Friday, January 11, 2008

Array Biopharma: CLSDF Reader’s Take

A few weeks back I posted (here) about the news on Array BioPharma's (NASDAQ: ARRY) outcome for ARRY-886 and the response Wall Street was having as well as AstraZeneca (NYSE: AZN), Array’s development partner, and Schering Plough (NYSE: SGP) and their competitive oncology product, reactions . My argument was that matching standard of care as an outcome in this particular trial should not necessarily be considered a failure, semantics?

Well I love when CLSDF readers call me out, when necessary and especially when not. I encourage you to keep the emails (arubenstein [at] rnaventures [dot] com) and the comments (to be entered at the bottom of each post) coming!

I would like to extend my most gracious appreciation to Eric Austin, Ph.D., DABT, Senior Tox Consultant with Redmond, WA-based Veritox who had the following to say,

“I work in cancer drug development and being equivalent to standard of care is considered a failure in drug development unless you can demonstrate some sort of significant advantage (e.g. greatly improved side-effect profile). This has everything to do with reimbursement. Managed healthcare will not pay a premium (which is what is charged for novel compounds to recoup costs) unless there is a demonstrated advantage, and the FDA will not approve a drug unless there is a demonstrated advantage over standard of care."
Net Eric’s point was that if the architected endpoint was improved survival and not matching SOC then, well then there is your failure.

But I’ll continue to maintain my stance that though this trial failed that new potential studies perhaps in combination with another drug may work to move ARRY-886 forward of course with the caveat that going somewhat back to the drawing board is a slow and expensive process. We’ll have to wait and see to hear about managements intentions. A quarterly conference call date has not been set yet.

So what are your thoughts? Is ARRY a bargain south of $8.00?

***Update*** Today is the final day to be entered in the CLSDF t-shirt giveaway simply by leaving a comment. Yes, haute couture finds its way to CLSDF!

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