Clal Biotechnology jumps on the stock market following the report of receiving FDA approval for the marketing of Medivand’s drug Nexobrid in the USA.
The FDA approved the marketing of NexoBrid for the removal of damaged (fresh) tissue in adults suffering from moderate-severe thermal burns. Clal Biotechnology owns about 22% of Medivand’s shares.
Medivend has an exclusive North American commercialization agreement with Vericel Corporation (NASDAQ: VCEL). Under the commercialization agreement, Medivand will receive from Vericel a milestone payment of $7.5 million upon receipt of FDA approval to market NexoBrid. Medivend estimates that Vericel will launch NexoBrid in the US in the second quarter of 2023.
The NexoBrid has already been approved for marketing in 43 countries, including the European Union, Japan, and India. Medivend stated that the FDA’s approval gives validity to the enzymatic technology platform that she developed, and that she will continue to promote the development programs and innovative solutions for the treatment of burns, wounds and tissue repair.
The CEO of Clal Biotechnology, Assaf Segal, said: “The approval of NexoBrid in the USA is an impressive achievement for Medivand, for Clal Biotechnology, and for Israeli Biomed. The approval of NexoBrid adds to patients in the USA an advanced and effective treatment option for severe thermal burns, which is already approved in Europe, Japan and India . For many years we believed in and supported Mediwind, and together we walked a long and complex development path until we received the approval.’
Segal added: “The achievement is even more impressive in light of the fact that this is the first FDA approval for an innovative drug given to an Israeli company in over a decade.” In addition to Medivand’s product, two other innovative drugs in the portfolio of Clal Biotechnology are in the process of being examined by the FDA and may receive approval during 2023. Receiving three approvals from the FDA within a year, if they are received, will be a turning point for Clal Biotechnology and the Israeli biomed, and we are happy to reap the fruits after many years of effort and investment in product development.’