NuPathe at last had something to celebrate yesterday with the US approval of its battery-powered sumatriptan patch, Zecuity, for the acute treatment of migraine with or without aura in adults.
As EP Vantage correctly predicted last week, the company’s rock-bottom valuation did indeed make it worthy of a punt: its shares rose 15% yesterday in the run-up to the FDA decision, and were changing hands up 40% in the premarket today before opening up another 17% (Event – Little chance of headache relief for NuPathe second time around, January 10, 2013). Given NuPathe’s limited cash and no immediate plans actually to launch Zecuity, its top priority now must be to sign a licensing deal.
The company is making a concerted effort to differentiate Zecuity from the array of triptans – several of which have gone generic – already on the market. It is touting Zecuity’s avoidance of nausea and vomiting, which it says lead to over 30% of patients delaying or even avoiding the use of oral triptans.
Of course, even though it cites data from physician surveys supporting the use of the patch over oral, injectable and nasal triptans, no actual head-to-head clinical studies have taken place. Whether Zecuity can be priced at a level that is both profitable for the company and sustainable in the market is a major unknown.
$95 is the magic number
NuPathe insists that pricing at a premium to the average price of triptans currently on the market is “appropriate”, and believes that Zecuity (previously known as Zelrix) should be priced roughly in line with the $95 per unit of the relatively expensive injectable forms.
At $100 per Zecuity patch a patient using two patches per month would generate $2,400 in annual gross revenue. “We will get a lot more visibility on pricing when we start shipping the first product,” the company’s CEO, Armando Anido, said on a call.
NuPathe reiterated that it would not launch Zecuity until the fourth quarter, once manufacturing is built up, and it will also need to fund a paediatric postmarketing study. Consensus sales estimates are a meaty $240m by 2018 – a level that it will be impossible to reach without strong differentiation and a significant marketing push by a partner.
The road to approval has been long and tortuous, but the big battle for NuPathe – in the marketplace – is just beginning.