Half Yearly Report - Part 3 o

RNS Number : 5510W

AstraZeneca PLC

30 July 2009

 

AstraZeneca Development Pipeline

30 July 2009

Line Extensions

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
Atacand Plus	angiotensin II antagonist/thiazide diuretic	32/12.5 mg, 32/25 mg for hypertension	III	Launched
Crestor	statin	outcomes in subjects with elevated CRP	III	Filed	Filed
Onglyza/ metformin FDC#	DPP-4 inhibitor + biguanide FDC	diabetes	III	1H 2010	4Q 2009
Dapagliflozin/ metformin FDC#	SGLT2 inhibitor + biguanide FDC	diabetes	III	2011	2011
Gastrointestinal
Nexium	proton pump inhibitor	peptic ulcer bleeding	III	Launched	Filed
Axanum (Nexium low dose aspirin combination)	proton pump inhibitor + low dose aspirin	low dose aspirin associated peptic ulcer	III	1H 2010**	Filed
Nexium	proton pump inhibitor	extra-oesophageal reflux disease	II	Published*	Published*
Neuroscience
Seroquel	D2/5HT2 antagonist	bipolar maintenance	III	Filed	Launched
Seroquel	D2/5HT2 antagonist	bipolar depression	III	Launched	Launched
Seroquel XR	D2/5HT2 antagonist	major depressive disorder	III	Filed	Filed
Seroquel XR	D2/5HT2 antagonist	bipolar mania	III	Launched	Launched
Seroquel XR	D2/5HT2 antagonist	bipolar depression	III	Launched	Launched
Seroquel XR	D2/5HT2 antagonist	generalised anxiety disorder	III	Filed	Filed
Oncology & Infection
FluMist	live, attenuated, intranasal influenza virus vaccine	influenza	III	Filed	Launched
Iressa	EGFR tyrosine kinase inhibitor	NSCLC	III	Launched
Zactima	VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity	medullary thyroid cancer	III	2H 2010	1H 2010
Faslodex	oestrogen receptor antagonist	first line advanced breast cancer	III
Faslodex	oestrogen receptor antagonist	high dose (500mg) second line advanced breast cancer	III	4Q 2009	1H 2010
Motavizumab	humanized MAb binding to RSV F protein	early and late treatment of RSV in paeds >1 yr	II		2015

*Publication only

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

#Partnered product

  Line Extensions (continued)

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Respiratory & Inflammation
Symbicort pMDI	inhaled steroid/fast onset, long-acting β2 agonist	asthma	III	Filed	Launched*
Symbicort pMDI	inhaled steroid/fast onset, long-acting β2 agonist	COPD	III	Filed	Launched

*US approval based on 12 years and above.

  NCEs

Phase III/Registration

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
Onglyza#	DPP-4 inhibitor	diabetes	III	Filed	Filed
Brilinta	ADP receptor antagonist	arterial thrombosis	III	4Q 2009	4Q 2009
Certriad# (Crestor/TriLipix)	statin + fibrate fixed combination	dyslipidaemia	III		Filed
Dapagliflozin#	SGLT2 inhibitor	diabetes	III	2H 2010	2H 2010
Neuroscience
Vimovo# (PN400)	naproxen + esomeprazole	signs and symptoms of OA, RA and AS	III	4Q 2009	Filed
Oncology & Infection
Motavizumab	humanized MAb binding to RSV F protein	RSV prevention	III	2H 2010	Filed
Zactima	VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity	NSCLC	III	Filed	Filed
Recentin	VEGFR tyrosine kinase inhibitor	CRC	III	2H 2010	2H 2010
Recentin	VEGFR tyrosine kinase inhibitor	recurrent glioblastoma	III	2H 2010	2H 2010
ZD4054	endothelin A receptor antagonist	hormone resistant prostate cancer	III	2011	2011

#Partnered product

  NCEs

Phases I and II

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
AZD0837	direct thrombin inhibitor	thrombosis	II
AZD1305	antiarrhythmic	arrhythmias	II
AZD6370	GK activator	diabetes	II
AZD1656	GK activator	diabetes/obesity	II
AZD6482	PI3K-beta inhibitor	thrombosis	I
AZD4017	11BHSD inhibitor	diabetes/obesity	I
AZD6714	GK activator	diabetes/obesity	I
Gastrointestinal
AZD3355	inhibitor of transient lower oesophageal sphincter relaxations (TLESR)	GERD	II	2013	2013
AZD2066	metabotropic glutamate receptor 5 antagonist	GERD	I
AZD1386	vanilloid receptor antagonist	GERD	I

  NCEs

Phases I and II (continued)

Neuroscience
AZD3480#	Alpha4/beta2 neuronal nicotinic receptor agonist	ADHD	II
AZD6765	NMDA receptor antagonist	major depressive disorder	II	2012	2012
AZD1386	vanilloid receptor antagonist	chronic nociceptive pain	II
AZD2327	enkephalinergic receptor modulator	anxiety and depression	II
AZD7325	GABA receptor subtype partial agonist	anxiety	II	2013	2012
AZD4694	FNAPD-1	Alzheimer's disease PET diagnostic	II
AZD2066	metabotropic glutamate receptor 5 antagonist	chronic neuropathic pain	II
AZD8529	glutamatergic modulator	schizophrenia	II
AZD5904	myeloperoxidase (MPO) inhibitor	multiple sclerosis	I
AZD3241	myeloperoxidase (MPO) inhibitor	Parkinson's disease	I
AZD6280	GABA receptor subtype partial agonist	anxiety	I
TC-5619#	Alpha7 neuronal nicotinic receptor agonist	cognitive disorders in schizophrenia	I
AZD2516	metabotropic glutamate receptor 5 antagonist	chronic neuropathic pain	I
AZD1446#	Alpha4/beta2 neuronal nicotinic receptor agonist	Alzheimer's disease/ADHD	I
AZD7268	enkephalinergic receptor modulator	depression/anxiety	I
AZD3043#	GABA-A receptor modulator	short-acting anaesthetic	I
AZD6088	muscarinic M1 receptor agonist	chronic neuropathic pain	I
AZD2423	chemokine antagonist	chronic neuropathic 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
CytoFab#	anti-TNF-alpha polyclonal antibody	severe sepsis	II
AZD6244#  (ARRY-142886)	MEK inhibitor	solid tumours	II	2014	2014
Olaparib (AZD2281)	PARP inhibitor	breast/ovarian cancer	II	2012	2012
Saracatinib (AZD0530)	SRC kinase inhibitor	solid tumours	II	2012	2012
AZD7295	NS 5a inhibitor	hepatitis C	II
AZD1152	aurora kinase inhibitor	haematological malignancies	II	2011	2011
MEDI-3250	flu vaccine (quadravalent)	seasonal influenza	II
AZD4769	EGFR tyrosine kinase inhibitor	solid tumours	I
AZD8931	erbB kinase inhibitor	solid tumours	I
AZD7762	CHK1 kinase Inhibitor	solid tumours	I
AZD8330# (ARRY-424704)	MEK inhibitor	solid tumours	I
CAT-8015	recombinant immunotoxin	haematological malignancies	I
MEDI-534	RSV/PIV-3 vaccine	RSV/PIV prophylaxis	I
MEDI-560	PIV-3 vaccine	intranasal immunisation	I
MEDI-550* (MEDI-566)	pandemic influenza virus vaccine	pandemic influenza vaccine	I
AZD9639# (MEDI-564)	RSV F protein inhibitor	RSV treatment	I
CMV Vaccine	CMV vaccine	cytomegalovirus	I
MEDI-557	YTE - extended half-life RSV MAb	RSV prophylaxis	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	I

*MEDI-550 is a library of vaccines and MEDI-566 was one strain that is no longer active

#Partnered product

  NCEs

Phases I and II (continued)

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Respiratory & Inflammation
AZD1981	CRTh2 receptor antagonist	asthma/COPD	II
MEDI-528	anti-IL-9 antibody	asthma	II
CAT-354	anti-IL-13 antibody	asthma	II
AZD9668	neutrophil elastase inhibitor	COPD	II
AZD1236	matrix metallo-proteinase inhibitor	COPD	II
AZD3199	iLABA	asthma/COPD	II
MEDI-563	anti-IL-5R antibody	asthma	II
MEDI-545	anti-IFN-alpha antibody	SLE, myositis	II
CAM-3001	anti-GM-CSFR	rheumatoid arthritis	I
AZD8848		asthma	I
AZD8566	CCR5	rheumatoid arthritis	I
AZD8075	CRTh2 antagonist	asthma/COPD	I
AZD5985	CRTh2 antagonist	asthma/COPD	I
AZD9164	LAMA	COPD	I
AZD2551	protease inhibitor	COPD	I

AstraZeneca Development Pipeline

Discontinued Projects vs 29 January 2009 FY

Neuroscience

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD1940	nociceptive and neuropathic pain
NCE	AZD2624	schizophrenia

Oncology & Infection

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD6918	solid tumours
NCE	MEDI-538	leukaemia/lymphoma
NCE	AZD4877	haematological malignancies
Faslodex	oestrogen receptor antagonist	adjuvant

Respiratory & Inflammation

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD9056	RA
NCE	AZD5672	RA
Unit Dose Budesonide	inhaled steroid	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.

Compounds in development are displayed by phase.

Key:

MAA - Marketing Authorisation Application (Europe).

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

 

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