Friday, September 2, 2016

D-Ibrutinib

A new patent for Concert Pharmaceuticals here, Deuterated Ibrutinib.  Ibrutinib is sold commercially under the name Imbruvica, and has a 50% - 50% sales sharing agreement by AbbVie and JNJ.  Imbruvica is a Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrom's macroglobulinemia, and is dosed once daily.  The patent expiration date is July 2032, for d-ibrutinib, and 2026 at the earliest for the non-deuterated ibrutinib. 

The drug is going head to head against Astra Zeneca's ACP-196, in a clinical trial below for previously treated subjects, with high risk chronic lymphocytic leukemia.

Estimated Enrollment:500
Study Start Date:June 2015
Estimated Primary Completion Date:June 2019 (Final data collection date for primary outcome measure)
ArmsAssigned Interventions
Experimental: ACP-196
ACP-196 will be orally administered until disease progression or unacceptable toxicity.
Drug: ACP-196
Active Comparator: ibrutinib
Ibrutinib will be orally administered until disease progression or unacceptable toxicity.
Drug: ibrutinib

Bottom Line:  Analyst have projected up to 6 billion in annual revenue for Imbruvica, for various cancer indications.  The 500 patient head to head clinical trial against ACP-196 above will not readout until 2019, but more importantly when complete, will display a safety and efficacy comparison for these two drugs.  Thank you for reading.                                        

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