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Salix revenue jumps 69 percent in fourth quarter

Salix Pharmaceuticals announced late today strong fourth quarter revenue as sales of the Morrisville company's best-selling drug Xifaxan increased 81 percent.

Revenue for the three-month period ended Dec. 31 was $118.5 million, up 69 percent from a year ago. That was slightly under Wall Street expectations.

For the year, Salix revenues increased 45 percent to $337 million. Xifaxan accounted for $250.5 million of that revenue.

Salix stock dropped 24 percent in one-day late last week after the company said it expects regulators to delay approving Xifaxan for treatment of irritable bowel syndrome.

The company reported earnings after the markets closed today. The stock closed at $33.34, down 15 cents.

Salix shares plummet after company says FDA approval next month unlikely

Salix Pharmaceuticals stock plummeted in early trading this morning after the Morrisville company announced that it doesn't expect to receive approval next month to market its best-selling drug Xifaxan for irritable bowel syndrome.

The stock was down more than 20 percent in early trading.

The company said in a release that it expects to soon receive an FDA Complete Response Letter, which the agency issues when the review process is complete and the application is not ready for approval.

Salix reached that conclusion based on telephone conversations with regulators on Wednesday evening.

Salix shares had soared more than 40 percent over the last year partially on anticipation that the company would win approval at a hearing to be held March 7.

Salix analyst likes Relistor deal; says FDA approval of Xifaxan likely

Salix Pharmaceuticals is paying a premium for the rights to the constipation drug Relistor,  but the price could be more than justified if the Morrisville company gains approval for an oral version of the drug, an analyst wrote in a report issued today.

James Molloy, an analyst with Caris & Company, raised his firm's target price for Salix shares from $47 to $50.

Molloy expressed optimism that the U.S. Food and Drug Administration next month will approve Salix's application to market its best-selling drug, Xifaxan, for irritable bowel syndrome.

"We don’t believe that acquiring Relistor signals any wavering of SLXP’s focus on Xifaxan for IBS, nor do we think that it signals any less conviction by SLXP that Xifaxan should get approved on March 7th," the report says.

"While we believe that SLXP paid a premium price for Relistor they have sufficient cash ($500M as of 3Q10) to fund the deal, and if the oral formulation works that could more than justify the price."

Icagen shares rise on pain-drug testing

Shares of Icagen surged today after the Durham company announced it has started an early clinical trial of an experimental pain treatment.

The pain drug, which still requires years of further testing, is being developed with Icagen's larger partner Pfizer. The partnership calls for Icagen to receive milestone payments as the drug moves through the clinical testing process.

Icagen also announced this afternoon that it expects to submit with the Food and Drug Administration results from studies of its experimental treatment for epilepsy within the next few weeks.

FDA delays ruling on GSK lupus drug to March

Federal regulators, which were scheduled to issue a decision on a new drug to treat lupus next week, have delayed their decision until March.

The drug, known as Benlysta, would be the first new treatment for the autoimmune disease in more than 50 years. It also would provide a needed boost for its developers, Human Genome Sciences and GlaxoSmithKline.

But that boost will be delayed, in a disappointment for the companies and investors.

The Food and Drug Administration has pushed back its review of the drug until March 10, the companies announced this afternoon. The FDA was scheduled to rule on Dec. 9, but requested more information on the drug.

FDA panel backs GSK's lupus drug

The first new treatment for lupus in more than 50 years won the blessing of a federal regulatory panel today, providing good news for patients and the drug's developers.

The U.S. Food and Drug Administration panel voted 13-2 that the drug, known as Benlysta, is safe and effective. Benlysta works well enough to outweigh risks of suicide, infection and cancer, and should be approved, the panel recommended.

The full FDA is scheduled to decide on the drug next month, and usually follows the recommendation of its advisory panels.

Analysts say the drug is likely to be approved because it addresses an unmet medical need, and some expect annual sales to exceed $2 billion eventually.

The drug to treat the incurable autoimmune disease would provide an important new revenue source for its developers, GlaxoSmithKline and Human Genome Sciences. 

FDA approves Eisai's breast cancer drug

Japanese drug maker Eisai won regulatory approval today for its new treatment for late-stage breast cancer.

The drug, known as Halaven, is a synthetic form of a compound found in sea sponges that works by inhibiting cancer cell growth, the Food and Drug Administration wrote in a prepared statement.

While the drug is made outside the U.S., Eisai will label and package it for the U.S. market at a $100 million, 65,000 square-foot facility that opened in May on its Research Triangle Park campus. The company has its U.S. headquarters in New Jersey, but employs about 325 people at its main manufacturing campus in RTP.

The injectable drug, also known as eribulin mesylate, will be the first oncology product packaged at the new facility. Eisai officials have said they may add more jobs in RTP as its cancer program expands.

Former Glaxo lawyer charged with making false statements to FDA

A Durham attorney who once worked in GlaxoSmithKline's legal department has been charged with obstructing an official proceeding, concealing and falsifying documents and five counts of making false statements to the Food and Drug Administration.

Lauren Stevens was indicted this week by the U.S. Justice Department for impeding an FDA inquiry in 2002.

The indictment doesn't name the company Stevens worked for other than to say it was a major pharmaceutical company. The company has not been charged with a crime.

Mary Anne Rhyne, a GSK spokesperson, confirmed that Stevens worked in the company's U.S. legal department and is now retired.

London-based GSK has its U.S. headquarters in Research Triangle Park.

In an e-mail , Stevens attorney, Brien T. O'Connor, said his client is innocent of the charges.

The indictment states that in October 2002 the FDA asked for information about the company’s promotion of a prescription drug as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the agency, also known as "off-label" uses.

The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison.

Pozen delays new clinical trial

Pozen reported weaker results and warned that it won't start key clinical trials of a new drug this year as expected.

The Chapel Hill company's net loss of $8.6 million during the third quarter was slightly worse than analysts had anticipated. Revenue, which includes royalties on sales of its Treximet migraine drug and Vimovo arthritis pain medicine, fell to $4.3 million.

FDA delays decision on Salix drug

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.

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