Final Results - part 3 of 3

RNS Number : 4476M

AstraZeneca PLC

29 January 2009

 

AstraZeneca Development Pipeline

29 January 2009

Line Extensions

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
Atacand	angiotensin II antagonist	diabetic retinopathy	III	Published*	Published*
Atacand Plus	angiotensin II antagonist/thiazide diuretic	32/12.5 mg, 32/25 mg for hypertension	III	Filed
Crestor	statin	outcomes in subjects with elevated CRP	III	2Q 2009	2Q 2009
Onglyza/ metformin FDC#	DPP-4 inhibitor + biguanide FDC	diabetes	III	2H 2010	4Q 2009
Dapagliflozin/ metformin FDC#	SGLT2 inhibitor + biguanide FDC	diabetes	III	2011	2011
Gastrointestinal
Nexium	proton pump inhibitor	peptic ulcer bleeding	III	Filed	Filed
Nexium low dose aspirin combination	proton pump inhibitor	low dose aspirin associated peptic ulcer	III	3Q 2009	2Q 2009
Nexium	proton pump inhibitor	extra-oesophageal reflux disease	II	3Q 2009*	3Q 2009*
Neuroscience
Seroquel	D2/5HT2 antagonist	bipolar maintenance	III	Filed	Launched
Seroquel	D2/5HT2 antagonist	bipolar depression	III	Approved	Launched
Seroquel XR	D2/5HT2 antagonist	major depressive disorder	III	Filed	Filed
Seroquel XR	D2/5HT2 antagonist	bipolar mania	III	Approved	Approved
Seroquel XR	D2/5HT2 antagonist	bipolar depression	III	Approved	Approved
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	Filed
Zactima	VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity	medullary thyroid cancer	III	2H 2010	4Q 2009
Motavizumab	humanized MAb binding to RSV F protein	early and late treatment of RSV in paeds >1 yr	II
Faslodex	oestrogen receptor antagonist	first line advanced breast cancer	III
Faslodex	oestrogen receptor antagonist	adjuvant	III

*Publication only

#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	Filed
Unit Dose Budesonide**	inhaled steroid	asthma	III

*US approval based on 12 years and above

**Partnered product. Subject to review under the Hart Scott Rodino Act

  NCEs

Phase III/Registration

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
Onglyza#	DPP-4 inhibitor	diabetes	III	Filed	Filed
Brilinta (AZD6140)	ADP receptor antagonist	arterial thrombosis	III	4Q 2009	4Q 2009
Crestor/TriLipix#	statin + fibrate fixed combination	dyslipidaemia	III		3Q 2009
Dapagliflozin#	SGLT2 inhibitor	diabetes	III	2H 2010	2H 2010
Neuroscience
PN400#	naproxen + esomeprazole	signs and symptoms of OA, RA and AS	III	4Q 2009	Mid 2009
Oncology & Infection
Motavizumab	humanized MAb binding to RSV F protein	RSV prevention	III	TBD	Filed
Zactima	VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity	NSCLC	III	2Q 2009	2Q 2009
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	2012	2012
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
Gastrointestinal
AZD3355	inhibitor of transient lower oesophageal sphincter relaxations (TLESR)	GERD	II	2011	2011
AZD2066	metabotropic glutamate receptor 5 antagonist	GERD	I
AZD1386	vanilloid receptor antagonist	GERD	I
Neuroscience
AZD3480#	neuronal nicotinic receptor agonist	Alzheimer's disease	II
AZD6765	NMDA receptor antagonist	depression	II	2012	2012
AZD1940	CB1 receptor agonist	nociceptive and neuropathic pain	II
AZD1386	vanilloid receptor antagonist	chronic nociceptive pain	II
AZD2624	NK receptor antagonist	schizophrenia	II
AZD2327	enkephalinergic receptor modulator	anxiety and depression	II
AZD7325	GABA receptor subtype partial agonist	anxiety	II	2013	2012
AZD5904	myeloperoxidase (MPO) inhibitor	multiple sclerosis	I
AZD3241	myeloperoxidase (MPO) inhibitor	Parkinson's disease	I
AZD2066	metabotropic glutamate receptor 5 antagonist	chronic neuropathic pain	I
AZD6280	GABA receptor subtype partial agonist	anxiety	I
TC-5619#	neuronal nicotinic receptor agonist	cognitive disorders in schizophrenia	I
AZD8529	glutamatergic modulator	schizophrenia	I
AZD2516	metabotropic glutamate receptor 5 antagonist	chronic neuropathic pain	I
AZD1446	neuronal nicotinic receptor agonist	Alzheimer's disease	I
AZD7268	enkephalinergic receptor modulator	depression/anxiety	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
AZD2281	PARP inhibitor	breast/ovarian cancer	II	2012	2012
EBV vaccine#	Epstein-Barr virus vaccine	post-transplant proliferative disease	II
AZD0530	SRC kinase inhibitor	solid tumours and haematological malignancies	II
AZD4877	cell cycle agent	haematological malignancies	II
AZD7295	NS 5a inhibitor	hepatitis C	II
AZD1152	aurora kinase inhibitor	haematological malignancies	II	2011	2011
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	intranasal immunisation	I
MEDI-538#	CD19 B cells	leukaemia/lymphoma	I
MEDI-560	PIV-3 vaccine	intranasal immunisation	I
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
AZD6918	TRK inhibitor	solid tumours	I
MEDI-559	RSV vaccine	RSV treatment	I

#Partnered product

  NCEs

Phases I and II (continued)

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Respiratory & Inflammation
AZD9056	ion channel blocker (P2X7)	rheumatoid arthritis	II	2012	2012
AZD5672	chemokine receptor antagonist (CCR5)	rheumatoid arthritis	II	2012	2012
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
Pneumococcal vaccine#	pneumococcal vaccine	Streptococcus pneumoniae	I
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

#Partnered product

  AstraZeneca Development Pipeline

Discontinued Projects vs 31 July 2008 HY

Cardiovascular & Gastrointestinal

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD1175	diabetes/obesity
NCE	AZD2207	diabetes/obesity
LCM	Crestor outcomes end stage renal disease*	renal disease

Neuroscience

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD3480	cognitive disorder in schizophrenia
NCE	AZD0328	Alzheimer's disease
NCE	AZD1704	analgesia

Oncology & Infection

NCE/Line Extension	Compound	Area Under Investigation
NCE	MEDI-561 (IPI-504)	GIST
NCE	MEDI-561 (IPI-504)	solid tumours
NCE	IPI-493	solid tumours
NCE	AZD4877	solid tumours
NCE	AZD1152	solid tumours
NCE	AZD2836	hepatitis C

Respiratory & Inflammation

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD4818	COPD

* Will proceed to publication

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.

Abbreviations:

MAA - Marketing Authorisation Application (Europe).

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

 

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