Salix Pharmaceuticals announced after the markets closed today that revenue jumped 23 percent in the third quarter while sales of its best-selling drug Xifaxan increased 53 percent.

The Morrisville drug company said revenue for the three month period ending Sept. 30 was $80.6 million, up from $65.7 million a year ago. That beat Wall Street expectations.

Xifaxan revenues were $65.2 million versus $42.7 million a year ago.

In March, the Food and Drug Administration said Salix could market Xifaxan as a treatment for serious liver disease, or hepatic encephalopathy.

The company projects that approval will eventually boost Xifaxan sales by as much as $1 billion a year.

Carolyn Logan, Salix's president and CEO, said in a release that Xifaxan continues to gain momentum in the marketplace.

"The service is being well received by physicians and is enhancing patients access to this important HE therapy," she said.
 

Salix Pharmaceuticals, which raised more than $300 million on Wall Street in May, is putting some cash to use by buying an experimental drug to detect colon cancer.

The Morrisville-based company announced this morning that it acquired the rights to Lumacan from Photocure of Norway. Salix will pay $4 million now and up to $126.5 million more if the drug wins regulatory approval and hits various sales milestones.

Salix also will pay Photocure royalties on net sales of Lumacan. The prescription product is designed to test for precancerous and cancerous lesions in the colon.

Salix Pharmaceuticals announced this morning that federal regulators need more time to review its request to market an existing drug as a new treatment for irritable bowel syndrome.

The news is a minor setback for the Morrisville drug company, which has projected that winning approval to treat IBS could mean billions of dollars in additional annual sales for the drug, known as Xifaxan.

Salix shares fell 69 cents in morning trading to $37.72. The stock is down about 12 percent in the past week.

The Food and Drug Administration had granted Salix's application priority review, and expected to make a decision by Dec. 7. But the FDA extended that deadline by three months to March 7.

Salix Pharmaceuticals announced today that it has reached an agreement to sell $300 million in new debt as investor demand proved to be even greater than the Morrisville company expected.

Salix's original plans, filed with the Securities and Exchange Commission Thursday, said the company was looking to raise as much as $200 million.

The announcement today said there's also an option for underwriters to purchase an additional $45 million in notes above the $300 million.

Salix plans to use all but $38.6 million of the proceeds for business development, clinical trials and other corporate purposes.

Salix has become an investor darling of late as the company's revenue prospects have blossomed with the Food and Drug Administration's approval in March of its best-selling drug, Xifaxan, for patients suffering from serious liver disease.

Salix also is expected to seek FDA approval by the end of June to market Xifaxan for treatment of irritable bowel syndrome.

Salix shares rose 25 cents Friday to close at $35.93. The stock has nearly quadrupled in the past year.

Salix Pharmaceuticals filed plans with the Securities and Exchange Commission today to raise as much as $200 million by selling debt.

Salix said it would use the money for business development, clinical trials and other corporate expenses.

Morrisville-based Salix expects to become profitable in the second quarter, with revenue growth fueled by sales of its best-selling drug Xifaxan. The drug received regulatory approval for patients suffering from serious liver disease in March.

Salix expects to seek Food and Drug Administration approval by the end of June to market Xifaxan for treatment of irritable bowel syndrome.

Salix Pharmaceuticals reported first-quarter sales this afternoon that beat Wall Street estimates.

The Morrisville company announced that revenue was $44.1 million, down less than two percent from the same period last year. Salix reported a net loss of $25.2 million, or 45 cents a share.

The results beat the average expectation of Wall Street analysts, which called for revenue of about $42 million and a 5 percent revenue decline, according to Thomson One Analytics.

In March, Salix received regulatory approval to expand the marketing of its best-selling drug Xifaxan to patients suffering from serious liver disease. The company anticipates as much as $1 billion in additional sales from the new market.

Xifaxan, which is already approved for travelers' diarrhea, had revenue of $29.9 million in the first quarter. The company's two other bowel cleansing drugs generated revenue of $10.5 million.

The 48,000 prescriptions for Xifaxan issued in March was a record for the drug. Overall demand for Xifaxan was up 15 percent in the first quarter compared to the same period last year.

Salix Pharmaceuticals reported late today that it has received positive news about its attempts to get its drug Xifaxan approved for treatment of irritable bowel syndrome.

The Morrisville company said data from Phase 3 clinical trials showed that a significantly greater portion of patients taking Xifaxan achieved "adequate relief from IBS symptoms" when compared to a placebo. The study included 1,260 patients.

Salix, which expects to seek Food and Drug Administration approval by the end of June, projects that a regulatory go-ahead for treatment of IBS could mean additional annual peak sales of $2.5 billion for Xifaxan.

“We are extremely pleased with the robustness of the data generated from these identically designed and executed Phase 3 trials of rifaximin in the treatment of non-constipation IBS,” Bill Forbes, as Salix executive vice president and its chief development officer.

Rifaximin is another name for Xifaxan.

Morrisville-based Salix Pharmaceuticals will launch a new program next month for patients and physicians dealing with serious liver disease that is designed to coincide with the expanded availability of the company's best-selling drug Xifaxan.

Salix received regulatory approval last month to expand the marketing of Xifaxan to patients suffering from serious liver disease.

Salix officials anticipate as much as $1 billion in additional sales from the new market.

The company's new program, the Hepatic Encephalopathy Living Program, will launch May 24. Hepatic encephalopathy, which affects about 200,000 U.S. patients, impairs brain functions and can put patients in a coma.

The new program will offer patients co-pay assistance and a 24-hour free hotline.

Morrisville-based Salix Pharmaceuticals made misleading claims about the risks associated with its acid-reflux drug Metozolv in certain marketing promotions, the Food and Drug Administration has ruled.

The FDA issued a warning letter to Salix saying the marketing materials "are false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims ... These violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstances other than those for which the drug has been shown to be safe and effective."

Salix received regulatory approval to market Metozolv in September and, at the time, projected annual sales could reach $50 million.

The drug treats diabetic gastroparesis, a stomach ailment that afflicts about 5 million diabetics. Metozolv also can treat gastroesophageal reflux disease, or GERD, a more serious form of acid reflux.

Shares of Salix Pharmaceuticals rose five percent today as investors hailed Wednesday's announcement that the FDA has approved the Morrisville company's application to market its best-selling Xifaxan for serious liver disease.

Salix shares closed at $35.29 today, up $1.77. Shares rose as high as $38 earlier in the day.

Analysts at Roth Capital Partners put a 12-month price target on the stock at $43 per share.

Roth's report said estimates of Xifaxan sales in 2010 being between $160 and $170 million appear low.

Roth's report said a conservative estimate of the drug's revenue target is $181 million.