Final Results - Part 3 of 3

RNS Number : 6676W

AstraZeneca PLC

02 February 2012

 



Development Pipeline as at

31 December 2011

Line Extensions

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Cardiovascular
Axanum	proton pump inhibitor + low dose aspirin FDC	low dose aspirin associated peptic ulcer in high risk CV patients	III		Withdrawn	Launched	1H 2013	Filed
Brilinta/ Brilique PEGASUS-TIMI	ADP receptor antagonist	outcomes study	III	4Q 2010	2014	2014	2014	2014
Crestor#	statin	outcomes in subjects with elevated CRP	III		Launched	Launched		Filed
dapagliflozin/ metformin FDC#	SGLT2 inhibitor + metformin FDC	diabetes	III	3Q 2007		3Q 2012
dapagliflozin#	SGLT2 inhibitor	diabetes - add on to DPP-4	III	1Q 2010		3Q 2012
dapagliflozin#	SGLT2 inhibitor	diabetes - add on to insulin and add-on to metformin LT data	III	2Q 2008		3Q 2012
dapagliflozin#	SGLT2 inhibitor	diabetes - in patients with high CV risk - Study 18 and 19 data	III	1Q 2010		2H 2013
Kombiglyze XRTM/ KomboglyzeTM FDC#*	DPP-4 inhibitor + metformin FDC	diabetes	III		Launched	Approved		Approved
OnglyzaTM SAVOR-TIMI#	DPP-4 inhibitor	outcomes study	III	2Q 2010	2016	2016		2016
Gastrointestinal
Entocort	glucocorticoid steroid	Crohn's disease and ulcerative colitis	III		Launched	Launched	2014	TBC
Nexium	proton pump inhibitor	peptic ulcer bleeding	III		Filed**	Launched		Launched
Nexium	proton pump inhibitor	GERD	III		Launched	Launched	Launched	Launched

^#Partnered product

*Kombiglyze XR^TM US; Komboglyze^TM FDC EU

**2^nd CRL received in June 2011

Line Extensions (continued)

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Infection
FluMist/Fluenz	live, attenuated, intranasal influenza virus vaccine	influenza	III		Launched	Approved		Launched
Neuroscience
Diprivan#	sedative and anaesthetic	conscious sedation	III			Launched	2H 2013	Launched
EMLA#	local anaesthetic	topical anaesthesia	III			Launched	Approved	Launched
Oncology
Faslodex	oestrogen receptor antagonist	high dose (500mg) 2nd line advanced breast cancer	III		Launched	Launched	Launched	Launched
Faslodex	oestrogen receptor antagonist	1st line advanced breast cancer	III		2016	2016	2016	2016
Iressa	EGFR tyrosine kinase inhibitor	1st line EGFR mut+ NSCLC	III			Launched	Launched	Launched
Iressa	EGFR tyrosine kinase inhibitor	treatment beyond progression	III			2015	2015	2015
Respiratory & Inflammation
Oxis	long-acting β2 agonist	COPD	III			Launched	Filed
Symbicort	inhaled steroid/ long-acting β2 agonist	asthma/ COPD	III		1H 2013
Symbicort	inhaled steroid/ long-acting β2 agonist	COPD	III		Launched	Launched	Filed	Launched
Symbicort	inhaled steroid/ long-acting β2 agonist	SMART	III			Launched	Filed	Launched

^#Partnered product

NCEs

Phase III/Registration

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Cardiovascular
Brilinta/Brilique	ADP receptor antagonist	arterial thrombosis	III		Launched	Launched	1H 2013	Launched
dapagliflozin#	SGLT2 inhibitor	diabetes	III	3Q 2007	Filed*	Filed	1H 2013	Filed
Infection
CAZ AVI# (CAZ104)	beta lactamase inhibitor/ cephalosporin	serious infections	III**	1Q 2012		2014	2014	2014
Q-LAIV Flu Vac  (MEDI-3250***)	live, attenuated, intranasal influenza virus vaccine  (quadrivalent)	seasonal influenza	III	1Q 2009	Filed	4Q 2012
Zinforo# (ceftaroline)	extended spectrum cephalosporin with affinity to penicillin- binding proteins	pneumonia / skin infections	III	1Q 2007		Filed		Filed
Neuroscience
NKTR-118#	oral peripherally-acting opioid antagonist	opioid-induced constipation	III	2Q 2011****	2H 2013	2H 2013
TC-5214#	neuronal nicotinic channel modulator	major depressive disorder (adjunct)	III	2Q 2010	3Q 2012	2015
Oncology
Caprelsa	VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity	medullary thyroid cancer	III		Launched	Filed	2014	Filed
Ranmark# (denosumab)	anti-RANKL MAb	bone disorders stemming from bone metastasis	III				Approved
Respiratory & Inflammation
fostamatinib#	spleen tyrosine kinase (SYK) inhibitor	rheumatoid arthritis	III	3Q 2010	2H 2013	2H 2013		2H 2013

^#Partnered product

*CRL received in January 2012

**Phase 3 dosing expected in 1Q 2012

***sBLA in US, MAA in EU

****Enrolment began in 1Q 2011

NCEs

Phases I and II

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Cardiovascular
AZD2927	ion channel blocker / inhibitor	atrial fibrillation	II	4Q 2011
AZD4017	11BHSD	glaucoma	II	1Q 2011
AZD2820#	melanocortin receptor type 4 (MC4r) partial agonist peptide	obesity	I	2Q 2011
Gastrointestinal
tralokinumab  (CAT-354)	anti-IL-13 MAb	ulcerative colitis	I	2Q 2011
Infection
AZD9773#	anti-TNF-alpha polyclonal antibody	severe sepsis	II	1Q 2008
CXL# (CEF104)	beta lactamase inhibitor/ cephalosporin	MRSA	II	4Q 2010
AZD5099	gyrase B	serious infections	I	2Q 2011
AZD5847	oxazolidinone antibacterial inhibitor	tuberculosis	I	4Q 2009
MEDI-534	RSV/PIV-3 vaccine	RSV/PIV prophylaxis	I	2Q 2005
MEDI-550	pandemic influenza virus vaccine	pandemic influenza prophylaxis	I	2Q 2006
MEDI-557	anti-RSV MAb - extended half-life	RSV prevention in high-risk adults (COPD/CHF/ Other)	I	3Q 2007
MEDI-559	paediatric  RSV vaccine	RSV prophylaxis	I	4Q 2008

^#Partnered product

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Neuroscience
AZD2423	CCR2b antagonist	chronic neuropathic pain	II	4Q 2010
AZD3480#	alpha4/beta2 neuronal nicotinic receptor agonist	Alzheimer's disease	II	3Q 2007
AZD6765	NMDA receptor antagonist	major depressive disorder	II	3Q 2007
TC-5214#	neuronal nicotinic channel modulator	major depressive disorder (monotherapy)	II	1Q 2011
AZD1446#	alpha4/beta2 neuronal nicotinic receptor agonist	Alzheimer's disease	I	4Q 2008
AZD3241	myeloper-oxidase (MPO) inhibitor	Parkinson's disease	I	2Q 2007
AZD3839#	beta-secretase (BACE) inhibitor	Alzheimer's disease	I	3Q 2011
AZD5213	histamine-3 receptor  antagonist	Alzheimer's disease / ADHD	I	2Q 2010
MEDI-578	anti-NGF MAb	OA pain	I	1Q 2010

^#Partnered product

NCEs

Phases I and II (continued)

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Oncology
AZD4547	FGFR tyrosine kinase inhibitor	solid tumours	II	4Q 2011
AZD8931	erbB kinase inhibitor	breast cancer chemo. combi./solid tumours	II	2Q 2010
fostamatinib#*	spleen tyrosine kinase (SYK) inhibitor	haematological malignancies	II	1Q 2012
MEDI-575#	anti-PDGFR-alpha MAb	NSCLC / glioblastoma	II	4Q 2010
selumetinib# (AZD6244) (ARRY-142886)	MEK inhibitor	solid tumours	II	4Q 2006
tremelimumab#	anti-CTLA4 MAb	solid tumours	II	3Q 2004
AZD1480	JAK1, 2 inhibitor	solid tumours	I	2Q 2009
AZD2014	TOR kinase inhibitor	solid tumours	I	1Q 2010
AZD3514	androgen receptor down-regulator	prostate cancer	I	3Q 2010
AZD5363#	AKT inhibitor	solid tumours	I	4Q 2010
AZD8330# (ARRY 424704)	MEK inhibitor	solid tumours	I	1Q 2007
MEDI-551#	anti-CD19 MAb	haematological malignancies	I	2Q 2010
MEDI-565#	anti-CEA BiTE	solid tumours	I	1Q 2011
MEDI-573#	anti-IGF MAb	solid tumours	I	1Q 2009
MEDI-3617#	anti-ANG-2 MAb	solid tumours	I	4Q 2010
moxetumomab pasudotox# (CAT-8015)	anti-CD22 recombinant immunotoxin	haematological malignancies	I	2Q 2007
olaparib	PARP inhibitor	solid tumours	I	4Q 2008
selumetinib (AZD6244)  (ARRY-142886) /MK2206#	MEK/AKT inhibitor	solid tumours	I	4Q 2009

^#Partnered product

*Added to pipeline table after starting Phase 2 in January 2012

NCEs

Phases I and II (continued)

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Respiratory & Inflammation
AZD1981	CRTh2 receptor antagonist	asthma/COPD	II	3Q 2005
AZD2423	CCR2b antagonist	COPD	II	4Q 2010
AZD5069	CXCR2	COPD	II	4Q 2010
AZD5423	inhaled SEGRA	COPD	II	4Q 2010
AZD8683	muscarinic antagonist	COPD	II	4Q 2010
benralizumab (MEDI-563)#	anti-IL-5R MAb	asthma/COPD	II	4Q 2008
mavrilimumab (CAM-3001)#	anti-GM-CSFR MAb	rheumatoid arthritis	II	1Q 2010
MEDI-8968#	anti-IL-1R MAb	COPD	II	4Q 2011
sifalimumab (MEDI-545)#	anti-IFN-alpha MAb	SLE	II	3Q 2008
tralokinumab (CAT-354)	anti-IL-13 MAb	asthma	II	1Q 2008
AZD2115	MABA	COPD	I	1Q 2011
MEDI-546#	anti-IFN-alphaR MAb	scleroderma	I	3Q 2009
MEDI-551#	anti-CD19 MAb	scleroderma	I	2Q 2010
MEDI-570#	anti-ICOS MAb	SLE	I	2Q 2010

^#Partnered product

Development Pipeline - Discontinued Projects between 27 January 2011 and 31 December 2011

Cardiovascular

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD1656	Safety/Efficacy	diabetes
NCE	AZD5658	Safety/Efficacy	diabetes
NCE	AZD6714	Safety/Efficacy	diabetes
NCE	AZD7687	Safety/Efficacy	diabetes
NCE	AZD8329	Safety/Efficacy	diabetes

Neuroscience

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD2066	Safety/Efficacy	major depressive disorder
NCE	AZD2066	Safety/Efficacy	chronic neuropathic pain
NCE	AZD3043	Economic	short acting sedative/anaesthetic
NCE	TC-5619	Economic	cognitive disorders in schizophrenia

Oncology

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD1152	Economic	haematological malignancies
NCE	AZD2461	Safety/Efficacy	solid tumours
NCE	AZD7762	Safety/Efficacy	solid tumours
NCE	AZD8055	Safety/Efficacy	range of tumours
NCE	olaparib (AZD2281)	Safety/Efficacy	serous ovarian cancer
NCE	Recentin	Safety/Efficacy	NSCLC
NCE	zibotentan (ZD4054)	Safety/Efficacy	castrate resistant prostate cancer

Infection

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD9742	Safety/Efficacy	MRSA
NCE	motavizumab	Regulatory	early and late treatment of RSV in paeds >1 yr

Respiratory & Inflammation

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD3199	Economic/Regulatory	asthma/COPD
NCE	AZD9819	Economic	COPD
NCE	MEDI-528	Safety/Efficacy	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.

Submission dates shown for assets in Phase III and beyond.

 

END

 

 

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