April 25, 2013

The Date $PVCT Will Be Acquired Is...

Getting a dramatic blog post title out of the way, three precedent transactions provide insight into the end-game (under certain circumstances or along one of several potential paths).

Precedent transaction #1: Plexxikon reported interim analysis of its MM Phase 3 trial in January 2011. In February, the following month, the company announced it was being acquired by Daiichi Sankyo. Transaction #2: BioVex commenced its MM Phase 3 trial in April 2010. In January 2011, Amgen announced it was acquiring BioVex, by which time the trial was about 90% enrolled.

Think about this information in the context of a PV-10 MM Phase 3 trial under SPA with the FDA commencing enrollment in mid-2013 (i.e., late-Q2 or early-Q3): Enrollment might take one or several quarters, and Interim analysis could be available 12 months after enrollment is completed (patients would be treated as enrolled).

Between somewhere in enrollment and interim analysis, after the SPA is received. Drawing out the numbers, the time frame to acquisition through the running of a Phase 3 trial, generally speaking, could be H2 2013 through H2 2014'ish. This back-of-the-envelope "time framing" examines a Phase 3 trial under SPA, with no benefit of an accelerated pathway to market (via accelerated approval or a more precise (shorter) SPA via breakthrough therapy designation).

Receiving an accelerated path to market through receipt of the breakthrough therapy designation -- either accelerated approval or a more precise (and thus shorter or faster) SPA -- certainly would change the timeframe. Of course, the rate limiting step here is clarity on timing and detail of the accelerated path.

Somewhere after the receipt of breakthrough therapy designation ("BTD") is announced, when and if BTD is achieved. Drawing out the numbers in this case, the time frame to acquisition could be H2 2013 through H1 2014'ish.

There's yet another way to look at Provectus' endgame, too. Transaction #3: Bristol Myers acquired Medarex on the basis of the latter's MM Phase 2 data and a strong understanding of ipilimumab's mechanism of actionDr. Jeffrey S. Weber, MD, PhD of Moffitt Cancer Center was highly involved in the elucidation of ipi's anti-tumor response. Dr. Weber also did translational research on vemurafenib (Zelboraf), Plexxikon's drug that was acquired by Daiichi Sankyo.

Soon? Drawing out the numbers in this case, the time frame to acquisition could be the end of 2013.

Provectus will be acquired when it is acquired. I found it helpful to review some precedent transactions in order to understand where the company currently resides in the bigger scheme of things.

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