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Confidential
An Assessment of a Prostate Cancer Opportunity
Confidential
Introduction
• What is Business Development or BD?
-BD is responsible for leading the evaluation and negotiation of
partnership opportunities (e.g. in-licensing, out-licensing, M&A,
and more)
• Recent deals completed by the BD group at Incyte:
-Acquired Ariad’s European infrastructure and licensed from Ariad
the right to develop and commercialize the drug Iclusig for $140
million upfront plus milestones and royalties
-Acquired the right to develop Jakafi in GVHD from Lilly
-Licensed anti-PD-1 monoclonal antibody from Hengrui
-Licensed 4 preclinical monoclonal antibodies from Agenus
• The following presentation is an example of the opportunity
evaluation process that the BD team uses as part of doing a deal
-The focus will be on prostate cancer
Confidential
Origination
•Prostate cancer occurs when prostate cells grow
uncontrollably and fail to be recognized and cleared
by the immune system
•Approximately half of all men over the age of 60
have prostate cancer
•The global incidence (newly diagnosed cases per
year) was approximately 570,000 in 2014
•Prevalence (total number of diagnosed patients
living with the disease) was greater than 4 million
3
Confidential
Treatment
• Diagnosis
-Physicians determine the stage of the disease and risk stratification
-This process evaluation helps physicians determine the best course of
treatment
• Treatment decision depends on an array of factors:
-Patient’s age and life expectancy
-Performance status and comorbidities
-Site of metastases
-Degree of symptoms
-Side-effect profiles of various treatments
• While hormonal agents are the cornerstone of prostate cancer
treatment, chemotherapy and immunotherapy are typically reserved
for metastatic castrate-resistant prostate cancer (mCRPC).
4
Confidential
Key Prostate Cancer Therapy Choices
5
Brand Name Generic Name Company MOA Stage of Disease
Price per
year
2015 WW
sales
Zytiga Abiraterone Janssen
Anti-
androgen
mCRPC $105 k $2.23 B
Xtandi Enzalutamide
Astellas/Mediva
tion
Anti-
androgen
mCRPC $114 k $1.91 B
Provenge Sipuleucel-T
Dendreon
(Valeant)
Cancer
vaccine
Asymptomatic/minimally
sympotomatic mCRPC
$121 k
(for three
doses)
$250 M
Xofigo Radium-223 Bayer
Alpha
radiation
mCRPC with symptomatic
bone metastases and no
visceral metastatic
disease.
$129 k (for
six doses)
$283 M
Jevtana Cabazitaxel Sanofi-Aventis
Microtubule
inhibitor
mCRPC, previously
treated with docetaxel
$57 k (for
six cycles) $354 M
Taxotere Docetaxel Sanofi-Aventis
Microtubule
inhibitor
Hormone refractory
metastatic prostatic
cancer
$24 k (for
six cycles)
$245 M
Lupron
Leuprolide
Acetate
AbbVie GnRH agonist
Advanced prostate
cancer
$15 k $826 M
Confidential
Prostate Cancer Share of Market by Line of Therapy
6
Confidential
Estimating the Size of the Opportunity for a Novel
Therapy in the US Prostate Cancer Market
Category
Total Newly-Treated Metastatic Prostate Cancer Patients
Patients Segmented by Line of Therapy
PI3k/mTOR Inhibitor (Class/MOA) Share of Treated Patients
Drug X Share of PI3k/mTOR Inhibitor
Duration of Therapy (months)
Compliance
Net Price Per Month
Net Sales by Line of Therapy for Drug X
7
50,000
1L
30,000
2L
20,000
3L+
0% 33% 20%
10,000 4,000
2,000
50%
6
80%
$8,500
X
X
X
X
X
X
50%
X
=
100,000
0
0
0
80%0
12
5,000
30%
50% 20%
$80 M$410 M$0 M
Confidential
Conclusions
•Evaluation of a new asset is driven by its Target
Product Profile (TPP), i.e. potential efficacy
(survival advantage over current therapy), safety,
and price.
•Asset Evaluation also needs to consider potential
competitors that are undergoing development.
•Ultimately, it is important to understand the current
landscape of treatment for a given disease.
8

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Evaluating a Prostate Cancer Drug Opportunity

  • 1. Confidential An Assessment of a Prostate Cancer Opportunity
  • 2. Confidential Introduction • What is Business Development or BD? -BD is responsible for leading the evaluation and negotiation of partnership opportunities (e.g. in-licensing, out-licensing, M&A, and more) • Recent deals completed by the BD group at Incyte: -Acquired Ariad’s European infrastructure and licensed from Ariad the right to develop and commercialize the drug Iclusig for $140 million upfront plus milestones and royalties -Acquired the right to develop Jakafi in GVHD from Lilly -Licensed anti-PD-1 monoclonal antibody from Hengrui -Licensed 4 preclinical monoclonal antibodies from Agenus • The following presentation is an example of the opportunity evaluation process that the BD team uses as part of doing a deal -The focus will be on prostate cancer
  • 3. Confidential Origination •Prostate cancer occurs when prostate cells grow uncontrollably and fail to be recognized and cleared by the immune system •Approximately half of all men over the age of 60 have prostate cancer •The global incidence (newly diagnosed cases per year) was approximately 570,000 in 2014 •Prevalence (total number of diagnosed patients living with the disease) was greater than 4 million 3
  • 4. Confidential Treatment • Diagnosis -Physicians determine the stage of the disease and risk stratification -This process evaluation helps physicians determine the best course of treatment • Treatment decision depends on an array of factors: -Patient’s age and life expectancy -Performance status and comorbidities -Site of metastases -Degree of symptoms -Side-effect profiles of various treatments • While hormonal agents are the cornerstone of prostate cancer treatment, chemotherapy and immunotherapy are typically reserved for metastatic castrate-resistant prostate cancer (mCRPC). 4
  • 5. Confidential Key Prostate Cancer Therapy Choices 5 Brand Name Generic Name Company MOA Stage of Disease Price per year 2015 WW sales Zytiga Abiraterone Janssen Anti- androgen mCRPC $105 k $2.23 B Xtandi Enzalutamide Astellas/Mediva tion Anti- androgen mCRPC $114 k $1.91 B Provenge Sipuleucel-T Dendreon (Valeant) Cancer vaccine Asymptomatic/minimally sympotomatic mCRPC $121 k (for three doses) $250 M Xofigo Radium-223 Bayer Alpha radiation mCRPC with symptomatic bone metastases and no visceral metastatic disease. $129 k (for six doses) $283 M Jevtana Cabazitaxel Sanofi-Aventis Microtubule inhibitor mCRPC, previously treated with docetaxel $57 k (for six cycles) $354 M Taxotere Docetaxel Sanofi-Aventis Microtubule inhibitor Hormone refractory metastatic prostatic cancer $24 k (for six cycles) $245 M Lupron Leuprolide Acetate AbbVie GnRH agonist Advanced prostate cancer $15 k $826 M
  • 6. Confidential Prostate Cancer Share of Market by Line of Therapy 6
  • 7. Confidential Estimating the Size of the Opportunity for a Novel Therapy in the US Prostate Cancer Market Category Total Newly-Treated Metastatic Prostate Cancer Patients Patients Segmented by Line of Therapy PI3k/mTOR Inhibitor (Class/MOA) Share of Treated Patients Drug X Share of PI3k/mTOR Inhibitor Duration of Therapy (months) Compliance Net Price Per Month Net Sales by Line of Therapy for Drug X 7 50,000 1L 30,000 2L 20,000 3L+ 0% 33% 20% 10,000 4,000 2,000 50% 6 80% $8,500 X X X X X X 50% X = 100,000 0 0 0 80%0 12 5,000 30% 50% 20% $80 M$410 M$0 M
  • 8. Confidential Conclusions •Evaluation of a new asset is driven by its Target Product Profile (TPP), i.e. potential efficacy (survival advantage over current therapy), safety, and price. •Asset Evaluation also needs to consider potential competitors that are undergoing development. •Ultimately, it is important to understand the current landscape of treatment for a given disease. 8

Notas do Editor

  1. Incyte has a great discovery organization and a fantastic pipeline, however BD seeks to supplement that by looking at opportunities that were discovered by other companies