AstraZeneca PLC — Regulatory Filings 2013

Jan 31, 2013

National Storage Mechanism | Additional information

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RNS Number : 7729W

AstraZeneca PLC

31 January 2013

Development Pipeline as at

31 December 2012

Line Extensions

## Compound	## Mechanism	Area Under Investigation	## Phase	#### Date Commenced Phase	#### Estimated Filing
#### US	#### EU	#### Japan	#### China
##### Cardiovascular
### Axanum	proton pump inhibitor + low dose aspirin FDC	low dose aspirin associated peptic ulcer in high risk CV patients	III		Withdrawn	Launched	2016
### Brilinta/ Brilique ### EUCLID	ADP receptor antagonist	outcomes study in patients with PAD	III	4Q 2012	2016	2016	2016	2017
### Brilinta/ ### Brilique PEGASUS-TIMI 54	ADP receptor antagonist	outcomes study in patients with prior MI	III	4Q 2010	2015	2015	2015	2017
### Bydureon EXSCEL#	GLP-1 receptor agonist	outcomes study	III	2Q 2010	2018
### Bydureon Dual Chamber Pen#	GLP-1 receptor agonist	diabetes	III		3Q 2013
### Forxiga ### (dapagliflozin)/ metformin FDC#	SGLT2 inhibitor + metformin FDC	diabetes	III	3Q 2007		Filed
### Forxiga (dapagliflozin)#	SGLT2 inhibitor	diabetes - add on to DPP-4	III	1Q 2010		Filed
### Forxiga (dapagliflozin)#	SGLT2 inhibitor	diabetes - add on to insulin and add-on to metformin long-term data	III	2Q 2008		Filed
### Forxiga (dapagliflozin)#	SGLT2 inhibitor	diabetes - in patients with high CV risk - Study 18 and 19 long-term data	III	1Q 2010		1H 2014
### Forxiga (dapagliflozin)#	SGLT2 inhibitor	diabetes - triple therapy (dapa+met+ SU)	III	1Q 2011		1Q 2013
### Kombiglyze XR/ Komboglyze FDC#*	DPP-4 inhibitor + metformin FDC	diabetes	III		Launched	Launched		1H 2014
### SaxaDapa FDC#	DPP-4 inhibitor / SGLT2 inhibitor	diabetes	III	2Q 2012	2015	2015
### Onglyza ### SAVOR-TIMI 53#	DPP-4 inhibitor	outcomes study	III	2Q 2010	4Q 2013	4Q 2013		2H 2014

## Compound	## Mechanism	Area Under Investigation	## Phase	#### Date Commenced Phase	#### Estimated Filing
#### US	#### EU		#### Japan	#### China
Gastrointestinal
### Entocort	glucocorticoid steroid	Crohn's disease / ulcerative colitis	III		Launched	Launched		2015
### Nexium	proton pump inhibitor	peptic ulcer bleeding	III		Filed**	Launched		N/A	Launched
## Neuroscience
### Diprivan#	sedative and anaesthetic	conscious sedation	III			Launched		1H 2014	Launched
## Oncology
### Faslodex	oestrogen receptor antagonist	1st line advanced breast cancer	III	4Q 2012	2016	2016	2016		2016
### Iressa	EGFR tyrosine kinase inhibitor	treatment beyond progression	III	1Q 2012		2015	2015		2015
Respiratory & Inflammation
### Symbicort***	inhaled steroid/ long-acting β2 agonist	Breath Actuated Inhaler asthma / COPD	III	4Q 2011	1H 2014

Partnered product

*Kombiglyze XR US; Komboglyze FDC EU

**2nd CRL received from FDA in 2011. AZ response submitted to FDA in December 2012

***Excludes Symbicort pMDI post marketing LABA safety study

NCEs

Phase III/Registration

## Compound	## Mechanism	Area Under Investigation	## Phase		#### Date Commenced Phase	#### Estimated Filing
#### US	#### EU	#### Japan		#### China
##### Cardiovascular
### Brilinta/Brilique	ADP receptor antagonist	arterial thrombosis		III		Launched	Launched	2Q  2013	Approved
### Forxiga (dapagliflozin)#	SGLT2 inhibitor	diabetes		III		Filed*	Launched	1Q 2013	1Q 2013
### metreleptin#	leptin analogue	lipodystrophy		III		2Q 2013		N/A
## Infection
CAZ AVI# ### (CAZ104)	beta lactamase inhibitor/ cephalosporin	serious infections		III	1Q 2012	N/A	2H 2014	2H 2014	2016
### Q-LAIV ### Flu Vaccination**	live, attenuated, intranasal influenza virus vaccine  (quadrivalent)	seasonal influenza		III		Approved	Filed
### Zinforo# (ceftaroline)	extended spectrum cephalosporin with affinity to penicillin- binding proteins	pneumonia / skin infections		III		N/A	Launched		1H 2014
## Neuroscience
### naloxegol (NKTR-118)#	oral peripherally-acting mu-opioid receptor antagonist	opioid-induced constipation		III	2Q 2011	3Q 2013	3Q 2013
## Oncology
Caprelsa	VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity	medullary thyroid cancer		III		Launched	Launched	2015		Filed
Respiratory & Inflammation
### brodalumab#	anti-IL-17R MAb	psoriasis		III	3Q 2012	2015	2015
### fostamatinib#	spleen tyrosine kinase (SYK) inhibitor	rheumatoid arthritis		III	3Q 2010	4Q 2013	4Q 2013
### lesinurad	selective inhibitor of URAT1	chronic management of hyperuricaemia in patients with gout		III	4Q 2011	1H 2014	1H 2014	2017	2017

Partnered product

*CRL received in January 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	#### China
Cardiovascular
### AZD1722#	NHE3 inhibitor	end stage renal disease / chronic kidney disorder	I	4Q 2010
Gastrointestinal
tralokinumab	anti-IL-13 MAb	ulcerative colitis	II	2Q 2012
Infection
AZD5847	oxazolidinone anti-bacterial inhibitor	tuberculosis	II	4Q 2012
CXL#	beta lactamase inhibitor/ cephalosporin	MRSA	II	4Q 2010
ATM AVI	BL/BLI	targeted serious bacterial infections	I	4Q 2012
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	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
### AZD3293#	beta secretase	Alzheimer's disease	I	4Q 2012
### MEDI5117	anti-IL-6 MAb	rheumatoid arthritis	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	#### China
Oncology
AZD4547	FGFR tyrosine kinase inhibitor	solid tumours	II	4Q 2011
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	MBC	II	4Q 2011
MEDI-575#	anti-PDGFR-alpha MAb	NSCLC	II	2Q 2011
### olaparib	PARP inhibitor	gBRCAm ovarian cancer, gBRCAm breast cancer, gastric 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
AZD2014	TOR kinase inhibitor	solid tumours	I	1Q 2010
AZD5363#	AKT inhibitor	solid tumours	I	4Q 2010
AZD8330# (ARRY 424704)	MEK inhibitor	solid tumours	I	1Q 2007
AZD9150	STAT3 inhibitor	haematological malignancies	I	1Q 2012
MEDI0639#	anti-DLL-4 MAb	solid tumours	I	2Q 2012
MEDI3617#	anti-ANG-2 MAb	solid tumours	I	4Q 2010
MEDI4736#	anti-PD-L1 MAb	solid tumours	I	3Q 2012
MEDI-565#	anti-CEA BiTE	solid tumours	I	1Q 2011
MEDI6469#	murine anti-OX40 MAb	solid tumours	I	1Q 2006
moxetumomab pasudotox#	anti-CD22 recombinant immunotoxin	haematological malignancies	I	2Q 2007
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	#### China
Respiratory & Inflammation
### AZD2115#	MABA	COPD	II	2Q 2012
### AZD5069	CXCR2	asthma	II	4Q 2010
### AZD5423#	inhaled SGRM	COPD	II	4Q 2010
### benralizumab#	anti-IL-5R MAb	asthma / COPD	II	4Q 2008
### mavrilimumab#	anti-GM-CSFR MAb	rheumatoid arthritis	II	1Q 2010
MEDI-546#	anti-IFN-alphaR MAb	SLE	II	1Q 2012
MEDI7183#	anti-a4b7 MAb	Crohn's disease / ulcerative colitis	II	4Q 2012
MEDI8968#	anti-IL-1R MAb	COPD	II	4Q 2011
sifalimumab#	anti-IFN-alpha MAb	SLE	II	3Q 2008
### tralokinumab	anti-IL-13 MAb	asthma / IPF	II	1Q 2008
AZD8848#	inhaled TLR7	asthma	I	2Q 2012
AZD7594#	inhaled SGRM	COPD	I	4Q 2012
MEDI2070#	anti-IL-23 MAb	Crohn's disease	I	2Q 2010
MEDI4212	anti-IgE MAb	asthma	I	1Q 2012
MEDI-551#	anti-CD19 MAb	multiple sclerosis	I	3Q 2012
### MEDI5872#	anti-B7RP1 MAb	SLE	I	4Q 2008
### MEDI7814	anti-C5/C5a MAb	COPD	I	1Q 2012
### MEDI9929#	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

Completed Projects

## Compound	## Mechanism	Area Under Investigation	## Phase	#### Date Commenced Phase	#### Estimated Filing
#### US	#### EU		#### Japan	#### China
Cardiovascular
### Crestor#	statin	outcomes in subjects with elevated CRP			Launched	Launched			Launched
Gastrointestinal
### Nexium	proton pump inhibitor	GERD			Launched	Launched		Launched	Launched
Infection
### FluMist/Fluenz	live, attenuated, intranasal influenza virus vaccine	influenza			Launched	Launched
## Neuroscience
### EMLA	local anaesthetic	topical anaesthesia				Launched		Launched
## Oncology
### Iressa	EGFR tyrosine kinase inhibitor	1st line EGFR mut+ NSCLC				Launched	Launched		Launched
### Faslodex	oestrogen receptor agonist	High dose (500mg) 2nd line advanced breast cancer			Launched	Launched	Launched
### Ranmark# (denosumab)	anti-RANKL MAb	Bone disorders stemming from bone metastasis					Launched
Respiratory & Inflammation
### Oxis	long-acting β2 agonist	COPD				Launched		Launched	Launched
### Symbicort	inhaled steroid/ long-acting β2 agonist	COPD			Launched	Launched		Launched	Launched
### Symbicort	inhaled steroid/long acting β2 agonist	SMART				Launched		Launched	Launched

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

Cardiovascular

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD2820	Safety/Efficacy	obesity
NCE	AZD4017	Safety/Efficacy	glaucoma

Infection

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD9773	Safety/Efficacy	severe sepsis

Oncology

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD1480	Safety/Efficacy	solid tumours
NCE	AZD3514	Safety/Efficacy	prostate cancer
NCE	AZD8931	Safety/Efficacy	breast cancer chemo. combi./solid tumours
NCE	selumetinib (AZD6244) (ARRY-142886)/MK2206#	Study completed	solid tumours

Respiratory & Inflammation

NCE/Line Extension	Compound	Reason for Discontinuation	Area Under Investigation
NCE	AZD8683	Safety/Efficacy	COPD
NCE	MEDI-570	Safety/Efficacy	SLE

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.

This information is provided by RNS

The company news service from the London Stock Exchange

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