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 December 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, “PN 400
Phase III studies show clinically meaningful benefit in reducing gastric
ulcers compared to enteric-coated naproxen”, dated 3 December
2008.
|
2.
|
Press release entitled,
“AstraZeneca and Bristol-Myers Squibb announce expansion of worldwide
collaboration to develop and commercialise Dapagliflozin in Japan”, dated 8 December
2008.
|
3.
|
Press release entitled,
“AstraZeneca and Targacept announce top-line results from Phase Ilb study
of AZD3480 in cognitive dysfunction in schizophrenia”, dated 8 December
2008.
|
4.
|
Press release entitled,
“AstraZeneca returns worldwide rights to IPI-504 and IPI-493 development
programs to infinity pharmaceuticals”, dated 11 December
2008.
|
5.
|
Press release entitled,
“AstraZeneca responds to FDA Joint Advisory Committees’ recommendation on
SYMBICORT”, dated 12 December
2008.
|
6.
|
Press release
entitled, “AstraZeneca and MAP Pharmaceuticals announce worldwide
collaboration to develop and commercialise Unit Dose Budesonide”, dated 19
December 2008.
|
7.
|
Press release
entitled, “AstraZeneca receives FDA Complete Response Letter on SEROQUEL
XR for Major Depressive Disorder”, dated 24 December
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.
|
AstraZeneca
PLC |
|
|
|
|
Date: 9 January
2009
|
By: /s/ Justin
Hoskins
|
|
Name: Justin
Hoskins
|
|
Title: Deputy Company
Secretary
|
Item 1
PN
400 PHASE III STUDIES SHOW CLINICALLY MEANINGFUL BENEFIT IN REDUCING GASTRIC
ULCERS COMPARED TO ENTERIC-COATED NAPROXEN
AstraZeneca and
POZEN Inc., co-development partner for the investigational compound PN 400, have
announced today results from two Phase III studies, PN 400-301 and PN 400-302
comparing PN 400 (enteric-coated naproxen 500 mg and immediate release
esomeprazole 20 mg) to enteric-coated naproxen 500 mg. These studies were
conducted by POZEN under an agreed Special Protocol Assessment (SPA) with the
FDA.
The PN 400-301 and
PN 400-302 studies both achieved the primary endpoints. Subjects taking PN 400
experienced statistically significantly fewer endoscopically confirmed gastric
ulcers than those taking naproxen. In each of the trials, approximately 400
subjects received either PN 400 or enteric-coated naproxen 500 mg, twice daily,
over a six-month treatment period. Subjects underwent upper
endoscopies at baseline and at one, three, and six months. The
primary endpoint was the cumulative incidence of gastric ulcers. Full results of
the PN 400-301 and PN-400 302 will be published in a timely manner.
The Food and Drug
Administration (FDA) has recently informed POZEN that they are conducting an
internal review on the acceptability of using endoscopic gastric ulcers as a
primary endpoint in clinical studies. The FDA has not indicated when
their internal review will be completed, although the FDA has scheduled an FDA
internal meeting to review this subject during the first quarter of
2009.
Two additional Phase
III studies, PN-400-307 and PN 400-309, are still ongoing. Upon
completion of the entire PN 400 Phase III clinical programme, AstraZeneca will
make a final determination regarding regulatory filing, which is planned for
mid-2009.
About
PN 400
PN 400 is an
investigational compound under co-development by AstraZeneca and POZEN, Inc.
that combines the pain reliever naproxen (an NSAID) with esomeprazole – a proton
pump inhibitor (PPI), for the treatment of osteoarthritis, rheumatoid arthritis,
and ankylosing spondylitis in patients who are at risk of developing gastric
ulcers.
Osteoarthritis is
one of the most frequent causes of physical disability among adults; with an
estimated 46 million adults in the US have physician-diagnosed arthritis,
accounting for 21 percent of the US adult population. Two thirds of the people
that have doctor-diagnosed arthritis are under the age of 65.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information visit www.astrazeneca.com
Media
Enquiries:
|
|
|
Chris
Sampson
|
+44 20 7304
5130 (24 hours)
|
|
Neil
McCrae
|
+44 207 304
5045 (24 hours)
|
|
|
|
|
Investor
Enquiries UK:
|
|
|
Jonathan
Hunt
|
+44 207 304
5087
|
mob: +44 7775
704032
|
Mina
Blair
|
+44 20 7304
5084
|
mob: +44 7718
581021
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
654364
|
|
|
|
Investor
Enquiries US:
|
|
|
Ed
Seage
|
+1 302 886
4065
|
mob: +1 302
373 1361
|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
3 December
2008
-
ENDS -
Item 2
ASTRAZENECA
AND BRISTOL-MYERS SQUIBB ANNOUNCE EXPANSION OF WORLDWIDE COLLABORATION TO
DEVELOP AND COMMERCIALISE DAPAGLIFLOZIN IN JAPAN
AstraZeneca and
Bristol-Myers Squibb today announced expansion of their worldwide collaboration
to include the development and commercialisation of dapagliflozin in
Japan. Dapagliflozin, one of two investigational drugs under joint
development by the companies, is currently being studied in Phase III clinical
trials in several countries, including the U.S., to assess its efficacy and
safety as a once-daily treatment for type 2 diabetes.
In January 2007,
Bristol-Myers Squibb and AstraZeneca entered into a global collaboration,
excluding Japan, to enable the companies to research, develop and commercialise
dapagliflozin. The companies now have agreed to co-develop dapagliflozin in
Japan with AstraZeneca having operational and cost responsibility for all
development and regulatory activities on behalf of the
collaboration. The two companies will jointly market the product in
Japan, sharing all commercialisation expenses and activities and splitting
profits/losses equally. Bristol-Myers Squibb will manufacture dapagliflozin and
also book sales. Dapagliflozin is currently being studied in Phase II clinical
trials in Japan.
“Bristol-Myers
Squibb and AstraZeneca have been working together to develop dapagliflozin for
type 2 diabetes for nearly two years – this inclusion of Japan was a natural
progression of our collaboration and an important strategic step in our
relationship,” said Lamberto Andreotti, Executive Vice President and Chief
Operating Officer,
Bristol-Myers Squibb. “Our companies have a shared vision for these diabetes
treatments, and this agreement will help ensure we can successfully launch and
maximize the potential of dapagliflozin for the more than 6 million people in
Japan living with type 2 diabetes.”
“Last year, the cost
of treating and preventing type 2 diabetes and its complications in Japan was
more than USD 18.4 billion, which is a significant cost to Japanese society,”
said Bruno Angelici, Executive Vice
President, International Sales and Marketing Organisation, AstraZeneca. “We have
a long-standing presence in Japan, and our agreement with Bristol-Myers Squibb
to bring a potentially important type 2 diabetes treatment to market in the
region will not only help reduce this cost burden, but also reduce the impact
this disease has on the country’s health.”
About
Dapagliflozin
Dapagliflozin was
specifically designed to be a novel, selective inhibitor of sodium glucose
cotransporter 2 (SGLT2), which regulates the reabsorption of glucose in the
kidney. It has a C-glucoside chemical structure, which prolongs the
pharmacokinetic half-life and duration of action. Dapagliflozin is
metabolized through the liver and excreted in the urine. Phase IIB data for
Dapagliflozin were presented at the 2008 American Diabetes Association Annual
Meeting and the 2008 European Association for the Study of Diabetes Annual
Meeting.
About
ONGLYZA™ (saxagliptin)
In addition to the
companies collaboration on dapagliflozin, Bristol-Myers Squibb and AstraZeneca
have been working together to develop another potential treatment for type 2
diabetes -- ONGLYZA™ (saxagliptin) -- globally, excluding Japan.
ONGLYZA, the
proposed tradename for saxagliptin, is an investigational DPP-4 inhibitor being
studied in clinical trials as a once-daily therapy to determine its efficacy and
safety. Saxagliptin was specifically designed to be a selective inhibitor with
extended binding to the DPP-4 enzyme, with dual routes of clearance. The
companies submitted a New Drug Application to the U.S. Food & Drug
Administration (FDA) on June 30, which has been officially filed by the FDA, and
a Marketing Authorisation Application to the European Medicines Agency (EMEA) on
July 1, which has been accepted for review by the Agency. The name
ONGLYZA, if approved by the FDA and the EMEA, will serve as the trade name for
saxagliptin.
Saxagliptin Phase
III data have previously been presented as a monotherapy, as well as in
combination with metformin, sulfonylureas and thiazolidinediones, commonly
prescribed oral anti-diabetic medications. The overall clinical development
program included over 5,000 individuals -- more than 4,000 of whom were given
saxagliptin. The worldwide collaboration for the development and
commercialisation of saxagliptin will continue to exclude Japan. On
December 27, 2006, Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.
announced an exclusive licensing agreement for saxagliptin in
Japan.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com
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.
Media
Enquiries:
|
|
|
Tracy Furey,
Bristol-Myers Squibb, 609-252-3208, tracy.furey@bms.com
|
Jim Minnick,
AstraZeneca, 302-866-5135, jim.minnick@astrazeneca.com
|
|
|
|
Investor
Enquiries:
|
|
|
John Elicker,
Bristol-Myers Squibb, 212-546-3775,
john.elicker@bms.com
|
Mina Blair,
AstraZeneca, 44-20-7304-5084,
mina.blair@astrazeneca.com
|
8
December 2008
-
Ends -
Item 3
ASTRAZENECA
AND TARGACEPT ANNOUNCE TOP-LINE RESULTS FROM PHASE IIb STUDY OF AZD3480 IN
COGNITIVE DYSFUNCTION IN SCHIZOPHRENIA
AstraZeneca and
Targacept, Inc. today announced top-line results from a Phase IIb clinical trial
of AZD3480 (TC-1734) conducted by AstraZeneca in cognitive dysfunction in
schizophrenia (CDS), known as the HALO trial.
AZD3480 did not meet
the trial’s criteria for statistical significance on the primary
outcome endpoints, improvement on various cognitive domains measured
by the IntegNeuro computerized test battery. AZD3480 was generally well
tolerated in the study. AstraZeneca and Targacept do not expect to
progress AZD3480 into Phase III studies for CDS.
In addition to the
HALO trial, AstraZeneca and Targacept previously announced top-line results from
a Phase IIb study of AZD3480 in mild to moderate Alzheimer's disease, known as
the Sirocco trial and are currently evaluating AZD3480 in a Phase II exploratory
study in attention deficit/hyperactivity disorder (ADHD) in adults. A
decision by AstraZeneca with respect to potential further development of AZD3480
in Alzheimer’s disease or ADHD is now expected in the first half of 2009,
pending completion of the adult ADHD study and other ongoing
evaluations.
“While this trial
outcome did not meet our objectives, we continue to pursue medicines that target
neuronal nicotinic receptors (NNRs) with Targacept to treat cognitive
disorders,” said Bob Holland, Vice President and Head of the Neuroscience
Therapy Area, AstraZeneca.
AstraZeneca and
Targacept also announced that the lead compound arising out of the parties’
preclinical research collaboration is poised to enter the clinic. AstraZeneca
plans by the end of 2008 to initiate a Phase I trial of AZD1446 (TC-6683), a
product candidate selective for the alpha4beta2 NNR. Under the terms
of the parties’ collaboration agreement, AstraZeneca has agreed to make a $2.0
million milestone payment to Targacept.
“We are obviously
disappointed that AZD3480 did not meet our goals in the HALO trial,” commented
J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept.
“We thank AstraZeneca for its commitment to AZD3480 and its investment in this
pioneering work in an emerging area considered to be critical in the treatment
of patients with schizophrenia. We look forward to continuing our
cognition-focused collaboration with AstraZeneca.”
Study
Design
The Phase IIb HALO
trial was conducted by AstraZeneca under the terms of an exclusive global
license and research collaboration agreement. The trial was a multi-center,
randomized, double blind, placebo controlled, dose-finding study conducted at
approximately 70 enrolling sites in the United States and
Canada. Subjects (n = 445) between 18 and 55 years of age who were
active smokers and taking medication from the class of drugs known as atypical
anti-psychotics were randomly assigned to one of three dose groups of AZD3480 or
to placebo and dosed over a 12-week period. The primary outcome
measures of the trial were change from baseline after 12
weeks on various domains of cognition as measured by the IntegNeuro computerized
test battery.
About
Cognitive Dysfunction in Schizophrenia
Schizophrenia is a
chronic, severe and disabling form of psychosis that, in addition to symptoms
such as delusions and hallucinations, is often marked by impairments in
cognitive functions such as attention, vigilance, memory and
reasoning. These cognitive impairments play a primary role in the
inability of schizophrenic patients to function normally. It has been estimated
that there are 7.9 million schizophrenic patients in the world’s seven major
pharmaceutical markets and that the majority of all schizophrenic patients are
cognitively impaired.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information
visit www.astrazeneca.com
About
Targacept
Targacept is a
clinical-stage biopharmaceutical company that discovers and develops NNR
Therapeutics (TM), a new class of drugs for the treatment of central nervous
system diseases and disorders. Targacept’s product candidates selectively
modulate neuronal nicotinic receptors that serve as key regulators of the
nervous system to promote therapeutic effects and limit adverse side effects.
Targacept has product candidates in development for Alzheimer’s disease,
cognitive dysfunction in schizophrenia, pain and depression, as well as multiple
preclinical programs. Targacept also has a cognition-focused collaboration with
AstraZeneca and a strategic alliance with GlaxoSmithKline. Targacept's news
releases are available on its website at www.targacept.com
Contacts
AstraZeneca:
Media
Enquiries US:
|
|
|
Jamie
Smith
|
+1 302 885
5725
|
|
|
|
|
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
|
Mina
Blair
|
+44 20 7304
5084
|
mob: +44 7718
581021
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
654364
|
|
|
|
Investor
Enquiries US:
|
|
|
Ed
Seage
|
+1 302 886
4065
|
mob: +1 302
373 1361
|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
Targacept:
Alan Musso, VP and
CFO, Targacept, Inc.
Tel: (336)
480-2186
Email:
alan.musso@targacept.com
Michelle Linn,
Linnden Communications
Tel: (508)
362-3087
Email:
linnmich@comcast.net
8 December
2008
- ENDS
-
Item 4
ASTRAZENECA
RETURNS WORLDWIDE RIGHTS TO IPI-504 AND IPI-493 DEVELOPMENT PROGRAMS TO INFINITY
PHARMACEUTICALS
AstraZeneca today
announced that it has returned worldwide rights to Infinity Pharmaceuticals for
the development and commercialisation of Infinity’s heat shock protein 90
(Hsp90) drug candidates IPI-504 (MEDI-561) and IPI-493, in development for the
treatment of cancer and related conditions.
The collaboration,
initiated in August 2006 between MedImmune and Infinity, was transferred to
AstraZeneca following its acquisition of MedImmune in June 2007.
After reviewing the potential
opportunity for these projects within its portfolio and considering competing
R&D investment priorities, AstraZeneca has decided to return the
responsibility for development and commercialisation of this program to
Infinity.
Infinity is fully
committed to targeting Hsp90 as a potential new treatment approach to cancer,
and to developing both IPI-504 and IPI-493. In particular, Infinity initiated a
late stage trial of IPI-504 in patients with refractory gastrointestinal stromal
tumors (GIST), a rare tumor of the gastrointestinal tract. IPI-504
and IPI-493 are in additional late- and early-stage ongoing clinical
trials.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com
Media
Enquiries:
|
|
|
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
|
Mina
Blair
|
+44 20 7304
5084
|
mob: +44 7718
581021
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
654364
|
|
|
|
Investor
Enquiries US:
|
|
|
Ed
Seage
|
+1 302 886
4065
|
mob: +1 302
373 1361
|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
11
December 2008
-
ENDS -
Item
5
ASTRAZENECA RESPONDS TO FDA JOINT
ADVISORY COMMITTEES’ RECOMMENDATION ON SYMBICORT
On 11 December 2008,
the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) –
including the Drug Safety & Risk Management Advisory Committee, the
Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee
– completed a review of the benefits and risks of asthma medications containing
long-acting beta-agonists (LABAs). The committees concluded that the benefits of
AstraZeneca’s SYMBICORT (budesonide/formoterol fumarate dihydrate), a
combination LABA/Inhaled Corticosteroid (ICS) medication, outweigh the risks in
adult and adolescent asthma patients.
Howard Hutchinson,
M.D., Chief Medical Officer of AstraZeneca, said: “The safety and efficacy of
SYMBICORT have been demonstrated in numerous clinical trials and from extensive
post-marketing use around the world. We are pleased that the joint advisory
committees’ recommendation confirms our view on the positive benefit-risk
profile of SYMBICORT.”
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 SYMBICORT outside the U.S.
SYMBICORT
(budesonide/formoterol fumarate dihydrate) is a combination of two proven
medications – budesonide, an inhaled corticosteroid (ICS), and formoterol, a
rapid and long-acting beta2-agonist (LABA). SYMBICORT is
approved in over 100 countries for the long-term maintenance treatment of asthma
and is available in two different inhalers, SYMBICORT TURBUHALER and SYMBICORT
pMDI.
SYMBICORT TURBUHALER is a combination
therapy indicated for the long-term maintenance treatment of paediatric and
adult asthma patients who cannot be adequately controlled on other medications
such as inhaled corticosteroids. SYMBICORT should not be used in
patients whose asthma can be successfully managed by inhaled corticosteroids
along with occasional use of inhaled short-acting beta2-agonists.
SYMBICORT TURBUHALER is also indicated
for use in patients with Chronic Obstructive Pulmonary Disease (COPD) in 88
countries.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information visit www.astrazeneca.com
Media
Enquiries UK:
|
|
|
Neil
McCrae
|
+44 207 304
5045 (24 hours)
|
|
Chris
Sampson
|
+44 20 7304
5130 (24 hours)
|
|
Sarah
Lindgreen
|
+44 20 7304
5033 (24 hours)
|
|
|
|
|
Media
Enquiries US:
|
|
|
Michele
Meeker
|
+1
610-662-3589 (24 hours)
|
|
|
|
|
Investor
Enquiries UK:
|
|
|
Jonathan
Hunt
|
+44 207 304
5087
|
mob: +44 7775
704032
|
Mina
Blair
|
+44 20 7304
5084
|
mob: +44 7718
581021
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
654364
|
|
|
|
Investor
Enquiries US:
|
|
|
Ed
Seage
|
+1 302 886
4065
|
mob: +1 302
373 1361
|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
12
December 2008
-
ENDS -
Item 6
ASTRAZENECA
AND MAP PHARMACEUTICALS ANNOUNCE WORLDWIDE COLLABORATION TO DEVELOP AND
COMMERCIALISE UNIT DOSE BUDESONIDE
AstraZeneca and MAP Pharmaceuticals,
Inc. announced today an exclusive worldwide agreement to develop and
commercialise Unit Dose Budesonide (UDB), MAP Pharmaceuticals’ proprietary
nebulised formulation of budesonide. UDB is being developed by MAP
Pharmaceuticals as a potential treatment for paediatric asthma and is currently
in Phase III clinical development. UDB has the potential to be nebulised more
quickly and at a lower nominal dose than the commercially available
product.
Under the terms of
the agreement, AstraZeneca will pay MAP Pharmaceuticals an upfront cash payment
of $40 million and an additional $35 million upon the successful achievement of
primary endpoint and safety results in the currently ongoing Phase III clinical
study. In addition, upon the occurrence of certain events and conditions, MAP
Pharmaceuticals is eligible to receive up to $240 million in other potential
development and regulatory milestones. The Agreement also provides
for additional progressively demanding sales performance-related milestone
payments of up to $585 million in the event the product is a considerable
commercial success. This agreement is subject to review by the United States
Government under the Hart-Scott-Rodino Act and becomes effective after the
expiration or earlier termination of the waiting period (or any extension
thereof).
AstraZeneca also
will support and fund the establishment of a MAP Pharmaceuticals sales force to
co-promote UDB in the United States for a certain period of time after product
launch. MAP Pharmaceuticals is also eligible to receive significant
double-digit royalty payments on net sales of UDB worldwide.
MAP Pharmaceuticals
and AstraZeneca will develop UDB in the United States and AstraZeneca has rights
to develop and commercialise UDB outside of the United States. Under
the agreement, AstraZeneca will be responsible for future UDB development costs
and AstraZeneca will reimburse MAP Pharmaceuticals for the costs of future UDB
development activities with respect to United States registration incurred by
MAP Pharmaceuticals.
David Brennan, Chief
Executive Officer of AstraZeneca said, “MAP Pharmaceuticals’ advancement in Unit
Dose Budesonide represents an important potential new option for treating
children confronting asthma. AstraZeneca’s heritage in treating
paediatric asthma, combined with MAP Pharmaceuticals’ expertise can open new
areas of opportunity for both companies and has the potential to bring
significant medical benefit to the wider community.”
“AstraZeneca is an
ideal partner for UDB given their extensive expertise in developing and
commercialising respiratory therapies, including for paediatric asthma,” said
Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals.
“We recognise AstraZeneca’s leadership position in this therapeutic area and
their potential to help MAP Pharmaceuticals achieve its key objective of
reaching the broadest set of children who suffer from asthma. This relationship
represents an important step in the evolution of our company, as we leverage our
partner’s significant expertise and resources to help us build a commercial
infrastructure for subsequent product launches. In addition,
this transaction greatly
strengthens our balance sheet and provides us with additional financial
resources moving forward.”
UDB is being
developed utilising a license to Elan's proprietary NanoCrystal®
Technology. The small size and stability of NanoCrystal® drug
particles are designed to enable improved delivery efficiency of drug
formulations to the lung via nebulisation.
About UDB
UDB is being studied as a novel version
of nebulised budesonide. Budesonide has been used clinically for more than 20
years. UDB is designed to be nebulised more quickly at a lower
nominal dose than the commercially available product. MAP
Pharmaceuticals has completed enrolment and randomised approximately 360
patients in a Phase III clinical trial to evaluate UDB for the potential
treatment of paediatric asthma. The last patient in this trial is expected to
complete the 12-week treatment period by the end of 2008. The safety
data generated to date has shown UDB to be well tolerated with no significant
adverse events.
About AstraZeneca
AstraZeneca is a major international
healthcare business engaged in research, development, manufacturing and
marketing of prescription pharmaceuticals and supplier for healthcare services.
AstraZeneca is one of the world's leading pharmaceutical companies with
healthcare sales of US $29.55 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infection product sales.
AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as
the FTSE4Good Index. For more information visit www.astrazeneca.com
About MAP
Pharmaceuticals
MAP Pharmaceuticals, Inc. develops and
plans to commercialise new therapies for children and adults who suffer from
chronic conditions that it believes are not adequately treated by currently
available medicines. The company applies its proprietary inhalation technologies
to enhance the therapeutic benefits and commercial attractiveness of proven
drugs while minimising risk by capitalising on their known safety, efficacy and
commercialization history. MAP Pharmaceuticals has two drug candidates in Phase
III clinical trials. Unit Dose Budesonide is being developed for the potential
treatment of paediatric asthma, and MAP0004 is being developed for the potential
treatment of migraine. MAP Pharmaceuticals' pipeline also includes a drug
candidate in early clinical development for the treatment of asthma and chronic
obstructive pulmonary disease. Additional information about MAP
Pharmaceuticals can be found at http://www.mappharma.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)
|
|
|
|
|
Media
Enquiries US:
|
|
|
Emily
Denney
|
+1 302 885
3451
|
mob: +1 302
897 4953
|
|
|
|
Investor
Enquiries UK:
|
|
|
Jonathan
Hunt
|
+44 207 304
5087
|
mob: +44 7775
704032
|
Mina
Blair
|
+44 20 7304
5084
|
mob: +44 7718
581021
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
654364
|
|
|
|
Investor
Enquiries US:
|
|
|
Ed
Seage
|
+1 302 886
4065
|
mob: +1 302
373 1361
|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
Peter Vozzo
(MedImmune)
|
+1 301 398
4358
|
mob: +1 301
252 7518
|
|
|
|
MAP
PHARMACEUTICALS CONTACTS
Christopher Y.
Chai
CFO, MAP
Pharmaceuticals
+1 650 386
3107
Daryl
Messinger
WeissComm
Partners
+1 415 999
2361
dmessinger@wcpglobal.com
19 December
2009
-
ENDS -
Item
7
ASTRAZENECA RECEIVES FDA COMPLETE
RESPONSE LETTER ON SEROQUEL XR FOR MAJOR DEPRESSIVE DISORDER
AstraZeneca today
announced the company has received a Complete Response Letter (CRL) from the
U.S. Food and Drug Administration (FDA) asking for additional information for
the supplemental New Drug Application for SEROQUEL XR (quetiapine fumarate)
Extended Release Tablets for the treatment of Major Depressive Disorder (MDD) in
adult patients.
AstraZeneca is
evaluating the contents of the CRL and the proposed labelling
revisions. AstraZeneca will continue discussions with the FDA and
will provide a response to the agency in due course.
SEROQUEL XR, a
once-daily, extended release formulation of SEROQUEL (quetiapine fumarate), 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. The CRL does not
change the current recommendations for the treatment of patients taking SEROQUEL
XR or SEROQUEL for approved indications in schizophrenia and bipolar
disorder.
An
update to AstraZeneca investors on progress will be provided when
appropriate.
About
AstraZeneca
AstraZeneca is a
major international healthcare business engaged in research, development,
manufacturing and marketing of prescription pharmaceuticals and supplier for
healthcare services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US $29.55 billion and is a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and
infection product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more Information visit www.astrazeneca.com
Media
Enquiries:
|
|
|
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
|
Mina
Blair
|
+44 20 7304
5084
|
mob: +44 7718
581021
|
Karl
Hard
|
+44 207 304
5322
|
mob: +44 7789
654364
|
|
|
|
Investor
Enquiries US:
|
|
|
Ed
Seage
|
+1 302 886
4065
|
mob: +1 302
373 1361
|
Jorgen
Winroth
|
+1 212 579
0506
|
mob: +1 917
612 4043
|
24
December 2008
-
ENDS -