Bausch Health's Rifaximin Receives FDA Orphan Designation For Sickle Cell Disease

Bausch Health Companies and its gastroenterology business, Salix Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to rifaximin for the treatment of sickle cell disease. The FDA's Orphan Drug Designation program provides orphan status to medicines that are intended for the treatment of a rare disease or condition and incentives for companies to study and further develop medicines to bring forward novel treatments.

Approximately 100,000 Americans have sickle cell disease, which is a group of inherited red blood cell disorders that affects hemoglobin, the protein that carries oxygen through the body. Patients with sickle cell disease have crescent or "sickle" shaped red blood cells that can block blood flow through the body, which can lead to serious problems, including stroke, eye problems, infections and unpredicted episodes of vaso-occlusive crisis, which is described as sharp, intense, stabbing or throbbing pain that can strike nearly anywhere in the body and often requires intravenous pain medication. Sickle cell disease is a lifelong illness, and its only cure is a blood and bone marrow transplant.1

Joseph C. Papa, chairman and CEO, Bausch Health Commented: "Early data suggests that rifaximin may be beneficial in reducing vaso-occlusive crisis in patients with sickle cell disease2, and we are currently finalizing trial protocols to further evaluate its potential in this patient population, We expect to start a Phase 2 trial in the first half of 2021 evaluating a novel rifaximin formulation for a potential sickle cell disease treatment, and we are hopeful to be able to bring this investigational oral formulation forward to help sickle cell patients."

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 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, New Jersey.

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