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'Uceris' Coming: FDA Gives Santarus Nod for Colitis Drug

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By Randy Osborne
Staff Writer

Beating the decision deadline by two days, the FDA cleared for marketing Santarus Inc.'s oral formulation of the corticosteroid budesonide, branded Uceris, for mild to moderate ulcerative colitis.

The San Diego-based firm said last month the FDA had agreed on a proposed label for the drug, so the approval surprised few on Wall Street – though at least two other candidates have met stumbling blocks at this stage: Relistor (methylnaltrexone bromide, Salix Pharmaceuticals Ltd.) and Horizant (gabapentin enacarbil, Xenoport Inc.). (See BioWorld Today, July 31, 2012.)

Relistor, though, was a member of a fairly new drug class, as a peripherally acting mu-opioid receptor antagonist. The indication – opioid-induced constipation in chronic pain – was new, too, and the FDA showed special caution on Relistor because the market for it is broadly distributed. Horizant was a new chemical entity.

Uceris is bound by no such considerations, belonging to a well-established class of drugs that are used systemically, and may have gained special benefit in the eyes of the FDA since the compound, developed in collaboration with Lainate, Italy-based Cosmo Pharmaceuticals SpA, acts locally in the colon, thanks to the latter's MMX technology. (See BioWorld Today, Dec. 16, 2008.)

Debra Crawford, chief financial officer, said during a conference call that Santarus is "looking at a commercial launch in the March time frame, so we expect the impact of Uceris to be small in the first quarter and to be increasing as we move throughout the year."

CEO Gerald Proehl said during the call that doctors like Uceris and understand how to use it. "Because they have so much experience with Entocort EC [a glucocorticosteroid, Prometheus Laboratories Inc.] for Crohn's disease, they have very good understanding of Uceris and where it fits in the treatment paradigm," he said. "They don't seem to have much issue with thinking about using Uceris to treat their patients that are flaring."

Educating patients about the drug is another matter. "I think what we've identified is, any time you launch a new product, probably the biggest challenge in a category like that is getting patients to actually go and seek treatment from their physician," Proehl said. "There hasn't been any really new therapy to treat patients with mild to moderate ulcerative colitis in quite a few years."

Uceris was not the only candidate in the Santarus hamper, and both of the others are late-stage compounds. There's Ruconest, for acute attacks of hereditary angioedema (HAE), partnered with Pharming Group NV, of Leiden, the Netherlands. The C1 esterase inhibitor proved worthy in a Phase III trial in November, and would go up against two already marketed products in the same class – Berinert, from King of Prussia, Pa.-based CSL Behring LLC, and Cinryze, from ViroPharma Inc., of Exton, Pa., though the latter is used as an HAE prophylactic. Ruconest, unlike both, is recombinant, rather than plasma-derived. (See BioWorld Today, Nov. 14, 2012.)

Santarus also has a therapy for traveler's diarrhea. Like Uceris, the formulation of the antibiotic rifamycin was developed by way of the MMX technology. In September, Santarus said a 264-patient Phase III study testing the compound met the primary endpoint of reducing time to last unformed stool (TLUS) in subjects with travelers' diarrhea. In the intent-to-treat population, the median TLUS was 46 hours for rifamycin SV MMX vs. 68 hours for placebo (p = 0.0008), and results from the per-protocol population were similar.

Among its marketed products, Santarus faces generic competition in 2016 for two. Glumetza (metformin hydrochloride extended-release tablets) for Type II diabetes could have trouble in February of that year, though Depomed Inc., of Menlo Park, Calif., filed a lawsuit in April seeking to prevent Watson Pharmaceuticals Inc., of Parsippany, N.J., from commercializing a generic version of Glumetza.

Also, Zegerid (omeprazole-sodium bicarbonate), an immediate-release proton pump inhibitor approved in upper gastrointestinal diseases and disorders, could be in the ring with its first generic opponent in July 2016, wrote Piper Jaffray analyst David Ansellem in a research report. But "even without Uceris, Santarus is likely to have north of $350 million in net cash on hand" by then, Ansellem wrote.

Santarus said 85 more sales reps will bring the force to 235 for the launch of Uceris, which will be promoted alongside Zegerid to gastroenterologists. The company also sells Cycloset (bromocriptine mesylate) for Type II diabetes and Fenoglide, a fenofibrate for hyperlipidemia.

At the same time that Santarus made known the Uceris approval, the company introduced financial guidance for 2013. Total revenues are expected to reach as high as $325 million, with net income of $50 million to $54 million, for adjusted earnings before interest, taxes, depreciation, and amortization of between $73 million and $79 million.

Santarus' stock (NASDAQ:SNTS) closed Tuesday at $12.52, up $1.24, or 11 percent.

In other earnings news:

• Ironwood Pharmaceuticals Inc., of Cambridge, Mass., said in its fourth-quarter investor update that sales of constipation drug Linzess (linaclotide) totaled $19.2 million during the period. The FDA approved the synthetic guanylate cyclase C agonist in August 2012 ahead of its PDUFA date, as a treatment for irritable bowel syndrome with constipation and for chronic constipation. Ironwood reported a net loss $43.9 million, or 41 cents per share, because of sales and administrative costs that rose to $33.3 million from $13.9 million. The firm ended 2012 with $168 million in cash, cash equivalents and available-for-sale securities. (See BioWorld Today, Aug. 31, 2012.)