SKNV Secures Exclusive Rights to Patented 5-FU/Calcipotriene Combination for Actinic Keratosis
Key Takeaways
- SKNV has secured exclusive commercialization rights to a Washington University patent portfolio covering the combination of fluorouracil (5-FU) and calcipotriene, marketed by the company as Kefunova Cream.
- The patented combination has been supported by randomized clinical trial data demonstrating rapid clearance of actinic keratoses (AKs) with a 4-day treatment regimen and long-term data suggesting reduced risk of squamous cell carcinoma (SCC) development.
- The announcement follows the inclusion of short-course fluorouracil/calcipotriene field therapy in recent expert recommendations and aligns with evolving treatment strategies emphasizing field-directed therapy for AK.
SKNV has obtained exclusive commercialization rights under a sublicense to a patent covering the combination of fluorouracil (5-FU) and calcipotriene, according to an announcement.
The patented combination is currently available through SKNV as Kefunova Cream (fluorouracil 5%/calcipotriene 0.005%). According to the company, the agreement provides exclusive rights to produce and distribute the patented combination therapy for dermatology practices nationwide. The topical combination is used as a field-directed therapy for actinic keratosis (AK), as well as selected low-risk superficial skin cancers.
"Since its introduction in 2025, Kefunova rapidly became the most prescribed medication across our portfolio," said Spencer Malkin, MD, founder and CEO of SKNV, in a news release from the manufacturer, adding that the agreement expands patient access to the patented technology.
Lynn A. Cornelius, MD, division chief of dermatology at Washington University in St. Louis and co-inventor of the technology, noted that the combination targets both clinically apparent and subclinical AKs through field therapy. She cited more than a decade of clinical research demonstrating not only lesion clearance but also evidence of an immunopreventive effect associated with reduced SCC development.
Clinical evidence supporting the combination includes randomized, placebo-controlled studies led by Cornelius and Shawn Demehri, MD, PhD, director of the High Risk Skin Cancer Clinic at Massachusetts General Hospital. Investigators reported greater reductions in AK lesion counts compared with fluorouracil monotherapy following a 4-day treatment course. Long-term follow-up extending beyond 1,500 days also demonstrated a reduced incidence of SCC on treated face and scalp sites within three years, findings associated with persistent tissue-resident memory T cells.
“Although field therapy has been studied by many investigators over the years, our team initiated the study of this topical combination treatment and has additionally conducted follow-up studies for over a decade," said Dr. Cornelius in the news release. "We have collected clinical data not only demonstrating the efficacy of treating AKs using the combination therapy over shorter time-course than conventionally used with other topical regimens but have additionally shown a novel immunopreventive effect by reducing the risk of developing squamous cell carcinoma.”
Source
Sincerus Pharmceutical Company press announcement. July 22, 2026.
References
- Rosenberg AR, Tabacchi M, Ngo KH, et al. J Clin Invest. 2017;127(1):106-116.
- Cunningham TJ, Tabacchi M, Eliane JP, et al. J Clin Invest. 2020.