Salix Pharmaceuticals reported late Monday that revenues increased 62 percent in the first quarter.

The Raleigh company had revenue of $171.1 million for the quarter, up from $105.9 percent in the first quarter of 2011. That beat the $168 million that was the consensus among Wall Street analysts who cover the company. Net income for the quarter was $10 million, or 15 cents per share.

Salix sells drugs to treat gastrointestinal ailments. Revenues from its best-selling drug, Xifaxan, which is approved to treat travelers' diarrhea and a rare liver condition, increased 40 percent in the first quarter to $112.9 million.

The company said in a statement that it plans to increase the size of its sales force from 160 to 195 over the next several months. The sales force focuses on building up relationships with gastroenterologists, colorectal surgeons and hepatologists. 

“Our core business is strong and growing,” CEO Carolyn Logan said. “In the near term we believe we can generate $1 billion in revenue in 2013.”

That belief, she said, is based on Salix winning regulatory approval in July to expand the allowed uses for Relistor, a drug that treats constipation in patients taking pain medicines.

It doesn’t include potential revenues from Salix winning approval to market Xifaxan for treatment of irritable bowel syndrome. At the FDA's request, Salix has begun a trial to test how patients would respond to repeated use of the treatment.

Salix shares closed Monday up $1.11 at $49.60. The stock is up 4 percent this year.

Salix Pharmaceuticals announced Monday that federal regulators have extended the date by which they expect to complete a review of Crofelemer, a potential drug treatment for HIV-associated diarrhea.

The Raleigh company said the review date has been extended from June 5 to Sept. 5. The Federal Drug Administration did not request additional studies.

The FDA granted Crofelemer priority review status in February. Such reviews are granted to drugs that offer major advances in treatment or which provide treatment where no adequate therapy exists.

Crofelemer's 125 mg tablets would treat diarrhea in patients with HIV or AIDS who are on anti-retroviral therapy. Salix estimates that some 150,000 patients on the therapy experience chronic diarrhea, which can cause weight loss and complicate treatment.

A second Salix drug, Relistor, also had its FDA review date pushed back last week. Relistor treats constipation in patients taking pain medicines.

Salix Pharmaceuticals reported fourth quarter earnings late today that beat Wall Street estimates thanks to robust sales of its best-selling drug Xifaxan.

The Raleigh company reported revenue of $155.2 million for the quarter, up 31 percent from the same period in 2010. Net income, excluding certain charges, for the quarter was $76 million, or $1.18 per share.

That beat the 93 cents per share that was the consensus among Wall Street analysts who cover the company.

For the year, Salix reported revenue of $540.5 million, up 60 percent from 2010.

Salix sells drugs to treat gastrointestinal ailments. Xifaxan is approved to treat travelers' diarrhea and hepatic encephalopathy, a rare liver condition.

Xifaxan revenue for the quarter was $107.2 million, up 29 percent from the same period in 2010. Xifaxan revenue for the year was $371.7 million, up 48 percent.

In a statement, Salix's chief financial officer, Adam Derbyshire, said the company expects revenues in 2012 to increase 36 percent to about $735 million.

Salix shares closed today up 3 cents at $46.14. The stock is up 38 percent over the past year.

Raleigh-based Salix Pharmaceuticals announced today that is has submitted a new drug application to the Food and Drug Administration for Crofelemer, a drug used to treat chronic diarrhea in HIV/AIDS patients.

Salix has an agreement to develop Crofelemer with San Francisco-based Napo Pharmaceuticals. Napo, which sued Salix earlier this year claiming it breached their collaboration agreement, announced last month that it had terminated the agreement.

Salix calls the lawsuit baseless and says Napo's termination of the license is groundless and without merit.

The FDA now has 60 days to conduct a filing review to determine if Salix's application is complete enough to warrant a more substantive review of Crofelemer.

Salix Pharmaceuticals announced today that a Food and Drug Administration advisory panel supports the proposed design of a clinical trial to evaluate the effectiveness of the company's drug Xifaxan in treating irritable bowel syndrome.

Salix expects to begin patient enrollment for the trial in the first quarter of next year. The company estimates it could take 24 months to complete the trial and file a resubmission with the FDA.

Trading in Salix shares was halted today in advance of the FDA ruling.
 

The Food and Drug Administration has raised several unexpected concerns in its review of Salix Pharmaceuticals application to get its best-selling drug Xifaxan approved for the treatment of irritable bowel syndrome.

Salix officials are meeting today with an advisory committee of experts that has reviewed the data the company included in its application.

The FDA identified a number of issues that had not previously been mentioned by Salix officials, said Jefferies & Company analyst Corey Davis in a research note released today.

Among the surprises were questioning whether Salix used the proper dose and proper patient population in its testing.

"We think the market is going to find these surprising given the magnitude of the agency's skepticism," Davis wrote.
 

A California drug company that filed a lawsuit earlier this year accusing Salix Pharmaceuticals of breaching a collaboration agreement has now terminated that agreement.

San Francsico-based Napo Pharmaceuticals announced last week that it had terminated an agreement with Raleigh-based Salix to develop crofelemer as a treatment for chronic diarrhea in HIV/AIDS patients.

Napo informed Salix of its intent to terminate the agreement on Nov. 4.

In a regulatory filing, Salix said it believes the termination notice is connected to the lawsuit.

"We dispute Napo’s right to terminate our Collaboration Agreement as well as Napo’s related claims that we have breached the Collaboration Agreement," the company wrote. "We believe that neither has any merit."

Salix bought the rights to crofelemer for a $5 million licensing fee and future milestone payments in December 2008.

Salix Pharmaceuticals reported strong third-quarter revenue late Tuesday as demand for the company’s best-selling drug Xifaxan continued to grow.

The Raleigh company also announced that it is adding two new products to its drug portfolio by acquiring privately-held Oceana Therapeutics for $300 million in cash.

The deal, which is expected to close by the end of the year, is Salix’s second major acquisition in 2011. The company earlier acquired the rights to Relistor, a drug that treats constipation in patients taking pain medicines.

Salix, which focuses on drugs used to treat gastrointestinal ailments, is one of the few small drug companies based in the Triangle with actual products and revenue. The company has about 450 employees, including 200 in North Raleigh.

Among the investors who is high on Salix Pharmaceuticals, the Raleigh company that specializes in gastrointestinal drugs, is hedge fund manager John Paulson.

Paulson, who made billions during the economic crisis by shorting mortgage-backed securities, now owns 1.5 million shares in the company as of June 30, according to regulatory filings.

That's an increase of 1.36 million shares over what his firm, Paulson & Co., reported at the end of the first quarter.

Paulson now owns 2.57 percent of Salix's outstanding shares, making his fund the ninth largest shareholder in the company.
 

Salix Pharmaceuticals announced this morning that the Food and Drug Administration will review its application to expand the allowed uses for Relistor, a drug that treats constipation in patients taking pain medicines.

Salix and its partner, Progenics Pharmaceuticals, are seeking to have Relistor approved to treat patients with chronic pain.

The injected drug is currently only approved to treat patients with advanced illnesses who are taking opioid painkillers, which often cause severe constipation.

The FDA will rule on the application on April 27.

Raleigh-based Salix purchased the rights to Relistor in February.