God-FDA, the American Food and Drug Administration, announced the granting of marketing authorization for a drug for the treatment of cancer by a company Hamida basket the Israeli one. Following the announcement, the company’s stock rose by 44% in Nasdaq trading, and the company trades at a value of $94 million. This is the second Israeli drug based on a new mechanism, which receives marketing approval in the US this year, after years of lack of approvals for new drugs. In January, Medivand received marketing approval for its medicine for the treatment of burns.

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Gamida Sel, whose factories are in Jerusalem and is managed by the American Abigail Jenkins, plans to market the product independently, in several dozen clinics that perform most of the treatments in the US in the company’s field, which is improving the chances of success of transplanting a new immune system from umbilical cord blood.

Gamida has developed a product designed to improve the success of umbilical cord blood transplantation in the treatment of blood cancer. In a clinical trial, the company showed that its product shortens the time needed to absorb the transplanted immune system from 22 days to 12. This is a significant reduction, since this time is expensive for the transplant center and dangerous for the patient who is without an active immune system. The company’s trial also showed a decrease in the number of infections experienced by the patients and a shortening of the hospitalization period.

The company estimates that the product will capture additional market shares for those who are candidates for umbilical cord blood transplantation anyway: transplants from a matched adult donor, from a non-matched donor, and also audiences who currently do not receive any treatment because no donor can be found for them (mainly the African-American community).

A market survey conducted by the company showed that the doctors believe that the product can shorten the treatment time compared to a donation from a matched source and save on side effects compared to a donation from a non-matched source. Comparing the company’s trial results to real-world data, it appears that compared to a matched donor, Gamida Sel’s implant was absorbed faster.

Gamida Sel recently announced significant cuts and the delay in the development of additional promising products in its pipeline, so that it can reach the marketing stage with a sufficient amount of cash.

A small market: the advantage and disadvantage of Hamida Sel

The company’s advantage and disadvantage is the small market. She believes that the product can be relevant to about 10,000 patients a year, in 70 medical centers, which can be covered with the help of about 25 sales people. 19 of these centers have already experienced the product as part of clinical trials, or as part of a program for pre-approval treatment in humanitarian cases – a program that is considered a positive sign of approval.

To reach a reasonable market potential, the company will have to price its product expensively. Will the insurance companies accept high pricing? Her card against them is the savings in hospitalization time and complications. In any case, receiving the indemnity may take a long time, and the company will have to prepare itself to finance some of the procedures at the beginning to help the product gain momentum.

Gamida Sel intends to manufacture its product in a factory in Jerusalem. This is a relatively complex production, and the company will have to make sure that it is economical for them.