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Medicus Pharma Ltd. Announces Amendment to LifeArc License Improving Teverelix® Long-Term Economic and Development Profile
Globenewswire· 2026-01-22 12:30
Core Insights - The amendment to the license agreement reduces the royalty rate on Teverelix® from approximately 4% to 2%, while maintaining global rights and intellectual property control [1][2] - Teverelix® is being developed as a first-in-class product for Acute Urinary Retention relapse prevention and as a best-in-class treatment for prostate cancer patients with high cardiovascular risk, representing a potential market opportunity of around US$6 billion [1][3] License Agreement Details - The amended agreement clarifies the royalty term on a country-by-country basis and does not change the scope of the license or the underlying intellectual property [2] - Medicus retains exclusive worldwide rights to develop, manufacture, and commercialize Teverelix, including the ability to grant sublicenses, which supports flexible global partnering strategies [3][4] Economic Impact - The reduced royalty burden is expected to enhance Teverelix's attractiveness for future partnerships, particularly for late-stage development and commercialization [3] - The amendment reflects scientific progress and intellectual property expansion achieved by the Antev team, aligning the parties under a simplified economic framework [5] Development Strategy - Medicus aims to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships for late-stage development and commercialization [10] - The company is focused on assembling decision-grade clinical and regulatory data packages to support its partnering-focused model [10] Clinical Development of Teverelix - Teverelix is a long-acting injectable GnRH antagonist that suppresses sex hormone production without an initial surge, potentially reducing cardiovascular risks for patients with existing conditions [7][18] - Previous studies have shown Teverelix to be well tolerated, with significant testosterone suppression achieved in clinical trials [19][20] SkinJect™ Program - Medicus is advancing its SkinJect™ program, a proprietary dissolvable microneedle array platform for treating basal cell carcinoma, with Phase 2 data expected in early 2026 [11][24] - The company has received regulatory approvals in the UK to expand its ongoing Phase 2 clinical study for SkinJect™ [23]
Medicus Pharma Ltd. to Present at Biotech Showcase 2026 as SkinJect Phase 2 Clinical Data Approaches Readout and Partnering Readiness Accelerates
Globenewswire· 2026-01-05 12:30
Core Insights - Medicus Pharma Ltd. is set to present at the Biotech Showcase 2026, highlighting its focus on advancing clinical development programs for innovative therapeutics [1][2] Company Strategy - The company's strategy involves advancing select programs through Phase 2 proof-of-concept and pursuing licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization [5] - Medicus aims to assemble decision-grade clinical, regulatory, and operational data packages aligned with its out-licensing strategy as data matures across its programs [5] Clinical Development Updates - The SkinJect™ Phase 2 program, designed to non-invasively treat basal cell carcinoma (BCC), has achieved execution milestones, including the completion of enrollment of 90 patients in a randomized, double-blind, placebo-controlled study [6][7] - Topline decision-grade Phase 2 results are expected to be reported in the first quarter of 2026, with plans for an End-of-Phase 2 meeting with the FDA in the first half of 2026 [8][31] - Interim findings from the study indicated greater than 60% clinical clearance in an exploratory analysis [9] Regulatory and Geographic Expansion - Medicus has expanded the clinical and regulatory footprint of SkinJect™ to support development and partnering readiness, including approvals in the UK and the UAE for ongoing studies [10][30] - The FDA provided positive feedback regarding the potential use of the 505(b)(2) regulatory pathway for SkinJect™ [11] Collaboration and Partnerships - Medicus has entered a non-binding letter of intent with Reliant AI Inc. to develop an AI-driven clinical data analytics platform aimed at supporting capital-efficient clinical development [15][32] - The company is exploring co-development opportunities with Helix Nanotechnologies for thermostable infectious disease vaccines [17][23] Pipeline Expansion - The acquisition of Antev Limited has added Teverelix, a next-generation GnRH antagonist targeting advanced prostate cancer patients, to Medicus's pipeline [18][24] - Teverelix has shown promising results in previous clinical trials, including a Phase 2a study demonstrating a 97.5% probability of achieving castration levels of testosterone suppression [26] Patient Access Initiatives - Medicus is collaborating with the Gorlin Syndrome Alliance to pursue an Expanded Access IND program for SkinJect™, aiming to provide access to patients with multiple or inoperable BCCs [19][29]