Interim Results Part 3 of 3

RNS Number : 2908A

AstraZeneca PLC

31 July 2008

 

AstraZeneca Development Pipeline

31 July 2008

Line Extensions

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
Atacand	angiotensin II antagonist	diabetic retinopathy	III	1H 2009*	1H 2009*
Atacand Plus	angiotensin II antagonist/thiazide diuretic	32/12.5 mg, 32/25 mg for hypertension	III	Filed
Crestor	statin	outcomes end stage renal disease	III	1H 2009	1H 2009
Crestor	statin	outcomes in subjects with elevated CRP	III	1H 2009	1H 2009
Onglyza (saxagliptin)/ metformin FDC	DPP-4 inhibitor + biguanide FDC	diabetes	III	2010	2010
Dapagliflozin/ metformin FDC	SGLT2 inhibitor + biguanide FDC	diabetes	III	2011	2011
Gastrointestinal
Nexium Sachet formulation	proton pump inhibitor	GERD	III	Launched	Launched
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		1H 2009
Nexium	proton pump inhibitor	extra-oesophageal reflux disease	II	2H 2009*	2H 2009*
Neuroscience
Seroquel XR	D2/5HT2 antagonist	schizophrenia	III	Launched	Launched
Seroquel	D2/5HT2 antagonist	bipolar maintenance	III	Filed	Launched
Seroquel	D2/5HT2 antagonist	bipolar depression	III	Filed	Launched
Seroquel XR	D2/5HT2 antagonist	major depressive disorder	III	Filed	Filed
Seroquel XR	D2/5HT2 antagonist	bipolar mania	III	Filed	Filed
Seroquel XR	D2/5HT2 antagonist	bipolar depression	III	Filed	Filed
Seroquel XR	D2/5HT2 antagonist	generalised anxiety disorder	III	4Q 2008	Filed
Oncology & Infection
FluMist	live, attenuated, intranasal influenza virus vaccine	influenza	III	4Q 2008	Launched
Iressa	EGFR tyrosine kinase inhibitor	NSCLC	III	Filed
Faslodex	oestrogen receptor antagonist	first line advanced breast cancer	III
Faslodex	oestrogen receptor antagonist	adjuvant	III

*Publication only.

  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

*To be supplemented in 2008 with data supporting two additional strengths.

**US approval based on 12 years and above.

  NCEs

Phase III/Registration

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
Onglyza (saxagliptin)	DPP-4 inhibitor	diabetes	III	Filed	Filed
AZD6140	ADP receptor antagonist	arterial thrombosis	III	2H 2009	2H 2009
Crestor/TriLipix	statin + fibrate fixed combination	dyslipidaemia	III		2H 2009
Dapagliflozin	SGLT2 inhibitor	diabetes	III	2010	2010
AZD0837	thrombin inhibitor	thrombosis	III	2012	2012
Neuroscience
PN400	naproxen +esomeprazole	signs and symptoms of OA , RA, and AS	III	2H 2009	1H 2009
Oncology & Infection
Motavizumab	humanized MAb binding to RSV F protein	RSV prevention	III	1H 2009	Filed
Zactima	VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity	NSCLC	III	1H 2009	1H 2009
Recentin	VEGFR tyrosine kinase inhibitor	CRC	III	2010	2010
Recentin	VEGFR tyrosine kinase inhibitor	recurrent glioblastoma	III	2010	2010
MEDI-561 (IPI-504)	Hsp90 inhibitor	GIST	III	2010	2010
ZD4054	endothelin A receptor antagonist	hormone resistant prostate cancer	III	2011	2011

NCEs

Phases I and II

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Cardiovascular
AZD2207	CB1 antagonist	diabetes/obesity	II
AZD1305	antiarrhythmic	arrhythmias	II
AZD6370	GK activator	diabetes	II
AZD1175	CB1 antagonist	diabetes/obesity	I
AZD6482	PI3K-beta inhibitor	thrombosis	I
AZD1656	GK activator	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 1 antagonist	GERD	I
Neuroscience
AZD3480	neuronal nicotinic receptor agonist	cognitive disorders in schizophrenia	II	2011	2011
AZD3480	neuronal nicotinic receptor agonist	Alzheimer's disease	II	2011	2011
AZD6765	NMDA receptor antagonist	depression	II	2012	2012
AZD1940	CB1 receptor agonist	nociceptive and neuropathic pain	II
AZD0328	selective neuronal nicotinic receptor agonist	Alzheimer's disease	II
AZD1386	vanilloid receptor antagonist	chronic nociceptive pain	II
AZD2624	NK receptor antagonist	schizophrenia	II
AZD2327	enkephalinergic receptor modulator	anxiety and depression	I
AZD5904	myeloperoxidase (MPO) inhibitor	multiple sclerosis	I
AZD3241	inhibitor of myeloperoxidase (MPO)	Parkinson's disease	I
AZD2066	metabotropic glutamate receptor 5 antagonist	chronic nociceptive pain	I
AZD7325	GABA receptor subtype partial agonist	anxiety	I
AZD6280	GABA receptor subtype partial agonist	anxiety	I
TC-5619	neuronal nicotinic receptor agonist	cognitive disorders in schizophrenia	I
AZD1704	CB1 receptor agonist	analgesia	I

  NCEs

Phases I and II (continued)

Compound	Mechanism	Area Under Investigation	Phase	Estimated Filing
				MAA	NDA
Oncology & Infection
Motavizumab	humanized MAb binding to RSV F protein	early and late treatment of RSV in paeds >1 yr	II
Zactima	VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity	medullary thyroid cancer	II	1H 2009	1H 2009
Recentin	VEGFR tyrosine kinase inhibitor	NSCLC	II
CytoFab	anti-TNF-alpha polyclonal antibody	severe sepsis	II
AZD6244  (ARRY-142886)	MEK inhibitor	solid tumours	II	2014	2014
AZD2281	PARP inhibitor	breast cancer/ovarian	II	2012	2012
EBV vaccine*	Epstein-Barr virus vaccine	post-transplant proliferative disease	II
AZD2836	NS 5a inhibitor	hepatitis C	II
AZD0530	SRC kinase inhibitor	solid tumours and haematological malignancies	II
MEDI-561 (IPI-504)	Hsp90 inhibitor	range of solid tumours	II
MEDI-538*	CD19 B cells	leukaemia/lymphoma	II
AZD4877	cell cycle agent	solid tumours and haematological malignancies	II
AZD1152	aurora kinase inhibitor	solid tumours and haematological malignancies	I
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-560	PIV-3 vaccine	intranasal immunisation	I
MEDI-566	pandemic influenza virus vaccine	pandemic influenza vaccine	I
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
AZD7295	NS 5a inhibitor	hepatitis C	I
IPI-493	oral HSP 90 inhibitor	solid tumours	I
AZD8055	TOR kinase inhibitor	range of tumours	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
AZD4818	CCR1 receptor antagonist	COPD	II
AZD9668	neutrophil elastase inhibitor	COPD	II
AZD1236	matrix metallo-proteinase inhibitor	COPD	I
MEDI-563	anti-IL-5R antibody	asthma	I
MEDI-545	anti-IFN-alpha antibody	SLE, myositis	I
Pneumococcal vaccine*	pneumococcal vaccine	streptococcus pneumoniae	I
AZD3199	iLABA	asthma/COPD	I
CAM-3001	anti-GM-CSFR	rheumatoid arthritis	I
AZD8848		asthma	I

*Partnered product

  AstraZeneca Development Pipeline

Discontinued Projects vs 31 January 2008 FY

Cardiovascular & Gastrointestinal

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD4121	dyslipidaemia

Respiratory & Inflammation

NCE/Line Extension	Compound	Area Under Investigation
NCE	AZD1744	COPD
NCE	AZD5904	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.

Abbreviations:

MAA - Marketing Authorisation Application (Europe).

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

 

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