AstraZeneca PLC
02 February 2006
AstraZeneca Development Pipeline
2 February 2006
Line Extensions
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
CV
Atacand angiotensin II antagonist diabetic retinopathy III > 2008 >2008
Crestor statin atherosclerosis III 1H 2007 1H 2007
Crestor statin outcomes CHF III >2008 >2008
Crestor statin outcomes renal III 2008 2008
Seloken/ beta-blocker HCTZ combination III Launched Filed
Toprol-XL
Exanta thrombin inhibitor prevention of stroke III Filed** Filed*
in AF
GI
Nexium proton pump inhibitor NSAID GI side effects III Promotable*** Filed
- symptom resolution
Nexium proton pump inhibitor NSAID GI side effects III Launched Filed
- ulcer healing
Nexium proton pump inhibitor peptic ulcer bleeding III >2008 >2008
Nexium Sachet proton pump inhibitor GERD III Q4 2006 Filed
formulation
Nexium proton pump inhibitor extra-oesophageal II >2008 >2008
reflux disease
Neuroscience
Seroquel SR D2/5HT2 antagonist schizophrenia III 3Q 2006 3Q 2006
Seroquel D2/5HT2 antagonist bipolar maintenance III 2H 2007 1H 2007
Seroquel D2/5HT2 antagonist bipolar depression III 1H 2007 Filed
Seroquel SR D2/5HT2 antagonist generalised anxiety III 2008 2H 2007
disorder
Seroquel SR D2/5HT2 antagonist major depressive III 2008 2008
disorder
Onc/infection
Merrem carbapenem antibiotic skin and soft tissue III Launched
infections
Faslodex oestrogen receptor 2nd line after III 2008 2008
antagonist aromatase inhibitor
failure
Faslodex oestrogen receptor 1st line advanced III >2008 >2008
antagonist breast cancer
Faslodex oestrogen receptor adjuvant III >2008 >2008
antagonist
Iressa EGFR-TK inhibitor head & neck cancer III 2H 2007 1H 2007
Iressa EGFR-TK inhibitor breast cancer II >2008 >2008
*AstraZeneca continues discussions with the FDA but the current assessment is
that it is unlikely a way forward or Exanta registration in the US will be
identified.
** Switch to EU centralised procedure
*** Authorities stated these symptoms were already captured within the GERD
label. Text stating 'No clinical interaction with naproxen or rofecoxib' was
approved.
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
Respiratory
Symbicort inhaled steroid/fast Symbicort Maintenance III Filed
Turbuhaler onset, long-acting ss2 and Reliever Therapy
agonist for asthma (SMART)
Symbicort pMDI inhaled steroid/fast asthma III Filed* Filed
onset, long-acting ss2
agonist
Symbicort pMDI inhaled steroid/fast COPD III Filed* 2008
onset, long-acting ss2
agonist
* To be supplemented in 2008 with data supporting two additional strengths.
NCE's
Phase III
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
CV
Galida PPAR agonist diabetes /metabolic III 2H 2007* 2H2007*
syndrome
AGI-1067 Anti-atherogenitic atherosclerosis III 1H 2007 1H 2007
(Atherogenics)
AZD6140 ADP receptor antagonist arterial thrombosis III >2008 >2008
Neuroscience
NXY-059 (Cerovive) free radical trapping agent stroke III 1H 2007 1H 2007
Oncology/Inf
Zactima VEGF/EGF TKI inhibitor with NSCLC III >2008 >2008
RET kinase activity
(ZD6474)
AZD2171 VEGF signalling inhibitor II/III >2008 >2008
(VEGFR-TKI)
NSCLC and CRC
* Subject to the results of Phase III studies and regulatory discussions
NCE's
Phases I and II
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
CV
AZD7009 antiarrhythmic IV atrial fibrillation - II 2008 2008
conversion
AZD9684 CPU inhibitor thrombosis II >2008 >2008
AZD0837 thrombin inhibitor thrombosis II >2008 >2008
AZD2479 (Avanir) Reverse Cholesterol dyslipidaemia I >2008 >2008
Transport enhancer
AZD6610 dyslipidaemia/ I >2008 >2008
diabetes
AZD8677 dyslipidaemia/ I >2008 >2008
diabetes
GI
AZD9056 Ion channel blocker inflammatory bowel II >2008 >2008
disease
AZD3355 inhibitor of transient lower GERD I >2008 >2008
oesophageal sphincter
relaxations (TLESR)
AZD9343 inhibitor of transient lower GERD I >2008 >2008
oesophageal sphincter
relaxations (TLESR)
AZD9272 GERD I >2008 >2008
Neuroscience
AZD3480 Neuronal nicotinic receptor cognitive disorders II >2008 >2008
(TC-1734,Targacept) agonist
AZD9272 neuropathic pain I >2008 >2008
Onc/Infection
Zactima VEGF/EGF TKI inhibitor with medullary thyroid II >2008 >2008
RET kinase activity cancer
(ZD6474)
CytoFab (Protherics) anti-TNF-alpha polyclonal severe sepsis II >2008 >2008
antibody
ZD4054 endothelin A receptor prostate cancer II >2008 >2008
antagonist
Patrin (KuDOS) AGT inhibitor solid tumours II >2008 >2008
AZD0530 SRC kinase inhibitor solid tumours and I >2008 >2008
haematological
malignancies
AZD6244 MEK inhibitor solid tumours I >2008 >2008
(ARRY-142886)
AZD1152 Aurora kinase inhibitor solid tumours and I >2008 >2008
haematological
malignancies
AZD4769 solid tumours I >2008 >2008
KU59436 (KuDOS) PARP inhibitor breast cancer I >2008 >2008
AQ4N (KuDOS) Hypoxia activated cytotoxic solid tumours I >2008 >2008
Phases I and II (continued)
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
Respiratory
AZD9056 ion channel blocker rheumatoid arthritis II >2008 >2008
AZD9056 ion channel blocker COPD II >2008 >2008
AZD8955 collagenase inhibitor osteoarthritis II >2008 >2008
AZD3778 chemokine receptor rhinitis II >2008 >2008
antagonist
AZD8309 chemokine receptor rheumatoid arthritis I >2008 >2008
antagonist
AZD8309 chemokine receptor COPD I >2008 >2008
antagonist
AZD3342 protease inhibitor COPD I >2008 >2008
AZD1981 asthma I >2008 >2008
NCE's
Pre Clinical
Compound Mechanism Area of investigation Phase Estimated Filing
MAA NDA
CV
AZD8450 dyslipidaemia PC >2008 >2008
AZD6370 diabetes PC >2008 >2008
AZD8593 haemostasis PC >2008 >2008
AZD1175 diabetes/obesity PC >2008 >2008
AZD2207 diabetes/obesity PC >2008 >2008
AZD1305 arrhythmias PC >2008 >2008
AZD1092 diabetes PC >2008 >2008
AZD4121 dyslipidaemia PC >2008 >2008
GI
AZD8081 functional GI disease PC >2008 >2008
AZD6538 GERD PC >2008 >2008
Neuroscience
AZD3102 Alzheimer's disease PC >2008 >2008
AZD1080 Alzheimer's disease PC >2008 >2008
AZD2327 anxiety PC >2008 >2008
AZD5904 multiple sclerosis PC >2008 >2008
AZD6538 neuropathic pain PC >2008 >2008
AZD8797 multiple sclerosis PC >2008 >2008
AZD3783 anxiety and depression PC >2008 >2008
AZD1940 nociceptive and PC >2008 >2008
neuropathic pain.
AZD9335 neuropathic pain PC >2008 >2008
AZD3241 Parkinson's disease PC >2008 >2008
Pre Clinical (continued)
Compound Mechanism Area of investigation Phase Estimated Filing
MAA NDA
Onc/Infection
AZD9935 VEGF signalling inhibitor solid tumours PC >2008 >2008
(VEGFR-TKI)
AZD0424 SRC kinase inhibitor solid tumours PC >2008 >2008
AZD8931 solid tumours PC >2008 >2008
AZD4877 solid tumours PC >2008 >2008
AZD7762 solid tumours PC >2008 >2008
AZD5180 (Abgenix) solid tumours PC >2008 >2008
AZD1845 solid tumours PC >2008 >2008
AZD8330 solid tumours PC >2008 >2008
AZD3646 solid tumours and PC >2008 >2008
haematological
malignancies
Respiratory
AZD6067 protease inhibitor COPD PC >2008 >2008
AZD6703 rheumatoid arthritis PC >2008 >2008
AZD6357 Osteoarthritis PC >2008 >2008
AZD7928 COPD PC >2008 >2008
AZD2914 COPD PC >2008 >2008
AZD2392 asthma/rhinitis PC >2008 >2008
AZD1744 asthma/rhinitis PC >2008 >2008
AZD5672 rheumatoid arthritis PC >2008 >2008
AZD3825 asthma PC >2008 >2008
AZD1236 COPD PC >2008 >2008
AZD4818 COPD PC >2008 >2008
AZD5069 COPD PC >2008 >2008
AZD9668 COPD PC >2008 >2008
AZD9215 asthma PC >2008 >2008
AZD1678 asthma PC >2008 >2008
AZD6605 osteoarthritis PC >2008 >2008
AstraZeneca Development Pipeline
Discontinued Projects vs HY 28 July 05
CV
NCE/Line Extension Compound Area under investigation
NCE AZD7009 Antiarrythmic oral atrial fibrillation - maintenance
NCE AZD7806 dyslipidaemia
NCE AZD4619 dyslipidaemia
NCE AZD8294 dyslipidaemia
Neuroscience
NCE/Line Extension Compound Area under investigation
NCE AZD7371 overactive bladder
NCE AZD4282 neuropathic pain
Oncology and Infection
NCE/Line Extension Compound Area under investigation
NCE AZD3409 solid tumours
NCE AZD5438 solid tumours
NCE ZD6126 solid tumours
NCE AZD4440 solid tumours
Respiratory and Inflammation
NCE/Line Extension Compound Area under investigation
NCE AZD3778 Indication asthma
Comments
As disclosure of compound information is balanced by the business need to
maintain confidentiality,
information in relation to some compounds listed here 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)
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