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Pfizer Turns To Ventana To Expand Companion Dx Options For Xalkori

This article was originally published in The Pink Sheet Daily

Executive Summary

Pfizer has partnered with Ventana to develop a second companion diagnostic to test for ALK gene mutations to identify patients who could benefit from treatment with Xalkori.

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Device/Diagnostics Quarterly Deal Statistics, Q1 2012

Medical device companies raised $1.1 billion, a 40% increase over Q4 2011’s $800 million. Two billion-dollar deals in the resuscitation market boosted device acquisition activity to $4.2 billion. Twenty diagnostics financings brought in a collective $302 million, soaring above the previous quarter’s $269 million. There were seven diagnostics M&A deals completed, totaling $589 million – down yet again.

Synchronized Regulation: Tandem Approvals Of Xalkori, Diagnostic Required Considerable Coordination

Pfizer’s Xalkori may be a model for fast development of a targeted oncologic and companion diagnostic, but that model is likely to be more aspiration than reality for future drug/diagnostic combinations. Extensive co-operation was required to keep two sponsors and two review centers on the same page – an effort that reflected the drug’s highly promising efficacy in early studies and FDA’s confidence that confirmatory studies would back up an accelerated approval.

Xalkori And The Art Of Modern Drug Development

Pfizer developed crizotinib and its companion diagnostic in just four years after identifying an aberrant ALK gene as the target, spanning a corporate restructuring, the Wyeth integration, and the departure of senior staff in the R&D organization and oncology BU. The next year or so will tell whether Xalkori was a flash in the pan, or whether it marks the long awaited turnaround for Pfizer’s oncology business and a model for nimble drug development.

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