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Oncology Product Highlight -  Boehringer Ingelheim's Tovok & Vargatef
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Oncology Product Highlight - Boehringer Ingelheim's Tovok & Vargatef

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Tovok and Vargatef product profiles.

Tovok and Vargatef product profiles.

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Oncology Product Highlight -  Boehringer Ingelheim's Tovok & Vargatef Oncology Product Highlight - Boehringer Ingelheim's Tovok & Vargatef 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
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  • 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. 4
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  • 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) 7
  • 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 8
  • 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!  
  • 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)
  • 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 11
  • 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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  • 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)  
  • Will  Roettger   Principal  Consultant   20/20  Market  Insights,  LLC   908-­‐391-­‐4362   will.roettger@gmail.com   20