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.

Cetero Research, a Cary-based contract research organization, announced Tuesday that it has reached a final resolution with the Food and Drug Administration over studies the company conducted between 2005 and 2010.

Last July, the FDA notified Cetero that it had uncovered “objectionable conditions” at a company lab in Houston, including falsification of dates and times, manipulation of data and other deficiencies.

On Tuesday, Cetero said that the agency would accept studies for submission and review without reanalysis or audit that were performed between Sept. 1, 2009 and

June 15, 2010. Studies performed between March 1, 2008 and Aug. 31, 2009 would need a third-party integrity audit. Studies performed between April 1, 2005 and

Feb. 28, 2008 that were previously submitted as part of an approved or pending application, or studies that will be submitted as part of a new application, will need complete reanalysis or a repeat of the study.

BioDelivery Sciences International announced today that it has signed a license and development agreement with Endo Pharmaceuticals for its experimental treatment for chronic pain.

The $180 million deal includes a $30 million upfront payment to Raleigh-based BioDelivery as well as $95 million in potential development milestone payments and $55 million in potential payments if the treatment reaches certain sales targets.

BioDelivery's stock more than doubled in early trading today on the news.

The deal represents a remarkable reversal of fortunes for the drug, BEMA Buprenorphine.

In September, BioDelivery's stock plummeted after it announced that the drug failed to outperform a placebo in a Phase 3 clinical trial.

The company subsequently launched a new study of the effectiveness of the drug based on some positive data collected in the latest trial.
 

Cornerstone Therapeutics, a specialty pharma in Cary, has acquired a small Philadelphia pharma that recently filed a new drug application with the FDA.

Cornerstone will acquire all outstanding shares of Cardiokine but financial terms of the deal were not disclosed.

Under CEO Craig Collard, Cornerstone has focused on acquiring and developing drugs used by hospitals. Cardiokine, which develops cardiovascular products for hospitals, fits in with that strategy.

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.
 

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.

Salix Pharmaceuticals reported second quarter earnings late today that beat Wall Street estimates, and the company also 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 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 Pharmaceuticals is set to meet with federal regulators today about their decision to delay approval of the company's drug Xifaxan for treatment of irritable bowel syndrome.

Morrisville-based Salix announced the meeting with Food and Drug Administration officials last month when it reported first quarter earnings.

Xifaxan is approved to treat travelers' diarrhea and hepatic encephalopathy, a rare liver condition.

In February, Salix received a Complete Response Letter from the FDA regarding its IBS application, which would be worth billions to the company.

That's what the agency issues when its review process is complete and a drug application is not ready for approval.

Salix officials are expected to make the case today as to why they believe such a study is not necessary.