Kitov Pharmaceuticals Restructures U.S. Marketing Deal with Coeptis, Secures Multi-Million Distribution Network for Consensi™ Launch

Kitov Pharmaceuticals has finalized an amended commercial agreement with Coeptis Pharmaceuticals for the U.S. market introduction of Consensi™, establishing a comprehensive distribution infrastructure and clarifying financial terms that position the drug for broader accessibility across American pharmacies.

Distribution Partnership Strengthens Market Entry Strategy

The partnership now includes a newly engaged distribution partner bringing established logistics capabilities and nationwide pharmacy access—a critical infrastructure layer for Consensi™’s commercial success. This distribution network expansion represents a strategic pivot in how Coeptis intends to reach patients, moving from a smaller-scale launch framework to one with deeper market penetration capabilities. The accompanying marketing plan and pricing strategy have been finalized, indicating that pre-launch preparations are entering their final phases.

On the manufacturing front, initial commercial batches are nearing completion and will soon transition to packaging and distribution stages for U.S. delivery.

Updated Financial Framework: Milestone Payments and Royalty Structure

Under the revised terms, Kitov Pharmaceuticals will receive up to $99.5M in milestone-based and reimbursement payments, structured across multiple tranches. The agreement guarantees minimum revenue of $7M over the next three years, with specific components already allocated: $1M previously received, $1.5M expected before year-end for commercial batch manufacturing, $1M following the first commercial sale, and $96M contingent on predefined commercial milestones.

Beyond these milestone payments, Kitov Pharmaceuticals secures 20% royalties on Consensi™’s net sales, with a minimum royalty floor of $4.5M over the three-year horizon. These financial terms create near-term revenue visibility for Kitov Pharmaceuticals, enabling continued investment in its oncology development pipeline—a stated corporate priority.

Product Profile and Market Differentiation

Consensi™ represents a fixed-dose combination addressing two prevalent chronic conditions simultaneously: osteoarthritis pain and hypertension. The formulation pairs celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), with amlodipine besylate, a calcium channel blocker antihypertensive agent.

The FDA granted marketing approval in May 2018, positioning Consensi™ for U.S. commercial launch by early 2020. Patent protection extends through 2030, granting Coeptis and Kitov Pharmaceuticals over a decade of market exclusivity. Notably, Consensi™ will be the only NSAID with labeling that explicitly indicates blood pressure reduction and associated risk reduction for cardiovascular events including heart attack and stroke—a differentiated claim in its therapeutic category.

The fixed-dose combination operates on a once-daily dosing schedule, with celecoxib strength standardized at 200 mg. Usage is indicated for patients requiring concurrent treatment for both osteoarthritis and hypertension where these individual therapies are clinically appropriate.

Strategic Context for Kitov Pharmaceuticals

Kitov Pharmaceuticals maintains a parallel commercialization presence in China and South Korea through separate partnerships, diversifying geographic revenue exposure. The company’s primary strategic focus remains its oncology pipeline, particularly NT-219—a small molecule targeting IRS1/2 and STAT3 pathways in cancer drug resistance—which is advancing in clinical trials for squamous cell carcinoma of the head and neck.

Additionally, Kitov Pharmaceuticals is acquiring FameWave Ltd. to advance CM-24, a monoclonal antibody against CEACAM1, in combination with anti-PD1 checkpoint inhibitors for non-small cell lung cancer treatment, with clinical collaboration support from Bristol Myers Squibb planned for Phase 1/2 trials.

The Consensi™ collaboration thus serves as a revenue-generating asset enabling sustained oncology research and development while maintaining the company’s market position in the combination therapeutic space.