Oncology product highlight of Bayer's Regorafenib and Nexavar.

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. Bayer has two lead oncology products in phase III clinical development – Nexavar (sorafenib) and
Regorafenib. Both are orally administered targeted agents (RTKIs) with nearly identical MOAs and
chemical structure. Unique to their chemical structure is the ability to inhibit multiple targets effecting
both cell proliferation and blood supply to tumors.
• Nexavar is co-developed by Bayer and Onyx pharmaceuticals. Current indications are in
hepatocellular and renal cell carcinoma. Development continues as a single agent or combination
treatment in a wide range of cancers including – non-small cell lung, breast, colorectal, ovarian,
and as an adjuvant therapy for renal and hepatocellular carcinoma.
• Regorafenib, fully developed by Bayer, is now in phase III development for the treatment of
metastatic colorectal cancer. Lifecycle development continues in other cancers including colorectal, hepatocellular, and renal cell carcinomas.
Although many targeting agents have failed to move past phase II development, Nexavar laying
much of the ground work, serves as the proof of concept for Regorafenib. The commercial and
clinical development of two very similar agents is a complex, expensive, and risky undertaking.
However, key to the successful commercialization of these agents will be the ability to: (1) leverage
internal knowledge across both brands and (2) to synthesize, forecast, and understand how these
products provide value to customers in the same therapeutic area and differentiate them
accordingly.
This brief is a short demonstration of the capability for providing strategic insight into competitive
clinical development programs and product profiles.
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6. Regorafenib 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:
regorafenib
BAY 73-4506
an oral multi-kinase inhibitor which targets angiogenic,
stromal and oncogenic receptor tyrosine kinase (RTK). A dual
targeted VEGFR2-TIE2 tyrosine kinase inhibitor. Also inhibits
oncogenic kinases such as RET, RAF, and c-KIT.
Bayer
oral tablet, QD, 160 mg, 4-week cycle (3-weeks on, 1-week off)
Q3 2014
CRC (3rd line)
HCC
RCC
$
July 2014
$
Phase III trial: CRC
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7. Apr 10
Dec 12
32-months
Jun 13
6-months
Oct 13
4-months
Jan 14
3-months
N=690
Enrolment
Complete
Data Lock
Analysis
Complete
Submission
Indication: 3rd line treatment (Regorafenib + BSC) of advanced metastatic
CRC following failure of standard treatment.
6-month FDA review, estimated approval on Jul 2014
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8. Aug ??
Aug ??
24-months
Jun ??
Sep ??
Dec ??
10-months
3-months
3-months
Data Lock
Analysis
Complete
Submission
N=???
Enrolment
Complete
Indication: 2nd line treatment (Regorafenib) of advanced metastatic CRC
following failure of standard treatment.
6-month FDA review, estimated approval on ??
This trial will has not yet been planned. Results will move
Regorafenib upstream in the treatment of CRC
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??

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10. Nexavar 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:
Nexavar
sorafenib
an oral multi-kinase inhibitor which targets angiogenic,
stromal and oncogenic receptor tyrosine kinase (RTK). A dual
targeted VEGFR2-TIE2 tyrosine kinase inhibitor. Also inhibits
oncogenic kinases such as RET, RAF, and c-KIT.
Bayer
Onyx Pharmaceuticals
oral tablet, 300 mg QD, 400 mg BiD
Q2 2011 (NSCLC)
HCC (approved)
RCC (approved)
NSCLC (1st Line)
$
March 2011
$
Phase III trial: NSCLC, HCC, RCC, Thyroid, BC
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11. Feb 06
Feb 08
Aug 09
Nov 09
Feb 10
Interim Analysis
ESCAPE
Trial
37-months
N=907
6-months
3-months
3-months
Failed
Enrolment
Complete
Data Lock
Analysis
Complete
Submission
Indication: 1st line treatment in combination with carboplatin/paclitaxel for
advanced metastatic (stage IIIb/IV) NSCLC
6-month FDA review
Trial failed to achieve endpoints. February 2008
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12. Sept 07
May 08
24-months
Nov 08
6-months
N=300
Enrolment
Complete
Feb 09
3-months
May 09
3-months
Failed
Data Lock
Analysis
Complete
Submission
Indication: 1st line treatment in combination with carboplatin/paclitaxel for
advanced metastatic (stage IIIb/IV) NSCLC
6-month FDA review
Trial failed to achieve endpoints.
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13. Feb 07
ExUS Trial
Mar 10
37-months
N=907
Enrolment
Complete
Jul 10
4-months
Oct 10
3-months
Jan 11
3-months
Failed
Data Lock
Analysis
Complete
Submission
Indication: 1st line treatment in combination with Gemcitabine/Cisplatin for
advanced metastatic (stage IIIb/IV) NSCLC
6-month FDA review, estimated approval in ??
Submission package will need a 2nd phase III trial.
Update added after the publication of this briefing, in June 2010
this trial failed to achieve trial endpoints.
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22. Will
Roettger
Principal
Consultant
20/20
Market
Insights,
LLC
908-­‐391-­‐4362
will.roettger@gmail.com
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