RedHill Biopharma Ltd – ADR (RDHL) GI Topline Is Set For 2016 Release

It’s a risk, of course. When the current version was under patent protection, its high cost was generally regarded as the limiting factor behind its failure to expand past a chemotherapy indication. With this in mind, RedHill is going to have to price as closely as possible to the current generics pricing, as the once daily dosing isn’t all that much of an advantage. For some people it might be, but in a cost benefit analysis spread across a sample of the target population, this author is betting it’s not going to warrant a ten times price multiple.

If it can market it correctly, however, and price it right, there’s still plenty of potential revenues to be had.
So what are we looking for from the trial? The primary endpoint is the proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose. There’s no comparison drug, only a placebo arm, so success will be measured by how well the active arm performs against the control. We don’t have the threshold figure, but chances are the company is looking for at least 50% improvement over placebo to qualify as statistically significant. There’s a chance an approval could come on a lower proportion, but if the drug is going to compete against a cheaper alternative, even with its dosing benefit, it’s going to to have to perform pretty well.

Safety and tolerability shouldn’t be an issue, as its extended release, so toxicity shouldn’t really be affected by the higher than standard dose a one-time pill requires.

What about timeframes? As mentioned, the company is looking to serve up topline before the year draws to a close. If we see efficacy, we’re probably looking at an NDA submission sometime during late Q1/Q2, which would slate early 2017 as a potential approval period. One to keep an eye on going forward, but keep in mind the cost/benefit and its impact on RedHill Biopharma Ltd – ADR (NASDAQ:RDHL)’s potential as things progress.

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