• Save
Oncology Product Highlight  - Regorafenib (bay 73-4506) & Nexavar (051010)
Upcoming SlideShare
Loading in...5
×
 

Oncology Product Highlight - Regorafenib (bay 73-4506) & Nexavar (051010)

on

  • 1,537 views

Oncology product highlight of Bayer's Regorafenib and Nexavar.

Oncology product highlight of Bayer's Regorafenib and Nexavar.

Statistics

Views

Total Views
1,537
Views on SlideShare
1,537
Embed Views
0

Actions

Likes
1
Downloads
4
Comments
0

0 Embeds 0

No embeds

Accessibility

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

Oncology Product Highlight  - Regorafenib (bay 73-4506) & Nexavar (051010) Oncology Product Highlight - Regorafenib (bay 73-4506) & Nexavar (051010) Presentation Transcript

  • By Will Roettger Principal Consultant 20/20 Market Insights, LLC May  10,  2010  
  • 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   2
  • 3
  • 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. 4
  • 5
  • 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 6
  • 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 7
  • 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 8 ??  
  • 9
  • 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 10
  • 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 11
  • 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. 12
  • 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. 13
  • 14
  • 15
  • 16
  • 17
  • 18
  • 19
  • 20
  • 21
  • Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   908-­‐391-­‐4362   will.roettger@gmail.com   22