Author: Jason deBruyn Source: bizjournals (
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Jason deBruyn
Staff Writer- Triangle Business Journal
Salix Pharmaceuticals, Raleigh's largest home-grown drug company, took a big step toward bringing another drug to market Thursday when it announced that the U.S. Food and Drug Administration had accepted its new drug application.
In the United States, drug developers must receive approval from the FDA before selling a drug. By accepting the application for this drug, called budesonide, the FDA has signaled that it will at least consider the drug's merits. The federal agency set a deadline of Sept. 15 to respond to Salix (Nasdaq: SLXP); at that point it could either approve, deny or ask for more information.
Salix, a specialty pharmaceutical company that develops prescription drugs and medical devices used in the treatment of a variety of gastrointestinal diseases, licensed budesonide from Germany-based Dr. Falk Pharma in 2008. The agreement gives Salix exclusive license to develop and commercialize budesonide products in the United States, including various patents which expire in 2015 and 2016. Depending on sales milestones, Salix could pay Dr. Falk Pharma up to $23 million in the deal; through Sept. 30, Salix had paid $1 million of those milestones.
Through Sept. 30, 2013, Salix had spent $38 million developing budesonide. That ranks the drug fourth in terms of Salix's significant projects. The project receiving the most financial support is a product to treat irritable bowl syndrome called rifaximin; Salix has spent $102 million developing that product, including $31 million in the first three quarters of 2013.
Salix had not reported full 2013 earnings by Thursday. Through the first nine months of the year, the company posted operating income of $176 million, about 40 percent higher than the same period of 2012, and net revenue of $676 million, about 25 percent higher than last year. Salix stock traded at more than $98 Thursday morning, up from Wednesday's close of just more than $96.
The specific application that the FDA accepted is for Budesonide 2 mg Rectal Foam, which would treat patients with active mild to moderate distal ulcerative colitis if approved.
"Patients with distal ulcerative colitis, also known as proctitis or proctosigmoiditis, are often difficult to treat and present the most challenging subset of patients given the limitations of available treatment options," said Bill Forbes, Salix executive vice president of Medical and Research and Development and chief development officer, in a statement.
