Ulcerative colitis, which is an inflammatory bowel disease, is a chronic inflammation of the large intestine, accompanied by symptoms of abdominal pain and bloody diarrhea. This disease is known to affect more than 500,000 people in the United States, according to the University of Maryland School of Medicine.
Though there is no cure for ulcerative colitis, there are a number of FDA-approved drug therapies like 5-ASA compounds and tumor necrosis factor inhibitor, which can help reduce the symptoms of the disease.
Let's take a look at specialty biopharmaceutical company Santarus Inc. (SNTS), which is also developing a drug to treat patients with mild or moderate active ulcerative colitis.
The company's investigational medication for ulcerative colitis - UCERIS, is a locally acting corticosteroid in a patented, oral tablet formulation. The drug is designed to work by releasing budesonide, which has topical anti-inflammatory activity, throughout the length of the colon. Santarus acquired rights to UCERIS in the U.S. under a strategic collaboration with Cosmo Technologies Ltd.
Two phase III clinical studies with over 1,000 patients have been conducted to evaluate UCERIS 9 mg and UCERIS 6 mg for the treatment of mild or moderate active ulcerative colitis. The primary endpoint was the achievement of clinical remission, defined as a UCDAI score of less than or equal to 1 after eight weeks of treatment with a score of 0 for rectal bleeding and stool frequency, and greater than or equal to 1 point reduction from baseline in the endoscopy score.
Analysis of pooled data from the two phase III clinical studies have shown that UCERIS 9 mg taken once daily for the induction of remission of mild or moderate active ulcerative colitis is statistically superior to placebo in clinical and endoscopic remission and in symptom resolution.
The company plans to submit a New Drug Application for UCERIS 9 mg by the end of this year. If approved, Santarus expects UCERIS to garner peak sales of around $300 million.
Santarus expects to initiate a phase IIIb clinical study to evaluate UCERIS 9 mg as an add-on therapy to current oral 5-ASA drugs for induction of remission of active ulcerative colitis in the first quarter of 2012.
Apart from UCERIS, Santarus has two other drugs in phase III testing. They are RHUCIN for treating acute attacks of hereditary angioedema and antibiotic Rifamycin SV MMX for treatment of travelers' diarrhea.
RHUCIN, which is a recombinant human C1 inhibitor, has orphan drug designation in the U.S. for acute attacks of hereditary angioedema. Santarus obtained rights to RHUCIN in the U.S., Canada and Mexico under its license and supply agreements with European biotech company Pharming Group NV.
Santarus has completed two pivotal studies for RHUCIN with statistically significant results. A Biologics License Application, or BLA, seeking approval for RHUCIN for hereditary angioedema was submitted to the FDA last December. But in February 2011, the regulatory agency issued a "refuse to file" letter indicating that the BLA was not sufficiently complete to enable a critical medical review.
Santarus and Pharming are conducting an additional phase III study with RHUCIN under a Special Protocol Assessment and it is expected to be completed by the third quarter of 2012. RHUCIN is already approved in Europe under the name RUCONEST for the treatment of acute attacks of hereditary angioedema.
As regards Rifamycin, a phase III study testing twice daily dosing for 3 days in travelers' diarrhea is currently enrolling patients. Enrollment is expected to be completed in the second half of 2012. Santarus licensed exclusive rights to develop and commercialize rifamycin SV MMX in the U.S. from Cosmo Technologies Ltd.
SAN-300, an anti-VLA-1 monoclonal antibody, or mAb, is the company's early-stage drug candidate, meant to be initially developed for the treatment of rheumatoid arthritis. A phase I clinical study with SAN-300 was initiated in March 2011 and is expected to be completed in the first half of 2012.
Santarus acquired the exclusive worldwide rights to SAN-300 in September 2010, through the acquisition of Covella Pharmaceuticals Inc., and a related amended license agreement with Biogen Inc. (BIIB).
Santarus has three commercial products namely, Glumetza and Cycloset, both of which are indicated to improve glycemic control in adult patients with type 2 diabetes and Zegerid, commonly prescribed to treat various conditions related to the stomach, esophagus, or intestines.
In August 2011, Santarus and Depomed Inc. (DEPO) entered into a new commercialization agreement for Glumetza replacing a promotion agreement that was signed in July 2008. Under the new agreement, Santarus broadened its rights and responsibility for Glumetza.
Zegerid was hit by generic competition in June 2010. Last April, a U.S. district court invalidated key patents over Zegerid, paving way for the generic entry. Santarus, which is defending its patent rights over Zegerid, appealed the decision of the District Court in May 2010. A decision on the appeal is expected in the second half of 2011 or at a later date.
Santarus inked an agreement with Schering-Plough HealthCare Products Inc., a subsidiary of Merck & Co. Inc. (MRK) in October 2006, pursuant to which Schering acquired rights to develop, manufacture, market and sell Zegerid OTC products in the lower dosage strength of 20 mg in the U.S. and Canada.
The company also has a deal in place with Glaxo Group Limited, an affiliate of GlaxoSmithKline plc, (GSK), under which it has licensed certain exclusive rights to develop, manufacture and commercialize prescription and over-the-counter, or OTC, immediate-release omeprazole products in up to 114 specified countries (including markets within Africa, Asia, the Middle-East, and Central and South America). Santarus has also licensed certain exclusive rights to Norgine B.V. to develop, manufacture and commercialize prescription immediate-release omeprazole products in specified markets in Europe and in Israel.
A quick look at the balance sheet...
In the third quarter ended September 30, 2011, total revenue rose to $26.8 million from $18.1 million in the year-ago quarter. Total revenue comprises of product sales, promotion revenue and royalty revenue. Net product sales in the third quarter of 2011 were $19.8 million, up 81 percent over the comparable quarter last year.
Santarus reported net income of $0.6 million or $0.01 per share in the third quarter of 2011, reversing a net loss of $25.7 million or $0.44 per share last year.
For 2011, the company expects total revenues of at least $115 million and net income of about $3.0 million.
Santarus went public in 2004, pricing its shares at $9 each. In the past 52 weeks, the stock has traded in a range of $2.40 to $3.70. SNTS closed Tuesday's trading at $2.80, up 0.36%.
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