AstraZeneca PLC · LSE:AZN
AstraZeneca — Technical Presentation (2000)
22 slides from AstraZeneca's technical presentation, 2000
Slide 1: R&D Organisation & Therapy Area update
A R&D Organisation & Therapy Area update Dr Claes Wilhelmsson Executive Director, R&D R&D organisation and process Therapy Areas & Development Discovery Product Target Hit Lead Lead CD Develop- Concept maint. & identifi- identifi- identifi- optimis- prenom- ment for Launch testing life cycle cation
Slide 2: Quantitative targets; High TA growth ambitions
Quantitative targets Deliver 3 medically important, commercially attractive products per year Contribute to doubling Launch in all the value of the portfolio major markets within first year Reduce time from CD to launch to <6 years Double project success rate CD output > 15 per year A High TA growth
Slide 3: A strong pipeline for tomorrow
A strong pipeline for tomorrow Diprivan® Seroquel® Losec® esomeprazole Nolvadex® Symbicort Casodex ® ® Accolate® Tenormin® Oxis® Crestor™ Zoladex® thrombin Atacand® Pulmicort® Seloken ® inhibitor Zomig ® Viozan™ Zestril® Xylocaine® Rhinocort® Iressa™ Faslodex™ Merrem® Prilosec® Arimidex® Plendil® A
Slide 4: Portfolio prioritisation
Portfolio prioritisation b Biannual development portfolio review b 152 projects in total development portfolio, of which 113 are in late development or are life cycle management activities b 5 NCE projects in Development for Launch b ∼20 % of development resources in ring-fenced projects A Portfolio
Slide 5: Breadth and depth of R&D portfolio
Portfolio changes since 2000 half-year report - New opportunities b Inflammation ZD2315 - Rheumatoid Arthritis CCR2b - Rheumatoid Arthritis b CNS AZD5106 - Overactive bladder b Cardiovascular Nortran in-license - Atrial fibrillation A Breadth and depth of R&D portfolio Respiratory GI CV Infection Pa
Slide 6: Respiratory Therapy Area directions
Japanese R&D – rapid progress towards globalisation b Strategy for all CDs include Japan – Bridging studies routinely applied b Clinical trials running to high quality and matching Western speed – Japanese patients in global studies and Western submissions b Expected: NCE approvals 2000 JNDAs 2001 S
Slide 7: Oxis Turbuhaler; Symbicort strategy
Oxis® Turbuhaler® b Since Dec 1999, improved label compared to other LABAs – Oxis® can now also to be used as a reliever on top of twice daily maintenance treatment b Oxis® is growing faster than LABA market - MAT Q200 +55% b Increasing acceptance from healthcare professionals that Oxis® is differen
Slide 8: Symbicort; Viozan
Symbicort® Turbuhaler® b First launch Sweden Aug 2000: strong sales to date b EU MRP in final stages: launches begin Q101 b OPTIMA study (low-dose combination): very positive results pMDI b EU-RoW clinical programme ongoing: NDA Q3 2002 b US clinical programme in planning: NDA >2003 A Viozan® b Inha
Slide 9: Inflammation and CNS Therapy Area directions
Inflammation Therapy Area directions Mission: Provide novel treatments for disease modification and symptom relief in inflammation/ immunological disorders Key Projects Key Pipeline Focus CCR2b b Rheumatoid Arthritis ZD2315 b Osteoarthritis A CNS Therapy Area directions Mission: To develop and maint
Slide 10: ZINC I – Zomig Nasal Spray study
Zomig® A ZINC I – Zomig® Nasal Spray study Percentage of attacks with headache response 80 77 73 70 70 % headache response Nasal Spray 5 mg 60 55 63 Oral 2.5 mg 50 46 Placebo 46 40 30 32 30 28 30 15 25 20 10 18 10 12 5 0 mins 15 mins 30 mins 45 mins 1 hour 2 hours 4 hours Time Point A Dr Claes Wilhe
Slide 11: Zomig Japanese dose-response study; Seroquel schizophrenia
Zomig® – Japanese oral dose-response study Comparison with Western pivotal study 100 90 % headache response 80 70 60 50 40 30 TRIAL 136-017 (Western Study) 20 TRIAL F-15-21 (Japanese Study) 10 0 0 1 2.5 5 Dose (mg) A Seroquel® – schizophrenia b Further indications – Acute bipolar/mania b Formulation
Slide 12: Seroquel – minimal effect on weight; Infection directions
Seroquel® – minimal effect on weight long term 97% of patients preferred long-term Seroquel® to their previous medication Hellewell et al 1999 Mean 12 olanzapine 15 mg/day change 10 Adapted from Beasley 1997 from 8 baseline 6 weight 4 (kg) 2 Seroquel® monotherapy 0 Kasper & Müller-Spahn 2000 -2 26 5
Slide 13: TA Infection strategy; Pain Therapy Area directions
TA Infection strategy b Grow Infection franchise, using Merrem®/ Meronem® as the foundation b Expand within and beyond hospital infection using licensing and AZD2563 b Move into primary care using NCEs from AZ Discovery - genomics-based research A Pain Therapy Area directions Mission: Maintain leade
Slide 14: Analgesia projects; Oncology Therapy Area directions
Analgesia projects LEF - peripheral µ-opioid receptor agonist b It has for the first time been shown that a systemically administered peripherally acting µ-opioid receptor agonist – produces analgesia in acute pain in patients – is not associated with respiratory depression – does not provoke nausea
Slide 15: The Oncology portfolio; Hormones affecting the breast
The Oncology portfolio Breast Cancer Prostate Cancer Nolvadex® Arimidex® Zoladex® Faslodex™ Casodex® Zoladex® Iressa™ ZD0473 ZD9331 ZD6126 AZD6474 AZD3409 Medical Oncology A Hormones affecting the breast Gonadotrophins (FSH + LH) Pre-menopausal Oestrogens Progesterone Zoladex® Ovary Faslodex™ X LHRH
Slide 16: Faslodex in breast cancer
Faslodex™ in breast cancer b Phase III 2nd line studies completed b NDA/MAA scheduled for 1Q 2001 b 1st line studies to report 3Q 2001 b 1st line regulatory submissions 3Q-4Q 2001 b NSABP adjuvant study to start 1Q 2001 b Faslodex™ will be positioned the best treatment for ER+ women with advanced br
Slide 17: Casodex in prostate cancer; Casodex 150mg
Casodex® in prostate cancer Change of disease at diagnosis (US) 1980’s 2000 Localized PCa 20% 70% Metastatic PCa 80% 30% Total number of PCa diagnosis (US): 1980: 66,000 1990: 106,000 1995: 244,000 2000 (to date): 180,000 Need: A treatment for localised prostate cancer that delays progression and ma
Slide 18: ZD6474 Angiogenesis Inhibitor
ZD6474 Angiogenesis Inhibitor ZD6474 is a potent inhibitor of VEGFR tyrosine kinase activity and a sub-micromolar inhibitor of EGFR tyrosine kinase b Broad-spectrum anti-tumour activity in human tumour xenografts is consistent with anti-angiogenic mechanism b Anti-tumour activity is not dependent up
Slide 19: What is Iressa?
What is Iressa™? Iressa™ (ZD1839) is an orally active, selective EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitor) which blocks signal transduction pathways implicated in cancer cell proliferation. EGF TGF Cancer cell EGFR membrane X Cell proliferation X Survival Kinase Iressa™ X
Slide 20: Iressa – fast and broad
Iressa™ – fast and broad Global Health Authorities’ Major congress activities endorsement of registration AACR , ASCO, WLCC Iressa™: NDA/MAA/JNDA NSCLC strategy & publications submissions 4Q 2001 2000 2001 2002 Phase I trials pivotal NSCLC combination trials NSCLC monotherapy trials prostate, gastri
Slide 21: Summary – the R&D business model
Summary – the R&D business model b Continued strong progress across all aspects of R&D b Organisation delivering benefits of scale without loss of creativity and innovation b Significant investment in key new technologies b Effective partnerships in academic and biotech sectors b Portfolio managemen
Slide 22: Industry leading R&D Portfolio
Creativity Medical need Industry Unquestionable leading R&D ethics Portfolio Commercial Quality/Safety opportunity …to create innovative products that add value! Dr Claes Wilhelmsson - TA Portfolio Page 22