AstraZeneca PLC
01 February 2007
AstraZeneca Development Pipeline
1 February 2007
Line Extensions
Compound Mechanism Area under investigation Phase Estimated Filing
MAA NDA
Cardiovascular
Atacand angiotensin II antagonist diabetic retinopathy III 2009 2009
Atacand Plus angiotensin II antagonist / 32/12.5 mg, 32/25 mg for III 2H 2008
thiazide diuretic hypertension
Crestor statin atherosclerosis III Filed Filed
Crestor statin outcomes CHF III 2H 2008 2H 2008
Crestor statin outcomes End Stage Renal III 2009 2009
Disease
Seloken/Toprol-XL beta-blocker HCTZ combination III Approved
Gastrointestinal
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 1H 2008 1H 2008
Nexium Sachet proton pump inhibitor GERD III Filed Approved
formulation
Nexium proton pump inhibitor extra-oesophageal reflux II >2009** >2009**
disease
Nexium low dose proton pump inhibitor low dose aspirin III >2009 >2009
aspirin combination associated peptic ulcer
Neuroscience
Seroquel SR D2/5HT2 antagonist schizophrenia III Filed Filed
Seroquel D2/5HT2 antagonist bipolar maintenance III Q4 2007 Q2 2007
Seroquel D2/5HT2 antagonist bipolar depression III Q4 2007 Approved
Seroquel SR D2/5HT2 antagonist generalised anxiety III 2H 2008 1H 2008
disorder
Seroquel SR D2/5HT2 antagonist major depressive III 2H 2008 1H 2008
disorder
Seroquel SR D2/5HT2 antagonist bipolar mania III 1H 2008 1H 2008
Seroquel SR D2/5HT2 antagonist bipolar depression III 1H 2008 1H 2008
Oncology & Infection
Faslodex oestrogen receptor 1st line advanced breast III >2009 >2009
antagonist cancer
Faslodex oestrogen receptor Adjuvant III >2009 >2009
antagonist
Iressa EGFR-TK inhibitor breast cancer II >2009 >2009
* Authorities stated these symptoms were already captured within the GERD label.
Text stating 'No clinical interaction with naproxen or rofecoxib' was approved.
**Project Extraesophageal reflux disease (reflux asthma) will be completed but
will not result in a regulatory filing.
Compound Mechanism Area under investigation Phase Estimated Filing
MAA NDA
Respiratory & Inflammation
Symbicort Turbuhaler inhaled steroid/fast onset, Symbicort Maintenance III Approved
long-acting ss2 agonist and Reliever Therapy for
asthma (SMART)
Symbicort pMDI inhaled steroid/fast onset, asthma III Filed* Approved **
long-acting ss2 agonist
Symbicort pMDI inhaled steroid/fast onset, COPD III Filed* 1H 2008
long-acting ss2 agonist
* To be supplemented in 2008 with data supporting two additional strengths
** US approval based on 12 years and above
NCE's
Phase III
Compound Mechanism Area under Phase Estimated Filing
investigation
MAA NDA
Cardiovascular
AGI-1067 Anti-atherogenic atherosclerosis III Q4 2007 Q2/Q3 2007
AZD6140 ADP receptor antagonist arterial thrombosis III >2009 >2009
Saxagliptin (BMS) dipeptidyl peptidase-4 diabetes III >2009 1H 2008
(DPP-4) inhibitor
Oncology & Infection
Zactima VEGF/EGF TKI inhibitor with NSCLC III 2H 2008 2H 2008
RET kinase activity
Recentin (AZD2171) VEGF signalling inhibitor II/III >2009 >2009
(VEGFR-TKI)
NSCLC and CRC
NCE's
Phases I and II
Compound Mechanism Area under investigation Phase Estimated Filing
MAA NDA
Cardiovascular
Crestor/ABT-335 statin + fibrate fixed dyslipidaemia II 2009
(Abbott) combination
AZD9684 CPU inhibitor thrombosis II >2009 >2009
AZD0837 thrombin inhibitor thrombosis II >2009 >2009
AZD6610 PPAR alpha with 'partial dyslipidaemia II >2009 >2009
gamma'
Dapagliflozin (BMS) sodium-glucose diabetes II >2009 >2009
cotransporter-2 (SGLT2)
inhibitor
AZD2479 Reverse Cholesterol Transport dyslipidaemia I >2009 >2009
enhancer
AZD1175 diabetes/obesity I >2009 >2009
AZD2207 diabetes/obesity I >2009 >2009
AZD1305 antiarrhythmic arrhythmias I >2009 >2009
Gastrointestinal
AZD9056 ion channel blocker (P2X7) inflammatory bowel II >2009 >2009
disease
AZD3355 inhibitor of transient lower GERD II >2009 >2009
oesophageal sphincter
relaxations (TLESR)
Neuroscience
PN-400 (Pozen) naproxen + esomeprazole Signs and symptoms of OA II >2009 2009
and RA
AZD3480 neuronal nicotinic receptor cognitive disorders in II >2009 >2009
agonist schizophrenia
AZD3480 neuronal nicotinic receptor Alzheimers II >2009 >2009
agonist
AZD9272 glutamate receptor modulator neuropathic pain I >2009 >2009
AZD2327 enkephalinergic receptor anxiety & depression I >2009 >2009
modulator
AZD5904 enzyme inhibitor multiple sclerosis I >2009 >2009
AZD1080 Alzheimers I >2009 >2009
AZD3783 anxiety and depression I >2009 >2009
Phases I and II (continued)
Oncology & Infection
Zactima VEGF/EGF TKI inhibitor with medullary thyroid II 2H 2H 2008
RET kinase activity cancer
2008
CytoFab anti-TNF-alpha polyclonal severe sepsis II >2009 >2009
antibody
ZD4054 endothelin A receptor prostate cancer II >2009 >2009
antagonist
AZD5896 AGT inhibitor solid tumours II >2009 >2009
AZD6244 MEK inhibitor solid tumours II >2009 >2009
(ARRY-142886)
CAT-3888 recombinant immunotoxin hairy hairy cell leukaemia II >2009 >2009
cell
AZD0530 SRC kinase inhibitor solid tumours and I >2009 >2009
haematological
malignancies
AZD1152 Aurora kinase inhibitor solid tumours and I >2009 >2009
haematological
malignancies
AZD4769 solid tumours I >2009 >2009
AZD2281 PARP inhibitor breast cancer I >2009 >2009
AZD4877 solid tumours I >2009 >2009
AZD1689 Hypoxia activated cytotoxic solid tumours I >2009 >2009
AZD8931 solid tumours I >2009 >2009
AZD7762 solid tumours I >2009 >2009
Respiratory & Inflammation
AZD9056 ion channel blocker (P2X7) rheumatoid arthritis II >2009 >2009
AZD1981 asthma II >2009 >2009
AZD5672 rheumatoid arthritis I >2009 >2009
AZD6703 rheumatoid arthritis I >2009 >2009
AZD4818 COPD I >2009 >2009
CAT-354 Anti-IL-13 antibody asthma I >2009 >2009
AZD5904 COPD I >2009 >2009
AZD1744 asthma I >2009 >2009
NCE's
Pre Clinical
Compound Mechanism Area under Phase Estimated Filing
investigation
MAA NDA
Cardiovascular
AZD6370 diabetes PC >2009 >2009
AZD8593 haemostasis PC >2009 >2009
AZD4121 cholesterol absorption dyslipidaemia PC >2009 >2009
inhibitor
AZD1283 thrombosis PC >2009 >2009
AZD5861 dyslipidaemia PC >2009 >2009
AZD1656 diabetes/obesity PC >2009 >2009
AZD3988 diabetes/obesity PC >2009 >2009
Gastrointestinal
AZD2066 GERD PC >2009 >2009
AZD5329 functional GI disease PC >2009 >2009
Neuroscience
AZD3102 Alzheimers PC >2009 >2009
AZD6538 neuropathic pain PC >2009 >2009
AZD8797 multiple sclerosis PC >2009 >2009
AZD1940 nociceptive and PC >2009 >2009
neuropathic pain.
AZD3241 Parkinson's disease PC >2009 >2009
AZD2066 analgaesia PC >2009 >2009
AZD6280 anxiety PC >2009 >2009
AZD1386 analgaesia PC >2009 >2009
AZD2624 schizophrenia PC >2009 >2009
AZD0328 Alzheimers PC >2009 >2009
AZD3043 GABA-A receptor modulator short acting PC >2009 >2009
anaesthetic
AZD7903 analgaesia PC >2009 >2009
Pre Clinical (continued)
Compound Mechanism Area under Phase Estimated Filing
investigation
MAA NDA
Oncology & Infection
AZD9935 VEGF signalling inhibitor solid tumours PC >2009 >2009
(VEGFR-TKI)
AZD0424 SRC kinase inhibitor solid tumours PC >2009 >2009
AZD5180 anti-angiogenic solid tumours PC >2009 >2009
AZD1845 solid tumours PC >2009 >2009
AZD8330 solid tumours PC >2009 >2009
AZD3646 solid tumours and PC >2009 >2009
haematological
malignancies
AZD9468 solid tumours PC >2009 >2009
AZD2932 solid tumours PC >2009 >2009
AZD4992 PC >2009 >2009
CAT-8015 recombinant immunotoxin haematological PC >2009 >2009
malignancies
CAT-5001 recombinant immunotoxin solid tumours PC >2009 >2009
AZD6918 solid tumours PC >2009 >2009
AZD5099 infection PC >2009 >2009
Respiratory & Inflammation
AZD6067 protease inhibitor COPD PC >2009 >2009
AZD6357 osteoarthritis PC >2009 >2009
AZD7928 COPD PC >2009 >2009
AZD2392 asthma PC >2009 >2009
AZD3825 asthma PC >2009 >2009
AZD1236 COPD PC >2009 >2009
AZD5069 COPD PC >2009 >2009
AZD9668 COPD PC >2009 >2009
AZD9215 asthma PC >2009 >2009
AZD1678 asthma PC >2009 >2009
AZD8848 asthma PC >2009 >2009
AZD8075 asthma PC >2009 >2009
AZD6605 osteoarthritis PC >2009 >2009
CAM-3001 rheumatoid arthritis PC >2009 >2009
AZD3199 asthma/COPD PC >2009 >2009
AstraZeneca Development Pipeline
Discontinued Projects vs 8 June ABR
Cardiovascular & Gastrointestinal
NCE/Line Extension Compound Area under investigation
NCE AZD8677 dyslipidaemia/diabetes
NCE AZD7009 atrial fibrillation conversion
NCE AZD8450 dyslipidaemia
NCE AZD8081 functional GI disease
NCE AZD9272 GERD
NCE AZD9335 GERD
Neuroscience
NCE/Line Extension Compound Area under investigation
NCE NXY-059 stroke
NCE AZD9272 anxiety
NCE AZD9335 neuropathic pain
NCE AZD7512 depression & anxiety
Oncology and Infection
NCE/Line Extension Compound Area under investigation
Line Extension Faslodex 2nd line after aromatase
inhibitor faliure
Line Extension Iressa Head & Neck
Respiratory and Inflammation
NCE/Line Extension Compound Area under investigation
NCE AZD8955 OA
NCE AZD9056 COPD
NCE AZD8309 RA
NCE AZD8309 COPD
NCE AZD3342 COPD
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).
This information is provided by RNS
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