Bausch Health Reports Promising R&D Trial Updates on Amiselimod and Scientific Data Presented at International Healthcare Conferences

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, recently presented at two global healthcare conferences. Bausch Health's gastroenterology (GI) business, Salix Pharmaceuticals presented data from its Amiselimod clinical trials at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on May 19, 2024, in Washington, D.C., and post hoc pooled data analysis of Rifaximin at the International Liver Congress 2024™ (ILC 2024): Annual Meeting of the European Association for the Study of the Liver (EASL) on June 8, 2024 in Milan, Italy

Amiselimod at DDW

Bausch Health shared positive late-breaking data from a global Phase 2 study evaluating Amiselimod for the treatment of patients with active, mild to moderate ulcerative colitis (UC) at Digestive Disease Week® (DDW) 2024. The data were presented by Dr. Steven Hanauer and Clifford Joseph Barborka, Professor of Medicine at Northwestern University. The randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of Amiselimod over a 12-week treatment period. The results demonstrated that Amiselimod was well-tolerated and showed promise as a potential treatment for inducing remission in UC patients.

Specifically:

  • In the primary endpoint measure - both doses of Amiselimod (0.2mg and 0.4mg daily) led to a significantly greater improvement in Modified Mayo Score (MMS) compared to a placebo group on Day 85. This score reflects disease activity, with a lower score indicating better outcomes. Patients taking Amiselimod experienced an average improvement of -2.3 points, compared to -1.6 points in the placebo group (p-score
  • In the secondary measures, endoscopic improvement and clinical remission, after 12 weeks, a significantly higher proportion of patients receiving Amiselimod achieved endoscopic improvement (over 42%) compared to placebo (23%) with statistically significant difference (p-score
  • In the safety evaluation patients were closely monitored for any adverse events throughout the 12 weeks. The findings concluded that Amiselimod treatment was well-tolerated.

"Our recent trial results are a testament to the dedication and expertise of our research teams," said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D. "The promising data from this Amiselimod trial brings us closer to offering new, effective treatment to patients suffering from ulcerative colitis (UC). We are excited to advance this therapy to the next stage of development."

Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.1 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).1

Rifaximin at EASL

At the European Association for the Study of the Liver (EASL) Conference, Bausch Health presented data comparing Rifaximin monotherapy to lactulose monotherapy in preventing overt hepatic encephalopathy (OHE) recurrence in cirrhosis patients with a history of OHE. This analysis, based on pooled data from two randomized trials (one phase 3 double-blind and one phase 4 open-label), focused on adult patients with cirrhosis and a history of OHE episodes showed that:

  • Significantly fewer patients treated with Rifaximin monotherapy experienced an OHE episode compared with lactulose monotherapy (23.2% vs 49.0%, respectively; P
  • Rifaximin monotherapy reduced the risk of a breakthrough OHE event by 60% versus lactulose monotherapy during 6 months of treatment.
  • Rifaximin monotherapy was well tolerated.

These data suggest Rifaximin monotherapy has the potential to be a viable treatment option for OHE recurrence risk reduction in appropriate patient populations.

About Amiselimod

Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5. 2

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

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 provide 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:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.

References

1 IBD Clinic, University of Alberta: http://www.ibdclinic.ca/what-is-ibd/ulcerative-colitis/.
2 BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019.

The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by Alfasigma S.p.A to Salix Pharmaceuticals or its affiliates.

©2024 Salix Pharmaceuticals or its affiliates.

Investor Contact:

Garen Sarafian
ir@bauschhealth.com
(877) 281-6642 (toll-free)

Media Contact:

Kevin Wiggins
corporate.communications@bauschhealth.com
(908) 541-3785

SOURCE: Bausch Health Companies Inc.



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Salix to Present Late-Breaking Data from Phase 2 Trial of Amiselimod in Active Ulcerative Colitis at Digestive Disease Week 2024

Salix to Present Late-Breaking Data from Phase 2 Trial of Amiselimod in Active Ulcerative Colitis at Digestive Disease Week 2024

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, today announced that they will be presenting data from its Phase 2 trial evaluating Amiselimod as treatment for active ulcerative colitis (UC). The data will be presented at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on Sunday, May 19, 2024, in Washington, D.C

"We are pleased to present late-breaking data on Amiselimod, our investigational, oral, sphingosine 1-phosphate (S1P) receptor modulator as a potential treatment for the induction of remission in UC," said Tage Ramakrishna, M.D., Chief Medical Officer and President of Research & Development, Bausch Health. "The abstract underscores our steadfast commitment to developing new and innovative therapies for patients with UC."

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  • Accelerates Solventum's business transformation and sharpens focus on strategic areas for growth to deliver long-term shareholder value

  • Strengthens balance sheet with proceeds to be used primarily for debt paydown

Solventum (NYSE: SOLV) today announced it has entered into a definitive agreement to sell its Purification & Filtration 1 business to Thermo Fisher Scientific Inc. (NYSE: TMO) (" Thermo Fisher ") for $4.1 billion . Solventum expects the transaction to be neutral to 2025 EPS and expects an estimated $3.4 billion in net proceeds, which it intends to use primarily to pay down debt. The transaction is expected to be completed by the end of 2025, subject to regulatory approval and customary closing conditions.

Solventum Logo (PRNewsfoto/3M Healthcare US Opco LLC)

"The sale of the Purification & Filtration business is part of phase three of our transformation plan and follows a thorough analysis of the value and strategic alignment of our businesses," said Bryan Hanson , Solventum CEO. "This transaction will enhance our strategic focus and key metrics while reducing leverage and significantly strengthening our balance sheet. It also enables us to invest in the innovation, programs and talent we need to execute our mission and deliver shareholder value."

Mr. Hanson continued, "Solventum is committed to ensuring a smooth transition for employees, customers and other stakeholders, and we are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions."

Solventum will discuss the transaction on its upcoming fourth quarter and full-year 2024 earnings call scheduled for February 27, 2025 . With this significant change in the Company's portfolio and the other major actions taken since becoming an independent publicly traded company on April 1, 2024 , Solventum has scheduled an Investor Day on March 20, 2025 , to provide investors with an update on the progress made, its go-forward positioning and long-range plan. The Investor Day will be held in New York City , and the Company will share additional logistical details in due course.

Morgan Stanley & Co. LLC, Perella Weinberg Partners and J.P. Morgan Securities LLC served as financial advisors to Solventum, and Cleary Gottlieb Steen & Hamilton served as legal advisor to Solventum.

1 Other than for its operations in Belgium , France and Ireland , for which Thermo Fisher granted a binding offer to Solventum

About Solventum  
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better — while empowering healthcare professionals to perform at their best. See how at Solventum.com .

Forward-Looking Statements
This news release contains forward-looking information about Solventum's financial results, estimates, and business prospects that involve substantial risks and uncertainties. In particular, statements regarding the future performance of Solventum, including guidance for 2024, are forward-looking statements. You can identify these statements by the use of words such as "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "projects," "seeks," "sees," "should," "targets," "will," "would," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or business plans or prospects. Among the factors that could cause actual results to differ materially are the following: (1) the effects of, and changes in, worldwide economic, political, regulatory, international, trade and geopolitical conditions, natural disasters, war, public health crises, and other events beyond Solventum's control; (2) operational execution risks; (3) damage to our reputation or our brands; (4) risks from acquisitions, strategic alliances, divestitures and other strategic events; (5) Solventum's business dealings involving third-party partners in various markets; (6) Solventum's ability to access the capital and credit markets and changes in Solventum's credit ratings; (7) exposure to interest rate and currency risks; (8) the highly competitive environment in which Solventum operates and consolidation in the healthcare industry; (9) reduction in customers' research budgets or government funding; (10) the timing and market acceptance of Solventum's new product and service offerings; (11) ongoing working relationships with certain key healthcare professionals; (12) changes in reimbursement practices of governments or private payers or other cost containment measures; (13) Solventum's ability to obtain components or raw materials supplied by third parties and other manufacturing and related supply chain difficulties, interruptions, and disruptive factors; (14) legal and regulatory proceedings and legal compliance risks (including third-party risks) with regards to antitrust, Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws, environmental laws, anti-kickback and false claims laws, privacy laws, tax laws, and other laws and regulations in the United States and other countries in which Solventum operates; (15) potential liabilities related to a broad group of perfluoroalkyl and polyfluoroalkyl substances, collectively known as "PFAS"; (16) risks related to the highly regulated environment in which Solventum operates; (17) risks associated with product liability claims; (18) climate change and measures to address climate change; (19) security breaches and other disruptions to information technology infrastructure; (20) Solventum's failure to obtain, maintain, protect, or effectively enforce its intellectual property ("IP") rights; (21) pension and postretirement obligation liabilities; (22) any failure by the 3M Company (" 3M ") to perform any of its obligations under the various separation agreements in connection with the separation from 3M (the "Spin-Off"); (23) any failure to realize the expected benefits of the Spin-Off, and/or that the Spin-Off will not be completed within the expected time frame, on the expected terms or at all; (24) a determination by the IRS or other tax authorities that the distribution or certain related transactions should be treated as taxable transactions; (25) expected financing transactions undertaken in connection with the separation and risks associated with additional indebtedness; (26) the risk that incremental costs of operating on a standalone basis (including the loss of synergies), costs of restructuring transactions and other costs incurred in connection with the separation will exceed Solventum's estimates; and (27) the impact of the Spin-Off on its businesses and the risk that the Spin-Off may be more difficult, time-consuming or costly than expected, including the impact on its resources, systems, procedures and controls, diversion of management's attention and the impact on relationships with customers, suppliers, employees and other business counterparties.

Changes in such assumptions or factors could produce significantly different results. A further description of these factors is located under "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" in Solventum's periodic reports on file with the U.S. Securities & Exchange Commission. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information or future events or developments.

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SOURCE Solventum

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