Poniard is waiting for the FDA on SPEAR, and then on a partner Print E-mail
By Simos Simeonidis, Ph.D.   
Wednesday, 10 March 2010 03:00

Is there a partner out there for picoplatin? This is obviously the most significant question for the company right now, in addition to what the FDA will say about the SCLC data : given the size and expense of the potential Phase III trials, and the fact that it is very difficult to figure out at this point which of the three oncology settings picoplatin would be best suited for, the company is seeking a partner interested in developing the compound.

We continue to see picoplatin as an A) active compound, B) with potential applicability in multiple tumor settings, and C) with an oral version behind the IV one, that looks promising and has long patent life. We thus believe that it is possible for Poniard for find interested parties for picoplatin, despite the unfortunate, close-but-no-cigar, SPEAR result, and the promising, yet not irresistible results in colorectal, prostate and ovarian.

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Yes, we believe that there is a pharma company out there that likes picoplatin. However, the situation has obviously changed significantly on the partnering front since November ’09: picoplatin is no longer seen as the high-flyer with platform-like potential (even if much of made picoplatin attractive is still here), and we believe that the wind behind picoplatin’s sails on the partnering front has receded quite a bit after the unfortunate SPEAR result, the hematologic toxicity in CRC and the promising-yet-not-overpowering 21.4 month overall survival in the 32-patient Phase II CRPC trial. Again, we continue to believe that the company could find a partner, or even an acquirer that believes in this compound and is willing to invest in its development: however, the obvious question is what this partner may be willing to pay for picoplatin, given the current regulatory status and the company’s currently financial position that does not give them a lot of leeway on the negotiation table. We expect that any serious discussions will not be finalized until after the FDA decides on its view on the SPEAR dataset.

Meetings with FDA on SPEAR data: The company has described its interactions with the agency as an ongoing process, and even though it is difficult to predict when this process will be concluded, Poniard is hoping to have an answer by the first half of 2010. The argument Poniard is trying to make with the agency is that it would make sense to have picoplatin in the market since A) second-line SCLC is a disease setting without treatment options and B) picoplatin showed evidence of efficacy, despite the fact that SPEAR did not meet its primary endpoint. We believe that this argument does makes sense; however, we also believe that this will be a tough sell for Poniard, since we believe that it will be difficult for them to find an advocate within the FDA, especially given the current increased scrutiny around safety issues (which, by the way, we believe should not really have an effect in a disease setting like second-line SCLC; we are not dealing with the chronic use of a TZD here). We believe that the market is not expecting the agency to go along with the company’s argument, and a positive outcome out of these discussions would obviously have a significant positive impact on the shares.

Discussions with FDA on potential CRC, CRPC and ovarian registration trials. Management is also in discussions with the FDA, and its own clinical advisors, on potential registrational trials in ovarian, colorectal and prostate and will not initiate a Phase III program until these discussions have been completed. Especially in the event that Poniard will have to take on one of these trials without a partner (which

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