Pipeline table: Second Quarter & Half Year(2 of 2)

RNS Number : 5549I

AstraZeneca PLC

26 July 2012

 



Development Pipeline as at

30 June 2012

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proton pump inhibitor + low dose aspirin FDC	low dose aspirin associated peptic ulcer in high risk CV patients	III		Withdrawn	Launched	1H 2013*	Approved
Brilinta/ Brilique EUCLID	ADP receptor antagonist	outcomes study in patients with PAD	III	3Q 2012	2016	2016	2016	2016
Brilinta/ Brilique PEGASUS-TIMI 54	ADP receptor antagonist	outcomes study in patients with ACS	III	4Q 2010	2015	2015	2015	2015
Crestor#	statin	outcomes in subjects with elevated CRP	III		Launched	Launched		Launched
ForxigaTM (dapagliflozin)/ metformin FDC#	SGLT2 inhibitor + metformin FDC	diabetes	III	3Q 2007		3Q 2012
ForxigaTM (dapagliflozin)#	SGLT2 inhibitor	diabetes - add on to DPP-4	III	1Q 2010		3Q 2012
ForxigaTM (dapagliflozin)#	SGLT2 inhibitor	diabetes - add on to insulin and add-on to metformin long-term data	III	2Q 2008		3Q 2012
ForxigaTM (dapagliflozin)#	SGLT2 inhibitor	diabetes - in patients with high CV risk - Study 18 and 19 long-term data	III	1Q 2010		2H 2013
ForxigaTM (dapagliflozin)#	SGLT2 inhibitor	diabetes - triple therapy (dapa+met+ SU)	III	1Q 2011		2H 2013
Kombiglyze XRTM/ KomboglyzeTM FDC#**	DPP-4 inhibitor + metformin FDC	diabetes	III		Launched	Approved		Approved
OnglyzaTM SAVOR-TIMI 54#	DPP-4 inhibitor	outcomes study	III	2Q 2010	2016	2016		2016

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Gastrointestinal
Entocort	glucocorticoid steroid	Crohn's disease / ulcerative colitis	III		Launched	Launched	2014	Launched
Nexium	proton pump inhibitor	peptic ulcer bleeding	III		Filed***	Launched		Launched
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	Launched	Launched
Oncology
Faslodex	oestrogen receptor antagonist	1st line advanced breast cancer	III		2016	2016	2016	2016
Iressa	EGFR tyrosine kinase inhibitor	treatment beyond progression	III	1Q 2012		2015	2015	2015
Respiratory & Inflammation
Oxis	long-acting β2 agonist	COPD	III			Launched	Approved
Symbicort	inhaled steroid/ long-acting β2 agonist	asthma / COPD	III	4Q 2011	2014
Symbicort	inhaled steroid/ long-acting β2 agonist	COPD	III		Launched	Launched	Filed	Launched
Symbicort	inhaled steroid/ long-acting β2 agonist	SMART	III			Launched	Launched	Launched

^#Partnered product

* Nexium low-dose aspirin indications approved in 1H 2012

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

***2^nd CRL received in June 2011

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
ForxigaTM (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	N/A	2014	2014	2014
Q-LAIV Flu Vac***	live, attenuated, intranasal influenza virus vaccine  (quadrivalent)	seasonal influenza		III		Approved	4Q 2012
Zinforo# (ceftaroline)	extended spectrum cephalosporin with affinity to penicillin- binding proteins	pneumonia / skin infections		III	1Q 2007	N/A	Filed**		Filed
Neuroscience
naloxegol (NKTR-118)#	oral peripherally-acting opioid antagonist	opioid-induced constipation		III	2Q 2011	2H 2013	2H 2013
Oncology
Caprelsa	VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity	medullary thyroid cancer		III		Launched	Launched	2014		Filed
Ranmark# (denosumab)	anti-RANKL MAb	bone disorders stemming from bone metastasis		III		N/A	N/A	Launched		N/A
Respiratory & Inflammation
fostamatinib#	spleen tyrosine kinase (SYK) inhibitor	rheumatoid arthritis		III	3Q 2010	2H 2013	2H 2013		2H 2013
lesinurad	selective inhibitor of URAT1	chronic management of hyperuricaemia in patients with gout		III	4Q 2011	2014	2014	2016	2014

^#Partnered product

*CRL received in January 2012

**Positive opinion received from CHMP in 1H 2012

***sBLA in US, MAA in EU

NCEs

Phases I and II

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Cardiovascular
AZD4017	11BHSD	glaucoma	II	1Q 2011
AZD2820#	melanocortin receptor type 4 (MC4r) partial agonist peptide	obesity	I	2Q 2011
Gastrointestinal
tralokinumab	anti-IL-13 MAb	ulcerative colitis	II	2Q 2012
Infection
AZD9773#	anti-TNF-alpha polyclonal antibody	severe sepsis	II	1Q 2008
CXL#	beta lactamase inhibitor/ cephalosporin	MRSA	II	4Q 2010
AZD5847	oxazolidinone antibacterial inhibitor	tuberculosis	I	4Q 2009
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
Neuroscience
AZD3241	myeloper-oxidase (MPO) inhibitor	Parkinson's disease	II	2Q 2012
AZD3480#	alpha4/beta2 neuronal nicotinic receptor agonist	Alzheimer's disease	II	3Q 2007
AZD5213	histamine-3 receptor  antagonist	Alzheimer's disease / ADHD	II	2Q 2012
AZD6765	NMDA receptor antagonist	major depressive disorder	II	3Q 2007
AZD1446#	alpha4/beta2 neuronal nicotinic receptor agonist	Alzheimer's disease	I	4Q 2008
MEDI-5117	anti-Il-6 MAb	OA Pain	I	2Q 2012

^#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-551#	anti-CD19 MAb	haematological malignancies	II	1Q 2012
MEDI-573#	anti-IGF MAb	solid tumours	II	2Q 2012
MEDI-575#	anti-PDGFR-alpha MAb	NSCLC / glioblastoma	II	4Q 2010
olaparib	PARP inhibitor	gBRCA ovarian cancer	II	1Q 2012
selumetinib# (AZD6244) (ARRY-142886)	MEK inhibitor	solid tumours	II	4Q 2006
tremelimumab	anti-CTLA4 MAb	solid tumours	II	3Q 2004
AZD1208	PIM kinase inhibitor	haematological malignancies	I	1Q 2012
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-0639	anti-DLL-4 MAb	solid tumours	I	2Q 2012
MEDI-3617#	anti-ANG-2 MAb	solid tumours	I	4Q 2010
MEDI-565#	anti-CEA BiTE	solid tumours	I	1Q 2011
MEDI-6469#	murine anti-OX40 MAb	solid tumours	I	1Q 2006
moxetumomab pasudotox#	anti-CD22 recombinant immunotoxin	haematological malignancies	I	2Q 2007
selumetinib (AZD6244)  (ARRY-142886) /MK2206#	MEK/AKT inhibitor	solid tumours	I	4Q 2009
volitinib#	MET inhibitor	solid tumours	I	1Q 2012

^#Partnered product

NCEs

Phases I and II (continued)

Compound	Mechanism	Area Under Investigation	Phase	Date Commenced Phase	Estimated Filing
					US	EU	Japan	Emerging
Respiratory & Inflammation
AZD2115	MABA	COPD	II	2Q 2012
AZD5069	CXCR2	asthma	II	4Q 2010
AZD5423	inhaled SGRM	COPD	II	4Q 2010
AZD8683	muscarinic antagonist	COPD	II	4Q 2010
benralizumab#	anti-IL-5R MAb	asthma / COPD	II	4Q 2008
brodalumab#	anti-IL-17R MAb	psoriasis / psoriatic arthritis / asthma	II	4Q 2009
mavrilimumab#	anti-GM-CSFR MAb	rheumatoid arthritis	II	1Q 2010
MEDI-546#	anti-IFN-alphaR MAb	SLE	II	1Q 2012
MEDI-8968#	anti-IL-1R MAb	COPD	II	4Q 2011
sifalimumab#	anti-IFN-alpha MAb	SLE	II	3Q 2008
tralokinumab	anti-IL-13 MAb	asthma	II	1Q 2008
AZD8848	inhaled TLR7	asthma	I	2Q 2012
MEDI-2070#	anti-IL-23 MAb	Crohn's disease	I	2Q 2010
MEDI-4212	anti-IgE MAb	asthma	I	1Q 2012
MEDI-551#	anti-CD19 MAb	scleroderma	I	2Q 2010
MEDI-570#	anti-ICOS MAb	SLE	I	2Q 2010
MEDI-5872#	anti-B7RP1 MAb	SLE	I	4Q 2008
MEDI-7183#	anti-A4b7 MAb	Crohn's disease / ulcerative colitis	I	3Q 2010
MEDI-7814	anti-C5/C5a MAb	COPD	I	1Q 2012
MEDI-9929#	anti-TSLP MAb	asthma	I	4Q 2008
RDEA3170	selective inhibitor of URAT1	chronic management of hyperuricaemia in patients with gout	I	3Q 2011

^#Partnered product

Development Pipeline - Discontinued Projects between 31 December 2011 and 30 June 2012

Cardiovascular

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD2927	Safety/Efficacy	atrial fibrillation

Neuroscience

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD2423	Safety/Efficacy	chronic neuropathic pain
NCE	AZD3839	Safety/Efficacy	Alzheimer's disease
NCE	MEDI-578	Regulatory	OA pain
NCE	TC-5214	Safety/Efficacy	major depressive disorder (monotherapy)
NCE	TC-5214	Safety/Efficacy	major depressive disorder (adjunct)

Infection

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD5099	Safety/Efficacy	serious infections
NCE	MEDI-534	Safety/Efficacy	RSV/PIV prophylaxis

Respiratory & Inflammation

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD1981	Safety/Efficacy	asthma/COPD
NCE	AZD2423	Safety/Efficacy	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.

Submission dates shown for assets in Phase III and beyond.

 

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