Transforming Molecules into Breakthrough Therapies. Timothy Wright, M.D. Global Head Pharma Development Investor Day London, 22 November 2013

Transcription

1 Transforming Molecules into Breakthrough Therapies Timothy Wright, M.D. Global Head Pharma Development Investor Day London, 22 November 2013

2 Disclaimer This presentation contains forward-looking statements that can be identified by terminology such as such as potential, expected, will, planned, or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; the potential completion of the divestiture of the Novartis blood transfusion diagnostics unit; potential shareholder returns or credit ratings, the potential outcome of the share buyback being initiated; or regarding potential future sales or earnings of the Novartis Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Group regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels. Nor can there be any guarantee that the proposed divestiture of the blood transfusion diagnostics unit will be completed in the expected form or within the expected time frame or at all. Nor can there be any guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the divestiture. Neither can there be any guarantee that shareholders will achieve any particular level of shareholder returns or regarding the potential outcome of the share buyback being initiated. Nor can there be any guarantee that the Group, or any of its divisions, will achieve any particular financial results or any particular credit rating. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally, including an unexpected failure to obtain necessary government approvals for the transaction, or unexpected delays in obtaining such approvals; the potential that the potential strategic benefits, synergies or opportunities expected from the transaction may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; unexpected clinical trial results, including additional analyses of existing clinical data or unexpected new clinical data; the Group's ability to obtain or maintain patent or other proprietary intellectual property protection, including the ultimate extent of the impact on the Group of the loss of patent protection and exclusivity on key products which commenced last year and will continue this year; unexpected product manufacturing and quality issues, including the resolution of the Warning Letter issued to us with respect to three Sandoz manufacturing facilities, and the completion of efforts to restart production of certain products formerly produced at the Consumer Health manufacturing facility at Lincoln, Nebraska, and the restructuring efforts at that site; government, industry, and general public pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, shareholder litigation, government investigations and intellectual property disputes; competition in general; uncertainties regarding the effects of the ongoing global financial and economic crisis, including the financial troubles in certain Eurozone countries; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; the impact that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this presentation as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

3 Results of our R&D Investments: Leading Total NME Approvals Across Key Regions New chemical/molecular entity (NCE/NME) approvals for selected companies (Q3) Novartis Merck/SGP Pfizer/Wyeth GSK J&J BMS EU US Japan China AstraZeneca Roche/Genentech Sanofi-Aventis Eli Lilly Bayer Notes: Does not include vaccines. Novartis includes Alcon, co-developed or co-marketed products from Ciba Vision, QLT, Idenix, Genentech; Pfizer includes products of Pharmacia + Wyeth; Merck includes products of Schering Plough + Organon; Roche includes products of Genentech and Chugai (JP); J&J includes products of Janssen + Centocor + RWJohnson. EU approvals for all companies are inclusive of fixed-dose combinations Source: FDA, EMA, PMDA, SFDA/CDE databases (snapshot as of 7 October 2013) 141

4 Industry-Leading Pipeline & Aspiring Higher Planned Filings OUR PIPELINE new molecules 25 new indications 3 new formulations 1 Includes GenMeds and Oncology 142

5 Three FDA Breakthrough Therapy Designations LDK378 (Q1) ALK+ Non Small Cell Lung Cancer RLX030 (Q2) Acute Heart Failure BYM338 (Q3) Sporadic Inclusion Body Myositis 143

6 Following the Science in Immune-Mediated Diseases Single target multiple indications AIN457 (Secukinumab) IL-1, TLRs, IL-4, TSLP, GM-CSF, TNF Psoriasis (Submitted) Psoriatic Dendritic Cells IL-12, IL-23, Processed Antigens Antigens: Foreign, Self Uveitis Asthma IL-17 Multiple Sclerosis Ankylosing Spondylitis Rheumatoid Th1 IFN- IL-2, IL-15 Tc1 Pathogen Defense Immune Surveillance Th17 Secukinumab IL-21 IL-22 IL-17F IL-17A Amplification of Immune Responses (esp. Autoimmune) 144

7 Following the Science in Immune-Mediated Diseases Psoriasis AIN457 (Secukinumab) Results in chronic plaque psoriasis Psoriasis (Submitted) Psoriatic Patient 1 Uveitis IL-17 Ankylosing Spondylitis Asthma Multiple Sclerosis Rheumatoid Patient 2 Source: Data from Phase III study in Psoriasis Week 0 Week 8 145

8 Following the Science in Immune-Mediated Diseases Psoriatic AIN457 (Secukinumab) Change from baseline HAQ-DI Uveitis Asthma Psoriasis (Submitted) IL-17 Multiple Sclerosis Psoriatic Ankylosing Spondylitis Rheumatoid * * Placebo (N=27) Secukinumab 150 mg (N=20) Etanercept (N=20) Secukinumab 300 mg (N=27) HAQ-DI reduction in Psoriasis patients indicates underlying activity in Psoriatic *P < 0.05 vs. placebo HAQ-DI, Health Assessment Questionnaire Disability Index; LOCF, last observation carried forward. Source: Data from Phase III study in Psoriasis (A2303) 146

9 Following the Science in Immune-Mediated Diseases Ankylosing Spondylitis AIN457 (Secukinumab) ASAS 20 (% of patients) Week 6 Psoriasis (Submitted) Psoriatic 61 AIN457 Placebo 85 Uveitis IL-17 Ankylosing Spondylitis 17 0 Asthma Multiple Sclerosis Rheumatoid All patients Biologic-naive patients ASAS 20: ASsessment in Ankylosing Spondylitis, improvement in 20% from baseline First non-tnf-α biologic to show activity in Ankylosing Spondylitis Source: Data from Phase II, Proof-of-Concept study in Ankylosing Spondylitis 147

10 Following the Science in Muscle-Wasting Conditions Single target multiple indications BYM338 Rationale for Activin RII Blockade Mechanically Ventilated Patients (PoC) Sporadic Inclusion Body Myositis Act RII blockade Hip Fracture Recovery BYM338 Cancer Cachexia (PoC) COPD Cachexia (PoC) Sarcopenia (PoC) 148

11 Following the Science in Muscle-Wasting Conditions Sporadic Inclusion Body Myositis BYM338 Sporadic Inclusion Body Myositis sibm* patient pre-treatment Mechanically Ventilated Patients (PoC) Cancer Cachexia (PoC) Act RII blockade COPD Cachexia (PoC) Hip Fracture Recovery Sarcopenia (PoC) 8 weeks after single infusion of BYM338 5% increase in muscle volume sibm: Sporadic Inclusion Body Myositis Data from Proof of Concept study in sibm patients Improvement in muscle function also observed 149

12 Novartis Committed to Advancing Cell Therapies Three different approaches using cell therapies HSC835 Infusion of processed and expanded cord blood stem cells into patients lacking stem cells FCRx Infusion of processed donor leukophoresis product enriched for facilitator cells and progenitors CTL019 Cell based therapy of isolated T- cells via lentivirus transfection and infusion into leukemia patients Facilitating cell Immune cells from patients Re-inject into patient Re-engineer to target cancer Target Indications Leukemias Leukodystrophies Hemoglobinopathies Target Indications Solid organ transplant Target Indications Leukemias Lymphomas 150

13 Expanded Cord Blood Stem Cell Infusion for Hematopoietic Stem Cell Transplants HSC835: Expansion of Cord Blood Stem Cells Source of hematopoietic stem cells Cord blood Steps involved 1. HLA mapping (readily available for banked cord blood) 2. Harvesting of stem cells 3. Expansion using proprietary technology 4. Patient infusion Target population Leukemia Leukodystrophies Hemoglobinopathies Note: This is an illustration of how HSC835-based stem-cell expansion is assumed to work in patients requiring stem cell transplants or others 151

14 Processed Donor Hematopoietic Stem Cells to Build Immune Tolerance in Transplant Patients FCRx: Use of Cell Therapy in Transplant Patients Organ transplant Avoid lifelong immunosuppression in some patients and reduce risk of rejection by building tolerance Donor CD56 low Support HSC reconstitution Promote HSC survival and homing CD56 high Protect donor HSC from recipient immune attack Prevent GVHD Facilitating cell Recipient Processed donor leukopheresis product enriched for: HSC Facilitator cells Progenitors (FCRx) Infusion Recipient with bone marrow chimera Note: This is an illustration of how FCRx technology is assumed to work in transplant patients 152

15 Innovations and Portfolio Prioritization to Drive R&D Productivity Going Forward R&D Focus to Shift to Greater Focus on Priority Programs in 2014 Unmet need Strength of evidence??? 1. Invest in priority programs 2. Re-evaluate non-priority programs 3. Contain fixed costs by monitoring R&D hiring 4. Other processes to improve productivity, e.g., Risk-Based Monitoring (RBM) 153

16 Novartis: One of MIT s Top 50 Disruptive Innovators Only pharmaceutical company in 2013 Novartis listed as one of the top 50 Disruptive Innovators Only pharmaceutical company in 2013 Recognized for developing a continuous drug manufacturing process and other initiatives Source: MIT technology review 2013, 154