March 2013: Santarus’ Uceris – Ulcerative Colitis

Last month, Santarus‘ Uceris for ulcerative colitis received FDA approval, and the company has announced a planned launch in March 2013.

Santaurs has already begun adding 85 new positions to its sales staff in anticipation of Uceris’ future.

The Uceris approval hopes to promise a stabilizing returns for a company with a checkered past, but a promising future.

During the 2008 and part of 2009, the company almost lost its lead product, Zegerid, when the U.S. District court for Delaware ruled in favor of Par Pharma on claims the Zegerid patents were invalid.

Upon the news, the stock price crumbled as Zegerid was responsible for 70% percent of the company’s 2009 net revenue. Santarus was left with a falling stock price, a deeply discounted generic and Glumetza, the company’s only branded marketed product – with 2009 revenue of $23.9 million.

In September 2012, however, U.S. Court of Appeals for the Federal Circuit reversed the decision made in Delaware. The Federal Circuit court ruled that Zegerid’s patents were not invalid due to obviousness. Par has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for these strengths of the product.

In a press release to the public, Santarus’ President and CEO Gerald T. Proehl made public the company’s intention to seek damages against Phar Pharma:

“We are very pleased with the ruling of the Federal Circuit and are assessing our options. Given that the Federal Circuit found certain claims to be not obvious, we believe Par has no meritorious basis to further dispute infringement or validity. We plan to aggressively pursue all remedies available to us, including damages as well as seeking an order halting further sales of Par’s generic product.”

Santurus, at a 52-week low of just $4.19, has experienced steady incline since the decision; shares have more than doubled (to over $13) since September 2012.

Uceris is a locally acting, non-systemic corticosteroid in a novel, patented, oral tablet that is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids. Uceris is being developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals.

Ulcerative colitis is a form of inflammatory bowel disease that interferes with the normal function of the colon, producing inflammation and ulcer inside one’s colon. The disease typically starts to manifest in patients as young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission.

Upon the approval announcement, Proehl highlighted the company’s goals in the coming quarters:

“We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis. With the incremental revenue from Uceris and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013. We expect total revenues of $320 million to $325 million, representing significant double-digit growth over our 2012 revenue guidance.”

Santarus markets five products, including three with indications in endocrinology. The company’s product development pipeline includes: Ruconest (Phase III), a recombinant human C1 esterase inhibitor for treatment of acute attacks of hereditary angioedema; Rifamycin SV MM (Phase III), an oral, non-systemic antibiotic for travelers’ diarrhea, and SAN-300 (Phase I) a humanized anti-VLA-1 monoclonal antibody with the potential to treat autoimmune and inflammatory diseases.

The company expects to submit a biologics license application to the U.S. Food and Drug Administration for Ruconest in the first half of 2013.

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