Salix And Its Partner Norgine Present New Data From PLENVU® (NER1006) Phase 3 Studies At Digestive Disease Week (DDW) 2018

WASHINGTON, June 5, 2018 /PRNewswire/ -- Salix Pharmaceuticals, Ltd. ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, and its partner Norgine B.V. ("Norgine") will present new data from Phase 3 clinical trial results for PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) at Digestive Disease Week (DDW) in Washington, D.C., from June 2-5, 2018.

PLENVU® is a low-volume (1L) polyethylene glycol based bowel preparation indicated to provide whole bowel cleansing, with an additional focus on the ascending colon.

"Given the recent FDA approval of PLENVU®, we are proud to present this positive data at DDW to leading gastroenterologists and researchers to further reiterate the clinical benefits of this product," said Mark McKenna, senior vice president and general manager, Salix Pharmaceuticals. "We look forward to bringing PLENVU® to market to meet the needs of both patients and physicians."

The complete schedule for all poster presentations of PLENVU® research that will be presented at DDW on June 5 includes:

• Epstein, Michael. Assessment Of Patient Satisfaction With NER1006 And Trisulfate Bowel Preparations For Colonoscopy: A Phase 3, Randomized, Multicenter Trial (poster #Tu1102, Hall C, 12:00pm – 2:00pm)
• Epstein, Michael. Comparative Assessment Of Bowel Cleansing Of 1 L Polyethylene Glycol Plus Ascorbate NER1006 Compared With 2 L Polyethylene Glycol Plus Ascorbate: A Phase 3, Randomized, Multicenter Trial (poster #Tu1070, Hall C, 12:00pm – 2:00pm)
• Hassan, Cesare. Impact Of Cleansing Quality Using The Harefield Cleansing Scale And Polyp And Adenoma Detection Rates: A Post Hoc Analysis Of Three Phase 3 Randomized Trials (poster #Tu1074, Hall C, 12:00pm – 2:00pm)
• Epstein, Michael. Impact Of Time Interval Between The Second Dose Of A Split-Dose Regimen Of NER1006 Versus Trisulfate And Start Of Colonoscopy: Evaluation Of Colon Cleansing Rates (poster #Tu1101, Hall C, 12:00pm – 2:00pm)

"The data presented at DDW further supports the benefits of PLENVU® in providing effective cleansing in preparation for colonoscopies," said Howard Franklin, M.D., vice president of medical affairs and strategy, Salix Pharmaceuticals. "As a physician, I am encouraged by these results and look forward to additional research in GI medicine to continue to support both patients and the health care professionals who treat them."  

About PLENVU®
PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

PLENVU® is a trademark of the Norgine group of companies.

IMPORTANT SAFETY INFORMATION

• PLENVU is contraindicated in patients with gastrointestinal (GI) obstruction, bowel perforation, gastric retention, ileus, toxic megacolon, and hypersensitivity to any of its ingredients.
• Advise patients to hydrate adequately before, during, and after the use of PLENVU. It is encouraged that patients drink additional clear liquids to help avoid cases of fluid and electrolyte abnormalities. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures, and renal impairment.
• There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances. Consider obtaining ECGs in patients at an increased risk of serious cardiac arrhythmias.
• Use PLENVU with caution in patients with a history of seizures and those at an increased risk of seizures, including patients taking medications that lower the seizure threshold, patients withdrawing from alcohol or benzodiazepines, or patients with hyponatremia.
• Use PLENVU with caution in patients with renal impairment or those taking concomitant medications that affect renal function. Advise these patients to adequately hydrate before, during, and after the use of PLENVU and consider performing laboratory tests in these patients.
• Do not administer PLENVU to patients with GI obstruction or perforation. If GI obstruction or perforation is suspected, perform appropriate diagnostic studies prior to administering PLENVU.
• Use caution in patients with severe ulcerative colitis.
• Patients with impaired gag reflex or those prone to regurgitation or aspiration should be observed during the administration of PLENVU.
• Use PLENVU with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Phenylalanine can be harmful to patients with phenylketonuria (PKU). PLENVU contains phenylalanine, a component of aspartame. Each PLENVU treatment contains 491 mg of phenylalanine.
• PLENVU contains polyethylene glycol and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.
• In clinical trials, the most common adverse reactions (>2% of patients taking PLENVU) were nausea, vomiting, dehydration, and abdominal pain/discomfort. Adverse reactions were similar between the two dosing regimens.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Please click here for full Prescribing Information

About Norgine
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine's total net sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

Norgine specialises in gastroenterology, hepatology, cancer and supportive care. Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France. For more information, please visit www.norgine.com

About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For almost 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix, a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., is headquartered in Bridgewater, New Jersey.

SAL.0069.USA.18

SOURCE Salix Pharmaceuticals, Ltd.

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