Opening Address: A Quick Survey Thinking 25 Years Backwards & Forwards

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1 Opening Address: A Quick Survey Thinking 25 Years Backwards & Forwards Jeffrey M. Bockman, PhD Vice President Defined Health 24 th Annual Cancer Progress Conference March 4 th 5 th, 2014 March 4 th 5 th, 2014 Conrad New York

2 Disclaimer The information in this report has been obtained from what are believed to be reliable sources and has been verified whenever possible. Nevertheless, we cannot guarantee the information contained herein as to accuracy or completeness. All expressions of opinion are the responsibility of Cancer Progress, and though current as of the date of this report, are subject to change. The opinions and information set forth herein are expressed solely for the benefit of the addressee and only for the purpose(s) for which the report was produced. Without the prior written consent of Cancer Progress, this report may not be relied on in whole or in part for any other purpose or by any other person or entity, provided that this report may be disclosed where disclosure is required by law. This report may contain information provided by third parties such as Thomson Reuters, Wolters Kluwer, EvaluatePharma, Datamonitor, Informa Healthcare, IMS Health and others with a proprietary interest in the data provided herein. Please note that you are not permitted to redistribute any such third party information without consent from the originator company. Cancer Progress 2014

3 Disclaimer (Cont.)

4 Anniversaries of Progress

5 25th Anniversary (More or Less): 1985 or 1989 Source: Journal of Clinical Oncology

6 Major Advances Peri-1989

7 Major Advances 2013/2014 Source: FierceBiotech, Citibank, Science

8 FDA Approvals: 2013 First Approval Bevacizumab, mcrc Doxorubicin liposomal, Kaposi s sarcoma/ovarian cancer Pomalidomide, MM Trastuzumab emtansine, Breast Cancer Dabrafenib, Malignant Melanoma Erlotinib, NSCLC Radium-223 chloride, Bone metastases Trametinib, Malignant melanoma Jan 10, FDA granted accelerated approval to trametinib (Mekinist tablets, GlaxoSmithKline, LLC) and dabrafenib (Tafinlar capsules, GlaxoSmithKline, LLC) for use in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test. Afatinib, NSCLC Pertuzumab, Breast cancer Crizotinib, NSCLC Ibrutinib, MCL Obinutuzumab, CLL Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec Lenalidomide, MCL Denosumab, Bone metastases Albumin-bound Paclitaxel, Pancreatic Cancer Sorafenib, DTC Line Extension Feb 12, FDA granted accelerated approval to ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib previously received accelerated approval on November 13, 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Source: FDA, Defined Health

9 FDA Approvals: 2012 First Approval Axitinib, Renal Cancer Glucarpidase, Chemoprotection Vismodegib, Basal Cell Cancer Pazopanib, STS Pertuzumab, Breast Cancer Carfilzomib, Multiple Myeloma Cetuximab, mcrc Enzalutamide, Prostate Cancer Vincristine liposomal, ALL Afilbercept, mcrc Bosutinib, CML Regorafenib, mcrc Omacetaxine mepsuccinate, CML Rituximab, NHL Cabozantinib, MTC Abiraterone acetate, Prostate Cancer Ponatinib, CML Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec Imatinib, GIST Everolimus, Angiomyolipoma Everolimus, Breast Cancer Everolimus, Astrocytoma Albumin-bound paclitaxel, NSCLC Line Extension Source: FDA, Defined Health

10 Dealmaking in Licensing in 2013 Continued Dominance of Oncology Thomson Reuters Recap Webinar: 2013 Year in Review, January 21, 2014

11 Oncology Licensing Vying With Autoimmune/Inflammatory Thomson Reuters Recap Webinar: 2013 Year in Review, January 21, 2014 Thomson Reuters Recap Webinar: 2013 Year in Review, January 21, 2014

12 The History of Oncology as a Pharma Market Is Surprisingly Short Source: EvaluatePharma, Defined Health

13 Oncology Will Grow from 8.3% to 12.4% of Pharma Sales Oncology Market, 2012 & 2018 Pharma Sales, 2012 & Source: EvaluatePharma, Defined Health

14 Oncology Market Snapshot Source: Evaluate Pharma - Feb 26, 2014

15 Top 20 Oncology Drugs, 2018 Ranking Antibodies Continue to Play Significant Role: 8 of 20 Products Contributing Over 50% of Sales in 2018 Annual Sales WW - Sales Product Company Avastin Roche 6,751 7,357 7,721 7,961 8,174 8,297 Revlimid Celgene 4,280 4,834 5,501 6,282 6,877 7,392 Rituxan Roche 7,503 8,020 8,207 8,108 7,882 7,381 Herceptin Roche 6,562 6,994 6,986 6,818 6,566 6,334 Xtandi Astellas Pharma 486 1,014 1,784 2,776 3,609 4,063 Nivolumab Bristol-Myers Squibb ,470 2,672 3,867 Kadcyla Roche ,267 1,962 2,604 3,214 Afinitor Novartis 1,309 1,785 2,200 2,536 2,776 3,119 Zytiga Johnson & Johnson 1,698 2,233 2,759 3,119 2,884 2,920 Perjeta Roche ,344 1,804 2,282 2,671 Imbruvica Pharmacyclics/J&J ,039 1,638 2,453 Tasigna Novartis 1,266 1,552 1,822 2,035 2,224 2,380 Alimta Eli Lilly 2,703 2,819 2,941 2,821 2,305 2,206 Velcade Johnson & Johnson 1,660 1,776 1,891 2,000 2,100 2,194 MK-3475 Merck & Co ,427 2,146 Sprycel Bristol-Myers Squibb 1,280 1,487 1,682 1,842 1,972 2,078 Abraxane Celgene ,270 1,543 1,806 2,002 Yervoy Bristol-Myers Squibb 960 1,159 1,370 1,581 1,790 1,960 Kyprolis Amgen ,180 1,605 1,859 Palbociclib Pfizer ,204 1,810 Source: Evaluate Pharma - Feb 26, 2014, Defined Health

16 The Oncology Pipeline Remains Robust WW Oncology Pipeline by Phase 1554 Active Programs Highest Phase, I to Registration Source: Adis R&D Insight Feb 2014, Defined Health

17 But Are We Nearing a Good or Problematic Tipping Point? Some novel Phase I programs KIF11 E2F1 Neuropilin Glutaminase KRAS FUS1 NKG2A Sphingosine Epherins TGF-beta TNFRSF10B EGFR PD1 ALK PI3K VEGF/R n Source: Defined Health, Adis R&D Insight (625 Highest Phase = Phase I)

18 Cancer Drugs Versus Need: Pipeline Activity vs. Incidence & Mortality 300, ,000 Number of Individuals 200, , ,000 Drugs in clinical development Number of Drugs 50,000 0 New Cases Deaths American Cancer Society, Leukemia & Lymphoma Society, Defined Health

19 We Have Come a Long Way, But Can Do Must Do Better Still Colorectal cancer, five-year relative survival rate, and (or nearest period) Source: CancerProgress.net (NCI); OECD Health Data 2011

20 CML Remains One of a Few Striking Successes (Not Without Controversies) The cost of managing CRC Estimated 10-year survival increased from less than 20% to above 80% J Clin Oncol 25: , 2007; Am J Manag Care May;17 Suppl 5 Developing:SP45-52 Am J Manag Care. 2012;18:S257-S264

21 Moving Beyond Standard Intracellular Mediators and Extracellular Targets Third Wave Anticancer Agents Complex, Multi-component Cellular Machinery Nature Reviews Drug Discovery 13, (March 2014)

22 When We Look Back in 25 Years Time

23 Defined Health is pleased to present: BioEurope Spring March 10 12, 2014 Turin, Italy Defined Health will also be participating in the following industry events: Therapeutic Insight by Defined Health at BIO-Europe Spring March 10-12, 2014 Turin, Italy AACR Annual Meeting April 5-9, 2014 San Diego Israel Innovation Conference 2014 May 20-22, 2014 Tel Aviv Fairgrounds, Israel ASGCT Annual Meeting May 21-24, 2014 Washington, D.C. ASCO Annual Meeting May 30 - June 3, 2014 Chicago BIO International Convention 2014 June 23-26, 2014 San Diego, CA BioPharm America 2014 September 22-24, 2014 Boston, MA Licensing Executives Society Annual Meeting October 5-8, 2014 San Francisco ASH Annual Meeting December 6-9, 2014 San Francisco