FDA Approves IBS-D Drugs, GBIM Plunges On Hepatitis B Drug Data, RTRX On A High

(RTTNews) - Valeant Pharmaceuticals International Inc.'s (VRX, VRX.TO) wholly owned subsidiary, Salix Pharmaceuticals Inc., has received FDA approval for Xifaxan 550 mg for the treatment of irritable bowel syndrome with diarrhea in adults. The recommended dosing for Xifaxan 550 mg for IBS-D is one 550 mg tablet three times a day for 14 days.

Xifaxan 550 mg received its initial approval in 2010 for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments.

Sales of Xifaxan 550 mg during the first four full quarters following the expanded approval approval are expected to be between approximately $125 million and $150 million, according to the guidance given by Salix last December.

Salix was acquired by Valeant on April 1, 2015 for a price of $173.00 per share in cash.

VRX touched a new high of $239.16 on Wednesday before closing the day's trading at $239.12. In after-hours, the stock was up 1.41% to $242.50.

Another drug, which received FDA approval on Wednesday for irritable bowel syndrome with diarrhea in adults is Actavis plc's (ACT) Viberzi.

Viberzi represents the first in class treatment for IBS-D as it treats the hallmark symptoms namely abdominal pain and diarrhea.

The FDA has recommended that Viberzi be classified as a controlled substance. This recommendation has been submitted to the U.S. Drug Enforcement Administration. Once Viberzi receives final scheduling designation, the updated label will be available. Pending final scheduling designation, product launch is anticipated in Q1 2016.

ACT closed Wednesday's trading at $306.79, up 2.24%.

Halozyme Therapeutics Inc. (HALO) and Ventana Medical Systems Inc., a member of the Roche Group have entered into a global agreement to collaboratively develop a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20.

Under the agreement, Ventana will develop an in vitro diagnostic, under design control, using Halozyme's proprietary hyaluronan binding protein, with the intent of submitting it for regulatory approval in the United States, Europe and other countries.

The financial terms of the agreement were not disclosed.

HALO closed Wednesday's trading at $17.82, up 0.45%.

Shares of Retrophin Inc. (RTRX) rose over 11% following the company's agreement to sell its Rare Pediatric Disease Priority Review Voucher to Sanofi (SNY) for a total consideration of $245 million in cash.

The total consideration includes a payment of $150 million, followed by two equal installments of $47.5 million in 2016 and 2017.

Retrophin received the Pediatric PRV when Cholbam was approved by the FDA on March 17, 2015 for the treatment of pediatric and adult patients suffering from bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

RTRX closed Wednesday's trading 11.83% higher at $30.05.

Shares of GlobeImmune Inc. (GBIM) cratered more than 51% on Wednesday as a phase II study of GS-4774 in patients with chronic hepatitis B on long term viral suppression with an oral antiviral treatment failed to meet the primary endpoint of reduction in hepatitis B surface antigen (HBsAg) at week 24.

The company noted that it looks forward to collaborating with its partner Gilead Sciences Inc. (GILD) to identify potential next steps for GS-4774 in patients with chronic hepatitis B on long term viral suppression with an oral antiviral treatment as well as to seeing the results from the second ongoing phase 2 trial of GS-4774 in HBV treatment-naïve patients.

GBIM plunged 51.33% on Wednesday to close at $4.01. In after hours, the stock fell another 3.74% to $3.86.