AEZS was badly burned by a trial designed by KERX. It's my belief that AEZS has stated a partnership would be sought after the Phase III is in place. We know the FDA has okayed a SPA, but I believe AEZS wants the trial either to start, or at least be in the hands of the IRB before they finalize a partnership. At that point a partner could expand the trial with many new sites, but they'd be running the trial IAW the protocol developed by AEZS.
I know it's speculation on my part, but the Phase II in colon cancer produced very successful data in Stage 3 patients, and very limited Stage 4 data. So why did KERX go with Stage 4 patients. I believe it was simple economics, Stage 4 patients don't live as long, the trial will be much shorter, the cost will be less, and the time to approval will be much faster. That of course is if the drug worked, which it apparently didn't. Had this trial been run in Stage 3 patients we'd probably only now be approaching the end of the trial, the cost would have been substantially higher to KERX, but we'd be looking at an approval.
I'm not suggesting a big Pharma partner would try the shortcut KERX attempted, but have no doubt in your mind, once partnered they'd have almost total control. By taking this trial into Phase III, AEZS has controlled the protocol to be used in the trial. A partner might choose to develop one or more additional trials, we know the drug works in several cancers, so this should certainly happen in time. Even big Pharma often prefers to gain the initial approval so sales revenue feed the cost of additional trials, but if they truly believe in a drug will have more than one pivotal trial in the works.
I believe in the case of the MM Trial, KERX is using essentially the same patients as were in the Phase II Trial which produced some excellent data. Had KERX not been in a cash bind and intending to be purchased on positive trial data in the failed trial, I believe they'd have stuck out the MM Trial however they simply couldn't afford it.
I do believe we'll get partnerships this year, perhaps as many as three of them, but they won't happen until AEZS wants them to. In AEZS-108's case, it's after the Phase III protocol is completely finalized. In Perifosine's case it's after the initial peek and recommendation to continue the MM Trial, or later. In AEZS-130's case it's after the NDA's filed and preliminary data's been received from the Cancer Cachexia Trial. In short, these partnerships could come in the current quarter, but more likely later in the year.
Gary, that's a really scary thought; 'more partnerships in 2013'. And just how is this incompetent management team going to pick the right partner this time? Why don't these idiots just fold up their tents and sell the company already? They can't manage their way out of a paper bag.
Btw, you might want to get your eyes checked before you update your rosy colored glasses.
AEZS 130 NDA (as a diagnostic test) will be done in Q1 - it does not cost much at this point. The revenue here is small. In fact I am surprised that they didn't just licence this off and raise the 16 million, instead of diluting away a third of the company recently.
AEZS 108 P3 will cost a lot and need to be partnered before P3 starts. With the SPA, the FDA has agreed to the process and what results are acceptable. So there is far less uncertainty for any potential partner. This can happen any time now - may be even tomorrow!!
Perifosine is another potential drug for partnership, if the interim results in April look good. Perifosine for multiple myeloma has been granted FDA fast track, SPA and orphan-drug status. They saw 8.8 months median PFS for bortezomib-relapsed patients in P2 and the FDA SPA needs only 7.5 month median PFS in P3.
My guess (and hope) is that AEZS 108 will be partnered in Q1 for a huge upfront payment.