Uceris approval kicks off what could be a record year for Santarus

US approval of Santarus’s Uceris late yesterday has fired the starting pistol on the San Diego company’s race to wring profit from the ulcerative colitis drug in the eight years before its patent expires. Partly as a consequence, Santarus said that it was on course for revenues of $320-325m in 2013, suggesting that this year would be the company’s best yet.

Though widely expected, the approval decision will come as a relief to Santarus – all the more so given that it had been delayed by three months. The company now has until the end of 2020 to exploit the extended-release budesonide pill before generic competition starts to erode sales.

The drug should net Santarus $21m this year following its launch in March, according to EvaluatePharma. This will rise steadily thereafter, with Uceris becoming Santarus’s main seller in 2016, when its revenues will outstrip those from Glumetza after the latter loses patent protection. The NPV of Uceris is pegged at $252m, 35% of Santarus’s market cap.

Profit prophecy

Ulcerative colitis is a crowded market currently dominated by Warner Chilcott’s Asacol, an aminosalicylate that is the first-line therapy. Uceris is intended for second-line use before systemic steroids. Results from a phase IIIb trial of the drug as an add-on therapy to aminosalicylate are expected in the second half of this year (Event – Santarus needs Uceris approval to boost flagging pipeline, December 24, 2012).

The disease affects about 620,000 patients in the US, according to the National Institutes of Health, though Uceris is only approved to treat mild to moderate cases.

In the future, Shire’s Lialda and AbbVie's behemoth Humira are forecast to become significant players in ulcerative colitis, with forecast 2018 sales of $503m and $425m respectively, dwarfing Uceris’s $169m. But Santarus wants to get sales going as soon as possible, and is hiring 85 reps to bring its total sales force to 235.

Santarus has suggested that, in addition to record revenues, its 2013 profits will also be four times higher than in 2012: $50-54m compared with $12-14m. EvaluatePharma’s consensus data put 2012 and 2013 revenues at $209m and $301m respectively. But consensus forecasts of net income are more positive even than those of the company itself, at $14m for last year and $59m 2013.

Observers will be watching closely when the firm announces its full-year 2012 results to see just how accurate Santarus’s claims turn out to be.

To contact the writer of this story email Elizabeth Cairns in London at elizabethc@epvantage.com or follow @LizEPVantage on Twitter

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