Second Quarter and Half Year

RNS Number : 1321Q

AstraZeneca PLC

29 July 2010

 



AstraZeneca Development Pipeline

29 July 2010

Line Extensions

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
Crestor	statin	outcomes in subjects with elevated CRP	III	Launched	Launched
Dapagliflozin/ metformin FDC#	SGLT2 inhibitor + metformin FDC	diabetes	III	1H 2012	1H 2012
Onglyza/ metformin FDC#	DPP-4 inhibitor + metformin FDC	diabetes	III	3Q 2010	Filed
Onglyza#	DPP-4 inhibitor	outcomes study	III		2016
Gastrointestinal
Axanum	proton pump inhibitor + low dose aspirin FDC	low dose aspirin associated peptic ulcer	III	Filed*	Filed
Nexium	proton pump inhibitor	peptic ulcer bleeding	III	Launched	Filed
Neuroscience
Seroquel XR	D2/5HT2 antagonist	major depressive disorder	III	Filed	Launched**
Seroquel XR	D2/5HT2 antagonist	generalised anxiety disorder	III	Filed	Withdrawn
Oncology & Infection
Faslodex	oestrogen receptor antagonist	first line advanced breast cancer	III
Faslodex	oestrogen receptor antagonist	high dose (500mg) second line advanced breast cancer	III	Launched	Filed
FluMist	live, attenuated, intranasal influenza virus vaccine	influenza	III	Filed	Launched
Iressa	EGFR tyrosine kinase inhibitor	NSCLC	III	Launched	TBD
Motavizumab#	humanized mAb binding to RSV F protein	early and late treatment of RSV in paeds >1 yr	II		2015

^#Partnered product

*Previously submission was indication only. Now covers fixed dose combination

**Adjunct only, monotherapy withdrawn

Onglyza and dapagliflozin are being co-developed with Bristol-Myers Squibb

NCEs

Phase III/Registration

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
Brilinta/Brilique	ADP receptor antagonist	arterial thrombosis	III	Filed	Filed
Certriad#	statin + fibrate FDC	dyslipidaemia	III		Filed
Dapagliflozin#	SGLT2 inhibitor	diabetes	III	4Q 2010*	4Q 2010*
Neuroscience
TC-5214#	nicotinic ion channel blocker	major depressive disorder (adjunct)	III	2014	2012
Vimovo#	naproxen + esomeprazole	signs and symptoms of OA, RA and AS	III	Filed	Approved
Oncology & Infection
Ceftaroline#	extended spectrum cephalosporin with affinity to penicillin- binding proteins	pneumonia /skin infections	III	4Q 2010	NA
MEDI-3250	flu vaccine (quadrivalent)	seasonal influenza	III		1H 2011
Motavizumab#	humanized MAb binding to RSV F protein	RSV prevention	III	4Q 2010	Filed
Vandetanib (Zactima)	VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity	medullary thyroid cancer - orphan	III	3Q 2010	3Q 2010
Zibotentan (ZD4054)	endothelin A receptor antagonist	castrate resistant prostate cancer	III	1H 2011	1H 2011

^#Partnered product

*Timing subject to CV event rate

NCEs

Phases I and II

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
AZD1656	GK activator	diabetes	II	2015	2015
AZD6370	GK activator	diabetes	II
AZD4017	11BHSD inhibitor	diabetes/obesity	I
AZD6714	GK activator	diabetes	I
AZD7687	diacylglycerol acyl transferase -1 inhibitor	diabetes/obesity	I
AZD8329	11BHSD inhibitor	diabetes/obesity	I
Gastrointestinal
AZD1386	vanilloid receptor antagonist	GERD	II
Lesogaberan (AZD3355)	GABAB agonist	GERD	II	2013	2013
AZD2066	metabotropic glutamate receptor 5 antagonist	GERD	I
AZD2516	metabotropic glutamate receptor 5 antagonist	GERD	I

NCEs

Phases I and II (continued)

Compound	Mechanism		Area Under Investigation		Phase		Estimated Filing
							MAA	NDA
Neuroscience
AZD1446#		Alpha4/beta2 neuronal nicotinic receptor agonist		Alzheimer's disease/ADHD	II
AZD2066		metabotropic glutamate receptor 5 antagonist		chronic neuropathic pain	II
AZD2066		metabotropic glutamate receptor 5 antagonist		major depressive disorder	II
AZD2327		enkephalinergic receptor modulator		depression/anxiety	II
AZD3480#		Alpha4/beta2 neuronal nicotinic receptor agonist		ADHD	II
AZD6765		NMDA receptor antagonist		major depressive disorder	II	2015			2014
AZD7268		enkephalinergic receptor modulator		depression/anxiety	II
AZD8529		glutamatergic modulator		schizophrenia	II
NKTR-118#		oral peripherally-acting opioid antagonist		opioid-induced constipation	II	2013			2013
TC-5214#		nicotinic ion channel blocker		major depressive disorder (monotherapy)	II
TC-5619#		Alpha7 neuronal nicotinic receptor agonist		cognitive disorders in schizophrenia	II
AZD2423		chemokine antagonist		chronic neuropathic pain	I
AZD2516		metabotropic glutamate receptor 5 antagonist		chronic neuropathic pain	I
AZD3043#		GABA-A receptor modulator		short acting sedative/anaesthetic	I
AZD3241		myeloperoxidase (MPO) inhibitor		Parkinson's disease	I
AZD5213		H3AN		Alzheimer's disease/ADHD	I
MEDI-578		anti-NGF mAb		OA pain	I

^#Partnered product

NCEs

Phases I and II (continued)

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Oncology & Infection
Recentin	VEGFR tyrosine kinase inhibitor	NSCLC	II	2013	2013
AZD9773 (CytoFab)#	anti-TNF-alpha polyclonal antibody	severe sepsis	II	2015	2015
AZD6244# (ARRY-142886)	MEK inhibitor	solid tumours	II	2014	2014
Olaparib	PARP inhibitor	gBRCA breast cancer	II	2014	2014
Olaparib	PARP inhibitor	serous ovarian cancer	II	2014	2014
AZD7295	NS 5A inhibitor	hepatitis C	II	2015	2015
AZD1152	aurora kinase inhibitor	haematological malignancies	II	2014	2014
CAZ104#	beta lactamase inhibitor/cephalosporin	serious infections	II	2012	NA
AZD8931	erbB kinase inhibitor	solid tumours	II	2015	2015
AZD4769	EGFR tyrosine kinase inhibitor	solid tumours	I
AZD7762	Chk1 kinase inhibitor	solid tumours	I
AZD8330# (ARRY-424704)	MEK inhibitor	solid tumours	I
CAT-8015	anti-CD22 recombinant immunotoxin	haematological malignancies	I
MEDI-534	RSV/PIV-3 vaccine	RSV/PIV prophylaxis	I
MEDI-551	CD19	haematological malignancies	I
MEDI-560	PIV-3 vaccine	PIV prophylaxis	I
MEDI-550	pandemic influenza virus vaccine	pandemic influenza prophylaxis	I
MEDI-557	RSV mAb - extended half-life	COPD	I
AZD8055	TOR kinase inhibitor	range of tumours	I
MEDI-559	RSV vaccine	RSV prophylaxis	I
MEDI-573	IGF	solid tumours	I
MEDI-575	PDGFR-alpha	solid tumours	I
AZD1480	JAK2 inhibitor	myeloproliferative diseases/solid tumours	I
AZD5847	Oxazolidinone antibacterial inhibitor	tuberculosis	I
AZD4547	FGFR tyrosine kinase inhibitor	solid tumours	I
MEDI-547#	EphA2 conjugate	solid tumours	I
AZD9742	BTGT4 IV	MRSA	I
CEF104#	beta lactamase inhibitor/cephalosporin	MRSA	I
AZD2014	TOR kinase inhibitor	solid tumours	I
AZD6244  (ARRY-142886) /MK2206#	MEK/AKT inhibitor	solid tumours	I

Phases I and II (continued)

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Respiratory & Inflammation
AZD1981	CRTh2 receptor antagonist	asthma/COPD	II
AZD3199	iLABA	asthma/COPD	II
AZD8848	Toll like receptor 7 agonist	asthma	II
AZD9668	neutrophil elastase inhibitor	COPD	II	2014	2014
CAM-3001#	anti-GM-CSFR mAb	rheumatoid arthritis	II
CAT-354	anti-IL-13 mAb	asthma	II
MEDI-528#	anti-IL-9 mAb	asthma	II
MEDI-545#	anti-IFN-alpha mAb	SLE, myositis	II
MEDI-563#	anti-IL-5R mAb	asthma	II
Fostamatinib Disodium#	spleen tyrosine kinase (syk) inhibitor	rheumatoid arthritis	II	2013	2013
AZD5069	CXCR2	COPD	I
AZD5423	iSEGRA	COPD	I
AZD6553	neutrophil elastase inhibitor	COPD	I
AZD8683	muscarinic antagonist	COPD	I
MEDI-546#	anti-IFNalphaR mAb	scleroderma	I
MEDI-551	anti-CD19 mAb	scleroderma	I
MEDI-570#	anti-ICOS mAb	SLE	I

^#Partnered product

AstraZeneca Development Pipeline

Discontinued Projects vs 28 Jan 2010 FY

Cardiovascular/Gastrointestinal

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD0837	thrombosis
NCE	AZD6482	thrombosis

Neuroscience

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD6280	anxiety
NCE	AZD8418	schizophrenia

Oncology & Infection

NCE/Line Extension	Compound	Area Under Investigation
NCE	RECENTIN	CRC
NCE	RECENTIN	recurrent glioblastoma

Respiratory & Inflammation

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD1236	COPD
NCE	AZD2551	COPD
NCE	AZD5122	COPD
NCE	AZD5985	asthma/COPD
NCE	AZD8075	asthma/COPD
NCE	AZD8566	COPD
NCE	AZD9164	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.

Compounds in development are displayed by phase.

Key:

MAA - Marketing Authorisation Application (Europe).

NDA - New Drug Application/Biologics Licensing Application (USA).

 

END

 

 

IR EKLBLBDFFBBL