Salix Pharmaceuticals reported second quarter earnings late today that beat Wall Street estimates, and the company said it would continue its efforts to get its best-selling drug Xifaxan approved for the treatment of irritable bowel syndrome.
Revenue for the three-month period that ended June 30 was $133.2 million, up 42 percent from the same period a year ago. That was slightly above the consensus of $130 million Wall Street analysts estimated.
The Raleigh company reported net income of $33.8 million, or 54 cents per share, excluding one-time charges.
Salix, which sells drugs to treat gastrointestinal ailments, is one of a handful of drug-development companies in the Triangle with medicines approved for patients' use.
Xifaxan is approved to treat travelers' diarrhea and hepatic encephalopathy, a rare liver condition.
Xifaxan revenue for the second quarter was $87 million, up 20 percent from the same period a year ago.
Salix said it would continue the development of Xifaxan for the treatment for IBS, a market that could be worth billions to the company.
In February, Salix received a Complete Response Letter from the FDA regarding its IBS application. That's what the agency issues when its review process is complete and a drug application is not ready for approval.
Often in such situations the FDA will request a long-term study of the drug that could take several years to complete. Many analysts expected the company to abandon the effort.
Salix officials met with the FDA in June to discuss the agency's ruling.
And in today's earnings release, Salix CEO Carolyn Logan said that during that meeting, and in subsequent discussions, the FDA has communicated its intention to work with the company to address concerns about the application.
Chief among them is the fact that Salix provided no data on whether IBS patients would respond to repeated use of the treatment.
Salix said today that the FDA has agreed to convene an advisory committee to review the IBS data that was submitted.
A patient trial involving repeat users of the treatment is expected to begin by the end of the year or early next year.
Salix now expects it could take about 24 months to complete a trial and secure FDA approval.
Salix shares closed down $1.90 at $32.70 today. The stock is down 21 percent over the last year.