AstraZeneca PLC
31 January 2008
AstraZeneca Development Pipeline
31 January 2008
Line Extensions
Compound Mechanism Area Under Investigation Phase Estimated Filing
MAA NDA
Cardiovascular
Atacand angiotensin II antagonist diabetic retinopathy III 1H 2009 1H 2009
Atacand Plus angiotensin II antagonist/ 32/12.5 mg, 32/25 mg for III 2Q 2008
thiazide diuretic hypertension
Crestor statin atherosclerosis III Launched Launched
Crestor statin outcomes End Stage Renal III 1H 2009 1H 2009
Disease
Crestor statin outcomes in subjects III 2010 2010
with elevated CRP
Saxagliptin/ DPP-4 + biguanide FDC diabetes III
Metformin FDC
Dapagliflozin/ SGLT2 + biguanide FDC diabetes III
Metformin FDC
Gastrointestinal
Nexium proton pump inhibitor peptic ulcer bleeding III 2Q 2008 2Q 2008
Nexium Sachet proton pump inhibitor GERD III Approved** Launched
formulation
Nexium proton pump inhibitor extra-oesophageal reflux II 2H 2009* 2H 2009*
disease
Nexium low dose proton pump inhibitor low dose aspirin III 1H 2009
aspirin combination associated peptic ulcer
Neuroscience
Seroquel XR D2/5HT2 antagonist schizophrenia III Approved Launched
Seroquel D2/5HT2 antagonist bipolar maintenance III 2Q 2008 Filed
Seroquel D2/5HT2 antagonist bipolar depression III 1Q 2008 Launched
Seroquel XR D2/5HT2 antagonist generalised anxiety III 4Q 2008 2Q 2008
disorder
Seroquel XR D2/5HT2 antagonist major depressive III 3Q 2008 1Q 2008
disorder
Seroquel XR D2/5HT2 antagonist bipolar mania III 1Q 2008 Filed
Seroquel XR D2/5HT2 antagonist bipolar depression III 1Q 2008 Filed
Oncology & Infection
Faslodex oestrogen receptor 1st line advanced breast III
antagonist cancer
Faslodex oestrogen receptor adjuvant III
antagonist
Iressa EGFR-TK inhibitor NSCLC III 2Q 2008
FluMist live, attenuated, influenza III 2Q 2008 Launched
(MedImmune) intranasal influenza virus
vaccine
*Project Extraesophageal reflux disease (reflux asthma) will be completed but
will not result in a regulatory filing.
** Approved by EU RMS, Mutual Recognition Procedure ongoing
Line Extensions (continued)
Compound Mechanism Area Under Investigation Phase Estimated Filing
MAA NDA
Respiratory & Inflammation
Symbicort pMDI inhaled steroid/fast onset, asthma III Filed* Launched**
long-acting beta2
agonist
Symbicort pMDI inhaled steroid/fast onset, COPD III Filed* 2Q 2008
long-acting beta2
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 Investigation Phase Estimated Filing
MAA NDA
Cardiovascular
AZD6140 ADP receptor antagonist arterial thrombosis III 2H 2009 2H 2009
Saxagliptin dipeptidyl peptidase-4 diabetes III 2H 2009 2Q 2008
(DPP-4) inhibitor
Dapagliflozin sodium-glucose diabetes III 2010 2010
cotransporter-2 (SGLT2)
inhibitor
Crestor/ABT-335 statin + fibrate fixed dyslipidaemia III 2H 2009
combination
Neuroscience
PN400 naproxen +esomeprazole signs and symptoms of OA III 1H 2009 1H 2009
, RA, and AS
Oncology & Infection
Zactima VEGF/EGF TK inhibitor with NSCLC III 4Q 2008 4Q 2008
RET kinase activity
Recentin VEGF signalling inhibitor NSCLC and CRC II/III 2010 2010
(VEGFR-TKI)
Recentin VEGF signalling inhibitor recurrent glioblastoma III 2010 2010
(VEGFR-TKI)
ZD4054 endothelin A receptor hormone resistant III 2011 2011
antagonist prostate cancer
Motavizumab humanized monoclonal RSV prevention III 1H 2009 1Q 2008
(MedImmune) antibody
NCE's
Phases I and II
Compound Mechanism Area Under Investigation Phase Estimated Filing
MAA NDA
Cardiovascular
AZD0837 thrombin inhibitor thrombosis II 2012 2012
AZD4121 cholesterol absorption dyslipidaemia II
inhibitor
AZD2207 CB1 antagonist diabetes/obesity II
AZD1175 CB1 antagonist diabetes/obesity I
AZD1305 antiarrhythmic arrhythmias I
AZD6370 GLK activator diabetes I
Gastrointestinal
AZD3355 inhibitor of transient GERD II 2011 2011
lower oesophageal sphincter
relaxations (TLESR)
AZD2066 metabotropic Glutamate GERD I
receptors subtype 5
AZD1386 Vanilloid receptor 1 GERD I
antagonist
Neuroscience
AZD3480 neuronal nicotinic receptor cognitive disorders in II 2011 2011
agonist schizophrenia
AZD3480 neuronal nicotinic receptor Alzheimers II 2011 2011
agonist
AZD6765 NMDA receptor antagonist depression II
AZD2327 enkephalinergic receptor anxiety and depression I
modulator
AZD5904 inhibitor of multiple sclerosis I
myeloperoxidase (MPO)
AZD3241 inhibitor of Parkinson's disease I
myeloperoxidase (MPO)
AZD0328 selective neuronal Alzheimers I
nicotinic receptor agonist
AZD1940 CB receptor agonist nociceptive and I
neuropathic pain
AZD2624 NK receptor antagonist schizophrenia I
AZD1386 Vanilloid receptor chronic nociceptive pain I
antagonist
AZD2066 metabotropic Glutamate chronic nociceptive pain I
receptors
AZD7325 GABA receptor subtype anxiety I
partial agonist
AZD6280 GABA receptor subtype anxiety I
partial agonist
TC-5619 (Targacept) neuronal nicotinic receptor cognitive disorders in I
agonist schizophrenia
Phases I and II (continued)
Compound Mechanism Area Under Investigation Phase Estimated Filing
MAA NDA
Oncology & Infection
Zactima VEGF/EGF TK inhibitor with medullary thyroid cancer II 4Q 2008 4Q 2008
RET kinase activity
CytoFab anti-TNF-alpha polyclonal severe sepsis II
antibody
AZD6244 MEK inhibitor solid tumours II
(ARRY-142886)
AZD2281 PARP inhibitor breast cancer II
EBV vaccine* Epstein-Barr Virus Vaccine post-transplant II
proliferative disease
AZD2836 5a replicon hepatitis C II
AZD0530 SRC kinase inhibitor solid tumours and II
haematological
malignancies
MEDI-524 MAb targets F-Protein early and late treatment II
(Motavizumab) of disease in paeds >1
yr
MEDI-561 HSP 90 inhibitor solid tumours II 2010
AZD1152 aurora kinase inhibitor solid tumours and I
haematological
malignancies
AZD4769 EGFR tyrosine kinase solid tumours I
inhibitor
AZD4877 Cell Cycle Agent solid tumours and I
haematological
malignancies
AZD8931 erbB kinase inhibitor solid tumours I
AZD7762 CHK1 Kinase Inhibitor solid tumours I
AZD8330 MEK inhibitor solid tumours I
(ARRY-424704)
CAT-8015 recombinant immunotoxin haematological I
malignancies
MEDI-534 RSV/PIV-3 vaccine intranasal immunisation I
MEDI-560 PIV-3 vaccine intranasal immunisation I
H5N1 H5N1 Influenza Virus pandemic influenza I
Vaccine vaccine
MEDI-538 CD19 B cells leukaemia/lymphoma I
MEDI-564 F protein inhibitor RSV treatment I
CMV Vaccine CMV vaccine cytomegalovirus I
MEDI-557 YTE - extended half-life RSV Prophylaxis I
RSV Mab
*Partnered product
Phases I and II (continued)
Compound Mechanism Area Under Investigation Phase Estimated Filing
MAA NDA
Respiratory & Inflammation
AZD9056 ion channel blocker (P2X7) rheumatoid arthritis II 2012 2012
AZD1981 Prostaglandin receptor asthma II
antagonist
AZD5672 Chemokine antagonist (CCR5) rheumatoid arthritis II 2012 2012
MEDI-528 anti-IL-9 antibody asthma II
AZD4818 CCR1 antagonist COPD I
CAT-354 anti-IL-13 antibody asthma I
AZD5904 MPO inhibitor COPD I
AZD1744 Dual CCR3/H1 receptor COPD I
antagonist
AZD1236 Matrix metalloproteinase COPD I
inhibition
AZD9668 Neutrophil Elastase COPD I
Inhibitor
MEDI-563 anti-IL-5R antibody asthma I
MEDI-545 anti-IFNa antibody SLE, myositis I
Pneumococcal Pneumococcal vaccine Streptococcus pneumoniae I
vaccine*
AZD3199 iLABA asthma/COPD I
CAM-3001 anti-GM-CSFR antibody rheumatoid arthritis I
*Partnered product
AstraZeneca Development Pipeline
Discontinued Projects vs 26 July 2007 HY
Cardiovascular & Gastrointestinal
NCE/Line Extension Compound Area Under Investigation
NCE AZD1283 thrombosis
NCE AZD3988 diabetes/obesity
NCE AZD3118 arrhythmias
LE Crestor Outcomes CHF CHF
LE Nexium NSAID GI US ulcer healing
LE Nexium NSAID GI side effects US symptom resolution
NCE AZD9056 Inflammatory bowel disease
Neuroscience
NCE/Line Extension Compound Area Under Investigation
NCE AZD3783 anxiety & depression
NCE AZD1080 Alzheimers
Oncology & Infection
NCE/Line Extension Compound Area Under Investigation
NCE AZD6495 range of tumours
NCE CAT-5001 solid tumours
NCE AZD5180 solid tumours
NCE hMPV MAb respiratory infection
NCE MEDI-552 leukaemia/lymphoma
NCE MEDI-555 solid tumours
NCE MEDI-562 solid tumours
NCE CAT-3888 hairy cell leukaemia
NCE AZD9935 solid tumours
NCE AZD4992 breast cancer
Respiratory & Inflammation
NCE/Line Extension Compound Area Under Investigation
NCE MEDI-552 inflammation
NCE Anti-IL6 MAb inflammation
NCE anti Chitinase MAb asthma/COPD
NCE AZD6357 osteoarthritis
NCE AZD6605 osteoarthritis
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.
Projects shaded in grey were communicated as discontinued at the Biologics
Review, Dec 7th 2007
Abbreviations:
MAA - Marketing Authorisation Application (Europe).
NDA - New Drug Application/Biologics Licensing Application (USA).
This information is provided by RNS
The company news service from the London Stock Exchange
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