Cancer Progress Conference Agenda: Day 1
8:15 Opening Remarks - Jeff Bockman, PhD8:45 Keynote: Angiogenesis- George D. Yancopoulos, MD, PhD9:30 Panel- Future of cancer therapy – Where have we been, where are we going?
Neal Rosen MD Steven Averbuch MD Larry Norton MD Geert Kolvenbag MD PhDNeal Rosen, MD, Steven Averbuch, MD, Larry Norton, MD, Geert Kolvenbag MD, PhD10:30 Networking Break10:45 Panel-Novel approaches in cancer drug development and clinical trials – Are we
adapting and adopting fast enough? Jamie Freedman, MD, PhD, Richard Gaynor, MD, Eric Rowinsky, MD, Robert Iannone, MDEric Rowinsky, MD, Robert Iannone, MD
11:45 Panel- Immunotherapy for cancer – Are we there yet? The Rights and wrongs of developing next generation immunotherapies: Mary L. (Nora) Disis, MD, JeddWolchok, MD, PhD, H. Kim Lyerly MD, FACS, Jon Wigginton, MD, James Trager, PhD
12:45 Networking Luncheong2:00 Panel- Apoptosis – Why has drug development in apoptosis been stymied?
Douglas R. Green, PhD, Tak Mak, PhD, David Weng, MD, PhD, John C. Reed, MD, PhD3:00 Panel- Data, data everywhere – Generating, harvesting, and analyzing the vast fields
of cancer information: Colin Hill, Eric Schadt, PhD, Alexis Borisy, Bryan Dechairo, PhDy y4:00 Networking Break4:30 Panel- Melanoma: Tackling the intractable – But what next? Jedd Wolchok, MD,
PhD, Paul Chapman, MD, David E. Fisher, MD, PhD
Introduction to Cancer Progress
It is through science that we prove, but through intuition that we discoverintuition that we discover.- Poincare
Jeffrey M. Bockman, PhDVice PresidentVice PresidentDefined Health
23rd A l C P C f23rd Annual Cancer Progress ConferenceMarch 6th – 7th, 2012
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
t th i f ti t i d h i t l t Allguarantee 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 wasthe 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
i h f h i iwithout consent from the originator company.
Cancer Progress © 2012
3/22/2012 4
3/22/2012 5
A Holmesian Perspective on Cancer Progress
• "You will not apply my precept," he said, shaking his head. "How often have I said to you that when you have eliminated the impossible,eliminated the impossible, whatever remains, however improbable, must be the truth?"
The Sign of the Four, ch. 6 (1890)(1890)
3/22/2012 6
Some observations…Some observations…
3/22/2012 7
We’ve Come a Long Way in Ten Years…
3/22/2012 8
Cell, Vol. 100, pp. 57–70, 7 January, 2000, Cell, Vol. 144, pp. 646-674, 4 March 2011
With Cytotoxics Are Largely Genericized, Targeted Biologics and SMIs Will Drive Even More GrowthBiologics and SMIs Will Drive Even More Growth
40
WW Revenue By Major Oncology Drug Category
30
35
Alkaloids
Alkylating agents
es $
B
y j gy g g y
mAbs
20
25Anti-metabolites
Anti-neoplastic Mabs
Cytotoxic antibiotics
Anti-angiogenics (LX1)rldw
ide
Sale mAbs
Small MoleculeCytostatics
10
15Other cytostatics (LX1)
Hormone therapies
Platinum compounds
Other anti-cancer
Wor
MultitargetedTKIs
0
5
Ot e a t ca ce
Unclassified oncology sales
1986 1989 1992 1995 1998 2001 2004 2007 2010 2013 2016EvaluatePharma
2011 Drug Approvals Show Continued Rise of Niche & Stratified Cancer IndicationsStratified Cancer Indications
• Preponderance of orphan products, which accounted for 11 out of 30 approvals, and reflects a shift towards “niche busters” — predominantly made up of cancer products (7 out of 11), in
fl h d b l f d ff b lpart reflecting the increased ability to stratify cancer patients into different subpopulations.– Pfizer’s crizotinib for the treatment of anaplastic lymphoma kinase-positive non-small-cell lung cancer and Roche’s
vemurafenib for the treatment of BRAF-V600 mutation-positive metastatic melanoma. In both cases, therapeutic–diagnostic co-development enabled short clinical trial paths and rapid approvals.
Cancer Drugs in US Development
• 85 out of 192 Phase III (US) have orphan ( ) pdesignation: 44%
•158 of 492 Phase II (US): 32%• 135 out of 768 Phase I or I/II (US): 18%
FDA drug approvals since 1993. New molecular entities (NME) and biologics license applications (BLA) approved by the Center for Drug Evaluation Source: Nature Reviews Drug Discovery 11, 91-94 (February 2012)
Source: Adis R&D Insight, Defined Health
3/22/2012 10
and Research (CDER) since 1993, the first full year during which the US Food and Drug Administration worked under a Prescription Drug User Fee Act (PDUFA) agreement.
Oncology Deals Slowed, But So Did Most Other TAs
Source: In Vivo , May 2011
3/22/2012 11
As in the Past, Some of the More Interesting and Largest Deals Over the Last Two Years Were Discovery D l A d N l Pl fDeals Around Novel Platforms
4 of top 10 deals of past two years: Boehringer Ingelheim’s deal with MacroGenics ($2.2B total value) around their DART bispecific antibodies , Kyowa Hakko Kirin’s deal with Dicerna ($1.4B) on RNAi, Roche’s deal with
Aileron around their stapled peptides ($1.1B) and the Amgen-Micromet deal (pre-acquisition) ($1B).
Average Licensing Deal Financials: Cancer Market, 2010-2011
Licensing Deals by Stage of Development at Signing: Cancer Market, 2010-2011
p p p ($ ) g (p q ) ($ )
Source: Deloitte Recap, www.recap.comAverages: Deal size $377.7 mil, Upfront $22.21 mil, Total milestones $299.11 mil. Additional payments available but not shown – R&D, equity,
Source: Deloitte Recap, www.recap.com . Includes pharma, biotech & university deals with or without financial details. Numbers in percentages
3/22/2012 12
p y q yadjusted milestones, loans, royalties. Includes pharma, biotech & university deals with financial details.
Large Molecule Deals Edged Out Small Molecule Ones, And While Antibodies Lead the Way, Other Approaches A G i i S T iAre Gaining Some Traction
Licensing Deals by Technology: C M k 2010 2011
Over the past two years, of the top 20 deals with
publically announced d l i (t t l d llCancer Market, 2010-2011 deal sizes (total dollars
from $467M to $2.2B), 11 of these deals involved
biologics, including primarily antibodies but
also fusion proteins, RNAi, recombinant
viruses with immune payloads and cell-based
therapiestherapies.
Source: Deloitte Recap, www.recap.comIncludes pharma, biotech & university deals with or without financial detailsNumbers in percentages
3/22/2012 13
Phase I to Market Transition Rates for Cancer Shows Heme as a Better Place to Place BetsHeme as a Better Place to Place Bets
Defined Health believes that the higher success rates in
heme malignancies reflect in part the inherent differences in the underlying biology of
these cancers versus the highly heterogeneous solid tumors.
In addition broad settingsIn addition, broad settings such as lymphoma actually
include a diversity of indications each with their
own unique treatment l i h d i (algorithm and regimens (NHL, HL, CLL, T-cell lymphomas
[PTCL and CTCL], etc.) as well as situations where the same drug has multiple approvals
Source: Deloitte Recap, www.recap.comData current as of January 31, 2012, see following slide for detailsDeloitte Recap DEVELOPMENT optimizer™
g p pp(e.g., Rituxan for aggressive and indolent non-Hodgkin’s lymphomas such as follicular
and DLBCL, respectively).
3/22/2012 14
Partnered Versus Un-Partnered Programs & Probability of Successof Success
As Deloitte notes, at least three factors could be
reflected in the data includingreflected in the data, including 1) Molecules that successfully undergo due diligence in the partnering process may be
inherently higher “quality” and thus more likely to succeed; 2)
Partnered molecules may benefit from the partner’s
increased resources and/or expertise as applied toexpertise as applied to
development decisions; or 3) Un-partnered drugs may
terminate more often due to funding or prioritization issues
h h d
Source: Deloitte Recap, www.recap.comData current as of January 31, 2012, see following slide for detailsDeloitte Recap DEVELOPMENT optimizer™
than their partnered counterparts.
3/22/2012 15
Early 2012 Deal: Will the Genentech and Constellation Deal Be a Landmark Collaboration?Deal Be a Landmark Collaboration?• The deal may be viewed as a right in Genentech’s “sweet spot of targeted therapies
and underlying biology” according to Kevin Sin, Director, Genentech Partnering, with whom Defined Health discussed this deal.
• This collaboration has some similarities to the original Roche Genentech deal, with Genentech now accessing through Constellation its domain expertise in chromatin biology, discovery tools, and the ability to look holistically at the nodes and crosstalk within epigenetics and not focusing on only one particular target.crosstalk within epigenetics and not focusing on only one particular target.
Genentech & Constellation
Under terms of the deal, Genentech committed funding of $95 million, including an upfront t d h f di th C t ll ti ill b li ibl f d l tpayment and research funding over three years. Constellation will be eligible for development
and commercialization milestone payments as well as up to double-digit royalties on commercial sales of products taken to market by Genentech.Constellation will retain exclusive development and commercialization rights to selected programs, the companies said in the press release, and Genentech would have to pay Constellation if those products are brought to market.The partnership does not cover Constellation’s other programs, the Boston Business Journal reported. Those include an inhibitor of the BET chromatin reader and EZH2 chromatin writer proteins
S S i i i J 1 2012 fi d H l h S i C J 23 2012
3/22/2012 16
Source: San Francisco Business Times, Jan 17, 2012; Defined Health Source: BioCentury, Jan 23, 2012
Top 20 Phase III Oncology Drugs by Sales Potential: Mostly Next Generation Approaches to Well-Validated T B I i l N l I h iTargets, But Increasingly Novel Immunotherapies
drug name Originator Licensee Lead Indication
Sales (M)
pert mab Genentech Ch ai 990 6
drug name Originator Licensee Lead Indication
Sales (M)
Axitinib Pfizer Inc SFJ Renal cancer 363 7pertuzumab Genentech Chugai 990.6
MDV-3100 University of California
Astellas, Medivation
Prostate cancer 903.7
BAY-88-8223 Algeta ASA, Bayer AG
Bone metastases 532.9
Axitinib Pfizer Inc PharmaRenal cancer 363.7
necitumumab ImClone BMS NSCLC 347.8
regorafenib Bayer AGColorectal cancer 297.6
pasireotide Novartis 471.0
aflibercept Regeneron Bayer, Sanofi
Colorectal cancer 434.8
Kirin
brivanibalaninate BMS Liver cancer 282.2
ridaforolimus ARIAD Merck & Co
Sarcoma 242.5
astuprotimut-r GSKMelanoma/
235 9tivozanib Kirin
Brewery Co 403.0
carfilzomib Yale University Ono
Multiple myeloma 388.5
trastuzumabemtansine Genentech Chugai,
RocheBreast cancer 387.4
astuprotimut r GSK NSCLC 235.9
obinutuzumab GlycartBiotech
B cell lymphoma 224.4
velimogenealiplasmid Vical Inc AnGes MG
Malignant melanoma 222.0
emtansine Roche cancer
Reolysin Oncolytics Biotech Inc
Head and neck cancer 385.8
pomalidomide EntreMedMultiple myeloma 378.5
bosutinib Wyeth Research
CML 202.7
emepepimut-S OncothyreonEMD, Merck KGaA, Ono
Non-small cell lung cancer 202.4
3/22/2012 17
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KGaA, Ono
Top 20 Phase III Oncology Drugs by Sales Potential*
drug name Originator Licensee Lead Indication
Sales (M)
pertuzumab Genentech Chugai 990.6
drug name Originator Licensee Lead Indication
Sales (M)
Axitinib Pfizer Inc SFJ Pharma
Renal cancer 363.7
MDV-3100 University of California
Astellas, Medivation
Prostate cancer 903.7
BAY-88-8223 Algeta ASA, Bayer AG
Bone metastases 532.9
necitumumab ImClone BMS NSCLC 347.8
regorafenib Bayer AGColorectal cancer 297.6
brivanib
Pertuzumab plus Herceptin (trastuzumab) plus docetaxel used as first-line treatment for HER2-positive metastatic breast cancer
significantly prolonged PFS with no increase in cardiac toxic effects (>90% of patients were HER2 3+), showing that the two
ti HER2 l l tib di ith l t MOApasireotide Novartis 471.0
aflibercept Regeneron Bayer, Sanofi
Colorectal cancer 434.8
tivozanib Kirin Brewery Co 403.0
brivanibalaninate BMS Liver cancer 282.2
ridaforolimus ARIAD Merck & Co
Sarcoma 242.5
astuprotimut-r SmithKline Beecham plc
Melanoma/NSCLC 235.9
anti-HER2 monoclonal antibodies with complementary MOAs have valuable combination clinical activity in preventing the
ligand-dependent formation of HER2 dimers. Interesting next generation biologic approaches around engineering the Fc
region could enhance the interactions for patients with the low-Brewery Co
carfilzomib Yale University Ono
Multiple myeloma 388.5
trastuzumabemtansine Genentech Chugai,
Roche Breast cancer 387.4
obinutuzumab GlycartBiotech
B cell lymphoma 224.4
velimogenealiplasmid Vical Inc AnGes MG
Malignant melanoma 222.0
binding alleles. In addition, agents like MacroGenics’ MGAH22 , which is in Phase I, could expand the potential beyond HER2 3+ patients in mBC and in other cancers where HER2 expression is
low. (Breast Cancer Research 2011, 13:R123)
Reolysin Oncolytics Biotech Inc
Head and neck cancer 385.8
pomalidomide EntreMedMultiple myeloma 378.5
bosutinib Wyeth Research
CML 202.7
emepepimut-S OncothyreonEMD, Merck KGaA, Ono
Non-small cell lung cancer 202.4
3/22/2012 18
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Top 20 Phase III Oncology Drugs by Sales Potential*
drug name Originator Licensee Lead Indication
Sales (M)
pertuzumab Genentech Chugai 990.6
drug name Originator Licensee Lead Indication
Sales (M)
Axitinib Pfizer Inc SFJ Pharma Renal cancer 363.7It has been a long road for Regeneron’s VEGF-Trap (aflibercept/Zaltrap) in cancer,
MDV-3100 University of California
Astellas, Medivation
Prostate cancer 903.7
BAY-88-8223 Algeta ASA, Bayer AG
Bone metastases 532.9
necitumumab ImClone BMS NSCLC 347.8
regorafenib Bayer AGColorectal cancer 297.6
brivanib
although it is having a very strong showing in AMD since its launch (as Eylea). From the early days of being developed with Aventis as a direct biologic competitor to Avastin, it
has faced numerous challenges, but despite the disappointing results in NSCLC and pancreatic cancer, the data from the VELOUR trial in CRC has demonstrated the potential value of adding aflibercept to FOLFIRI in metastatic colorectal cancer patients previously
pasireotide Novartis 471.0
aflibercept Regeneron Bayer, Sanofi
Colorectal cancer 434.8
tivozanib Kirin Brewery Co 403.0
brivanibalaninate BMS Liver cancer 282.2
ridaforolimus ARIAD Merck & Co Sarcoma 242.5
astuprotimut-r SmithKline Beecham plc
Malignant melanoma 235.9
value of adding aflibercept to FOLFIRI in metastatic colorectal cancer patients previously treated with oxaliplatin-based regimens, including those progressing on Avastin, with benefits in OS and PFS that are statistically significant and clinically meaningful. The
clinical development activity around next generation anti-angiogenesis approaches, both large and small molecules, has been intense. Results with MTKIs have been mixed ,
d di th t t S t ti h i l d th t tiBrewery Co
carfilzomib Yale University Ono
Multiple myeloma 388.5
trastuzumabemtansine Genentech Chugai,
Roche Breast cancer 387.4
obinutuzumab GlycartBiotech
B cell lymphoma 224.4
velimogenealiplasmid Vical Inc AnGes MG
Malignant melanoma 222.0
depending on the tumor type. Some next generation approaches include those targeting the splice variants and processing of VEGF transcripts. For example, PTC Therapeutics’ PTC299 is an oral small molecule VEGF inhibitor that acts upstream of current VEGF-targeted therapies by targeting the untranslated region (UTR)-mediated processes regulating translation and thereby inhibiting VEGF protein expression, as well as
Reolysin Oncolytics Biotech Inc
Head and neck cancer 385.8
pomalidomide EntreMedMultiple myeloma 378.5
bosutinib Wyeth Research
CML 202.7
emepepimut-S Oncothyreon
EMD, Merck KGaA, Ono
Non-small cell lung cancer 202.4
modulating other angiogenic cytokines such as IL-6 and PlGF. PTC299 is hypothesized to inhibit tumor VEGF production while sparing physiological VEGF production, and inhibits
the production of all angiogenic VEGF-A splice variants (San Antonio Breast Cancer Symposium 2011, P2-16-08).
3/22/2012 19
*THOMSON REUTERS CORTELLIS™ FOR COMPETITIVE INTELLIGENCE
Top 20 Phase III Oncology Drugs by Sales Potential*
drug name Originator Licensee Lead Indication
Sales (M)
pertuzumab Genentech Chugai 990.6
drug name Originator Licensee Lead Indication
Sales (M)
Axitinib Pfizer Inc SFJ Pharma
Renal cancer 363.7
Viral-based therapies (whether truly gene therapies or not) have been pursued for many years, with the early generation products dogged by many of the same issues that faced early generation immunotherapies:
suboptimal first gen products, problematic trial design, and an evolving standard of care with monoclonals
MDV-3100 University of California
Astellas, Medivation
Prostate cancer 903.7
BAY-88-8223 Algeta ASA, Bayer AG
Bone metastases 532.9
necitumumab ImClone BMS NSCLC 347.8
regorafenib Bayer AGColorectal cancer 297.6
brivanib
subop a s ge p oduc s, p ob e a c a des g , a d a e o g s a da d o ca e o oc o a sand M/TKIs that has complicated the relevance of outcomes. Oncolytic viruses have been designed to
specifically exploit some of the same altered/defective pathways that promote/drive tumor growth, whether tumor-specific mutations in antiviral defense programs, signaling pathways or transcriptional programs that
are constitutively activated or by restriction of virus to cancer cells by binding/entry via unique or over-d ll f ti I dditi f th t ti h d li ipasireotide Novartis 471.0
aflibercept Regeneron Bayer, Sanofi
Colorectal cancer 434.8
tivozanib Kirin Brewery Co 403.0
brivanibalaninate BMS Liver cancer 282.2
ridaforolimus ARIAD Merck & Co
Sarcoma 242.5
astuprotimut-r SmithKline Beecham plc
Malignant melanoma 235.9
expressed cell surface antigens. In addition, more of the next generation approaches are delivering immunotherapy payloads, such as OncovexGM-CSF, from BioVex , which was acquired in 2011 by Amgen for up to $1B and became the first significant partnering validation in the space. While adenovirus-based systems
have been most studied, along with pox and herpes, the Reovirus system offers the advantage of replication being limited to RAS activating mutations or activating mutations of upstream signals (EGFR, PDGFR) found in
Brewery Co
carfilzomib Yale University Ono
Multiple myeloma 388.5
trastuzumabemtansine Genentech Chugai,
Roche Breast cancer 387.4
obinutuzumab GlycartBiotech
B cell lymphoma 224.4
velimogenealiplasmid Vical Inc AnGes MG
Malignant melanoma 222.0
many high unmet need cancers (pancreatic, SCCHN, GBM, CRC, lung), which could be exploited through patient stratification approaches such as Reolysin’s in KRAS mutant NSCLC and CRC.
Reolysin Oncolytics Biotech Inc
Head and neck cancer 385.8
pomalidomide EntreMedMultiple myeloma 378.5
bosutinib Wyeth Research
CML 202.7
emepepimut-S OncothyreonEMD, Merck KGaA, Ono
Non-small cell lung cancer 202.4
3/22/2012 20
*THOMSON REUTERS CORTELLIS™ FOR COMPETITIVE INTELLIGENCE
Top 20 Phase III Oncology Drugs by Sales Potential*
drug name Originator Licensee Lead Indication
Sales (M)
pertuzumab Genentech Chugai 990.6
drug name Originator Licensee Lead Indication
Sales (M)
Axitinib Pfizer Inc SFJ Pharma
Renal cancer 363.7
MDV-3100 University of California
Astellas, Medivation
Prostate cancer 903.7
BAY-88-8223 Algeta ASA, Bayer AG
Bone metastases 532.9
necitumumab ImClone BMS NSCLC 347.8
regorafenib Bayer AGColorectal cancer 297.6
brivanib
More MTKIs targeting angiogenesis and/or proliferation targets, from
Aveo/Astellas, Pfizer, Bayer, and BMS. Will these any of these become
More MTKIs targeting angiogenesis and/or proliferation targets, from
Aveo/Astellas, Pfizer, Bayer, and BMS. Will these any of these become
More MTKIs targeting angiogenesis and/or proliferation targets, from
Aveo/Astellas, Pfizer, Bayer, and BMS. Will these any of these become
pasireotide Novartis 471.0
aflibercept Regeneron Bayer, Sanofi
Colorectal cancer 434.8
tivozanib Kirin Brewery Co 403.0
brivanibalaninate BMS Liver cancer 282.2
ridaforolimus ARIAD Merck & Co
Sarcoma 242.5
astuprotimut-r GSKMelanoma/NSCLC 235.9
blockbusters to rival the monoclonals, especially outside of
heme malignancies like CML?
blockbusters to rival the monoclonals, especially outside of
heme malignancies like CML?
blockbusters to rival the monoclonals, especially outside of
heme malignancies like CML?
Brewery Co
carfilzomib Yale University Ono
Multiple myeloma 388.5
trastuzumabemtansine Genentech Chugai,
Roche Breast cancer 387.4
obinutuzumab GlycartBiotech
B cell lymphoma 224.4
velimogenealiplasmid Vical Inc AnGes MG
Malignant melanoma 222.0
Reolysin Oncolytics Biotech Inc
Head and neck cancer 385.8
pomalidomide EntreMedMultiple myeloma 378.5
bosutinib Wyeth Research
CML 202.7
emepepimut-S OncothyreonEMD, Merck KGaA, Ono
Non-small cell lung cancer 202.4
3/22/2012 21
*THOMSON REUTERS CORTELLIS™ FOR COMPETITIVE INTELLIGENCE
Top 20 Phase III Oncology Drugs by Sales Potential
drug name Originator Licensee Lead Indication
Sales (M)
pertuzumab Genentech Chugai 990.6
drug name Originator Licensee Lead Indication
Sales (M)
Axitinib Pfizer Inc SFJ Pharma
Renal cancer 363.7
MDV-3100 University of California
Astellas, Medivation
Prostate cancer 903.7
BAY-88-8223 Algeta ASA, Bayer AG
Bone metastases 532.9
necitumumab ImClone BMS NSCLC 347.8
regorafenib Bayer AGColorectal cancer 297.6
brivanib
Has the age of immunotherapy at last arrived? The approval of Provenge and Yervoy
has invigorated the field, but has probably pasireotide Novartis 471.0
aflibercept Regeneron Bayer, Sanofi
Colorectal cancer 434.8
tivozanib Kirin Brewery Co 403.0
brivanibalaninate BMS Liver cancer 282.2
ridaforolimus ARIAD Merck & Co
Sarcoma 242.5
astuprotimut-r GSKMelanoma/NSCLC 235.9
xxx
xxx
g , p ynot de-risked across the diverse range of
approaches. Just represented in this list are three different platforms, 2 antigen-based
and one co-stimulatory-based: GSK’s recombinant MAGE A3 antigen MerckBrewery Co
carfilzomib Yale University Ono
Multiple myeloma 388.5
trastuzumabemtansine Genentech Chugai,
Roche Breast cancer 387.4
obinutuzumab GlycartBiotech
B cell lymphoma 224.4
velimogenealiplasmid Vical Inc AnGes MG
Malignant melanoma 222.0
recombinant MAGE A3 antigen; Merck Serono’s 25-mer peptide fragment of MUC-1
antigen; and Vical’s plasmid-based system encoding HLA-B7 and ß2 microglobulin for
enhancing antigen presentation. Reolysin Oncolytics
Biotech IncHead and neck cancer 385.8
pomalidomide EntreMedMultiple myeloma 378.5
bosutinib Wyeth Research
CML 202.7
emepepimut-S OncothyreonEMD, Merck KGaA, Ono
Non-small cell lung cancer 202.4
DATA SOURCE THOMSON REUTERS CORTELLIS™ FOR COMPETITIVE INTELLIGENCE DEFINED HEALTH
3/22/2012 22
DATA SOURCE: THOMSON REUTERS CORTELLIS™ FOR COMPETITIVE INTELLIGENCE; DEFINED HEALTH
Top 20 Phase III Oncology Drugs by Sales Potential*
drug name Originator Licensee Lead Indication
pertuzumab Genentech Chugai 990.6
drug name Originator Licensee Lead Indication
Sales (M)
Axitinib Pfizer Inc SFJ Pharma
Renal cancer 363.7
Follow-on biologics, specifically monoclonals, has limited precedence in cancer, other than the Erbitux-
Vectibix and Rituxan Arzerra examples Anti CD20
Follow-on biologics, specifically monoclonals, has limited precedence in cancer, other than the Erbitux-
Vectibix and Rituxan Arzerra examples Anti CD20MDV-3100 University of
CaliforniaAstellas, Medivation
Prostate cancer 903.7
BAY-88-8223 Algeta ASA, Bayer AG
Bone metastases 532.9
necitumumab ImClone BMS NSCLC 347.8
regorafenib Bayer AGColorectal cancer 297.6
brivanib
Vectibix and Rituxan-Arzerra examples. Anti-CD20, along with anti-EGFR and HER2, have represented a
sizeable portion of next generation approaches, typically utilizing modification of glycosylation or protein engineering. Given the impending paten
Vectibix and Rituxan-Arzerra examples. Anti-CD20, along with anti-EGFR and HER2, have represented a
sizeable portion of next generation approaches, typically utilizing modification of glycosylation or protein engineering. Given the impending paten
pasireotide Novartis 471.0
aflibercept Regeneron Bayer, Sanofi
Colorectal cancer 434.8
tivozanib Kirin Brewery Co 403.0
brivanibalaninate BMS Liver cancer 282.2
ridaforolimus ARIAD Merck & Co
Sarcoma 242.5
astuprotimut-r GSKMelanoma/NSCLC 235.9
expiration of Rituxan and anticipated biosimilars (at least in certain geographies), it will be a fascinating case study in action to see how Roche’s own follow-
on plays out. Similarly, necitumumab is a fully human IgG1 mAb directed against EGFR Preclinical
expiration of Rituxan and anticipated biosimilars (at least in certain geographies), it will be a fascinating case study in action to see how Roche’s own follow-
on plays out. Similarly, necitumumab is a fully human IgG1 mAb directed against EGFR PreclinicalBrewery Co
carfilzomib Yale University Ono
Multiple myeloma 388.5
trastuzumabemtansine Genentech Chugai,
Roche Breast cancer 387.4
obinutuzumab GlycartBiotech
B cell lymphoma 224.4
velimogenealiplasmid Vical Inc AnGes MG
Malignant melanoma 222.0
human IgG1 mAb directed against EGFR. Preclinical studies indicated that the antitumor activity is either
comparable with or superior to that of ImClone'schimeric anti-EGFR mAb cetuximab.
Alternative approaches include th two epitope,
human IgG1 mAb directed against EGFR. Preclinical studies indicated that the antitumor activity is either
comparable with or superior to that of ImClone'schimeric anti-EGFR mAb cetuximab.
Alternative approaches include the two epitope,
Reolysin Oncolytics Biotech Inc
Head and neck cancer 385.8
pomalidomide EntreMedMultiple myeloma 378.5
bosutinib Wyeth Research
CML 202.7
emepepimut-S OncothyreonEMD, Merck KGaA, Ono
Non-small cell lung cancer 202.4
double mAb mix against EGF from Symphogen. Animal data show better efficacy than Erbitux, activity in Erbitux partial responders, and
possible activity in non-responders.
double mAb mix against EGF from Symphogen. Animal data show better efficacy than Erbitux, activity in Erbitux partial responders, and
possible activity in non-responders.
3/22/2012 23
*THOMSON REUTERS CORTELLIS™ FOR COMPETITIVE INTELLIGENCE
Some speculation…Some speculation…
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The Pressure Is On, But Can Targeted Agents Allied to Stratified Patient Segments Allay the Risk?Stratified Patient Segments Allay the Risk?• Reliance on oncology just when payers are applying more scrutiny to cancer drugs – it is no
longer sacrosanct.• Payers are starting to experiment with “clinical pathways” rather than prior authorization.
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Source: In Vivo , May 2011, “What New Cancer Pathway Programs Mean for the Drug Industry”
Stratifying Ad Infinitum: The Old Worry of the Oncology Marketing Head Was Fragmentation of the MarketMarketing Head Was Fragmentation of the Market…
Source: http://costprojections.
Source: Nature, 455: 1069-1075, 2008; Cancer Res 68: 6913-6921, 2008
p p jcancer.gov/
…And 10-15 Xalkori’s to equal the…And 10 15 Xalkori s to equal the 2015 NSCLC Market
3/22/2012 26
Source: EvaluatePharma, Feb 28, 2012
And It Takes Many Niche-busters to Equal an Avastin
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Data Is No Longer Limiting…But Does Data = The Answer?But Does Data The Answer?
S 4 4 Lif i / h O f d h l i S i i 22 b 2012
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Source: 454 Lifesciences/Roche, Oxford Nanopore Technologies, New Scientist, 22 February 2012
How To Treat Metastases – Secondary Prevention & Maintenance Therapy (Preventing Recurrence)?Maintenance Therapy (Preventing Recurrence)?
Late Dissemination Model
Early/Parallel Dissemination Model
Nature Reviews Cancer 12, 133-143 (February 2012)
Cancers 2011, 3, 298-318
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Nature Reviews Cancer 9, 302-312 (April 2009)
When Will We Move Beyond Treatment to Prevention?
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Nature Reviews Drug Discovery 8, 213-225 (March 2009)
Thinking Mechanistically, Holistically & DynamicallyNature Reviews Cancer 6, 924-935 (December 2006)Cancer as an evolutionary and ecological processLauren M.F. Merlo, John W. Pepper, Brian J. Reid3 & Carlo C. Maley
Nature Reviews Cancer 11, 375-382 (May 2011)An analogy between the evolution of drug resistance in bacterial communities and malignant tissuesG ill L b t L i E té S l St OhGuillaume Lambert, Luis Estévez-Salmeron, Steve Oh, David Liao, Beverly M. Emerson Thea D. Tlsty & Robert H. Austin
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How Do We Balance Data, Deduction & Inspiration?
• In the great Argentinean writer Jorge Luis Borges’ short story "Funes the Memorious" ("Funes el memorioso” La Nación in June 1942) Borgesmemorioso , La Nación in June 1942), Borges describes his character, Ireneo Funes, whose memory is following a fall becomes so prodigious that he remembers everything, “not only every leaf of every tree of every wood but also every one ofof every tree of every wood, but also every one of the times he had perceived or imagined it.”
• “He was…almost incapable of ideas of a general, Platonic sort. Not only was it difficult for him to
h d th t th i b l d bcomprehend that the generic symbol dog embraces so many unlike individuals of diverse size and form; it bothered him that the dog at three fourteen (seen from the side) should have the same name
th d t th fift ( f th f t) ”as the dog at three fifteen (seen from the front).”
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