Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

Our Take On Spectrum Pharmaceuticals, Inc. (SPPI)’s Near Term Panel Review

Next month, an advisory panel will get together to discuss, and rule upon, Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI)’s lead bladder cancer development candidate, apaziquone. The agency accepted the company’s NDA back in February, and has set a PDUFA date of December 11, 2016.

There’s a bit of distance between advisory review and PDUFA (often it is much shorter) and so the PDUFA is likely going to dictate sentiment towards Spectrum’s development efforts for the majority of the fourth quarter. With this in mind, here’s a look at the drug in question, and what we expect from the panel.

As mentioned, its called apaziquone, and Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) is targeting commercialization under the brand name EOquin. It’s a prodrug of an already widely established and used drug called mitomycin C. In this instance, it’s targeting the above mentioned bladder cancer.

pharmacist, senior, man, talking, helpful, nhs, helping, counter, medication, older, american, drugs, woman, shelves, male, pack, usa, medical, practice, horizontal, adult,

Monkey Business Images/Shutterstock.com

SOC in bladder cancer is surgical resection, however in bladder cancer patients that have undergone this resection there is a large potential for recurrence. When recurrence happens, physicians turn to a drug like mitomycin C. Spectrum is trying to get its version approved on the prodrug quality, which theoretically reduces the toxicity and the currently associated bone marrow issues caused by the current formulation.

So what about data to date?

Well, this one is a bit of a strange one. The drug underwent two phase III trials between 2011-2015, as part of a collaboration agreement between the already mentioned Spectrum and the then Actavis, but now Allergan plc Ordinary Shares (NYSE:AGN). Primary endpoint was a rate of recurrence in both trials, with the comparable arm a placebo control.

In both, the primary endpoint was missed. Apaziquone didn’t achieve stat sig improvement I rate of recurrence in the trialed bladder cancer patients over placebo, and so the trials were deemed a failure – initially. After analysis of pooled data, however, Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) reported that as a pooled report the trial had succeeded, and not only had the pooled data met the endpoint of stat sig improvement in rate of recurrence, with a pretty impressive P value of 0.0174, but that it had also met a key secondary endpoint, time to recurrence, with an even stronger P value of 0.0076.

The company subsequently sat down with the FDA to discuss the findings, and then kicked off another phase III that, reportedly, builds on the learnings from the two previous failed trials. It also submitted an NDA, based on the data from the failed trials, which the FDA subsequently accepted, and here we are.

So what do we expect from the advisory panel? Well, it depends how the panel interprets the pooled data. The trial wasn’t set up for retrospective endpoint analysis, and to recommend approval based on such is always a risky approach. As such, we expect the panel to be cautious in its recommendation.

There’s every chance that the panel will want data from the ongoing trial before it can come to a decision, but primary completion isn’t expected until 2020, and study completion until 2021.

As such, it’s hard to be anything other than pretty bearish on this one as things stand. There’s an unmet need, but likely not regarded as significant enough to approve a treatment that has not yet demonstrated stat sig improvement in anything other than pooled data, and the FDA (and the panel) will likely take this stance. This isn’t guaranteed, of course, but it’s difficult to see any other outcome right now.

Follow Spectrum Pharmaceuticals Inc (NASDAQ:SPPI)
Trade (NASDAQ:SPPI) Now!

Note: This article is written by Mark Collins and originally published at Market Exclusive.

Biotech Stock Alert - 20% Guaranteed Return in One Year

Hedge Funds and Insiders Are Piling Into

One of 2015's best hedge funds and two insiders snapped up shares of this medical device stock recently. We believe its transformative and disruptive device will storm the $3+ billion market and help it achieve 500%-1000% gains in 3 years.

Get your FREE REPORT and the details of our 20% return guarantee today.

Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.
Loading Comments...
X

Thanks! An email with instructions is sent to !

Your email already exists in our database. Click here to go to your subscriptions

Insider Monkey returned 102% in 3 years!! Wondering How?

Download a complete edition of our newsletter for free!