Tovok and Vargatef product profiles.

1. By Will Roettger
Principal Consultant
20/20 Market Insights, LLC
May
10,
2010

2. Will Roettger is an established career professional in the
pharmaceutical and biotech industry. Having worked for Novartis,
AstraZeneca, Merck, Alexion, and Dendreon he has developed
expertise across the therapeutic areas of oncology, hematology, and
immunology for pipeline and launch products. He has been
instrumental in establishing marketing intelligence as a core capability
in support of clinical and commercial new product development, solving
the many commercial challenges that high-priced specialty products
face from a patient, provider, and investor perspective. Additionally he
has supported two specialty product launches, providing actionable
insights and recommendations by integrating market research findings
with competitive intelligence. As a principal for 20/20 Market Insights,
LLC, he is dedicated to providing clients with clear vision into
competitor landscapes, strategies, and product assessments that drive
strategic business decisions in new drug development.
Contact Information:
Will Roettger
Principal Consultant
20/20 Market Insights, LLC
908-391-4362
will.roettger@gmail.com
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4. This briefing is a short demonstration of the capability for utilizing competitor
product profiling and clinical developmental modeling to provide insight into
competitor threat assessments. The insights and the conclusions formed from
them will drive many key marketing and strategy decisions that make a brand a
success. In this example we evaluate two oncology products undergoing clinical
and commercial development by Boehringer-Ingelheim.
Boehringer-Ingelheim has two oncology products in phase III clinical development
– Tovok and Vargatef. Both are orally administered novel targeted agents with lead
indications for the treatment of 2nd line patients with advanced metastatic NSCLC.
Tovok is the lead product in development with an estimated Jun 2012 approval
followed by a Q3 2012 launch. Although many targeting agents have failed to
move past phase II development, two similar signal transduction inhibitors (STI’s)
have successfully obtained marketing approval – Iressa and Tarceva. Key to the
successful development and marketing of these agents is the ability to synthesize,
forecast, and understand the dynamic competitive landscape.
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7. Tovok Profile
Trademark:
Generic Name:
Synonyms:
Mode of Action (brief):
Primary Developer:
Licensing Company:
Dose & Administration:
Est. 1st Launch:
Patent Expiry:
1st Indication:
2nd Indication:
3rd Indication:
Price:
Est. Approval Date:
Duration of Treatment (mean):
Annual Cost:
Status:
Tovok
na
BIBW 2992
an orally administered tyrosine kinase inhibitor, a irreversible
dual inhibitor of EGFR and HER2,1
Boehringer-Ingelheim
DxS to provide a companion diagnostic test kit
oral pill, BID
Q3 2012 (US)
NSCLC (2nd line, advanced metastatic)
BC
Glioma
$
Jun 2012
$ (price comp to Iressa or Tarceva – premium based upon efficacy
differentiator)
Phase III trial (2x) NSCLC (pivotal trials)
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8. Apr 08
Mar 10
23-months
Jan 11
10-months
Apr 11
3-months
Jul 11
3-months
N=560
Enrolment
Complete
Data Lock
Analysis
Complete
Submission
Indication: 2nd line treatment of advanced metastatic NSCLC following failure
of platinum and either Iressa (gefitinib) or Tarceva (erlotinib)
6-month FDA review, estimated approval on Jan 2012
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9. Aug 09
Aug 11
24-months
Jun 12
Sep 12
Dec 12
10-months
3-months
3-months
Data Lock
Analysis
Complete
Submission
N=330
Enrolment
Complete
Indication: 1st line treatment in advanced metastatic (Stage IIIb/IV) NSCLC
tumors harboring EGFR mutation
6-month FDA review, estimated approval on Jun 2012
9
On
Track!

10. Vargatef Profile
Trademark:
Generic Name:
Synonyms:
Mode of Action (brief):
Primary Developer:
Licensing Company:
Dose & Administration:
Est. 1st Launch:
Patent Expiry:
1st Indication:
2nd Indication:
3rd Indication:
Price:
Est. Approval Date:
Duration of Treatment (mean):
Annual Cost:
Status:
Vargatef
na
BIBF 1120
a orally administered novel triple angiokinase inhibitor that
simultaneously inhibits vascular endothelial growth factor receptors
(VEGFRs), platelet derived growth factor receptors (PDGFRs), and
fibroblast growth factor receptors (FGFRs).
Boehringer-Ingelheim
oral capsule, BID on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity
Q1 2015 (US)
NSCLC (2nd line, advanced metastatic)
HRPC
CRC
$
Dec 2014
$ (price comp to Iressa or Tarceva – premium based upon efficacy
differentiator)
Phase III trial (2x) NSCLC (pivotal trials)

11. Dec 08
Aug 12
44-months
Jun 13
10-months
Sep 13
3-months
Dec 13
3-months
N=1,300
Enrolment
Complete
Data Lock
Analysis
Complete
Submission
Indication: 2nd line treatment in combination with chemotherapy Taxotere
(docetaxel) for advanced metastatic (stage IIIb/IV) NSCLC
6-month FDA review, estimated approval on Jun 2014
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12. Dec 08
Feb 13
50-months
Dec 13
Mar 14
Jun 14
10-months
3-months
3-months
Data Lock
Analysis
Complete
Submission
N=1,302
Enrolment
Complete
Indication: 2nd line treatment in combination with Alimta (pemetrexed) for
advanced metastatic (Stage IIIb/IV) NSCLC
6-month FDA review, estimated approval on Dec 2014
12
On
Track!

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19. Tovok
Vargatef
Tarceva
(erlotinib)
Iressa
(gefitinib)
MOA
EGFR,
HER1,
2
VEGFR,
PDGFR,
FGFR
EGFR/HER1
EGFR-­‐TKI
Formulation
Oral,
tablet
Oral,
capsule
Oral,
tablet
Oral,
tablet
Rx
BID
200mg/BID
150mg/QD
250mg/QD
ILD
?
?
Yes
(0.8%)
Yes
(1%)
CR
1.8%
1.8%
PR
10.5%
11.8%
SD
48%
31.7
31%
ORR
(PR+CR)
11%
12.3%
13.6%
DCR
(CR+PR+SD)
59%
44%
44.6%
Median
OS
9.5
mo
6.7
mo
6.3
mo
1-­‐yr
Survival
31%
30%
PFS
9.9
mo
9.2
mo
TTP
3.3
mo
2.6
mo
Cost
$4721/month
($147/150mg
tablet)
$4000/month
($133/250mg
tablet)

20. Will
Roettger
Principal
Consultant
20/20
Market
Insights,
LLC
908-­‐391-­‐4362
will.roettger@gmail.com
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