June 15, 2013

I think the situation with $PFE and $PVCT has escalated

Following the week of June 10th, during which Peter spent a considerable amount of time in New York and Eric later did as well, it appears to me the situation with Pfizer, the relationship, such as it was and now is, changed.

Call it what you wish: The situation or relationship evolved. The relationship was taken to a new level. The situation escalated in a positive way. Etc.

However you wish to describe or frame it, Eric being brought further into the picture points to a discussion that very likely broadened and deepened from what it only was the week before when Peter and Eric were at ASCO with Pfizer's Craig Eagle.

From what I have discerned thus far, and I certainly do not have anywhere near the entire picture, Peter again met with Dr. Eagle, a member of Pfizer's Oncology Business Unit ("OBU"), which is part of the Specialty Care and Oncology organization that also includes the Specialty Care Business Unit ("SCBU"). Eric's visit included, at least, meetings with OBU senior leadership. Peter also met with senior corporate leadership (not, however, Pfizer's Chairman and CEO Ian Read).

There were more meetings, too.

Peter's role encompasses represents the first-line of and continuing business development interaction and communications with potential license partners, both regional and global. Given the demands on Eric's time, bringing him into New York City for further discussions with Pfizer is not atypical of a relationship that has grown, poised to grow or being considered for growth.

The question for me is the nature of the discussions, both the ones Peter had and the one(s) Peter and Eric had. Did discussions include or address regulatory clarity, commercial validation, and/or business strategy of one sort or another? Time only will tell.

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Click to enlarge the picture.
I also understand Peter met with the company's Chinese intermediaries. I believe Pfizer is encouraging, as best it can or in a manner consistent with and in its own interests, a relationship between Hisun-Pfizer Pharmaceuticals, Pfizer's Chinese joint venture with Zhejiang Hisun Pharmaceuticals, and Provectus.

Since no press release was made nor 8-K filed last week, it would seem more work is needed and/or more time is required for a relationship to be consummated, if at all.

Peter leaves for his trip to Japan next week. If a deal is to be had, it will require him to take a side trip to Taizhou Zhejiang, China, where Zhejiang Hisun Pharmaceuticals is headquartered (and where I presume Pfizer-Hisun has its China location, although not necessarily). I think it is more likely Peter returns with an MOU and no upfront payment. Recent chatter suggests the upfront payment is lower than I first expected, at $10 million, but with two healthy-sized, regulatory-oriented milestone payments of $50 million each.

Should Peter secure the MOU, it is possible the company announces the event via a PR on June 18 at the earliest. If this happens, I would not be surprised if Maxim Group equity research analyst Dr. Echo Yinghui He, MD, PhD, then issues a research note describing the deal and valuing it at $1 billion on a net present value (i.e., taking into account upfront and milestone payments, royalties, market penetration, indications, cash flows).

If we hear nothing upon or shortly after his return, then follow-up is required.

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Moffitt Cancer Center has definitively and unambiguously concluded PV-10 has systemic properties and benefits, which the FDA wanted to understand before considering accelerated approval.

We're now trying to digest a larger truth, that local chemoablation of a cutaneous lesion with PV-10 leads to transferable immunity. As described in Provectus' recent white paper, according to Moffitt's Dr. Shari Pilon-Thomas, "We think that when you inject PV-10 into a tumor, it  destroys the tumor, releasing tumor fragments that are then taken up by immune cells. The immune cells travel to the lymph nodes where they ‘educate’ or activate T-cells which can in turn travel anywhere in the body."

The question of PV-10's systemic properties and benefits has been answered. Academics and researchers will read it in a peer-reviewed journal in the coming months, now that the manuscript has been approved for publication.

The next question for Moffitt is how does it maximize the process by which PV-10 generates immunity. Moffitt's Dr. Jeffrey Weber, the driving force behind the approvals of immunotherapy treatments ipilimumab (Yervoy) and vemurafenib (Zelboraf) for Stage IV metastatic melanoma patients (and considered a/the "god" of immunotherapy), is now firmly behind PV-10. The landscape for treatment therapies for Stage III patients is barren, and wide open for PV-10, which is and has been the point of the regulatory path Provectus chose for its drug. Stage I, II and IV are, of course, also in play.

Dr. Pilon-Thomas now searches for answers to questions like “Is it just because you inject the drug and it goes everywhere and then kills tumor cells at other sites? Or is injecting PV-10 inducing
a T-cell response, such that T-cells travel throughout the body and kill tumors in their various locations?”

To Pfizer's Dr. Eagle and his Big Pharma counterparts, none of what Dr. Pilon-Thomas asks matters as much as the massive creation of antigens that PV-10 causes, and how can PV-10 be optimized to treat and cure all stages of cancer.

PV-10 creates antigens. It creates a lot of them. The creation of lots of antigens is the key to the successful, sustainable treatment of cancer and, thus, its cure.

Antigen presentation is a process in the body's immune system by which macrophages, dendritic cells and other cell types capture antigens and then enable their recognition by T-cells.

PV-10 creates an "antigen storm." Provectus' drug compound is more powerful than any other antigen-creating material for the expression of antigens to the immune system.

Dr. Eagle knows this, and his counterparts at Big Pharma are quickly learning this too.

The not-so-incremental innovation of Abraxane's nanotechnology delivery system -- the albumin-bound formulation of, say, paclitaxel may help you understand the paradigm shift that is PV-10 better. PV-10's genius and innovation is its stimulation of the immune system. PV-10's storm of antigen creation is singularly unique.

For Dr. Eagle and others, the question now is how to optimize the use of PV-10 by itself and in combination with other therapies, when, and with what specific therapies for what situation. How. When. With what.

Even when  PV-10 is an approved, Pfizer will be use it in combination (typically for late/end stage patients) until it does not have to because PV-10 is then able to run the entire race and not be handed the baton to cross the finish line. Thus, the very intent of the joint Pfizer-Provectus combination patent application is strategic, financial and commercial.

The Pfizer-Provectus relationship has changed. How much is the question now.

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