SPPI has developed a Strategy focused on "Drug Delivery". This is a more likely success strategy than new chemical entities, hence lower risk. Let's review.
Folotyn is an analog of MTX, but more cell permeable--Delivery
Zevalin is CD20 (Rituxan) with isotope payloade---------Delivery
Marqibo is encapsulated Vincristine--------------------------Delivery
Captisol Melphalan is encapulated melphalan-------------Delivery
Apaziquone is given in bladder---------------------------------Delivery focus
SPI 2012 is stabilized CSF--------------------------------------Delivery
SPI-1620 is designed to open tumor vessels-why---------Delivery
See any patterns here?
What's frustrating with Zevalin, is that we have a fantastic drug and we aren't even chipping away at taking share from Rituxan. We have WW rights and still no real incremental sales. We need to be spending some big $$ on a lobbying effort to get an NucRA waiver. I don't like Harry Reid, but he may be the guy SPPI needs to get to. SPPI is in Vegas. How many biotechs can Reid boast about being in Nevada?
Does anyone here know what the revenue level was for Bexxar? I hope that SPPI is visiting every oncologist that has used Bexxar to switch them to using Zevalin. GSK discontinuation of Bexxar last month could give us a little incremental bump in Zevalin sales. I'd like to get an idea of what that $$ is.
Not new but reemphasized that SPPI management is most hyped about SPI-2012.
Repeated that they will run a second single instillation phase III for Apaz.
Hinted at some new marketing efforts with Zevalin, but nothing to get excited about yet.
There is a new updated slide presentation. Not sure if it is on the SPPI site yet.
With the time line between single-instillation NDA and multi-instillation P-III data being so short I don't see any benefit to a second single instillation P-III. Perhaps SPPI and FDA came to this same conclusion. Why run a P-III on a protocol that won't even apply in the clinics?
If the multi-instillation data is superior to the single instillation data, which I expect, the only benefit to filing an NDA for single instillation is to expedite the approval process. Of course, the multi-instillation protocol will become the adopted protocol if all goes as expected.
I think the roll out of Apaz. will be complex, especially if we get single instillation approval. By the time the FDA rules on a single instillation NDA, we will have the multi-instillation data in hand. Perhaps the plan is to get NDA approval with single-instillation data, and just file for a label change with the multi-instillation data (much quicker I think). This is not my area of expertise, so I am open to counter interpretations and speculations.
Some thoughts on this. Maybe SPPI believes that positive P-III results in an indication werer R does not work will create enough interest and movement to get an exemption from the NucRA. I think that Raj also believes that Zevalin will start selling much better in the ROW if the trials are successful (total bust ROW right now). I agree that SPPI does not deserve the benefit of the doubt with Zevalin, but that does not really matter. They will complete the trials. I hope they prove us all wrong. I am not really looking to Zev., versus other opportunities.
Nice overview antihama. I've been thinking about and looking into Apaziquone. We know that the two single instillation P-III just missed efficacy. We know that the combined single-installs had stat sig. of 0.017 for recurrence rate and 0.0076 for time to recurrence. We also know that these numbers are better for the subset once SPPI removes the patients that had the blood issues. This data tells me that Apaziquone works, which is what SPPI has been saying. Fastforward to the two current multi-instillation P-III trials. The patients in these trials all get the same single-dose treatment right after resection, so if the trial stopped there the results would mirror the completed trials. But it doesn't stop. These patients get another dose after one week when the bleeding issues should be completely eliminated. They then get four more doses. The benefit of the initial instillation plus week one instillation should easily meet the recurrence rate and time endpoints. The additional instillation provide even greater assurance. While this is speculation, it is predicated on two large single instillation trials. I think that the odds of Apaz being approve base on single instillation may be 50%, but based on multi-instillation I put the odds at %80.
Talking just to talk?
I owned NEOT in the late 1990s. Sold it when I lost faith in Neotrophin trials. Watched the collapse and warned my friend to get out before it happened. This is when and where Raj learned not to put hopes on one product. I stayed away when Raj renamed and resurrected Neot as SPPI. Came back in right before Satraplatin. I am green today with a big stake. It's called investing, not blind faith. I sell when it makes sense to me. I am not selling SPPI now.
All drugs go through an Active, not recruiting phase as the tria in question moves to the endpoints. Not sure which drug you are referring to, but this is a normal and necessary status. You need another reason to speculate anything other than that the trial is on track.
I've been here since 1998 NEOT days. Total garbage. Never happened.
I've thought for some time now that we need to dilute the Fusilev revenue contribution to less than 20%. Once, that happens, we should see steady growth in the PPS. My preference is that we see this dilution occur while Fusilev revenue remains steady in the $80-100M range. This may take another two to three years, but it is very doable.
I'm please with the progress SPPI has made and the potential it has built over the last 8 years. I'm please with our future prospects.
"On either book value or cash flow basis SPPI is nowhere near "cheap"
You can't be serious. This is a fledgling biotech, not Ford.