PharmaTher Launches Strategic Initiative to Pursue Health Canada Approval for Generic Semaglutide in Canada, Building on FDA-Approved Ketamine Success

Rhea-AI Summary

PharmaTher (OTCQB: PHRRF) announced a strategic initiative to seek Health Canada approval for generic semaglutide and, if approved, commercialize in Canada. Regulatory exclusivity expired in January 2026, opening a pathway for generics. The plan targets Health Canada approval in 2026 with broad dose coverage (0.25 mg–2.4 mg) and a sterile injectable manufacturing strategy audited by regulators. The company cites prior U.S. FDA approval and monetization of ketamine rights with potential proceeds exceeding US$25 million, and notes Ozempic generated an estimated C$2.9 billion in Canadian sales in 2025.

Positive

• Regulatory exclusivity for semaglutide expired in Jan 2026
• Targeting Health Canada approval in 2026
• Planned broad dose coverage from 0.25 mg to 2.4 mg
• Sterile injectable supply from a regulator-audited manufacturer
• Prior FDA approval and ketamine monetization experience

Negative

• Commercialization is subject to Health Canada approval
• Early Canadian entry invites regulated generic competition
• Estimated proceeds from ketamine monetization are potential, not guaranteed

Toronto, Ontario--(Newsfile Corp. - February 2, 2026) - PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) (the "Company" or "PharmaTher"), a specialty pharmaceutical company, today announced a new strategic initiative to pursue Health Canada approval for generic semaglutide in Canada and, subject to regulatory approval, its commercialization. Semaglutide is the active ingredient in Ozempic® and Wegovy®. The initiative builds on PharmaTher's demonstrated regulatory and partnering execution, including its U.S. FDA approval of ketamine and the monetization of U.S. rights with potential proceeds exceeding US$25 million.

Canada Opens as an Early Major Market for Generic Semaglutide

In January 2026, regulatory exclusivity for semaglutide in Canada expired, creating a pathway for regulated generic competition and drawing global attention to Canada as an early major market for generic semaglutide.

Ozempic® was estimated to have generated approximately C$2.9 billion in Canadian sales in 2025 (Source: IQVIA Canada). Industry estimates suggest the broader GLP-1 receptor agonist opportunity in Canada could grow to approximately US$6.5 billion by 2033 (Source: Grand View Research), reflecting increasing demand and broader adoption.

PharmaTher's Plan: Speed-to-Market, Reliable Supply, Broad Dose Coverage

PharmaTher's initiative is designed to position the Company among the early suppliers of generic semaglutide in Canada following regulatory approval, supported by:

• Clear near-term milestone: pursuing Health Canada approval in 2026
• Broad dose coverage across the treatment journey (0.25 mg to 2.4 mg)
• Sterile injectable manufacturing strategy: leveraging a cost-effective, high-quality commercial sterile injectable manufacturer with facilities audited by regulatory health authorities
• Platform-building focus: scaling injectable capabilities to support long-term semaglutide supply reliability and enable future global partnering opportunities

"Canada's semaglutide market is entering a pivotal transition: demand is growing, and affordable access and reliable supply will matter," said Fabio Chianelli, Founder, Chairman and CEO of PharmaTher. "We've already proven we can execute on FDA approval of injectable drugs and structure a meaningful pharma partnership in ketamine. We are now applying that same execution playbook to pursue Health Canada approval for generic semaglutide and build a scalable sterile injectable platform for the obesity and diabetes market."

Ozempic® and Wegovy® are registered trademarks of Novo Nordisk A/S. Use of these trademarks is for identification purposes only and does not imply affiliation, sponsorship, or endorsement.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) is a specialty pharmaceutical company focused on developing, acquiring, and commercializing pharmaceutical products and enabling technologies. For more information, visit PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary and Forward-Looking Statements

This news release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking information"). Forward-looking information may include statements regarding, among other things: the timing and outcome of regulatory submissions and reviews (including potential Health Canada approval and the timing of any commercial launch); the Company's ability to secure, maintain and scale manufacturing, supply, logistics and distribution arrangements; anticipated market size, pricing dynamics and demand and broader adoption for semaglutide products in Canada; and the Company's ability to enter into or realize the benefits of strategic partnerships, collaborations or other transactions. Forward-looking information is based on management's current expectations and assumptions and is subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those expressed or implied by such forward-looking information, including risks related to regulatory processes and timelines, manufacturing and supply constraints, competition, market acceptance, pricing and reimbursement, and general economic and market conditions. Readers are cautioned not to place undue reliance on forward-looking information. Except as required by law, PharmaTher undertakes no obligation to update any forward-looking information, whether as a result of new information, future events or otherwise. Other risk factors are described under the heading "Risk Factors" in the Company's management's discussion and analysis for the three and six months ended November 30, 2025, dated January 29, 2026, available under the Company's profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and the Company does not undertake any obligation to update or revise such information, whether as a result of new information, future events, or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein.

This news release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/282371

FAQ

What is PharmaTher announcing about semaglutide and Health Canada (PHRRF) on February 2, 2026?

PharmaTher is pursuing Health Canada approval for generic semaglutide in 2026. According to the company, exclusivity expired in January 2026, creating a pathway for regulated generic competition and early market entry in Canada.

How quickly does PharmaTher (PHRRF) plan to bring generic semaglutide to Canadian patients?

The company is aiming for Health Canada approval in 2026. According to the company, the initiative emphasizes speed-to-market, broad dose coverage, and a sterile injectable supply strategy to support rapid commercialization.

What doses of semaglutide does PharmaTher (PHRRF) plan to supply in Canada?

PharmaTher plans broad dose coverage from 0.25 mg to 2.4 mg. According to the company, this range addresses the full treatment journey for obesity and diabetes patients pending regulatory approval.

How large is the semaglutide opportunity in Canada cited by PharmaTher (PHRRF)?

Ozempic was estimated at C$2.9 billion in Canadian sales in 2025. According to the company, industry estimates project the broader GLP-1 opportunity could grow to about US$6.5 billion in Canada by 2033.

What manufacturing approach will PharmaTher (PHRRF) use for generic semaglutide?

PharmaTher intends to use a cost-effective, regulator-audited sterile injectable manufacturer. According to the company, this supports supply reliability and a platform for scaling injectable production and future partnerships.