AstraZeneca PLC
27 January 2005
AstraZeneca Development Pipeline: NCEs and line extensions
27 January 2005
Cardiovascular
NCEs
Compound Mechanism Area under investigation Phase Estimated Filing
MAA NDA
Exanta thrombin inhibitor prevention of VTE III Launched Filed*
Exanta thrombin inhibitor (s.c.) prevention of VTE III Launched >2007
SC formulation
Galida PPAR agonist diabetes /metabolic III 2007 2007
syndrome
AZD6140 ADP receptor antagonist arterial thrombosis II >2007 >2007
AZD7009 antiarrhythmic IV atrial fibrillation - II >2007 >2007
conversion
AZD7009 antiarrhythmic oral atrial fibrillation - II >2007 >2007
maintenance
AZD9684 CPU inhibitor thrombosis II >2007 >2007
AZD0837 thrombin inhibitor thrombosis II >2007 >2007
AZD7806 IBAT inhibitor dyslipidaemia I >2007 >2007
AZD4619 dyslipidaemia I >2007 >2007
AZD6610 dyslipidaemia/diabetes I >2007 >2007
AZD8294 dyslipidaemia PC >2007 >2007
AZD8677 dyslipidaemia/diabetes PC >2007 >2007
AZD8450 dyslipidaemia PC >2007 >2007
AZD6370 diabetes PC >2007 >2007
Line Extensions
Atacand angiotensin II antagonist CHF outcomes III Approved Filed
(CHARM study)
Atacand angiotensin II antagonist diabetic retinopathy III > 2007 >2007
Crestor statin atheroma III 2H2006 2H2006
Crestor statin outcomes CHF III >2007 >2007
Crestor statin outcomes Renal III 2007 2007
Seloken/Toprol-XL beta-blocker HCTZ combination III 3Q2005
Exanta thrombin inhibitor prevention of stroke in III Filed Filed*
AF
Exanta thrombin inhibitor treatment of VTE III Filed >2007
Exanta thrombin inhibitor arterial/post MI II >2007 >2007
* Discussions are ongoing with the FDA to determine if there is now a realistic prospect of bringing Exanta to
the US market. The NDA file remains open.
Gastrointestinal
NCEs
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
AZD0865 potassium-competitive acid acid related GI disease II 2007 2007
blocker (P-CAB).
AZD7371 functional GI disease II >2007 >2007
AZD3355 inhibitor of transient lower gastro-oesophageal I >2007 >2007
oesophageal sphincter reflux disease (GERD)
relaxations (TLESR)
AZD9343 inhibitor of transient lower gastro-oesophageal I >2007 >2007
oesophageal sphincter reflux disease (GERD)
relaxations (TLESR)
AZD5745 acid related GI disease PC >2007 >2007
AZD8081 functional GI disease PC >2007 >2007
Line Extensions
Nexium proton pump inhibitor NSAID GI side effects - III Promotable* Filed
symptom resolution
Nexium proton pump inhibitor parenteral formulation III Launched Filed
Nexium proton pump inhibitor NSAID GI side effects - III Launched Launched
ulcer prevention
Nexium proton pump inhibitor NSAID GI side effects - III Launched Filed
ulcer healing
Nexium proton pump inhibitor extra-oesophageal II >2007 >2007
reflux disease
* Authorities stated these symptoms were already captured within the GERD label. Text stating 'No clinical
interaction with naproxen or rofecoxib' was approved.
Neuroscience
NCEs
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
Cerovive free radical trapping agent stroke III 2H 2006 2H 2006
AZD 7371 overactive bladder II >2007 >2007
AZD8129 (AR-A2) 5HT1B antagonist anxiety/depression II >2007 >2007
AZD4282 NMDA antagonist neuropathic pain I >2007 >2007
AZD3102 Alzheimer's disease PC >2007 >2007
AZD1080 Alzheimer's disease PC >2007 >2007
AZD9272 neuropathic pain PC >2007 >2007
AZD2327 anxiety PC >2007 >2007
AZD5904 multiple sclerosis PC >2007 >2007
AZD6538 neuropathic pain PC >2007 >2007
Line Extensions
Seroquel D2/5HT2 antagonist sustained release III 1H 2006 1H 2006
Seroquel D2/5HT2 antagonist bipolar maintenance III 2007 2007
Seroquel D2/5HT2 antagonist bipolar depression III 2007 1H 2006
Oncology and Infection
NCEs
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
Iressa EGFR-TK inhibitor NSCLC III Withdrawn Launched
ZD6474 angiogenesis inhibitor solid tumours II >2007 >2007
(VEGFR-TKI)
ZD4054 endothelin A receptor solid tumours II >2007 >2007
antagonist
AZD2171 angiogenesis inhibitor solid tumours I >2007 >2007
(VEGFR-TKI)
AZD3409 farnesyl-transferase solid tumours I >2007 >2007
inhibitor
( FAR )
AZD0530 SRC kinase inhibitor solid tumours and I >2007 >2007
haematological
malignancies
AZD5438 selective cyclin dependent solid tumours I >2007 >2007
kinase inhibitor
AZD6244 MEK inhibitor solid tumours I >2007 >2007
ZD6126 vascular targeting agent solid tumours PC >2007 >2007
AZD4440 vascular targeting agent solid tumours PC >2007 >2007
AZD9935 angiogenesis inhibitor solid tumours PC >2007 >2007
(VEGFR-TKI)
AZD0424 SRC kinase inhibitor solid tumours PC >2007 >2007
AZD1152 aurora kinase inhibitor solid tumours and PC >2007 >2007
haematological
malignancies
AZD4769 solid tumours PC >2007 >2007
AZD3841 solid tumours PC >2007 >2007
AZD8931 solid tumours PC >2007 >2007
Line Extensions
Merrem carbapenem antibiotic skin and soft tissue III Filed
infections
Faslodex oestrogen receptor 1st line advanced III >2007 >2007
antagonist breast cancer
Iressa EGFR-TK inhibitor head & neck cancer* III 2H 2006 2H 2006
Iressa EGFR-TK inhibitor breast cancer* II >2007 >2007
Iressa EGFR-TK inhibitor colorectal cancer* II >2007 >2007
* under review
Respiratory and Inflammation
NCEs
Compound Mechanism Area under Phase Estimated Filing
investigation MAA NDA
AZD9056 ion channel blocker rheumatoid arthritis II >2007 >2007
AZD9056 ion channel blocker osteoarthritis II >2007 >2007
AZD8309 chemokine receptor antagonist rheumatoid arthritis I >2007 >2007
AZD8955 collagenase inhibitor osteoarthritis I >2007 >2007
AZD8309 chemokine receptor antagonist COPD I >2007 >2007
AZD3778 chemokine receptor antagonist asthma / rhinitis I >2007 >2007
AZD9056 ion channel blocker COPD I >2007 >2007
AZD3342 protease inhibitor COPD I >2007 >2007
AZD6067 protease inhibitor COPD PC >2007 >2007
AZD2098 asthma PC >2007 >2007
AZD1981 asthma PC >2007 >2007
AZD0902 ion channel blocker rheumatoid arthritis PC >2007 >2007
AZD6703 rheumatoid arthritis PC >2007 >2007
AZD6357 osteoarthritis PC >2007 >2007
AZD7928 COPD PC >2007 >2007
AZD2914 COPD PC >2007 >2007
AZD2392 asthma/rhinitis PC >2007 >2007
AZD1744 asthma/rhinitis PC >2007 >2007
AZD5672 rheumatoid arthritis PC >2007 >2007
Line Extensions
Symbicort Turbuhaler inhaled steroid/fast onset, single therapy for III 2H 2005
long-acting ss2 agonist asthma
Symbicort pMDI inhaled steroid/fast onset, asthma III Filed 2Q/3Q 2005*
long-acting ss2 agonist
Symbicort pMDI inhaled steroid/fast onset, COPD III Filed 2007
long-acting ss2 agonist
* US development of the Symbicort pMDI is progressing and the Phase III clinical programme in asthma is
complete. Following a pre-NDA meeting with the FDA in the fourth quarter of 2004, an NDA filing for this
formulation is now targeted for Q2/Q3 2005, although FDA has identified some issues associated with the inhaler
that require the generation of additional chemistry and manufacturing data or possible modification of the
device in order to achieve approval.
AstraZeneca Development Pipeline: Discontinued Projects
6 October 2004 vs. 27 January 2005
Cardiovascular
NCE /Line Extension Compound Area under investigation
NCE AZD0303 thrombosis
Gastrointestinal
NCE /Line Extension Compound Area under investigation
NCE AZD9139 Acid related GI disease
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)
NCE - New Chemical Entity
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