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thOpening Address, 26th Annual Cancer Progress Conferenceg

Jeff Bockman, PhD, VP, Defined Health

Cancer Progress by Defined HealthNew York, NY | March 17-18, 2015Cancer Progress by Defined HealthNew York, NY | March 17-18, 2015

March 17-18, 2015New York, NY

DisclaimerDisclaimerThe 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 hereinbeen 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 y p p ( ) p p pProgress, 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, WoltersKluwer, EvaluatePharma, Datamonitor, Informa Healthcare, IMS Health and others with a proprietary i t t i th d t id d h i Pl t th t t itt d t di t ib t hinterest 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 © 2015


Oncology Is Still a Leading Driver of Growth i Bi Phin BioPharma

200000

Worldwide Sales by Therapeutic Area 2013-2020

160000

180000

200000

Oncology & ImmunomodulatorsBlood

100000

120000

140000

es M

illio

ns

CVCNSDermEndocrine

60000

80000

100000

$WW

Sal

e Gastro-IntestinalGenito-UrinaryMusculoskeletalRespiratorySensory Organs

0

20000

40000Sensory OrgansSystemic Anti-infectivesVarious

Cancer Progress by Defined HealthNew York, NY | March 17-18, 2015

02013 2014 2015 2016 2017 2018 2019 2020

EvaluatePharma, Defined Health

Top Selling BioPharma ProductsTop Selling BioPharma Products


EvaluatePharma

Top Selling Oncology ProductsTop Selling Oncology Products


EvaluatePharma

Small Molecules Still Are the Main C t ib t t th C M k tContributors to the Cancer Market…

WW Oncology Sales by Technology Type

80%

90%

100%

68% 66%

50%

60%

70%

32% 34%20%

30%

40%

%

0%

10%

2013 WW Sales 2020 WW Sales

Biotechnology Conventional



But, Biologics Have & Will Continue to D t t Si ifi t G thDemonstrate Significant Growth

200,000Historic and Future Growth by Technology Type

160,000

180,000

Vaccine

Small molecule chemistry

Protein extractonve

ntio

nal

Tech

nolo

gy

100,000

120,000

140,000

ales

($M

)

Plant extract

Chiral chemistry

Recombinant product

Co T

60,000

80,000WW

Sa

Other biotechnology product

Monoclonal antibody (conjugated)

Monoclonal antibody

Gene therapy

Biol

ogic

s

20,000

40,000

py

DNA & RNA therapeutics

Cell therapy

Bioengineered vaccine


02003 WW Sales 2013 WW Sales 2020 WW Sales


The Oncology Pipeline Remains The Most A ti f A Th ti AActive of Any Therapeutic Area

Clinical Development by Therapeutic Area (Percentages)

O l &Systemic

Anti

Various2%

Oncology & Immunomod

ulators21%

Blood3%Respiratory

Sensory Organs

4%

Anti-infectives

14%

%

CV7%

GU

Musculoskeletal7%

5%

CNS13%

Derm5%

Endocrine7%

GI5%

GU7%


Adis R&D Insight, Defined Health

The Oncology Pipeline Remains The Most A ti f A Th ti AActive of Any Therapeutic Area

OncologyClinical Development by Phase Oncology

Clinical Development by Phase

5%3%

11%

18191

376

p y

2%37%

376

621231

26%854

16%

Registered PreregistrationPhase III Phase II/IIIPhase II Phase I/II

543

Registered PreregistrationPhase III Phase II/III


Adis R&D Insight, Defined Health

Phase II Phase I/IIPhase I

Phase II Phase I/IIPhase I

Number of Product Deals by Therapeutic A 2010 2014Area, 2010-2014


IMS Pharma Deals

Top Deals of 2014Top Deals of 2014

Cancer Progress by Defined HealthNew York, NY | March 17-18, 2015Cancer Progress by Defined HealthNew York, NY | March 17-18, 2015 11

Thomson Reuters

Largest Upfronts of 2014Largest Upfronts of 2014


Thomson Reuters

The Age of Collaborative R&D Deals, Driven E i ll b I O lEspecially by Immuno-Oncology


IMS Pharma Deals

2015 Immuno-Oncology Deals (I d t I d t O l )(Industry-Industry Only)

Date BMS Originator Platform/Product

Phase Terms

1/5/2015 Amgen Kite ACT: CART Pre Kite to Receive a $60 Million Upfront Payment From Amgen and Eligible for1/5/2015 Amgen Kite ACT: CART Pre Kite to Receive a $60 Million Upfront Payment From Amgen and Eligible for up to $525 Million in Regulatory and Sales Milestone Payments per Amgen Program; Plus, Tiered High Single- to Double-Digit Royalties for Sales and License of Kite's Intellectual Property for CAR T Cell Products Amgen Eligible to Receive up to $525 Million in Milestone Payments per Kite Program; Plus, Tiered Single-Digit Sales Royalties

1/9/2015 Incyte Agenus Checkpoints and costims:

Pre Agenus to receive $60 million comprised of a $25 million technology and program access fee under the collaboration plus $35 million equity investmentand costims:

GITR, OX40, LAG-3 and TIM-3

program access fee under the collaboration plus $35 million equity investment in Agenus at $4.51/share Agenus eligible to receive up to $350 million in development, regulatory and commercial milestones across the four lead programs

1/12/2015 MedImmune Omnis OV -Genetically engineered strain of VSV

I ND

1/21/2015 C l Z k Bi ifi P Z k ill i i iti l f t t ll it1/21/2015 Celgene Zymeworks Bispecific Pre Zymeworks will receive an initial upfront payment, as well as an equity investment from Celgene. Zymeworks is eligible to receive clinical, regulatory, and commercial milestones on successful candidates totaling up to US $164Mper therapeutic candidate. Additionally, Zymeworks will receive royalties on worldwide net sales. Further financial details are not disclosed.

1/27/2015 Janssen Macrogenics Bispecific T-cell engager

Pre MacroGenics will receive a $50 million upfront license fee and Johnson & Johnson Innovation - JJDC, Inc. has invested $75 million with the purchase of 1 923 077 new shares of MacroGenics common stock at a price of $39 00of 1,923,077 new shares of MacroGenics common stock at a price of $39.00 per share. Janssen will be fully responsible for developing MGD011 following submission of the IND, which is planned for 2015. Assuming successful development and commercialization, MacroGenics could receive up to an additional $575 million in clinical, regulatory and commercialization milestone payments. MacroGenics may elect to fund a portion of late-stage clinical development in exchange for a profit share in the U.S. and Canada. If commercialized, MacroGenics would be eligible to receive double-digit royalties on any global net sales and has the option to co-promote the



14

royalties on any global net sales and has the option to co-promote the molecule with Janssen in the U.S.

2015 Immuno-Oncology Deals (I d t I d t O l )(Industry-Industry Only)

Date BMS Originator Platform/Product

Phase Terms

2/11/2015 Incyte Advaxis Vaccine: ADXS-HPV

II Advaxis and Incyte will collaborate on a non-exclusive basis to evaluate the combination of ADXS-HPV with IDO1 inhibitor for the treatment of cervical cancer. The companies will collaboratively conduct and fund the study, which is expected to begin later this year. Results from the study will be used to determine whether further clinical development of this combination is warranted. Further details of the agreement were not disclosed.

2/23/2015 BMS Rigel TGF-beta kinase inhibitors

Pre Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel’s TGF betainhibitors commercialize small molecule therapeutics derived from Rigel s TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30 million upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309 million for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.

2/23/2015 BMS Flexus IDO1 inhibitors Pre $800 million upfront to gain control of a preclinical IDO1 immunotherapy that2/23/2015 BMS Flexus IDO1 inhibitors Pre $800 million upfront to gain control of a preclinical IDO1 immunotherapy that shows promise in treating cancer, buying out San Carlos, CA-based Flexuswith another $450 million set aside for milestones.

3/4/2015 BMS Bavarian Nordic Vaccine:Prostvac

Up to $975 million: $80 million upon exercise of the option plus additional incremental payments starting at $50 million, but with a potential to exceed $230 million should the median overall survival benefit of PROSTVACexceed the efficacy seen in Phase 2 results. Furthermore, Bavarian Nordic could receive regulatory milestone payments of $110 million, up to $495 million in sales milestones as well as tiered double-digit royalties on future sales of PROSTVAC.



15

The History of Oncology as a Pharma Market Is Surprisingly ShortIs Surprisingly Short



The Perfect Illustration of the Old & New O lOncology


The Perfect Illustration of the Old & New O l (C t )Oncology (Cont.)

BMS really established the modern oncology market and th bl kb t d l t t t d h

Taxol WW Sales Opdivo WW Sales

the blockbuster development strategy, and now has repositioned itself for the 21st century…

Taxol, WW Sales Opdivo, WW Sales



But Are We Nearing a Good or Problematic Ti i P i t?Tipping Point?

KIF11

KRASE2F1

Gl t iNeuropilinSome novel KRAS

Sphingosine

GlutaminaseFUS1

TGF-beta

NKG2AEpherins TNFRSF10B

early stage programsA whole lot

of apparent copycats

PD1

S 0

EGFR

copycats

ALK

PI3K

EGFR

VEGF/Rn


Defined Health, Adis R&D Insight (625 Highest Phase = Phase I)

Cancer Drugs vs. Need: Pipeline Activity vs Incidence & MortalityPipeline Activity vs. Incidence & Mortality

300,000

200,000

250,000

NuIn

divi

dual

s

100,000

150,000

Drugs in clinical …

umber of D

ruNum

ber o

f

0

50,000

New Cases

ugs


American Cancer Society, Leukemia & Lymphoma Society, Defined Health

We Have Come a Long Way, But Can Do –Must Do – Better StillMust Do Better Still

Colorectal cancer, five-year relative survival rate, 1997-2002 and 2004-09 (or nearest period)


CancerProgress.net (NCI); OECD Health Data 2011

CML Remains One of a Few Striking Successes (Not Without Controversies)Successes (Not Without Controversies)

Estimated 10-year survival in CMLincreased from less than 20% to above 80%The cost of managing CRC


J Clin Oncol 25:180-186, 2007; Am J Manag Care. 2011 May;17 Suppl 5 Developing:SP45-52 Am J Manag Care. 2012;18:S257-S264

Fun With Math Riddle: More Drugs Than Possible But Less Than Necessary?Possible, But Less Than Necessary?

Phase* Number of Cancer Drugs

Cancer Drugs Reaching Market – BioMedTracker**

Cancer Drugs Reaching Market - Nat Rev Drug Discov***

Number of Lung Cancer Drugs

Lung Cancer DrugsReaching Market**

Prereg-Reg

42 34 159 10 8

Phase III 145 64 50 22

Phase II 476 71 320 115 17Phase II 476 71 320 115 17

Phase I 771 69 456 35 3

Total 1434 238 935 210 50

Cancer Progress by Defined HealthNew York, NY | March 17-18, 2015 24

Adis R&D Insight, WW*Phase II/III categorized as Phase II; Phase I/II as Phase I

**BioMedTracker, BIO presentation, BIO 2011

***Nature Reviews Drug Discovery 8, 15-16 (January 2009)

Pressure – 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.


In Vivo , May 2011, “What New Cancer Pathway Programs Mean for the Drug Industry”

To Be Addressed or Not, That Is the Question: Complexity, Heterogeneity, Q p y, g y,

Plasticity


How To Treat/Prevent Metastases – Moving Earlier Mo ing Smartl D T PEarlier, Moving Smartly: Dx, Tx, Px

Late Dissemination ModelModel

Early/Parallel Dissemination Model

Nature Reviews Cancer 12, 133-143 (February 2012)

Cancer Progress by Defined HealthNew York, NY | March 17-18, 2015 27Cancers 2011, 3, 298-318

Nature Reviews Cancer 9, 302-312 (April 2009)

Key Themes Running Through Cancer P 2015Progress 2015

• We open with the touchiest of topics: How to think about pricing cancer drugs and regimens – it may not be the elephant in the closet but it is still an unwieldy and wild beastelephant in the closet, but it is still an unwieldy and wild beast

• Mutations and biomarkers are important…but not enough• Learning from the outliers in extraordinary responders• Beyond DNA are other omics, but integration and validation and then implementation of the data remains to be

optimizedp• New ways to managing and bringing the data to physicians and patients are being beta tested• Cancer will likely continue to require combinations of agents hitting multiple pathways, and thinking of how and

why and when to combine brings in many scientific, clinical and market issues• We are still evolving the development and regulatory approaches with umbrella and bucket studies to better study

the drugs in their various settings and to make sure these are accessible to patients in as timely a fashion as possible

• There are still key underserved segments, such as rare and pediatric cancers• Heme malignancies such as B-cell cancers are a good surrogate of the scientific advances and of the commercial

issues like competitive dynamicsissues like competitive dynamics• The industry is diversifying in its approach to funding innovation, in discovery and development• Immunotherapy is all the rage, seems to be something distinct from what we have seen before, but still no

panacea• And finally, we will conclude the conference by taking a step back – and maybe forward – in challenging the


y, y g p y g gconventional way we approach targeting cancer in light of the latest understanding of how cancers develop and evolve.

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That Was Then…This Is When?That Was Then…This Is When?


opening address, 26th annual€¦ · opening address, 26thannual cancer progress conference jeff...

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