AstraZeneca PLC
3 December 2001
TWO OF TWO
AstraZeneca R&D Pipeline: NCEs
3 December 2001
Cardiovascular
Compound Mechanism Indication Phase Estimated
Filing
MAA NDA
Crestor Statin Hyperlipidemia DFL Filed Filed
Exanta(TM) Thrombin inhibitor (s.c) Prevention of VTE DFL 3Q >2004
(melagatran) 2002
Exanta(TM)(H376 Thrombin inhibitor Prevention of VTE DFL 3Q 2Q
/95) 2002 2003
Exanta(TM)(H376 Thrombin inhibitor Prevention of DFL 2Q 2Q
/95) stroke in AF 2003 2003
Exanta(TM)(H376 Thrombin inhibitor Treatment of VTE DFL 1H 2004
/95) 2003
Exanta(TM)(H376 Thrombin inhibitor Post Acute CT >2004 >2004
/95) Coronary Syndrome
AZD 6140 P2T antagonist Arterial CT >2004 >2004
thrombosis
AZ 242 PPAR agonist Diabetes /Insulin CT >2004 >2004
resistance
AZD 7545 PDK inhibitor Diabetes CT >2004 >2004
(anti-diabetic)
AZD 7009 Atrial Repolarisation Atrial CT >2004 >2004
Delaying Agent (ARDA) Fibrillation
Gastrointestinal
AR-H047108 Reversible acid pump inhibitor Acid related GI CT > >
disease 2004 2004
AZD 3355 Inhibitor of transient lower Gastroesophageal CT > >
(Reflux esophageal sphincter relaxations reflux disease 2004 2004
inhibitor) (TLESR ) (GERD)
Rofleponide Oral steroid with topical action Inflammatory bowel CT > >
disease 2004 2004
CNS
NXY-059 Free radical trapping agent Stroke CT >2004 >2004
NAD 299 5HT1A antagonist Anxiety/ CT >2004 >2004
Depression
AR-A2 5HT1symbol 98 /f 'Symbol' /s 12b Anxiety/ CT >2004 >2004
antagonist Depression
ZD 0947 K+ channel opener overactive CT >2004 >2004
bladder
AZD 5106 NK-2 antagonist overactive CT >2004 >2004
bladder
Oncology
Compound Mechanism Indication Phase Estimated
Filing
MAA NDA
Faslodex Estrogen Receptor Down regulator 2nd line Advanced DFL Filed
TM breast cancer 2002
Faslodex Estrogen Receptor Down regulator 1st line Advanced DFL 2002
TM breast cancer 2002
IressaTM Signal transduction inhibitor NSCLC and other DFL 2Q 4Q
(Epidermal growth factor receptor solid tumours 2002 2001*
tyrosine kinase inhibitor) *
ZD 9331 Thymidilate synthase inhibitor (iv) Solid tumours CT 2004 2004
ZD 9331 Thymidilate synthase inhibitor Solid tumours CT > >2004
(oral) 2004
ZD 6126 Vascular targeting agent Solid tumours CT > >2004
2004
AZD 6474 Angiogenesis inhibitor (Vascular Solid tumours CT > >2004
endothelial cell growth factor 2004
receptor tyrosine kinase inhibitor)
AZD 2171 Angiogenesis inhibitor (Vascular Solid tumours and CT > >2004
endothelial cell growth factor haematological 2004
receptor tyrosine kinase inhibitor) malignancies
AZD 3409 Farnesyl-transferase inhibitor Solid tumours CT > >2004
2004
( FAR )
*US filing NSCLC monotherapy 4Q 2001, combination 2Q 2002; EU filing NSCLC
monotherapy and combination 2Q 2002
Respiratory and Inflammation
Rofleponide Intranasal steroid Rhinitis CT 2004 2004
palmitate
ZD 4407 5-lipoxygenase inhibitor COPD CT >2004 >2004
ZD 2315 Immuno modulator Rheumatoid CT >2004 >2004
Arthritis
AZD 9056 P2X7 receptor antagonist Rheumatoid CT >2004 >2004
Arthritis
AZD 8309 Chemokine receptor Rheumatoid CT >2004 >2004
antagonist Arthritis
Pain Control
AZD 3582 Nitric oxide NSAID Acute /chronic CT >2004 >2004
(NO-naproxen) derivative pain
AZD 4282 (oral NMDA Antagonist Neuropathic pain CT >2004 >2004
glycine)
Infection
AZD2563 Oxazolidinone Gram positive infections, including CT > >
antibiotic multi-resistant strains 2004 2004
AstraZeneca R&D Pipeline: Line Extensions
Cardiovascular
Compound Mechanism Indication Phase Estimated
Filing
MAA NDA
Atacand(R) Angiotensin II Hypertension DFL 3Q 2002 3Q 2002
antagonist outcomes
(SCOPE study)
CHF outcomes DFL 2H 2003 2H 2003
(CHARM study)
Diabetic retinopathy DFL >2004 >2004
NB. Paediatric programmes ongoing/planned: Atacand(R), Seloken(R)/Toprol(R).
Gastrointestinal
Nexium(R) Proton pump inhibitor Multiple indications DFL 2003* 2003*
*Multiple indications from 2003 onwards
CNS
Seroquel(R) D2/5HT2 antagonist Granules DFL 1H 2003 1H 2003
Seroquel(R) D2/5HT2 antagonist Sustained release DFL 4Q 2002 4Q 2002
Seroquel(R) D2/5HT2 antagonist Mania DFL 1H 2003 2H 2002
Zomig(R) 5-HT1B/1D receptor agonist Adolescents DFL 2H 2003 2H 2003
Zomig(R) 5-HT1B/1D receptor agonist Nasal spray DFL Filed 1Q 2002
Oncology
Arimidex(R) Aromatase inhibitor Adjuvant Breast Cancer DFL 1Q 2002 1Q 2002
Casodex(R) Anti-androgen Early Prostate Cancer DFL Filed 4Q 2001
Zoladex(R) LHRH agonist Premenopausal DFL Launched 1H 2003
Adjuvant Breast Cancer
Respiratory
Symbicort(R) Inhaled steroid/long-acting COPD DFL 1Q
Turbuhaler(R) ss2 agonist 2002
Symbicort Inhaled steroid/long-acting Single therapy DFL 2H
Turbuhaler b2 agonist for asthma 2003
Symbicort(R) pMDI Inhaled steroid/long-acting Asthma DFL 2H 2004
ss2 agonist 2003
Oxis(R) Long-acting b2 agonist COPD DFL 2Q
Turbuhalera* 2002
Oxis(R) Long-acting b2 agonist Paediatrics DFL Filed
Turbuhalera* Asthma
Oxis(R) pMDI* Long-acting b2 agonist Asthma / COPD DFL 2H
2003
* Following a review, Oxisa will not be developed for the US market and
resources will focus on Symbicort(R) pMDI
Pain Control
Compound Mechanism Indication Phase Estimated Filing
MAA NDA
Naropin(R) Sodium channel blocker Spinal anaesthesia DFL Filed *
* Naropin will not be filed for spinal anaesthesia in the US
Infection
Compound Mechanism Indication Phase Estimated Filing
MAA NDA
Merrem Carbapenem Use in Neutropenics DFL 2H 2003
(R) antibiotic
Merrem Carbapenem Skin and soft tissue DFL 1H 2003
(R) antibiotic infections
AstraZeneca R&D Pipeline: Discontinued Compounds
Cardiovascular
Compound Mechanism
AR-H050642 Atrial Repolarisation Delaying Agent (ARDA) - replaced by AZD 7009
ZD 4927 Factor Xa inhibitor
Oncology
Compound Mechanism
ZD 0473* 3rd generation platin (iv)
ZD 0473* 3rd generation platin (oral)
*Handed back to Anormed 26 Nov 2001
Respiratory and Inflammation
Compound Mechanism
AZD 6942 (CCR2b) Immuno modulator
Comments
As disclosure of compound information is balanced by the business need to
maintain competitive advantage, some compound information has not been
disclosed at this time.
Previous pipeline tables have displayed projects in the pre-clinical stage
(prior to the selection of a candidate drug). The current table shows
compounds in concept testing and development for launch only.
AstraZeneca is using a new terminology for the stage of development;
CT - concept testing, from CD nomination, through to phase I and phase II
completion
DFL - development for launch, phase IIIa and phase IIIb activities conducted
prior to filing
Other abbreviations;
CD - Candidate Drug
MAA - Marketing Authorisation Application (Europe)
NDA - New Drug Application (USA)
- Ends -
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