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Exelixis, Orphan Drug Comretiq, And Business Developments

February 22, 2013
Exelixis' Logo Available For The Media http://www.exelixis.com/investors-media/media-resources

 

On February 21, 2013, Exelixis, a San Francisco biopharmaceutical company developing and commercializing therapies for cancer treatments, announces 2 important events :

  1. 4th Quarter and Full Year (FY) 2012 financial results
  2. Selection of Swedish Orphan Biovitrum AB (SOBI) for a 3-year agreement as the European distributor for Cometriq.

4th Quarter 2012 Highlights & Recent Events

–  In November 2012, the FDA approves orphan drug Cometriq (Cabozantinib), the company’s 1st approved product, for treatment of progressive, metastatic Medullary Thyroid Cancer (MTC)

–  In November 2012 , Exelixis announces that the European Medicines Agency (EMA) accepts for review the Marketing Authorization Application (MAA) for Cometriq for MTC

–  In January 2013, Exilixis announces the plan to initiate Phase III pivotal trials of Cabozantinib in advanced HepatoCellular Cancer (HCC) and metastatic Renal Cell Cancer (RCC)

–  In January 2013, Exilixis announces the commercial availability of Cometriq in the US for the treatment of MTC

–  Under the February 21, 2013, 3-year agreement with SOBI, Exelixis will maintain full commercial rights for Cometriq in MTC outside the covered territory and for all other indications on a global basis.

Other emerging drugs in development for thyroid cancer are :

  1. Bayer HealthCare/Onyx Pharmaceuticals’ orphan drug Nexavar (Sorafenib)
  2. Eisai’s orphan drug Lenvatinib
  3. Genentech/Roche’s Zelboraf (Vemurafenib)
  4. GlaxoSmithKline’s combination of Dabrafenib and Trametinib
  5. OXiGENE’s Zybrestat (Fosbretabulin).

Michael M. Morrissey, Ph.D., President and CEO of Exelixis, says that “ …. The focus moving forward remains on expanding the commercial franchise for Cabozantinib. Our primary objective in 2013 is to execute on the broad Cabozantinib clinical development program, including our COMET pivotal trial program in metastatic, castration-resistant prostate cancer (CRPC), and planned pivotal trials in HCC and RCC …..”.

Since the FDA approval of Cometriq in November 2012, several online articles identify Exelixis as the BioTech to watch in 2013 because of the company’s plans on expanding Cometriq for future treatment of additional cancer indications :

– Metastatic Castration-Resistant Prostate Cancer (mCRPC)

– RCC

– HCC.

According to a January 2013 SeekingAlpha.com article, the author believes that Cometriq will “ …. find limited success in MTC …. investors are most interested in its potential in the prostate cancer market ….”. COMET-1, is the Phase III trial for Cabozantinib for men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease. It is the data from this clinical trial according to the article, that is the catalyst the investors are waiting for to determine if the drug will make it in the prostate cancer drug market. The clinical trial is not to be completed until 2014.

References

Orphan Druganaut Blog Post “Exelixis, Orphan Drug Cometriq, And J.P. Morgan Healthcare Conference

Please note:  Exelixis’ Logo For Media use Available from company website.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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