George Medicines signs exclusive licensing agreement with Bausch Health to commercialize GMRx2 in Canada, Mexico, Columbia and Central America
- Bausch Health gains exclusive rights to single-pill triple combination therapy for hypertension
- George Medicines receives upfront milestone payment and is eligible for regulatory and commercial milestones, and a stepped royalty rate in licensed territories
- GMRx2 has potential to be the only triple combination approved for the treatment of hypertension including initial treatment
GMRx2, George Medicines' lead pipeline candidate for the treatment of hypertension including initial treatment, is a proprietary single-pill combination of three best-in-class medicines: telmisartan, amlodipine and indapamide. Developed in ultra-low dose, low-dose, and standard-dose options, it has the potential to be the only triple combination approved for the initial treatment of hypertension. The innovative formulation is designed for optimal efficacy, safety and adherence. With a multi-mechanism approach and at lower dosing than today's therapies, GMRx2 is designed to deliver the synergistic efficacy benefits of a triple therapy while maintaining tolerability.
Under the terms of the licensing agreement, George Medicines receives an upfront milestone payment and is eligible for regulatory and commercial milestone payments, as well as a future recurring revenue stream through a stepped royalty rate on sales of GMRx2 in the licensed territories. In return, Bausch Health is granted a license to exclusively commercialize GMRx2, supplied by George Medicines, in Canada, Mexico, Columbia and Central America. Bausch Health is responsible for seeking regulatory approval of GMRx2, with support from George Medicines.
Mark Mallon, Chief Executive Officer of George Medicines, said: "This announcement marks a significant milestone for George Medicines, and in Bausch Health we have secured a strong commercial partner who shares our belief in the potential of GMRx2 to enable more patients to achieve better blood pressure control and improve on current hypertension treatment approaches.”
Cees Heiman, Senior Vice President, Europe and Canada, Bausch Health, said: "In Canada, seven and a half million people, about 1 in 4 adults, live with hypertension1, and too many do not have their condition under control. The clinically-proven efficacy of GMRx2 compared to dual combinations, coupled with its good tolerability, have the potential to address key challenges in current hypertension treatment approaches. This partnership with George Medicines underscores our commitment to deliver better health outcomes for patients.”
Fernando Zarate, Vice President, Latin America, Bausch Health, said: "GMRx2 is a critical innovation that we believe can meaningfully advance cardiovascular care in Mexico, Colombia and Central America. While prevalence of hypertension remains high in the region, its treatment and control is low2. In GMRx2 we have an opportunity to change that.”
Globally, many diagnosed hypertension patients are not currently achieving sufficient blood pressure (BP) control because they are on inadequate therapy, are not receiving the right combination of medicines at the right doses or are not taking their treatment as prescribed. With the latest professional guidelines from the European Society of Cardiology3 recommending lower target BP levels and early use of combination therapy, an effective, low-dose, single-pill triple combination with good tolerability provides an opportunity to significantly advance the management of hypertension.
GMRx2 is backed by a comprehensive clinical development program, including two pivotal Phase III studies, published in 2024 in the Journal of the American College of Cardiology4 and The Lancet5, demonstrating GMRx2 significantly reduced BP and improved BP control rates, when compared against dual therapy and against placebo. The triple combination was also investigated in the Nigerian VERONICA trial6, which compared GMRx2 with existing, standard of care and reported better BP lowering and control among those receiving GMRx2. In all trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events. A global trial investigating the potential of GMRx2 for the prevention of stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) is ongoing7.
GMRx2 has not received regulatory approval for commercial use in any country. A New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking US approval of GMRx2 for the treatment for hypertension, including initiation of treatment, is ongoing with a Prescription Drug User Fee Act (PDUFA) goal date of 5 June 2025. Regulatory submissions in other territories are anticipated in 2025.
George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world's leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia's leading life sciences venture capital firm.
Ends
References:
- Hypertension Canada Annual Report https://hypertension.ca/wp-content/uploads/2024/10/HC-2024-Annual-Report-Final.pdf)
- Prevalence, Awareness, Treatment, and Control of Hypertension in the Southern Cone of Latin America; Am J Hypertens; doi: 10.1093/ajh/hpw092 https://academic.oup.com/ajh/article/29/12/1343/2708296
- 2024 ESC Guidelines for the management of elevated blood pressure and hypertension; European Heart Journal, Volume 45, Issue 38, 7 October 2024, Pages 3912-4018, https://doi.org/10.1093/eurheartj/ehae178
- Rodgers A, Salam A, Schutte AE, . . .Whelton P. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. Journal of the American College of Cardiology. 2024;0(0). doi:10.1016/j.jacc.2024.08.025
- Efficacy and safety of a novel low-dose triple single-pill combination, compared with dual combinations for treatment of hypertension; The Lancet; doi: 10.1016/S0140-6736(24)01744-6
- Ojji DB, Salam A, Sani MU, . . .Rodgers A. Low-dose triple-pill vs standard-care protocols for hypertension treatment in Nigeria: a randomized clinical trial. doi:10.1001/jama.2024.18080. JAMA. 2024.10.1001/jama.2024.18080
- TRIDENT: Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial https://www.tridentstudy.org/
George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative combinations of best-in-class existing treatments, designed for optimal efficacy and safety.
Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments to be more efficacious, safer and accessible than currently available treatment options. These multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic disorders, including hypertension and diabetes, each of which remain the leading causes of premature death and disability worldwide.
For more information, please visit www.george-medicines.com.
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