Mr. Thomas Appio reports

COURT OF APPEALS FOR THE FEDERAL CIRCUIT ISSUES RULING IN NORWICH CASE THAT PREVENTS FDA APPROVAL OF NORWICH'S ABBREVIATED NEW DRUG APPLICATION UNTIL 2029

The U.S. Court of Appeals for the Federal Circuit in the matter of Salix Pharmaceuticals Ltd. (Bausch Health Companies Inc.'s gastroenterology business) et al. versus Norwich Pharmaceuticals Inc., has affirmed the May 17, 2023, decision of the U.S. District Court for the District of Delaware that had denied Norwich Pharmaceuticals' motion for modification of the court's final order preventing the U.S. Food and Drug Administration (FDA) from approving its abbreviated new drug application (ANDA) for Xifaxan (rifaximin) 550 milligrams before Oct. 2, 2029. The Court of Appeals also affirmed the Aug. 10, 2022, decision of the District Court that invalidated certain U.S. patents protecting the composition and use of Xifaxan for treating IBS-D (irritable bowel syndrome with diarrhea). As a result of the Federal Circuit's decision, Norwich's abbreviated new drug application for Xifaxan (rifaximin) 550 milligrams remains barred from approval by the U.S. Food and Drug Administration until Oct. 2, 2029.

"We are pleased that the Federal Circuit maintained the judgment preventing the approval of Norwich's abbreviated new drug application for Xifaxan (rifaximin) 550 mg by the U.S. Food and Drug Administration until October, 2029," said Thomas J. Appio, chief executive officer. "While we are disappointed that the Federal Circuit affirmed the invalidity of certain Xifaxan IBS-D patents and disagree with this aspect of the court's decision, we will continue to vigorously defend our intellectual property. We remain committed to advocating for the safety of patients who have benefited from continued access to Xifaxan, and we look forward to continuing to serve those patients."

About Xifaxan

Xifaxan (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

About Salix Pharmaceuticals

Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 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 is headquartered in Bridgewater, N.J.

About Bausch Health Companies Inc.

Bausch Health is a global diversified pharmaceutical company enriching lives through its relentless drive to deliver better health outcomes. The company develops, manufactures and markets a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through its controlling interest in Bausch + Lomb. The company's ambition is to be a globally integrated health care company, trusted and valued by patients, health care providers, employees and investors.

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