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Abbott Plans Companion Diagnostic Test in Collaboration with Pfizer

Posted Oct 05 2009 10:02pm

Companion diagnostics are lab tests designed to screen patients as candidates for treatment with new biotech drugs (see: A Closer Look at Companion Diagnostics Strategies; Consideration of a Broader Definition for "Companion Diagnostics"; Some Interesting Insights into Companion Diagnostics ). Although they may limit the sale of these drugs, such tests appeal to pharmaceutical companies because they increase the likelihood that the treatment will be effective. These companies often approach diagnostic firms as partners early in the drug development cycle so that they can be used to screen subjects during the clinical trials. Now comes news about another such partnership between Abbott and Pfizer (see: Abbott to partner with Pfizer to develop a companion diagnostic test for non-small cell lung cancer ):

Abbott announced...that it has entered into an agreement with Pfizer Inc to develop a molecular diagnostic test intended to screen non-small cell lung cancer...tumors for the presence of gene rearrangements. Pfizer has developed a novel investigational agent that selectively targets cancer-causing genes implicated in the progress of many cancers. To be eligible to receive Pfizer's oral therapy, a particular genetic translocation (rearrangement) known to be found in NSCLC [non-small cell lung cancer] tumors and a wide variety of other cancers, but not in normal cells, must be present. Under terms of the agreement, Abbott will develop a companion diagnostic test that will determine a patient's genetic status and will be used in patient selection for future clinical trials of PF-02341066.

In a related article (see: Pfizer, Abbott Ink Deal to Develop Companion Dx for PGx-based NSCLC Drug ), it is revealed that the experimental drug in question, PF-02341066, is currently in Phase III trials while Abbott is in the process of designing validating trials for the companion test designed to detect ALK gene rearrangements. Of interest is the following statement from this latter article:

...[D]uring lean economic times, Pfizer may have decided to work with Abbott, searching for a diagnostics partner that would require less investment than a smaller company. Historically, Pfizer has worked with comparatively smaller diagnostic shops, such as Monogram Biosciences and Genomic Health to develop tests for its pharmacogenomically guided drugs. In doing so, Pfizer has made significant investments in the companies, shouldering the brunt of the development and marketing costs.

This makes a lot of sense to me. Previous notes have discussed how large pharmaceutical companies are reducing their costs by turfing many of the drug developmental costs to contract research organizations, also known as CROs (see:  CROs Continue to Prosper; Benefits of Big Pharma Outsourcing ). Roche Diagnostics also has considerable expertise in the area of companion diagnostics (see: More Details About Roche's Companion Diagnostics Strategy ).

:: Update on September 10, 2009, at 9:10 a.m.
See: Q&A: Pfizer's Dx Division Head Discusses Pharma Giant's Focus on Personalized Medicine
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