Bausch Health's OraPharma Expands into Canada and Puerto Rico, Helping to Address Unmet Needs in Periodontal Disease

Rhea-AI Summary

Bausch Health (NYSE:BHC) and its dental business OraPharma announced commercial expansion of Arestin into Canada and Puerto Rico on November 5, 2025, aiming to improve access to periodontal disease treatments and strengthen distributor and dental professional partnerships.

Arestin is described as the only FDA‑approved locally applied antibiotic for use with scaling and root planing and is supported by over 20 years of clinical experience. The release highlights high regional disease prevalence and includes safety and prescribing information for Arestin.

Positive

• Commercial launch of Arestin in Canada and Puerto Rico
• Arestin is the only FDA‑approved locally applied antibiotic for SRP
• Over 20 years of clinical experience cited for Arestin

Negative

• Arestin contraindicated in children, pregnant and nursing women due to tooth discoloration
• Safety profile includes sun sensitivity and reports of allergic reactions
• Arestin not studied in immunocompromised patients (HIV, diabetes, chemo/radiation)

Insights

Dental market strategist

OraPharma's commercial launch in Canada and Puerto Rico expands access to an FDA‑approved adjunct periodontal therapy.

Business mechanism: The move places Arestin—the only FDA‑approved locally applied antibiotic adjunct to scaling and root planing—into new commercial channels on November 5, 2025. Expanding distribution and local dental‑professional partnerships directly increases product availability where the release cites substantial disease prevalence, including >1 billion affected globally and 44.5% moderate‑to‑severe prevalence in older adults in Puerto Rico.

Dependencies and risks: Commercial success depends on effective distributor onboarding, dental professional adoption, and adherence to the product's labeled safety constraints such as allergies and contraindications. Uptake may be limited where clinicians prefer non‑local antibiotics, alternative care pathways, or where safety notes (pregnancy, children, photosensitivity, autoimmune signals) restrict use.

What to watch and timeframe: Monitor local product availability, distributor agreements, and any published uptake metrics or prescribing patterns over the next 6–18 months; watch for region‑specific promotional activity and any regulatory notices that would affect labeling or use.

Expansion improves access to treatment options within periodontal care and helps strengthen partnerships with dental professionals within these populations.

LAVAL, QC / ACCESS Newswire / November 5, 2025 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global diversified pharmaceutical company, and OraPharma, its dental products business, today announced the commercial expansion of OraPharma into Canada and Puerto Rico. This strategic move reflects OraPharma's commitment to improving oral health awareness, providing access to treatments within periodontal disease management, and strengthening partnerships with local distributors and dental professionals in these markets.

Periodontal disease continues to be one of the most prevalent chronic oral conditions worldwide. Findings from the Global Burden of Disease Study (2021) reveal that over 1 billion people are affected globally.¹ In Canada, the Canadian Dental Association estimates that seven in ten Canadians will develop gum disease during their lifetime.² In Puerto Rico, 44.5% of older adults are living with moderate to severe periodontal disease.³ These figures highlight the urgent need for greater awareness and improved access to treatment options.

For more than two decades, OraPharma has been dedicated to helping advance periodontal care. Its flagship product, Arestin^®, is the only Food and Drug Administration (FDA) approved locally applied antibiotic for use with scaling and root planing (SRP) as part of periodontal disease management and is supported by over 20 years of clinical experience. Arestin is indicated as an adjunct to SRP for pocket depth reduction in adult periodontitis, helping dental professionals in delivering comprehensive care. This expansion into Canada and Puerto Rico is intended to improve access to periodontal care in these areas.

"OraPharma remains committed to addressing periodontal disease, a condition that affects more than 1 billion globally," said Tom Stern, Vice President and General Manager, OraPharma, Bausch Health. "By expanding access to Arestin in Canada and Puerto Rico, we aim to help address the gaps in care and provide dental professionals with a treatment option to support improved oral health for their adult periodontitis patients."

What is ARESTIN?

ARESTIN^® (minocycline HCl) Microspheres, 1mg is used in combination with scaling and root planing (SRP) procedures to treat patients with adult periodontitis (gum disease). ARESTIN^® may be used as part of an overall oral health program that includes good brushing and flossing habits and SRP.

IMPORTANT SAFETY INFORMATION

• Do not use ARESTIN if you are allergic to minocycline or tetracyclines, ask your dentist if you are not sure. Do not use ARESTIN in children, pregnant or nursing women as the use of tetracycline class drugs, including ARESTIN, during tooth development may cause permanent discoloration of the teeth.

• ARESTIN may cause you to be sensitive to sunlight. Patients exposed to direct sunlight or ultraviolet light may develop a severe sunburn. At the first evidence of skin redness, call your dentist.

• Serious allergic reactions have occurred with oral minocycline. Get emergency help right away if you experience any signs of an allergic reaction including shortness of breath, swelling of the face, throat and tongue, rash, hives, itching, fever, or enlarged lymph nodes.

• Tetracyclines, including oral minocycline, have been associated with the development of autoimmune syndromes with symptoms such as joint pain, muscle pain, rash, swelling, fever, enlarged lymph nodes, and general body weakness.

• Tell your dentist about all the medicines you take, and about any health problems you have, including if you've had oral candidiasis ("thrush").

• ARESTIN has not been studied in patients with weakened immune systems, such as patients with HIV infections or diabetes, or those receiving chemotherapy or radiation.

• The most frequently reported non-dental side effects were headache, infection, flu symptoms, and pain.

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 see full Prescribing Information at arestin.com/pi OR click here for full Prescribing Information.

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 care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. More information can be found at www.orapharma.com. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.

Forward-looking Statements

This news release may contain forward-looking statements within the meaning of applicable securities laws, including the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, 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. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports 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. 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. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

REFERENCE:

⁽¹⁾ Hu M, Zhang R, Wang R, Wang Y, Guo J. Global, regional, and national burden of periodontal diseases from 1990 to 2021 and predictions to 2040: an analysis of the Global Burden of Disease Study 2021. Front Oral Health. 2025;6:1627746. doi:10.3389/froh.2025.1627746. [frontiersin.org]
⁽²⁾Canadian Dental Association
⁽³⁾Low vitamin D status strongly associated with periodontitis in Puerto Rican adults | BMC Oral Health

ORAPHARMA is a trademark Bausch Health Companies Inc. or its affiliates.

© 2025 Bausch Health Companies Inc. or its affiliates.

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

Media Contact: Katie Savastano corporate.communications@bauschhealth.com (908) 569-3692

SOURCE: Bausch Health Companies Inc.

View the original press release on ACCESS Newswire

FAQ

When did Bausch Health announce OraPharma's expansion of Arestin into Canada and Puerto Rico (BHC)?

Bausch Health announced the commercial expansion on November 5, 2025.

What is Arestin and how is it used in periodontal treatment (BHC)?

ARESTIN is minocycline HCl microspheres, 1mg used adjunctively with scaling and root planing (SRP) for adult periodontitis pocket depth reduction.

How does the FDA status of Arestin affect BHC's dental business growth?

Arestin is described as the only FDA‑approved locally applied antibiotic for SRP, which supports commercial positioning in new markets.

Are there safety restrictions investors should note about Arestin (BHC)?

Yes—Arestin is contraindicated in children and pregnant or nursing women and may cause sun sensitivity and serious allergic reactions.

Will Arestin be available through local distributors and dental professionals in Canada and Puerto Rico (BHC)?

The expansion is intended to improve access via partnerships with local distributors and dental professionals in those markets.

What prevalence data did Bausch Health cite to justify the expansion (BHC)?

The release cites that over 1 billion people are affected globally and notes Canadian and Puerto Rico prevalence figures to highlight unmet need.