In this Part 1 post, I am including highlights from the SPPI and (former) partner Allergan AGN's earnings calls regarding apaziquone.
(continue reading full post for details)
"As we reviewed our urology R&D portfolio, we have determined which products to fund for late-stage development. ... Furthermore, as regards our partnership with Spectrum Pharmaceuticals for Apaziquone, we have returned the clinical development program and commercialization rights to them. In exchange, Allergan will receive a royalty on any future revenue after regulatory approval."
Here is the discussion around apaziquone on the SPPI call (via SeekingAlpha):
Apaziquone is one of two NDA's we are in a position to file in the next 12 months.
"In addition, last month, we were able to reacquire U.S. and European rights to a later-stage drug apaziquone, formally known as EOquin. Our goal is to accelerate apaziquone's potential registration. There continues to be a significant unmet medical need, but no drugs have been approved and marketed in the United States for more than 20 years for low-grade non-muscle invasive bladder cancer."
"We had a meeting with the FDA, and the bottom line message that we received was the following: that number one, we can file the NDA with the existing data; number two, FDA will most likely convene an advisory board meeting; and number three, FDA encourages us to start at least one new trial to which they will contribute their suggestions. We have written a protocol. We have sent it to the FDA and as soon as it comes in, we have got over 100 sites ready to start enrolling patients. These are the sites that have already worked on 2 previous trials, 611 and 612. And the interesting thing about the 2 studies we have submitted is that both studies don't read the criteria of 0.05. The data is so close that when you combine the 2 trials, the data is significant at 0.01 level, what we call highly significant. And also when you see the 2 studies, they are like mirror images. They will turn in different patient population, by different investigators and yet the results are almost identical. And that's very pointing. For us it is very exciting to see the 2 studies done apart have such similar findings, and I think the FDA's persuaded. And we are going to pursue the registration for this indication as quickly as possible."
Question: won't the new trial take a long time?
"Well, we plan to file the NDA before this trial is completed. So there is -- what we are trying to do is take advantage of the fact that FDA take certain times, review time, for any drug ensuring that -- so when we file the NDA, we are hoping that by the time our review process comes, we will have completed enrollment in that trial."
So you won't have the data when you file?
"That is true. We could have interim results at that time. That's what we are negotiating with the FDA."