The Biotech Mailbag opens this week with an email from Dean M.
"Any thoughts about
(NGSX) positive phase III data for post-herpetic neuralgia and their pending applications in Europe and the U.S.?"
NeurogesX is a tiny drugmaker with a pain patch, NGX-4010, that applies a synthetic form of capsaicin (yes, the hot stuff from chili peppers) directly to the site of pain. NGX-4010 provides longer-lasting relief than other pain patches and creams, and it does so without significant side effects.
The company is seeking Food and Drug Administration approval for NGX-4010 as a treatment for post-herpetic neuralgia, or nerve pain associated with shingles. The company filed a new drug application Oct. 22 and hasn't yet announced whether the agency has accepted the filing. The FDA has 60 days to accept or reject a new drug application filing, so NeurogesX should have something more to say toward the end of December.
NGX-4010 is also under review by European regulators, with an approval decision expected in the first half of next year.
All of this seems good, yet NeurogesX shares, at $1.60, are barely above the company's cash on hand. So what gives?
Well, NeurogesX is going to have to raise some money fairly soon, which in this market is a black mark. And there are questions about how the company plans to commercialize the pain patch if approved here or in Europe. A domestic sales force is going to cost money to build (hence the need to raise cash or find a co-promote partner here) while across the pond, NeurogesX definitely needs to find a partner.
The commercial market for pain patches, pills and ointments can be tricky. The space holds some big competitors, like
and many smaller ones, like
. How well will tiny NeurogesX compete, especially if NGX-4010's label is restricted, at least initially, to treating shingles-related nerve pain?
The best thing that could happen to NeurogesX is to be gobbled up by a larger drugmaker with an existing pain drug franchise. Absent that, my sense is that investors in this market will be gun-shy with this stock until they see tangible results. Don't forget that the FDA is a fickle place these days when it comes to new drug approvals, and the pain-drug area is notorious for delays.