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

- Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health") and its gastroenterology business, Salix Pharmaceuticals ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, today 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

"Early data suggests that rifaximin may be beneficial in reducing vaso-occlusive crisis in patients with sickle cell disease 2 , and we are currently finalizing trial protocols to further evaluate its potential in this patient population," said Joseph C. Papa , chairman and CEO, Bausch Health . "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 .  For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn .

About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com .

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.









1

Sickle Cell Disease. National Heart, Lung, and Blood Institute. [online] Available at: https://www.nhlbi.nih.gov/health-topics/sickle-cell-disease . Accessed Oct. 29, 2020.

2

Lim, Sean H., Dutta, Dibyendu, Moore, Judy. "Rifaximin for sickle cell disease." American Journal of Hematology. 2019 Dec; 94(12): E325-E328.

Investor Contact:




Media Contacts:

Arthur Shannon




Lainie Keller

arthur.shannon@bauschhealth.com




lainie.keller@bauschhealth.com

(514) 856-3855




(908) 927-1198

(877) 281-6642 (toll free)









Karen Paff





karen.paff@salix.com





(908) 927-1190

Bausch Health logo (PRNewsfoto/Bausch Health Companies Inc.)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/bausch-healths-rifaximin-receives-fda-orphan-designation-for-sickle-cell-disease-301163412.html

SOURCE Bausch Health Companies Inc.

News Provided by PR Newswire via QuoteMedia

The Conversation (0)

Healing People and Planet: 3 Things You Need to Know About This Shared Innovation Challenge

By Ken Washington, Chief Technology and Innovation Officer, and Raman Venkatesh, Chief Sustainability Officer, Medtronic

When you think about healthcare technology, you may imagine the pacemaker assisting your dad's ailing heart, the sutures your child received after a bike accident, or the pulse oximeter placed on your finger during your annual physical exam. You probably don't think about the energy or resources required to manufacture those products, nor the resulting emissions and waste.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Healing People and Planet: New Impact Report Outlines How Medtronic Is Shaping the Future of Health

Medtronic

Medtronic releases 2024 Impact Report highlighting success in healthcare equity with new data from the Healthy Neighbor program, in addition to community engagement and environmental sustainability progress

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Artificial Intelligence Reshaping Healthcare Industry with Unimaginable Potential

FN Media Group News Commentary - The Healthcare Artificial Intelligence (AI) market exhibits a high degree of innovation, characterized by ongoing advancements in technology. Rapid developments in ML, deep learning, NLP, and computer vision are driving the evolution of AI-powered healthcare solutions. One primary factor driving market growth is the increasing demand in the healthcare sector for enhanced efficiency, accuracy, and better patient outcomes. According to a March 2024 Microsoft-IDC study, 79% of healthcare organizations are presently utilizing AI technology. In addition, the return on investment (ROI) is realized within 14 months, generating USD 3.20 for every USD 1 invested in artificial intelligence (AI). AI technologies hold transformative potential in various areas including medical imaging analysis, predictive analytics, personalized treatment planning, and drug discovery, potentially transforming conventional healthcare practices. A report from Grand View Research said the global AI in healthcare market size, which was estimated at USD 19.27 billion in 2023, is expected to grow at a CAGR of 38.5% from 2024 to 2030. The report said: "Mergers & acquisitions (M&As) play a significant role in shaping the healthcare AI market landscape. Companies [that] engage in M&A activities to expand their AI software and services increase their market reach or acquire specialized technology and expertise. End-users are becoming increasingly aware of the potential benefits of AI in improving patient care, operational efficiency, and healthcare outcomes. Education initiatives and industry events helped raise awareness about the capabilities and applications of AI in healthcare." A.I. companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Teladoc Health, Inc. (NYSE: TDOC), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Clover Health Investments, Corp. (NASDAQ: CLOV).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Medtronic receives FDA clearance for new InPen app, paving the way for its Smart MDI system launch with Simplera CGM

New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM). The company's Smart MDI system combines its InPen™ smart insulin pen with its newest Simplera™ CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic reports second quarter fiscal 2025 financial results

Delivering on commitments, executing ahead of expectations, and raising guidance

Innovation driving sustained growth across many franchises:  TAVR, PFA, Leadless Pacemakers, Diabetes, Spine, and Neuromodulation

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×