Energenesis Biomedical announced on the 17th that it has signed a Memorandum of Understanding (MOU) with Swiss pharmaceutical company Medvisis Switzerland AG. Under the agreement, the two companies will collaborate on multiple projects and jointly expand their presence in the European market.

According to the MOU, Energenesis will grant Medvisis the commercialization rights in Switzerland and Europe for three of its innovative products: F703DFU, a new gel drug for diabetic foot ulcers; F703VLU, a new gel drug for venous leg ulcers; and F701, a topical spray developed to prevent abnormal hair loss. Medvisis will be responsible for conducting Phase III clinical trials, applying for marketing authorizations, and overseeing post-launch marketing and promotion in the licensed territories.

Medvisis is a Swiss healthcare company specializing in the introduction of innovative pharmaceuticals, product registration, health insurance pricing negotiations, and commercialization strategies. Its core management team includes seasoned professionals from international pharmaceutical companies such as Novartis and GlaxoSmithKline (GSK). With their extensive expertise and experience, Medvisis has become a preferred partner for many innovative pharmaceutical and biotech companies.

Energenesis noted that Medvisis’ clinical trial design and drug pricing recommendations are often referenced by regulatory authorities across Europe. This makes the collaboration particularly significant for the expansion of Energenesis’ F703DFU in the European market. The company has decided to initiate this partnership ahead of its planned European clinical trials for F703DFU. Through Medvisis, Energenesis aims to establish an early foothold in Switzerland and use it as a starting point for broader market expansion across Europe. The partnership is expected to extend to include F703VLU and F701 in the future, further strengthening the collaboration between the two companies.

Currently, F703DFU is undergoing Phase III clinical trials in both the United States and Taiwan for the treatment of diabetic foot ulcers. Enrollment is progressing smoothly, with trial completion and data unblinding anticipated by the end of this year. If the results meet expectations, Energenesis plans to first apply for marketing authorization in Taiwan and work with its business partners to promote the product both domestically and internationally, seizing the market opportunity for unmet needs in diabetic foot ulcer treatment.

Additionally, Energenesis is planning to initiate Phase III clinical trials for F703DFU in Europe in the fourth quarter of this year. The resulting clinical data will support subsequent regulatory submissions in both the U.S. and Europe, completing the global marketing authorization strategy for F703DFU.

Resource: 華安與瑞士Medvisis藥廠展開合作共同拓展歐洲市場