordinary
Share.
As
a result of this transaction, Mr Brennan’s interest is now 500,921 Ordinary
Shares and 75,883 AstraZeneca ADSs, which together represent approximately 0.04%
of the Company’s issued ordinary capital.
The
market price of AstraZeneca PLC Ordinary Shares of $0.25 each on 19 May 2009 was
2604 pence.
A
C N Kemp
Company
Secretary
20
May 2009
Item 4
COURT GRANTS ASTRAZENECA PRELIMINARY
INJUNCTION AGAINST APOTEX IN PULMICORT RESPULES PATENT
LITIGATION
On 20 May 2009, the
US District Court for the District of New Jersey granted AstraZeneca’s request
for an injunction barring Apotex (Apotex, Inc. and Apotex Corp.) from launching
a generic version of AstraZeneca’s PULMICORT RESPULES (budesonide inhalation
suspension) in the US. No trial date for the patent litigation has
been set.
On 30 March 2009,
the US Food and Drug Administration granted approval for a generic version of
AstraZeneca's PULMICORT RESPULES to Apotex. AstraZeneca then filed
suit following Apotex’s indication of intent to market a generic version of
AstraZeneca’s PULMICORT RESPULES in the US prior to the expiration of
AstraZeneca’s patents.
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 2008 totalled $982 million, about 90 percent of which is accounted for by
PULMICORT RESPULES.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in the research, development,
manufacturing and marketing of meaningful prescription medicines and supplier
for healthcare services. AstraZeneca is one of the world's leading
pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a
leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology
and infectious disease medicines. For more information about
AstraZeneca, please visit: www.astrazeneca.com
Media
Enquiries UK:
Chris
Sampson
+44 20 7304
5130 (24 hours)
Neil
McCrae
+44 207 304
5045 (24 hours)
Sarah
Lindgreen
+44 20 7304
5033 (24 hours)
Investor
Enquiries UK:
Jonathan
Hunt
+44 207 304
5087
mob: +44 7775
704032
Karl
Hard
+44 207 304
5322
mob: +44 7789
654364
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
21
May 2009
-
ENDS -
Item 5
Transaction
by Persons Discharging Managerial Responsibilities
Disclosure
Rule DTR 3.1.4
We hereby inform
you that on 26 May 2009, the interest of Tony Zook, a person discharging
managerial responsibilities, in the shares of AstraZeneca PLC has changed as
detailed below. Tony Zook has interests in the American Depositary
Shares (ADSs) of AstraZeneca PLC. One ADS equals one Ordinary
Share.
The change in
interest relates to a previously announced award made in May 2008 under the
AstraZeneca Restricted Share Plan, whereby, in accordance with the terms of the
award, Tony Zook has now become beneficially entitled to 8,710 of the 34,841
ADSs originally awarded. After certain mandatory tax deductions, Mr
Zook has received 5,017 ADSs into a personal brokerage account.
The market price of
AstraZeneca ADSs on 26 May 2009 was US$41.35.
A
C N Kemp
Company
Secretary
27
May 2009
Item 6
ASTRAZENECA
REGULATORY UPDATE ON SEROQUEL XR
FOR
THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
AstraZeneca today
announced that the company has referred its application for SEROQUEL XR
(quetiapine fumarate) Extended Release Tablets for the treatment of recurrent
depressive episodes in adult patients with major depressive disorder (MDD) to
the Committee for Medicinal Products for Human Use (CHMP; a scientific committee
of the European Medicines Agency, EMEA). This follows notification to
AstraZeneca by the Netherlands Health Authority (MEB), acting as the Reference
Member State for the Mutual Recognition Process (MRP), that the SEROQUEL XR
application for MDD has been refused.
AstraZeneca
believes that results from the clinical trial programme demonstrate that
SEROQUEL XR has potential as a valuable treatment option for patients with MDD.
The proposed indication in the submitted marketing application for SEROQUEL XR
is for the treatment of recurrent depressive episodes in patients with MDD who
are not appropriately managed on alternative antidepressant
treatments.
Also today,
AstraZeneca announced that the Canadian regulators, Health Canada, have approved
SEROQUEL XR for the treatment of adult patients with MDD.
About
CHMP
The CHMP arbitrates
in cases where the product manufacturer believes that further assessment of the
file is required in the event of a non-approval via the MRP. The
assessments conducted are based on scientific criteria to determine whether or
not a product meets the necessary quality, safety and efficacy requirements to
provide a positive risk-benefit profile of that product once it reaches the
marketplace.
The company
submitted the application for SEROQUEL XR to the regulatory authority in the
Netherlands as part of the Mutual Recognition Procedure in June 2008 seeking
approval for the treatment of major depressive disorder (MDD) including
maintenance therapy.
Both SEROQUEL and
SEROQUEL XR are approved in Europe for the treatment of bipolar disorder and
schizophrenia, and this decision by AstraZeneca does not change any current
recommendations for the treatment of patients taking SEROQUEL or SEROQUEL XR for
approved indications.
About
SEROQUEL XR and SEROQUEL
SEROQUEL XR has
been approved in 53 countries for schizophrenia, 19 countries for bipolar mania,
in 20 countries for bipolar depression, in nine markets for bipolar maintenance,
in one market for Generalised Anxiety Disorder (GAD), and in two markets for
Major Depressive Disorder (MDD), with Canada receiving approval in May
2009.
Launched in 1997,
SEROQUEL has been approved in 94 countries for schizophrenia, 92 countries for
bipolar mania, in 41 countries for bipolar depression and in 6 countries for
bipolar maintenance.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in the research, development,
manufacturing and marketing of meaningful prescription medicines and supplier
for healthcare services. AstraZeneca is one of the world's leading
pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a
leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology
and infectious disease medicines. For more information about
AstraZeneca, please visit: www.astrazeneca.com
CONTACTS:
Media
Enquiries:
Neil
McCrae
+44 207 304
5045 (24 hours)
Chris
Sampson
+44 20 7304
5130 (24 hours)
Sarah
Lindgreen
+44 20 7304
5033 (24 hours)
Investor
Enquiries UK:
Jonathan
Hunt
+44 207 304
5087
mob: +44 7775
704032
Karl
Hard
+44 207 304
5322
mob: +44 7789
654364
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
29
May 2009
ENDS
Item 7
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 May 2009 the
issued share capital of AstraZeneca PLC with voting rights is 1,447,842,830
ordinary shares of US$0.25. No shares are held in Treasury.
Therefore, the total number of voting rights in AstraZeneca PLC is
1,447,842,830.
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.
A
C N Kemp
Company
Secretary
29
May 2009
