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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 June
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, “AstraZeneca and Abbott submit New Drug Application to the FDA
for the approval of CERTRIAD for the treatment of mixed dyslipidemia”,
dated 4 June 2009.
2.
Press release
entitled, “Favourable vote from FDA Advisory Committee on Seroquel
paediatric supplemental New Drug Applications”, dated 11 June
2009.
3.
Press release
entitled, “ONGLYZA (saxagliptin) receives positive opinion in Europe for
the treatment of Type 2 diabetes”, dated 26 June
2009.
4.
Press release
entitled, “Transparency Directive Voting Rights and Capital”, dated 30
June 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
July 2009
By:
/s/ Adrian C N
Kemp
Name:
Adrian C N
Kemp
Title:
Company
Secretary
Item
1
ASTRAZENECA AND ABBOTT SUBMIT NEW DRUG
APPLICATION TO THE FDA FOR THE APPROVAL OF CERTRIAD FOR THE TREATMENT OF MIXED
DYSLIPIDEMIA
AstraZeneca and
Abbott announced today that the companies have submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for an investigational
compound for the treatment of mixed dyslipidemia, a combination of two or more
lipid abnormalities including high LDL cholesterol (the “bad” cholesterol), high
triglycerides and low HDL-cholesterol (the “good” cholesterol). The NDA
submission for this investigational compound, containing the active ingredients
of CRESTOR (rosuvastatin
calcium) and TRILIPIX (fenofibric acid), is supported by data from multiple
studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses
of rosuvastatin combined with fenofibric acid. Pending approval of
the NDA, the treatment will be marketed as CERTRIAD.
“This NDA
submission is an important
milestone in the development of CERTRIAD and demonstrates our commitment to
developing treatments for dyslipidemia,” said Howard Hutchinson, Chief
Medical Officer, AstraZeneca. “We look forward to continued
discussions with the FDA about this potential new medicine."
"Patients with
mixed dyslipidemia are an underserved segment of the dyslipidemic population,"
said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical
Development, Abbott. “If approved, CERTRIAD could become an
important treatment option for physicians looking to provide comprehensive management of mixed
dyslipidemia to their patients.”
According to the
American Heart Association, more than 100 million adults in the United States
have dyslipidemia. Of those, approximately 34 million people are
affected by mixed dyslipidemia. Treatment guidelines endorsed by the
National Cholesterol Education Program (NCEP), the American College of
Cardiology and the American Heart Association have called for more aggressive
management of lipids, including a lower LDL goal for many patients, as well as
more aggressive management of HDL and triglycerides.
About
CERTRIAD
CERTRIAD is an
investigational compound under joint development by AstraZeneca and Abbott for
the treatment of mixed dyslipidemia. Phase III data for CERTRIAD have been
presented and evaluate the efficacy and safety of this therapy in improving
HDL-C and triglycerides compared to rosuvastatin monotherapy, and improving
LDL-C compared to fenofibric acid monotherapy in patients with mixed
dyslipidemia.
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
Abbott
Abbott is a global,
broad-based health care company devoted to the discovery, development,
manufacture and marketing of pharmaceuticals and medical products, including
nutritionals, devices and diagnostics. The company employs more than 72,000
people and markets its products in more than 130 countries. Abbott's
news releases and other information are available on the company's Web site at
www.abbott.com.
AstraZeneca
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)
AstraZeneca
Media Enquiries US:
Donna
Huang
+1 302 885
6396
Abbott
Media Enquiries:
Elizabeth
Hoff
+1 847 935
4236
AstraZeneca
Investor Enquiries UK:
Jonathan
Hunt
+44 207 304
5087
mob: +44 7775
704032
Karl
Hard
+44 207 304
5322
mob: +44 7789
654364
AstraZeneca
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
Abbott
Investor Enquiries:
Larry
Peepo
+1 847 935
6722
4
June 2009
- ENDS
-
Item 2
FAVOURABLE
VOTE FROM FDA ADVISORY COMMITTEE ON SEROQUEL PAEDIATRIC SUPPLEMENTAL
NEW
DRUG APPLICATIONS
On 10 June 2009,
the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory
Committee conducted a review of the efficacy and safety of supplemental new drug
applications (sNDAs) for SEROQUEL (quetiapine fumarate) proposed for the acute
treatment of schizophrenia in adolescents (13-17 years of age), and the acute
treatment of bipolar mania in children and adolescents (10-17 years of
age).
The Advisory
Committee voted as follows:
Questions
to the Advisory Committee
Yes
No
Abstain
1. Has
Seroquel been shown to be effective for the treatment of schizophrenia in
paediatric
patients ages
13-17?
17
1
0
2. Has
Seroquel been shown to be acceptably safe for the treatment of
schizophrenia in
paediatric
patients ages 13-17?
16
0
2
3. Has
Seroquel been shown to be effective for the treatment of bipolar mania in
paediatric
patients ages
10-17?
17
0
1
4. Has
Seroquel been shown to be acceptably safe for the treatment of bipolar
mania in paediatric patients ages 10-17?
13
0
5
Howard Hutchinson,
M.D., Chief Medical Officer of AstraZeneca, said: “We are pleased that the committee
found SEROQUEL to be
effective and acceptably safe for treating adolescents with schizophrenia and
children and adolescents with bipolar mania, and we look forward to having
further discussions with the FDA regarding the sNDAs.”
The current approved indications for
SEROQUEL are unchanged. SEROQUEL is not approved for use in
patients under the age of 18 in any country.
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.
ABOUT
SEROQUEL
SEROQUEL was first
approved in the US in 1997 and is currently approved for adults in the treatment
of depressive episodes in bipolar disorder; acute manic episodes in bipolar I
disorder, as either monotherapy or adjunct therapy to lithium or divalproex; for
the maintenance treatment of bipolar I disorder as adjunct therapy to lithium or
divalproex; and for the treatment of schizophrenia. The safety of SEROQUEL has
been evaluated in clinical trials with thousands of adult patients and continues
to be reviewed by the FDA.
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
James
Mead
+44 20 7304
5084
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
June 2009
- ENDS
-
Item
3
ONGLYZA (SAXAGLIPTIN) RECEIVES POSITIVE
OPINION IN EUROPE FOR THE TREATMENT OF TYPE 2
DIABETES
AstraZeneca and
Bristol-Myers Squibb Company have announced that their marketing authorisation
application for ONGLYZA (saxagliptin) received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) for the treatment of type
2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a
sulphonylurea.
The positive
opinion was reached after the CHMP reviewed data from a comprehensive clinical
development programme that included six core Phase III trials assessing the
safety and efficacy of saxagliptin as a once daily therapy. These involved 4,148
patients with type 2 diabetes, including 3,021 patients treated with
saxagliptin.
Saxagliptin belongs
to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to
enhance the body’s ability to decrease blood sugar (glucose) when it is elevated
by acting on the natural hormones, incretins, thereby increasing insulin
production, and by reducing the liver’s production of
glucose.
This application to
the CHMP is for use as a once daily 5mg dose in adult patients with type 2
diabetes mellitus to improve glycaemic control:
·
in
combination with metformin, when metformin alone, with diet and exercise,
does not provide adequate glycaemic control;
·
in
combination with a sulphonylurea, when the sulphonylurea alone, with diet
and exercise, does not provide adequate glycaemic control in patients for
whom use of metformin is considered inappropriate; or
·
in
combination with a thiazolidinedione, when the thiazolidinedione alone,
with diet and exercise, does not provide adequate glycaemic control in
patients for whom use of a thiazolidinedione is considered
appropriate.
The CHMP’s positive
opinion on ONGLYZA will now be reviewed by the European Commission which has the
authority to approve medicines for the European Union. AstraZeneca and
Bristol-Myers Squibb expect the European Commission to issue its decision on a
Marketing Authorisation for this type 2 diabetes investigational drug in the
European Union in the coming months.
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 decreasing glucagon
secretion.
AstraZeneca
and Bristol-Myers Squibb partnership
AstraZeneca and
Bristol-Myers Squibb entered into a collaboration in January 2007 to enable the
companies to research, develop and commercialise two investigational drugs for
type 2 diabetes – saxagliptin and dapagliflozin. The
AstraZeneca/Bristol-
Myers Squibb
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.
ONGLYZA is a
trademark of the Bristol-Myers Squibb Company.
CONTACTS:
AstraZeneca
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)
Bristol-Myers
Squibb Media Enquiries:
Carmel
Hogan
+33 674 107
658
AstraZeneca
Investor Enquiries UK:
Jonathan
Hunt
+44 207 304
5087
mob: +44 7775
704032
AstraZeneca
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
Bristol-Myers
Squibb Investor Enquiries:
John
Elicker
+1 609 252
4611
26
June 2009
- ENDS
-
Item 4
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 30 June 2009 the
issued share capital of AstraZeneca PLC with voting rights is 1,448,032,428
ordinary shares of US$0.25. No shares are held in Treasury.
Therefore, the total number of voting rights in AstraZeneca PLC is
1,448,032,428.
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
30
June 2009
