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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 April 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,
“Transaction by Persons Discharging Managerial Responsibilities Disclosure
Rule DTR 3.1.4”, dated 1 April
2009.
2.
Press release entitled, “ONGLYZA
(Saxagliptin) cardiovascular profile acceptable according to FDA Advisory
Committee”, dated 2 April
2009.
3.
Press release entitled,
“Transaction by Persons Discharging Managerial Responsibilities Disclosure
Rule DTR 3.1.4”, dated 2 April
2009.
4.
Press release entitled, “FDA
Advisory Committee documents for Seroquel XR available on AstraZeneca
website”, dated 3 April
2009.
5.
Press release entitled, “Sale of
AstraZeneca OTC product portfolio cleared by Swedish Competition
Authority”, dated 6 April
2009.
6.
Press release
entitled, “AstraZeneca receives FDA Complete Response Letter on Symbicort
for the treatment of asthma in children 6 to 11 years old”, dated 6 April
2009.
7.
Press release
entitled, “AstraZeneca files suit against Apotex for a declaratory
judgment of infringement against PULMICORT RESPULES patents”, dated 7
April 2009.
8.
Press release
entitled, “FDA Advisory Committee recommendation on Seroquel SR
supplemental new drug applications”, dated 9 April
2009.
9.
Press release
entitled, “Court grants AstraZeneca temporary order against Apotex in
PULMICORT RESPULES patent litigation”, dated 17 April
2009.
10.
Press release
entitled, “IRESSA (gefitinib) recommended for approval for the treatment
of non-small cell lung cancer in Europe”, dated 23 April
2009.
11.
Press release
entitled, “US Food and Drug Administration extends review timeline for
ONGLYZA (Saxagliptin) New Drug Application”, dated 23 April
2009.
12.
Press release entitled,
“AstraZeneca First
Quarter Results 2009”, dated 29 April
2009.
13.
Press release entitled,
“AstraZeneca PLC First Quarter Results 2009” (front half), dated 30 April
2009.
14.
Press release entitled,
“AstraZeneca PLC First Quarter Results 2009 Condensed Consolidated
Statement of Comprehensive Income” (back half), dated 30 April
2009.
15.
Press release entitled,
“AstraZeneca PLC Annual General Meeting : 30 April 2009”, dated 30 April
2009.
16.
Press release entitled,
“Transparency Directive Voting Rights and Capital”, dated 30 April
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: 7 May
2009
By:
/s/ Adrian
Kemp
Name:
Adrian Kemp
Title:
Company
Secretary
Item 1
Transaction
by Persons Discharging Managerial Responsibilities
Disclosure
Rule DTR 3.1.4
We hereby inform
you that on 31 March 2009, the interest of David Smith, 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 March 2006 under the AstraZeneca
Performance Share Plan, whereby, following the application of performance
measures specified at the time of grant, David Smith 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
Smith
14,231
89%
1,565
12,666
5,194
7,472
The market price of
AstraZeneca PLC Ordinary Shares of $0.25 each on 31 March 2009 was 2451
pence.
A
C N Kemp
Company
Secretary
1
April 2009
Item
2
ONGLYZA (SAXAGLIPTIN) CARDIOVASCULAR
PROFILE ACCEPTABLE ACCORDING TO FDA ADVISORY COMMITTEE
AstraZeneca and
Bristol-Myers Squibb today announced that the U.S. Food and Drug
Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee
determined (by a vote of 10 to 2) that the data supporting the new drug
application for ONGLYZA (saxagliptin) for the treatment of adults with type 2
diabetes were sufficient to rule out unacceptable cardiovascular risk relative
to comparators in the programme.
The Advisory
Committee unanimously recommended that the sponsors perform a post-marketing
trial to confirm the cardiovascular profile of ONGLYZA. AstraZeneca and
Bristol-Myers Squibb are working on a series of Phase IIIb and IV studies,
including a large, controlled, randomised post-marketing trial, to further
characterise the long-term clinical effectiveness as well as the cardiovascular
profile of ONGLYZA. The companies will now work with the FDA to finalise the
post-marketing trial design.
“We are encouraged
by the Advisory Committee’s recommendation and look forward to ongoing
discussions with the FDA. AstraZeneca and Bristol-Myers Squibb are committed to
delivering new therapeutic options that offer real benefits to patients and
healthcare providers,” said Howard Hutchinson, Chief Medical Officer,
AstraZeneca.
ONGLYZA is an
investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4
(DPP-4) enzyme. The ONGLYZA application to the FDA includes use as a
monotherapy, as an adjunct to diet and exercise, use in combination with three
types of commonly used oral anti-diabetic (OAD) medications – metformin,
thiazolidinediones and sulfonylureas (SUs) when the single agent alone does not
provide adequate glycemic control, as an adjunct to diet and exercise – and use
in initial combination therapy with metformin, as an adjunct to diet and
exercise.
The Advisory
Committee based its recommendation on review of data from the comprehensive
ONGLYZA clinical development program, which included more than 5,000
individuals, more than 4,000 of whom were given ONGLYZA. Data presented included
safety and efficacy results from six pivotal Phase 3 trials, in addition to
comprehensive post hoc pooled analyses evaluating cardiovascular risk in the
Phase IIb and Phase III studies, which included individuals followed for up to
2.5 years and more than 3,700 person-years of exposure to ONGLYZA. The post hoc
pooled analyses did not show evidence of a cardiovascular safety signal in
individuals taking ONGLYZA.
The FDA is not
bound by the Advisory Committee’s recommendations, but takes its advice into
consideration when reviewing new drug applications. Bristol-Myers Squibb and
AstraZeneca will review the information leading to the Advisory Committee’s
decision and continue to work closely with the FDA to support the review of
ONGLYZA. The new drug application for ONGLYZA was submitted to the FDA on 30
June 2008, and has an action date of 30 April 2009.
ONGLYZA, an
investigational drug under joint development by Bristol-Myers Squibb and
AstraZeneca for the treatment of type 2 diabetes, was specifically designed to
be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual
routes of clearance. ONGLYZA is being studied in ongoing and further planned
clinical trials.
About
DPP-4 Inhibitors
DPP-4 inhibitors
are a class of compounds that work by affecting the action of natural hormones
in the body called incretins. Incretins decrease elevated blood sugar levels
(glucose) by increasing the body’s utilisation of sugar, mainly through
increasing insulin production in the pancreas, and by reducing the liver’s
production of glucose.
Bristol-Myers
Squibb and AstraZeneca partnership
Bristol-Myers
Squibb and AstraZeneca entered into collaboration in January 2007 to enable the
companies to research, develop and commercialise two investigational drugs for
type 2 diabetes – saxagliptin and dapagliflozin. The Bristol-Myers
Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care,
improving patient outcomes and creating a new vision for the treatment of type 2
diabetes.
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
About
Bristol-Myers Squibb
Bristol-Myers
Squibb is a global biopharmaceutical company whose mission is to extend and
enhance human life. For more information visit www.bms.com.
ONGLYZA™ is a
trademark of the Bristol-Myers Squibb Company
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)
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:
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Seage
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4065
mob: +1 302
373 1361
Jorgen
Winroth
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0506
mob: +1 917
612 4043
2
April 2009
- ENDS
-
Item 3
Transaction
by Persons Discharging Managerial Responsibilities
Disclosure
Rule DTR 3.1.4
We hereby inform
you that on 1 April 2009, Mr Jean-Philippe Courtois, a Director of the Company,
notified us that, on 31 March 2009, he purchased 2,135 AstraZeneca PLC USD0.25
Ordinary Shares at a price of 2299 pence per share.
Following this
purchase, Mr Courtois has a total interest in 2,635 shares, which represents
approximately 0.0002% of the issued ordinary capital of the
Company.
A
C N Kemp
Company
Secretary
2
April 2009
Item 4
FDA
ADVISORY COMMITTEE DOCUMENTS FOR SEROQUEL XR AVAILABLE ON ASTRAZENECA WEB
SITE
AstraZeneca is
aware that earlier today, the US Food and Drug Administration (FDA) posted to
its web site - and subsequently removed - briefing documents for the 8 April
2009 Psychopharmacologic Drugs Advisory Committee (PDAC) meeting. The PDAC
meeting is scheduled to discuss the safety and efficacy data provided in
supplemental new drug applications (sNDA) for SEROQUEL XR proposed for the
treatment of major depressive disorder (MDD) and generalized anxiety disorder
(GAD).
AstraZeneca
understands that some people accessed these documents before they were removed
from the FDA site. To ensure that all investors have access to the information
contained in the previously released FDA briefing materials, the company has now
posted these documents, along with the AstraZeneca briefing documents, to its
web site.
A
link can be found on the AstraZeneca homepage at www.astrazeneca.com
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
3
April 2009
- ENDS
-
Item 5
SALE
OF ASTRAZENECA OTC PRODUCT PORTFOLIO CLEARED BY SWEDISH COMPETITION
AUTHORITY
AstraZeneca today
announced that the Competition Authority in Sweden has approved the divestment
to GlaxoSmithKline of a portfolio of over-the-counter (OTC)
products.
Under the
agreement, which was announced in November 2008, AstraZeneca receives SEK 1770
million, approximately $220 million at current exchange rates. The OTC brands,
predominantly sold in Sweden, include analgesics Alvedon and Reliv,
Nezeril/Nasin for decongestion, Minifom for gastrointestinal disorder and
Duroferon for treatment of iron deficiency.
The divestment will
be reflected in "other operating income” in AstraZeneca’s second quarter
accounts.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in the research, development,
manufacturing and marketing of meaningful prescription medicines and supplier
for healthcare services. AstraZeneca is one of the world's leading
pharmaceutical companies with healthcare sales of US$ 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
6
April 2009
- ENDS
-
Item 6
ASTRAZENECA
RECEIVES FDA COMPLETE RESPONSE LETTER ON SYMBICORT FOR THE TREATMENT OF ASTHMA
IN CHILDREN 6 TO 11 YEARS OLD
AstraZeneca today
announced the company has received a Complete Response Letter (CRL) from the US
Food and Drug Administration (FDA) for SYMBICORT (budesonide/formoterol fumarate
dihydrate) pressurized metered dose inhaler (pMDI) for the long-term maintenance treatment
of asthma in pediatric patients ages 6-11 years.
The FDA stated that
AstraZeneca did not provide adequate data to establish the appropriate dose or
doses of the individual components of SYMBICORT – budesonide and formoterol –
and to establish how the individual components contribute to the combination
product, in pediatric patients ages 6-11 years. AstraZeneca is
evaluating the CRL and will provide a response to the Agency in due
course.
SYMBICORT was
approved in the US in July 2006 for the long-term maintenance treatment of
asthma in patients 12 years of age and older and in February 2009 for the
maintenance treatment of airflow obstruction in patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis and
emphysema. The CRL has no impact on the current prescribing information for the
treatment of patients taking SYMBICORT for approved indications in asthma and
COPD.
NOTES
TO EDITORS:
About SYMBICORT
In the US, SYMBICORT is indicated for the long-term maintenance treatment
of asthma in patients 12 years of age and older. Administered twice daily,
SYMBICORT is a combination of two proven respiratory medications – budesonide,
an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting
beta2-agonist (LABA). SYMBICORT 160/4.5 mcg
is also indicated for the maintenance treatment of airflow obstruction in
patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and
emphysema. For patients with COPD, the approved dosage of SYMBICORT is 160/4.5
mcg two inhalations twice daily.
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
ASTRAZENECA
CONTACTS
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
6
April 2009
-ENDS-
Item 7
ASTRAZENECA
FILES SUIT AGAINST APOTEX FOR A DECLARATORY JUDGMENT OF INFRINGEMENT AGAINST
PULMICORT RESPULES PATENTS
AstraZeneca has
filed a lawsuit in the US District Court for the District of New Jersey against
Apotex (Apotex, Inc. and Apotex Corp.) seeking a declaration of patent
infringement. On 30 March 2009, the US FDA granted approval for a generic
version of AstraZeneca's PULMICORT RESPULES (budesonide inhalation suspension)
to Apotex. The lawsuit follows 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.
Additionally,
AstraZeneca has filed a Motion for Interim Relief seeking to prohibit sales of
Apotex’s generic product until the patent infringement case has
concluded. The Court has indicated that it will hear oral arguments
regarding the motion on 16 April 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
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
7
April 2009
- ENDS
-
Item
8
FDA ADVISORY COMMITTEE RECOMMENDATION ON
SEROQUEL XR SUPPLEMENTAL NEW DRUG APPLICATIONS
On 8 April 2009,
the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory
Committee (PDAC) conducted a review of the safety and efficacy of supplemental
new drug applications (sNDA) for SEROQUEL XR (quetiapine fumarate)
extended-release tablets proposed for the treatment of major depressive disorder
(MDD) and generalised anxiety disorder (GAD).
The Advisory
Committee concluded:
·
SEROQUEL XR
was shown to be effective in MDD as both monotherapy and adjunctive
therapy, and shown to be effective in GAD as
monotherapy.
·
SEROQUEL XR
was shown to be acceptably safe as an adjunctive treatment for
MDD.
·
SEROQUEL XR
was not shown to be acceptably safe as a monotherapy for broad treatment
for MDD.
·
The committee
was undecided as to whether SEROQUEL XR was shown to be acceptably safe in
certain instances as a monotherapy treatment for
MDD.
·
SEROQUEL XR
was not shown to be acceptably safe as a monotherapy for the treatment of
GAD.
Howard Hutchinson, M.D., Chief Medical Officer
of AstraZeneca, said: “We
are pleased that the committee found SEROQUEL XR to be effective and
acceptably safe for use as adjunctive therapy for the treatment of MDD. Although
the committee recognised the effectiveness of SEROQUEL XR as monotherapy for MDD
and GAD, they had concerns around the long-term safety profile in these new
populations. We look forward to having further discussions with the FDA
regarding both sNDAs.”
The FDA frequently
convenes advisory committee meetings to obtain independent expert guidance and
recommendations on clinical matters. While the FDA is not required to follow
this guidance, the agency usually takes the advice into consideration when
rendering its final decisions on pending applications and other public health
matters.
SEROQUEL XR is not
approved for the treatment of MDD and GAD.
NOTE
TO EDITORS:
Questions
to the Advisory Committee
Yes
No
Abstain
1. Has
SEROQUEL XR been shown to be effective as a treatment of:
· MDD as an
adjunct therapy?
9
1
0
· MDD as a
monotherapy?
8
1
1
· GAD as a
monotherapy?
7
2
1
2. Has
SEROQUEL XR been shown to be acceptably safe as an adjunctive treatment
for MDD?
6
3
0
3. Has
SEROQUEL XR been shown to be acceptably safe as a treatment
for:
· MDD as a
monotherapy?
0
9
0
· GAD as a
monotherapy?
0
9
0
4. Has
SEROQUEL XR been shown to be acceptably safe in certain instances as a
treatment:
· MDD as a
monotherapy?
4
4
1
· GAD as a
monotherapy?
2
6
1
In
due course the full vote will be available on the FDA web site.
About
SEROQUEL XR and SEROQUEL
SEROQUEL XR, a
once-daily, extended-release tablet formulation of SEROQUEL, was approved in the
U.S. in 2007 for the acute and maintenance treatment of schizophrenia in adult
patients and in October 2008 for the acute treatment of the depressive episodes
associated with bipolar disorder, the manic and mixed episodes associated with
bipolar I disorder, and the maintenance treatment of bipolar I disorder as
adjunctive therapy to lithium or divalproex.
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)
Media
Enquiries US:
Michele
Meeker
+1 302 885
6351
Kirsten
Evraire
+1 302 885
0435
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
9 April
2009
- ENDS
-
Item
9
COURT
GRANTS ASTRAZENECA TEMPORARY RESTRAINING ORDER
AGAINST
APOTEX IN PULMICORT RESPULES PATENT LITIGATION
On
16 April 2009, the US District Court for the District of New Jersey granted
AstraZeneca’s request for a temporary restraining order, barring Apotex (Apotex,
Inc. and Apotex Corp.) from launching a generic version of AstraZeneca’s
PULMICORT RESPULES until further order of the court. On 27 April
2009, the court will commence a hearing to determine whether the injunction
should be continued.
On
30 March 2009, the US FDA granted approval for a generic version of
AstraZeneca's PULMICORT RESPULES (budesonide inhalation suspension) 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)
Media
Inquiries US:
Emily
Denney
+1 302 885
3451
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
17
April 2009
- ENDS
-
Item
10
IRESSA (GEFITINIB) RECOMMENDED FOR
APPROVAL FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER IN EUROPE
AstraZeneca announced today that the
Committee for Medicinal Products for Human Use (CHMP), the scientific advisory
committee of the European Medicines Agency (EMEA), has issued a positive opinion
supporting approval of the targeted oral anti-cancer drug, IRESSA
(gefitinib).
The CHMP has recommended the approval of
IRESSA for adults with locally advanced or metastatic non-small cell lung cancer
(NSCLC) with activating mutations of EGFR-TK (epidermal growth factor
receptor-tyrosine kinase), in all lines of therapy.
IRESSA acts by
inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the
transmission of signals involved in the growth and spread of tumours. A mutation
in the EGFR is a characteristic occurring in 10-15% of lung cancers in Europe,
and studies have shown that these types of tumours are particularly sensitive to
IRESSA. There are approximately 106,000 new cases of advanced lung cancer in
Europe (top 5 countries) per year.
Anders Ekblom,
Executive Vice President for Development at AstraZeneca, said: "Today’s positive
CHMP opinion on IRESSA is an important step towards addressing the great unmet
medical need of lung cancer patients in Europe, and supports AstraZeneca’s
personalised healthcare strategy to develop the right medicine for the right
patient. If IRESSA is approved, for the first time patients with these types of
tumours will have a better alternative to chemotherapy as a first-line
treatment.”
The CHMP opinion is
based on a submission package including two pivotal Phase III studies, IPASS and
INTEREST.
The IPASS study
exceeded its primary objective, demonstrating superior progression-free survival
(PFS, the time a patient lives without their cancer progressing), greater
objective response rate (ORR, tumour shrinkage), improved tolerability and
significant quality of life benefits for IRESSA compared to
carboplatin/paclitaxel doublet chemotherapy in clinically selected first-line
patients in Asia. However, the treatment effect was not constant over time, with
the probability of being progression-free in favour of carboplatin/paclitaxel in
the first 6 months and in favour of IRESSA in the following 16 months. This was
likely due to the different effect of IRESSA in subgroups defined by EGFR tumour
mutation status. PFS was significantly longer for IRESSA than doublet
chemotherapy in patients with EGFR mutation positive tumours, and significantly
longer for doublet chemotherapy than IRESSA in patients with EGFR mutation
negative tumours.
The INTEREST study met its primary
objective, demonstrating equivalent overall survival (OS) and significant
quality of life benefits for IRESSA compared to standard chemotherapy
(docetaxel) in the pre-treated setting. Pre-planned sub-group analyses showed a
significant improvement in PFS and ORR for IRESSA over docetaxel in patients
with EGFR mutation positive tumours.
AstraZeneca will be required to conduct
a Follow-up Measure Study, to generate further data in a Caucasian NSCLC patient
population. AstraZeneca is in discussion with the CHMP to finalise
the study design and endpoints.
The CHMP positive opinion is now
referred for final action to the European Commission, which grants marketing
approval in the European Union.
IRESSA is already an established therapy
for pre-treated NSCLC in the Asia-Pacific region, where AstraZeneca is in
consultation with regulatory authorities to discuss the potential use of IRESSA
in first-line therapy.
NOTES
TO EDITORS:
In 2005,
AstraZeneca withdrew its EU marketing authorisation application for IRESSA
following data from the Phase III international ISEL study in pre-treated
patients not eligible for further chemotherapy. ISEL did not meet its primary
objective of a statistically significant improvement in OS for IRESSA compared
to placebo, but did confirm a number of important clinical benefits for IRESSA
including tumour shrinkage and a significant improvement in time to treatment
failure. The refractory* nature of the ISEL population is the most likely
explanation for the magnitude of the survival improvement with IRESSA compared
to placebo not reaching statistical significance.
* Patients whose tumours had grown
during or soon after receiving prior chemotherapy
Following delivery
of the INTEREST data, AstraZeneca submitted a new regulatory package to the EMEA
in May 2008; the IPASS data were added to the submission package when they
became available in Q3 2008.
There is a rolling
programme of approvals and licence updates for IRESSA around the world in a
broad second-line population based on data from the INTEREST study.
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 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
23
April 2009
- ENDS
-
Item 11
US
FOOD AND DRUG ADMINISTRATION EXTENDS REVIEW TIMELINE
FOR
ONGLYZA (SAXAGLIPTIN) NEW DRUG APPLICATION
AstraZeneca and
Bristol-Myers Squibb reported today that the US Food and Drug Administration
(FDA) has determined it needs additional time to complete the review of the New Drug Application (NDA)
for ONGLYZA (saxagliptin) for the treatment of type 2 diabetes. Accordingly, the
FDA has extended the Prescription Drug User Fee Act (PDUFA) date from 30 April
2009 to 30 July 2009. The
NDA for ONGLYZA was submitted to the FDA on 30 June 2008. The companies continue to work
closely with the FDA to support the review of ONGLYZA.
ONGLYZA is an
investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4
(DPP-4) enzyme under joint development by Bristol-Myers Squibb and AstraZeneca
for the treatment of type 2 diabetes. The ONGLYZA application to the FDA
includes use as a monotherapy, as an adjunct to diet and exercise, use in
combination with three types of commonly used oral anti-diabetic (OAD)
medications - metformin, thiazolidinediones and sulfonylureas (SUs) when the
single agent alone does not provide adequate glycemic control, as an adjunct to
diet and exercise – and use in initial combination therapy with metformin, as an
adjunct to diet and exercise.
Bristol-Myers
Squibb and AstraZeneca Partnership
Bristol-Myers
Squibb and AstraZeneca entered into a collaboration in January 2007 to enable
the companies to research, develop and commercialize two investigational drugs
for type 2 diabetes – ONGLYZA and dapagliflozin. The
Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global
patient care, improving patient outcomes and creating a new vision for the
treatment of type 2 diabetes.
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
About
Bristol-Myers Squibb
Bristol-Myers
Squibb is a global biopharmaceutical company whose mission is to extend and
enhance human life. For more information, visit www.bms.com.
ONGLYZA™ is a
trademark of the Bristol-Myers Squibb Company
CONTACTS:
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:
Jim
Minnick
+1
302-886-5135
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
23
April 2009
- ENDS
-
Item 12
AstraZeneca First Quarter
Results 2009
Tomorrow, Thursday,
30 April 2009, AstraZeneca will release First Quarter Results 2009 at 11:00
BST.
There will be an
analyst teleconference covering the results at 13:00BST for which the numbers
are: UK: 0800 012 1327 for Sweden: 0200 110 487, for US: 1 866 804 8688 and for
International: +44 (0)844 8000 810. These numbers, and
details of the replay facility available through 17:00BST Friday, 15 May 2009,
are available on the Investors section of the AstraZeneca website www.astrazeneca.com.
Item 13
AstraZeneca
PLC
FIRST
QUARTER RESULTS 2009
London,
30 April 2009
Sales
for the first quarter increased by 7 percent at constant exchange rates (CER) to
$7,701 million.
-Crestor sales increased by 35
percent at CER.
-Emerging Markets
sales increased by 15 percent at CER.
-Benefit to US
sales of Toprol-XL from
withdrawal of some generic competitors.
Core
operating profit increased by 19 percent at CER to $3,362 million.
-Core operating
margin improved on sales growth, operational efficiencies, higher other income
from
disposals and
currency benefit.
Core
EPS increased by 20 percent at CER to $1.58.
Reported
EPS increased by 39 percent at CER to $1.48.
-Reported EPS
growth rate affected by higher intangible impairment and restructuring costs
last year.
Progress
on previously announced restructuring programmes on track.
Strong
cash performance; after payment of the second interim dividend of $2,103
million, net debt was reduced by a further $321 million since 31
December.
Core
EPS guidance confirmed; Core EPS target remains $5.15 to $5.45.
On
23 April, the European CHMP recommended approval of Iressa.
-Recommendation is
for adults with locally advanced or metastatic non-small cell lung cancer
with
activating
mutations of EGFR-TK, in all lines of therapy.
Financial Summary
Group
1st
Quarter
2009
$m
1st
Quarter
2008
$m
Actual
%
CER
%
Revenue
7,701
7,677
-
+7
Reported
Operating
Profit
3,163
2,257
+40
+37
Profit
before Tax
3,003
2,143
+40
+36
Earnings
per Share
$1.48
$1.03**
+44
+39
Core*
Operating
Profit
3,362
2,765
+22
+19
Profit
before Tax
3,202
2,651
+21
+17
Earnings
per Share
$1.58
$1.28
+24
+20
*
Core
financial measures are supplemental non-GAAP measures which management
believe useful to understanding the Company’s performance; it is upon
these measures that financial guidance for 2009 is based. See
page 8 for a definition of Core financial measures and a reconciliation of
Core to Reported financial measures.
**
Included
in Reported EPS for Q1 2008 is a ($0.12) charge for impairment of
intangible assets related to Ethyol, a product acquired with
MedImmune, arising from an “at risk” launch of a generic product by Sun
Pharmaceutical Industries, Ltd., prior to the conclusion of ongoing patent
litigation.
David Brennan, Chief
Executive Officer, said: “Our business has proved to be
resilient in the first quarter, the result of excellent execution in driving
growth in key product franchises and in all regions, whilst delivering
improvements in operating efficiency. Our full year target for Core EPS remains
unchanged, reflecting our continued caution about the 2009 outlook for the
pharmaceutical sector in the context of global economic
conditions.”
AstraZeneca
PLC
Business
Highlights All
narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Sales in the first
quarter increased by 7 percent at CER, but were unchanged on an as reported
basis as a result of the negative impact of exchange rate
movements. Sales in the US were up 7 percent compared with the first
quarter 2008 which was affected by higher levels of destocking. Sales
in the US also benefited from increased Toprol-XL franchise sales as
two generic competitors withdrew their products from the
market. Excluding Toprol-XL, US sales increased
by 3 percent. Group sales in the Rest of World were up 7
percent. Sales in Established Markets were up 4
percent. Strong sales growth continued in Emerging Markets; the 15
percent increase in these markets accounted for more than half of Rest of World
sales growth.
Core operating
profit in the first quarter was up 19 percent to $3,362 million, as a result of
sales growth and operational efficiencies together with higher other income
related to proceeds from the agreement returning Abraxane® co-promotion rights
to Abraxis BioScience LLC. Reported operating profit increased by 37
percent to $3,163 million, chiefly as a result of the Ethyol impairment charge and
somewhat higher restructuring costs taken in the first quarter of
2008.
Core earnings per
share in the first quarter were $1.58 compared with $1.28 in the first quarter
2008, a 20 percent increase at CER. Reported earnings per share in
the first quarter were $1.48, up 39 percent compared with the first quarter
2008, in line with the previously identified factors affecting reported
operating profit growth.
Research and Development
Update
A comprehensive
update of the AstraZeneca R&D pipeline was presented in conjunction with the
Full Year 2008 results and the pipeline table remains available on the Company’s
website, www.astrazeneca.com,
under information for investors.
Developments since
the last update include:
Symbicort
On 27 February,
AstraZeneca announced that the US Food and Drug Administration (FDA) has
approved Symbicort for
the twice daily maintenance treatment of airflow obstruction in patients with
chronic obstructive pulmonary disease (COPD), including chronic bronchitis and
emphysema.
On 6 April,
AstraZeneca announced the Company has received a Complete Response Letter (CRL)
from the US Food and Drug Administration (FDA) for Symbicort pressurised metered
dose inhaler (pMDI) for the long-term maintenance treatment of asthma in
paediatric patients ages 6-11 years. The FDA stated that AstraZeneca did not
provide adequate data to establish the appropriate dose or doses of the
individual components of Symbicort – budesonide and
formoterol – and to establish how the individual components contribute to the
combination product, in paediatric patients ages 6-11
years. AstraZeneca is evaluating the CRL and will provide a response
to the Agency in due course.
ONGLYZATM
On 1 April,
AstraZeneca and Bristol-Myers Squibb announced that the FDA’s Endocrinologic and
Metabolic Drugs Advisory Committee determined (by a vote of 10 to 2) that the
data supporting the new drug application for ONGLYZATM
(saxagliptin) for the treatment of adults with type 2 diabetes were sufficient
to rule out unacceptable cardiovascular risk relative to comparators in the
programme.
The Advisory
Committee unanimously recommended that the sponsors perform a post-marketing
trial to confirm the cardiovascular profile of ONGLYZATM.
AstraZeneca and Bristol-Myers Squibb are working on a series of Phase IIIb and
IV studies, including a large, controlled, randomised post-marketing trial, to
further characterise the long-term clinical effectiveness as well as the
cardiovascular profile of ONGLYZATM. The
companies will now work with the FDA to finalise the post-marketing trial
design.
The new drug
application for ONGLYZATM was
submitted to the FDA on 30 June 2008.
On 23 April,
AstraZeneca and Bristol-Myers Squibb reported that the FDA has determined it
needs additional time to complete the review of the New Drug Application (NDA)
for ONGLYZATM for the
treatment of type 2 diabetes. Accordingly, the FDA has extended the Prescription
Drug User Fee Act (PDUFA) date from 30 April 2009 to 30 July
2009. The companies continue to work closely with the FDA to support
the review of ONGLYZATM.
AstraZeneca
PLC
Seroquel
XR
On 8 April 2009,
the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review
of the safety and efficacy of supplemental new drug applications (sNDA) for
Seroquel XR proposed
for the treatment of major depressive disorder (MDD) and generalised anxiety
disorder (GAD).
The FDA frequently
convenes advisory committee meetings to obtain independent expert guidance and
recommendations on clinical matters. While the FDA is not required to
follow this guidance, the agency usually takes the advice into account when
rendering its final decisions on pending applications and other public health
matters.
The Advisory
Committee concluded:
·
Seroquel XR was shown
to be effective in MDD as both monotherapy and adjunctive therapy, and
shown to be effective in GAD as monotherapy.
·
Seroquel XR was shown
to be acceptably safe as an adjunctive treatment for
MDD.
·
Seroquel XR was not
shown to be acceptably safe as a monotherapy for broad treatment for
MDD.
·
The committee
was undecided as to whether Seroquel XR was shown
to be acceptably safe in certain instances as a monotherapy treatment for
MDD.
·
Seroquel XR was not
shown to be acceptably safe as a monotherapy for the treatment of
GAD.
The Company looks
forward to having further discussions with the FDA regarding both
sNDAs.
Crestor
In April, AstraZeneca submitted an sNDA
to the FDA to amend the Crestor label to reflect the significant
reductions in cardiovascular events demonstrated in the landmark JUPITER
clinical trial. Regulatory submissions in Europe are planned for later this
quarter.
Iressa
On 23 April, the
Company announced that the Committee for Medicinal Products for Human Use
(CHMP), the scientific advisory committee of the European Medicines Agency
(EMEA), has issued a positive opinion supporting approval of the targeted oral
anti-cancer drug, Iressa.
The CHMP has
recommended the approval of Iressa for adults with
locally advanced or metastatic non-small cell lung cancer (NSCLC) with
activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine
kinase), in all lines of therapy.
AstraZeneca will be
required to conduct a Follow-up Measure Study, to generate further data in a
Caucasian NSCLC patient population. AstraZeneca is in a discussion
with CHMP to finalise the study design and endpoints.
The CHMP positive opinion is now
referred for final action to the European Commission, which grants marketing
approval in the European Union.
Enhancing
Productivity
In the first
quarter, $72 million in restructuring and synergy costs were charged to the
accounts in relation to previously announced business reshaping programmes
which, when fully implemented, are expected to deliver benefits of $2.1 billion
per annum by the end of 2010, with a further $0.4 billion by 2013.
All programmes
remain on track for costs incurred and benefits achieved.
AstraZeneca
PLC
Future
Prospects
The strong first
quarter sales performance reflects determined execution of our plans combined
with the favourable impact in the US related to the Toprol-XL
market.
Global economic
conditions remain difficult. Management believes that continued
caution is warranted when assessing the potential impact of these conditions on
the pharmaceutical sector and AstraZeneca. For the full year, the
Company confirms that its guidance for Core EPS remains in the range of $5.15 to
$5.45. Actual performance within this range is dependent on the
extent of the impact of the downward pressures from the global
economy.
This Core EPS
guidance has been based on January 2009 average exchange rates for our principal
currencies, and actual first quarter results were broadly in line with this
currency assumption. The target takes no account of the likelihood
that average exchange rates for the remainder of 2009 may differ materially from
the rates upon which our earnings guidance is based. An estimate of
the sales and earnings sensitivity to movements of our major currencies versus
the US dollar was provided in conjunction with the Full Year 2008 results
announcement, and can be found on the AstraZeneca website.
AstraZeneca
PLC
Sales
All
narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Gastrointestinal
First
Quarter
CER
%
2009
$m
2008
$m
Nexium
1,192
1,238
+2
Losec/
Prilosec
211
252
-15
Total
1,427
1,510
-
·
In the US,
Nexium sales in
the first quarter were $705 million, down 4 percent compared with first
quarter last year. Dispensed retail tablet volume increased by
3.6 percent; average realised selling prices were around 9 percent
lower.
·
Nexium sales in other
markets were up 12 percent to $487 million. Sales in Western
Europe increased by 8 percent despite the 35 percent decline in
Germany. Sales in Emerging Markets were up 19 percent,
including good growth in China.
·
Prilosec sales in the
US were down 62 percent in the first quarter following generic entry of
the 40mg dosage form in the second half of 2008.
·
Losec sales in other
markets were down 4 percent, although sales were up 14 percent in Emerging
Markets.
AstraZeneca
PLC
Cardiovascular
First
Quarter
CER
%
2009
$m
2008
$m
Crestor
969
772
+35
Seloken /
Toprol-XL
288
190
+59
Atacand
323
346
+6
Plendil
61
66
-5
Zestril
47
59
-14
Total
1,810
1,571
+24
·
In the US,
Crestor sales in
the first quarter were $478 million, a 35 percent increase over last
year. Crestor total
prescriptions increased by 24 percent, more than 4 times the market growth
rate of 5 percent. Crestor remains the
only branded statin to gain market share; Crestor share of total
prescriptions in the US reached 10.3 percent in March 2009.
·
Crestor sales in Rest
of World were up 34 percent to $491 million. Crestor year-to-date
volume growth was 4 times the market growth rate. Sales in
Canada were up 26 percent. Sales in Established Markets
grew by 34 percent. There was strong growth in Western Europe (up 22
percent), where Crestor volume share is
over 20 percent in France and Italy. Sales in Australia were up
96 percent, and sales in Japan grew by 61 percent. Sales in
Emerging Markets increased by 41 percent. Crestor has become the
market leading statin by value and volume in Mexico.
·
US sales of
the Toprol-XL
product range, which includes sales of the authorised generic, increased
by 175 percent to $176 million. This increase is the result of
the withdrawal of two generic products from the market. It is
difficult to ascertain as to when or if these products will return to the
market or when potential new entrants will be
approved. AstraZeneca is making every effort to increase the
supply of Toprol-XL and the
authorised generic to meet patient needs.
·
Sales of
Seloken in other
markets in the first quarter were up 1 percent. The 14 percent
growth in Emerging Markets more than offset the 26 percent decline in
Western Europe.
·
US sales for
Atacand were down
2 percent in the quarter. Sales in the Rest of World were up 7
percent on broadly equal contribution for Established and Emerging
markets.
AstraZeneca
PLC
Respiratory and
Inflammation
First
Quarter
CER
%
2009
$m
2008
$m
Symbicort
515
471
+24
Pulmicort
292
411
-26
Rhinocort
64
80
-15
Oxis
12
17
-12
Accolate
16
18
-6
Total
935
1,040
-1
·
Symbicort sales in the
US were $99 million, a 125 percent increase over the first quarter last
year, fuelled by continued growth in asthma and the launch of the COPD
indication. Symbicort share of new
prescriptions for fixed combination products increased to 12.8 percent in
March 2009, paced by a market share of patients new to combination therapy
that is now over 20 percent.
·
Symbicort sales in
other markets in the first quarter were $416 million, 13 percent ahead of
last year. Sales in Western Europe were up 12
percent. Emerging Market sales were up 19 percent in the
quarter.
·
US sales for
Pulmicort were
down 37 percent to $173 million. Pulmicort Respules
sales were down 42 percent. The dispensed prescription share
attributable to the Teva generic product was 52 percent in the quarter,
which is lower than expected. As a result, the impact on Pulmicort Respules
sales will likely persist through the second quarter.
·
Sales of
Pulmicort in the
Rest of World were down 3 percent in the quarter, to $119
million.
Oncology
First
Quarter
CER
%
2009
$m
2008
$m
Arimidex
463
430
+14
Casodex
236
316
-27
Zoladex
232
255
-
Iressa
68
58
+10
Faslodex
59
56
+14
Nolvadex
20
18
+6
Ethyol
4
14
-71
Total
1,083
1,165
-3
·
In the US,
sales of Arimidex
were up 20 percent in the first quarter to $219 million. Total
prescriptions for Arimidex were down 3
percent, in line with the market decline of around 2 percent.
·
Arimidex sales
in other markets were up 10 percent to $244 million. Sales in
Western Europe were up 10 percent, whilst sales in Emerging Markets
increased by 21 percent.
·
Casodex sales in the US
were down 18 percent in the first quarter to $54 million. Total
prescriptions were down 5 percent, and there was some destocking in
anticipation of generic entry following loss of market exclusivity in
April.
·
Casodex sales in the
Rest of World were down 29 percent to $182 million. Sales in
Western Europe declined by 58 percent as a result of the generic
competition that began in the third quarter of last year.
·
Iressa sales were up 10
percent to $68 million. Sales in China were up 42 percent and
sales in Japan increased by 12 percent over last year.
·
Faslodex sales were up
4 percent in the US and were up 23 percent in the Rest of
World.
AstraZeneca
PLC
Neuroscience
First
Quarter
CER
%
2009
$m
2008
$m
Seroquel
1,125
1,050
+11
Zomig
101
107
+1
Total
1,432
1,378
+9
·
In the US,
Seroquel sales
were up 14 percent to $800 million. With the indications for
bipolar depression and bipolar mania now launched for Seroquel XR, the
market-leading 31.5 percent share of total prescriptions for
antipsychotics for Seroquel franchise was
broadly unchanged in the quarter. Total prescriptions increased
by 3 percent, with more than 80 percent of this increase attributable to
Seroquel
XR.
·
Seroquel sales in the
Rest of World were up 6 percent despite the 68 percent decline in Canada
due to generic competition, on the strength of a 19 percent increase in
Western Europe.
·
Zomig sales in the US
were down 2 percent to $43 million. Sales in the Rest of World
were up 3 percent to $58 million.
Infection and
Other
First
Quarter
CER
%
2009
$m
2008
$m
Synagis
545
519
+5
Merrem
202
213
+8
FluMist
2
-
n/a
Total
792
787
+5
·
Sales of
Synagis were up 5
percent to $545 million. Sales in the US were $471 million, a 3
percent increase. Sales in the Rest of World increased by 17
percent to $74 million.
Geographic
Sales
First
Quarter
CER
%
2009
$m
2008
$m
North
America
3,891
3,723
+6
US
3,624
3,401
+7
Established
ROW*
2,834
2,973
+4
Emerging
ROW
976
981
+15
*Established
ROW comprises Western Europe (including France, UK, Germany, Italy, Sweden, and
others), Japan, Australia and New
Zealand.
·
In the US,
sales were up 7 percent. Excluding Toprol-XL, sales
increased by 3 percent. Estimated underlying demand growth was
below reported sales growth as a result of higher levels of destocking in
the prior year quarter. Crestor and Symbicort were the key
drivers of underlying demand growth in the quarter, more than offsetting
the sales declines for Pulmicort Respules and
Nexium.
·
Sales in the
Established Rest of World segment were up 4 percent. Sales in
Western Europe were up 2 percent, as growth for Crestor, Seroquel and Symbicort more than
offset the decline in Casodex sales resulting
from generic competition. Sales in Japan were up 10 percent
chiefly on sales growth for Crestor and the
oncology franchise. Crestor was the primary
driver of the 14 percent increase in sales in Australia.
·
Sales in
Emerging Markets were up 15 percent. More than one-third of the
increase is attributable to Crestor and Nexium; the balance
achieved across a broad range of product franchises. Sales in
Emerging Europe were up 16 percent. Sales in China increased by
35 percent in the quarter.
AstraZeneca
PLC
Operating
and Financial Review
All
narrative in this section refers to growth rates at constant exchange rates
(CER) and on a Core basis unless otherwise indicated. These measures
are non-GAAP measures which management believe useful to understanding the
Group’s performance. The Core financial measure is adjusted to
exclude certain items, such as charges and provisions related to restructuring
and synergy programmes, amortisation and the impairment of the significant
intangibles arising from corporate acquisitions and those related to our current
and future exit arrangements with Merck in the US, and other specified
items.
First
Quarter
All
financial figures, except earnings per share, are in $
millions. Weighted average shares in millions.
Reported
2009
Restructuring
and
synergy costs
MedImmune
Amortisation
Intangible
Impairment
Merck
Amortisation
Core
2009
Core
2008
Actual
%
CER
%
Sales
7,701
-
-
-
-
7,701
7,677
-
7
Cost of
Sales
(1,383)
31
-
-
-
(1,352)
(1,470)
Gross
Margin
6,318
31
-
-
-
6,349
6,207
2
8
%
sales
82.0%
82.4%
80.9%
+1.5
+0.9
Distribution
(64)
-
-
-
-
(64)
(66)
(3)
16
%
sales
0.8%
0.8%
0.9%
+0.1
-0.1
R&D
(980)
-
-
-
-
(980)
(1,182)
(17)
-
%
sales
12.7%
12.7%
15.4%
+2.7
+1.0
SG&A
(2,376)
41
76
-
23
(2,236)
(2,345)
(5)
5
%
sales
30.9%
29.1%
30.6%
+1.5
+0.5
Other
income
265
-
28
-
-
293
151
94
111
%
sales
3.4%
3.8%
2.0%
+1.8
+1.9
Operating
Profit
3,163
72
104
-
23
3,362
2,765
22
19
%
sales
41.0%
43.6%
36.0%
+7.6
+4.2
Net finance
expense
(160)
-
-
-
-
(160)
(114)
Profit
before Tax
3,003
72
104
-
23
3,202
2,651
21
17
Taxation
(859)
(21)
(30)
-
-
(910)
(782)
Profit
after Tax
2,144
51
74
-
23
2,292
1,869
23
19
Minority
Interests
2
-
-
-
-
2
(2)
Net
Profit
2,146
51
74
-
23
2,294
1,867
23
19
Weighted
Average Shares
1,447
1,447
1,447
1,447
1,447
1,447
1,457
Earnings
per Share
1.48
0.03
0.05
-
0.02
1.58
1.28
24
20
Sales were
unchanged on a reported basis and grew by 7 percent on a constant currency
basis. Currency movements resulted in a negative impact of 7
percent.
Core gross margin
of 82.4 percent in the first quarter was 0.9 percentage points higher than last
year in constant currency terms. Lower payments to Merck (0.7 percentage points)
and continued efficiency gains and mix factors (1.1 percentage points) were
partially offset by higher royalty payments (0.9 percentage
points).
Core R&D expenditure was $980
million in the first quarter, unchanged from last year in constant currency
terms as increased costs associated with the growing number of later stage
pipeline projects were offset by continued R&D productivity
improvements.
Core SG&A costs
of $2,236 million were 5 percent higher than the first quarter of 2008 as a
result of continued investment in Emerging Markets and the phasing of certain
costs within G&A, partially offset by operational efficiencies.
Core other income
of $293 million was $142 million higher than the first quarter of 2008, chiefly
as a result of the Abraxane® disposal.
Core operating
profit was $3,362 million, an increase of 19 percent at CER, up 22 percent on an
as reported basis. Currency movements increased Core operating profit by 3
percent. In comparison with last year, the dollar was 15 percent stronger
against the euro (reducing sales and costs), 33 percent stronger against the
Swedish krona (reducing costs), and 38 percent stronger against sterling
(reducing costs). On a constant currency basis, Core operating margin
increased by 4.2 percentage points to 43.6 percent of sales, as a result of
sales growth, efficiencies in gross margin, SG&A and R&D, as well as the
Abraxane® disposal within other income.
AstraZeneca
PLC
Core earnings per
share in the first quarter were $1.58, up 20 percent at CER, as the increase in
Core operating profit and the lower tax rate was partially offset by