Annual Review
AstraZeneca PLC
07 November 2002
ASTRAZENECA REPORTS SIGNIFICANT PROGRESS
ACROSS ITS PROMISING RESEARCH AND
DEVELOPMENT PORTFOLIO
AstraZeneca today updated analysts on the company's late stage development
products and projects; the progress of earlier stage products, notably in the
cardio-vascular and oncology therapeutic areas; and the improved productivity in
drug discovery, at its annual business review meeting in Alderley Park,
Cheshire, UK, a centre of excellence for Oncology Research and Development at
AstraZeneca.
Late Stage Development Progress and Product Line Extensions
• CRESTOR has received its first approval in The Netherlands, and will
enter European Mutual Recognition Procedure in December. The US NDA will be
supplemented with a data package in 1Q 2003; the Japan NDA was submitted in 2Q
2002.
• EXANTA is set to be the first new oral anticoagulant for 50 years:
o The first indication in prevention of venous thromboembolism (VTE) in
patients undergoing orthopaedic surgery was filed in Europe in July 2002.
o Positive top-line results in the EXULT A study (confirming EXANTA's
efficacy in preventing VTE when compared to warfarin in US patients) announced
today will support the US filing for prevention of VTE in orthopaedic surgery,
scheduled for 4Q 2003.
o The main chronic indication, the prevention of stroke in patients with
atrial fibrillation, based on the SPORTIF trials, will be filed in the US and
Europe in 4Q 2003.
o Encouraging data from THRIVE III, the first study to report using
EXANTA in a chronic indication, were announced today and showed a significant
reduction in VTE events and no difference in bleeding when compared to placebo.
The study used a fixed dose of EXANTA without the need for coagulation
monitoring, which is normally required for warfarin. A further indication for
the treatment of VTE, based on the THRIVE studies, will also be filed in Europe
in 4Q 2003.
o Full details of EXULT A and THRIVE III will be presented at the
American Society of Hematology meeting in Philadelphia in December 2002.
• IRESSA, the first epidermal growth factor receptor inhibitor, is
already approved in Japan. In the US, IRESSA is under active review by the FDA,
following a positive US Oncology Drugs Advisory Committee (ODAC) recommendation.
A further ODAC meeting is not anticipated. The European filing is now
scheduled for 1Q 2003.
• The completion of the EU Mutual Recognition Procedure for approval of
ARIMIDEX in early breast cancer, a significant market opportunity, was announced
today. An approval has been granted in the UK and other European approvals
(Austria, Germany, Italy, Portugal and Spain) will follow. ARIMIDEX was
approved for early breast cancer in 3Q 2002 in the US, and other reviews are
ongoing in the rest of world.
• CASODEX is now approved for early prostate cancer (EPC) in 26 markets.
An EPC indication for CASODEX in the US will be the subject of a US ODAC
meeting scheduled for December 18th.
• FASLODEX has been approved for second-line treatment of breast cancer
in the US. European submission for this indication is scheduled for 2003, while
the Japanese submission is under consideration.
• NEXIUM is growing strongly with sales of $1.6 billion (MAT 3Q). New
indications for treatment of NSAID GI side effects and a new parenteral
formulation for the hospital setting will be submitted for approval in 2Q 2003.
• SEROQUEL, now a $1 billion brand, has demonstrated efficacy in
treating bipolar disease (mania). Filing for this indication is scheduled for 1Q
2003 in the US and Europe.
• Promising results for SYMBICORT in the treatment of chronic
obstructive pulmonary disease (COPD) (a $2.9 billion global market) were
announced, supporting the filing submitted to the EU earlier in 2002.
• Additional significant line extensions are planned for FASLODEX,
IRESSA, EXANTA, ATACAND, SEROQUEL and CRESTOR.
New Cancer Therapies
• Further information was provided on new cancer therapies that target
tumour growth mechanisms:
o ZD6474, an anti-angiogenic, in phase II development, and AZD2171,
another anti-angiogenic in phase I development, both target the growth of blood
vessels of tumours.
o ZD6126, a vascular targeting agent that will soon enter phase II
development, targets and destroys the vasculature of tumours, working to destroy
the tumour from within.
o AZD4054, an endothelin antagonist in phase II development, works by
inhibiting the ETA receptor, which is responsible for tumour cell proliferation.
o AZD0530, an anti-invasive designed to prevent tumours from spreading,
will enter clinical testing in 2Q 2003.
o AZD3409, a prenylation inhibitor designed to inhibit proliferation of
cancer cells, will enter clinical testing in 2Q 2003.
New Cardiovascular Therapies
• Positive phase II data has been generated with GALIDA (AZ242), a new
treatment for type II diabetes.
• AZD6140, an anti-platelet approach to prevent blood clots (which can
lead to heart attacks and strokes) is currently in phase I development.
• AZD7009, a new treatment for atrial fibrillation, is also now in phase
I development.
New CNS/Pain Therapies
• Phase III clinical trials for NXY-059, a novel neuroprotectant for
acute stroke, will commence in early 2003.
• Encouraging clinical data was presented on AZD3582, the first Cox
Inhibiting Nitric Oxide Donator (CINOD) for pain control, further demonstrating
its attractive efficacy and side effect profile, versus COX-2 selective NSAID's.
The full AstraZeneca development pipeline update is attached.
Drug Discovery Enhancements
• Candidate drug (CD) delivery has increased by 20 per cent in the last
three years--one quality CD is now entering preclinical development each month.
• The number of CD's that have progressed to clinical development has
doubled this year.
• To increase the likelihood that CD's will progress through late-stage
development to market, AstraZeneca is:
o Bringing new aspects of clinical medicine to the drug discovery process
-enabling better understanding of human diseases and how future drugs will work
to prevent and treat those diseases.
o Front-loading risk in clinical development by introducing more
stringent safety and drug metabolism/pharmacokinetic (DMPK) testing earlier-
allowing for early identification of CD's that will not succeed.
• 200 new collaborations with leading academic centres and biotech
companies have been initiated in 2002, supporting AstraZeneca's drug discovery
strategy.
Tom McKillop, Chief Executive, AstraZeneca, said:
'The transformation of AstraZeneca's product portfolio continues apace with
today's significant news of CRESTOR's first approval in Europe; progress with
other late stage development projects; and the announcement of a raft of
exciting new compounds in early development. A changing external environment
and the rapid adoption of new technologies are combining to provide new
challenges for the pharmaceutical industry, but they will also bring new
opportunities. We are driving productivity not only in R&D, but also in our
overall business-bringing forward new indications for our key growth products
and enhancing our sales forces effectiveness. By operating in a creative, fast
and efficient manner, I am confident that AstraZeneca will continue to deliver
important new medicines and deliver top-tier financial performance.'
Jan Lundberg, Executive Vice President, Head of Global Discovery Research, in an
overview of the company's discovery strategy said:
'With the research environment increasingly focused on finding disease relevant
mechanisms combined with a plethora of fantastic new technologies, AstraZeneca
is working as one global team to improve the predictability of drug discovery.
We are introducing elements of clinical development in the earliest stages of
our activities to make our research as relevant to man as possible, and using
the latest technology for the early identification of projects unlikely to
succeed in development. These actions will result in a much better ratio of
CD's reaching the market. AstraZeneca has already been able to deliver a
fruitful pipeline that is admired across the industry, and we will continue to
populate that pipeline with novel quality compounds to provide added value and
benefits to patients worldwide, faster than ever before.'
Martin Nicklasson, Executive Vice President, Head of Clinical Development, in an
overview of the AstraZeneca portfolio said:
'AstraZeneca's key growth products have delivered strong business performances
in the past year, and will continue to as their indications are broadened
through aggressive life-cycle management programmes. Underpinning an already
impressive portfolio of products in our key therapeutic areas, we are happy to
announce the progression of several promising early-stage research projects
including NXY-059, a novel neuroprotectant agent for stroke, GALIDA, a new
treatment for type II diabetes and lipid disorders, and our CINOD, AZD3582, a
new
treatment for pain. These projects along with a score of others will ensure the
future success of AstraZeneca as a global leader in pharmaceutical research and
development.'
7 November 2002
Media Enquiries: Steve Brown/Emily Denney (London) (020) 7304 5033/5034
Staffan Ternby (Sodertalje) (8) 553 26107
Rachel Bloom (Wilmington) (302) 886 7858
Analyst/Investor Enquiries: Mina Blair-Robinson (London) (020) 7304 5084
Jonathan Hunt (London) (020) 7304 5087
Staffan Ternby (Sodertalje) (8) 553 26107
Ed Seage (Wilmington) (302) 886 4065
Jorgen Winroth (New York) (212) 581 8720
For copies of the presentations from today's annual business review, please
visit www.astrazeneca.com.
This press release contains forward-looking statements with respect to
AstraZeneca's business. By their nature, forward-looking statements and
forecasts involve risks and uncertainties because they relate to events and
depend on circumstances that will occur in the future. There are a number of
factors that could cause actual results and developments to differ materially.
For a discussion of those risks and uncertainties, please see the company's
Annual Report/Form 20-F for 2001.
TRADE MARKS
The following brand names are trade marks of the AstraZeneca group of companies:
ARIMIDEX, ATACAND, CASODEX, CRESTOR, EXANTA, FASLODEX, GALIDA, IRESSA, NEXIUM,
SYMBICORT, SEROQUEL.
AstraZeneca Development Pipeline: NCEs and line extensions
7 November 2002
Gastrointestinal
NCE's
Compound Mechanism Areas under Phase Estimated Filing
investigation MAA NDA
AZD0865 Reversible acid pump inhibitor Acid related GI disease I >2005 >2005
(was AR-H044277)
AZD3355 Inhibitor of transient lower Gastroesophageal reflux I >2005 >2005
esophageal sphincter disease (GERD)
relaxations (TLESR )
Line Extensions
Nexium(R) Proton pump inhibitor Treatment of NSAID GI III 2Q 2003 2Q 2003
Side effects
Nexium(R) Proton pump inhibitor Parenteral formulation III 2Q 2003 2Q 2003
Nexium(R) Proton pump inhibitor Prevention of NSAID GI III 1H 2004 1H 2004
Side effects
Nexium(R) Proton pump inhibitor Extraeosophageal II >2005 >2005
reflux disease
Cardiovascular
NCE's
CrestorTM Statin Hyperlipidemia III Filed Filed
CrestorTM Statin Atheroma III >2005 >2005
CrestorTM Statin Outcomes III >2005 >2005
ExantaTM (melagatran) Thrombin inhibitor (s.c) Prevention of VTE III Filed >2005
ExantaTM (H376/95) Thrombin inhibitor Prevention of VTE III Filed 4Q 2003
ExantaTM (H376/95) Thrombin inhibitor Prevention of stroke III 4Q 2003 4Q 2003
in AF
ExantaTM (H376/95) Thrombin inhibitor Treatment of VTE III 4Q 2003 >2005
ExantaTM (H376/95) Thrombin inhibitor Arterial/Post MI II >2005 >2005
AZ242 PPAR agonist Diabetes /Metabolic II >2005 >2005
Syndrome
AZD6140 ADP antagonist Arterial thrombosis I >2005 >2005
AZD7009 Atrial Repolarisation Delaying Atrial Fibrillation I >2005 >2005
Agent (ARDA)
AZD9684 CPU inhibitor Thrombosis PC >2005 >2005
AZD0837 Thrombin inhibitor Thrombosis PC >2005 >2005
AZD7806 IBAT inhibitor Dyslipidaemia PC >2005 >2005
Line Extensions
Atacand(R) Angiotensin II antagonist Hypertension outcomes III 4Q 2002* 4Q 2002*
(SCOPE)
Atacand(R) Angiotensin II antagonist CHF outcomes III 4Q 2003 4Q 2003
(CHARM)
Atacand(R) Angiotensin II antagonist Diabetic retinopathy III >2005 >2005
Toprol-XL(R) Beta-blocker HCTZ combination III >2005
*submission for variation to existing label.
CNS
NCE's
Compound Mechanism Areas under investigation Phase Estimated Filing
MAA NDA
NXY-059 Free radical trapping agent Stroke III >2005 >2005
ZD 0947 K+ channel opener Overactive bladder II >2005 >2005
AR-A2 5HT1symbol 98 /f 'Symbol' /s Anxiety/Depression I >2005 >2005
12b antagonist
AZD1134 5HT1symbol 98 /f 'Symbol' /s Anxiety/Depression PC >2005 >2005
12b antagonist
AZD5106 NK-2 antagonist Overactive bladder PC >2005 >2005
AZD4750 Chemokine receptor antagonist Multiple sclerosis PC >2005 >2005
Line Extensions
Seroquel(R) D2/5HT2 antagonist Granules III 2004 2004
Seroquel(R) D2/5HT2 antagonist Sustained release III Under Under
evaluation evaluation
Seroquel(R) D2/5HT2 antagonist Mania III 1Q 2003 1Q 2003
Zomig(R) 5-HT1B/1D receptor agonist Nasal spray III Launched Filed
Oncology
NCE's
Faslodex(R) Oestrogen Receptor Antagonist 2nd line Advanced breast III 1Q 2003 Launched
cancer
Faslodex(R) Oestrogen Receptor Antagonist 1st line Advanced breast III >2005 >2005
cancer
Iressa(R) EGFR-TK inhibitor NSCLC III 1Q 2003 Filed
ZD6474 Angiogenesis inhibitor Solid tumours II >2005 >2005
(Vascular endothelial cell
growth factor receptor
tyrosine kinase inhibitor)
ZD4054 Endothelin A receptor Solid tumours II >2005 >2005
antagonist
ZD6126 Vascular targeting agent Solid tumours I >2005 >2005
AZD2171 Angiogenesis inhibitor Solid tumours and I >2005 >2005
(Vascular endothelial cell haematological
growth factor receptor malignancies
tyrosine kinase inhibitor)
AZD3409 Farnesyl-transferase inhibitor Solid tumours PC >2005 >2005
( FAR )
AZD0530 Non-receptor tyrosine kinase Solid tumours PC >2005 >2005
inhibitor
AZD4440 Vascular targeting agent Solid tumours PC >2005 >2005
Line Extensions
Compound Mechanism Areas under investigation Phase Estimated Filing
MAA NDA
Arimidex(R) Aromatase inhibitor Adjuvant Breast Cancer III Approved Launched
Casodex(R) Anti-androgen Early Prostate Cancer III Launched Filed
Zoladex(R) LHRH agonist Pre-menopausal III Launched
Adjuvant Breast Cancer
Iressa(R) EGFR-TK inhibitor Head & Neck cancer III >2005 >2005
Iressa(R) EGFR-TK inhibitor Breast cancer II >2005 >2005
Iressa(R) EGFR-TK inhibitor Colorectal cancer II >2005 >2005
Respiratory and Inflammation
NCE's
AZD2315 Immuno modulator Rheumatoid Arthritis* II >2005 >2005
AZD4407 5-lipoxygenase inhibitor COPD I >2005 >2005
AZD9056 Ion channel blocker Rheumatoid Arthritis* I >2005 >2005
AZD8309 Chemokine receptor Rheumatoid Arthritis* PC >2005 >2005
antagonist
AZD7140 Chemokine receptor Rheumatoid Arthritis* PC >2005 >2005
antagonist
AZD3342 Protease Inhibitor COPD PC >2005 >2005
AZD0275 Chemokine receptor COPD PC >2005 >2005
antagonist
AZD0902 Ion channel blocker COPD PC >2005 >2005
AZD8955 Collagenase inhibitor Osteoarthritis PC >2005 >2005
*First indication; use in other diseases eg. COPD under consideration.
Line Extensions
Symbicort(R)Turbuhaler(R) Inhaled steroid/fast onset, COPD III Filed
long-acting B2 agonist
Symbicort(R)Turbuhaler(R) Inhaled steroid/fast onset, Single therapy for III 3Q 2003
long-acting B2 agonist asthma
Symbicort(R) pMDI Inhaled steroid/fast onset, Asthma III 4Q 2003 1H 2004
long-acting B2 agonist
Oxis(R) Turbuhaler(R) Long-acting B2 agonist COPD III Filed
Oxis(R) pMDI Long-acting B2 agonist Asthma III 3Q 2003
Pain Control
NCE's
Compound Mechanism Areas under Phase Estimated Filing
investigation MAA NDA
AZD3582 COX inhibiting nitric oxide Acute /chronic II >2005 >2005
donator nociceptive pain
AZD4282 NMDA Antagonist Neuropathic pain PC >2005 >2005
AZD 4717 COX inhibiting nitric oxide Acute /chronic PC >2005 >2005
donator nociceptive pain
Line Extensions
Naropin(R) Sodium channel blocker Spinal anaesthesia III Filed
Infection
Line Extensions
Merrem(R) Carbapenem antibiotic Skin and soft tissue III 4Q 2003
infections
AstraZeneca Development Pipeline: Discontinued Projects
GI
Compound Mechanism
Rofleponide Oral steroid
CV
Compound Mechanism
AZD7545 PDK Inhibitor
Respiratory and Inflammation
Compound Mechanism
Rofleponide palmitate Intranasal steroid
Infection
Compound Mechanism
Merrem(R) for use in neutropenics Carbapenem antibiotic
Comments
As disclosure of compound information is balanced by the business need to
maintain competitive advantage, some compound information has not been disclosed
at this time.
Compounds in development are displayed by phase.
Abbreviations:
PC - Pre-clinical: Candidate Drug accepted for development but not yet
administered to man.
MAA - Marketing Authorisation Application (Europe)
NDA - New Drug Application (USA)
7 November 2002
This information is provided by RNS
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