The Israeli-American company Etox Bio announced in 2020 the submission of a marketing authorization application for its drug for the treatment of a carnivorous bacterium. The answer of theFDA, The U.S. Food and Drug Administration, was scheduled to arrive in September 2021, but time passed without further notice from the company. Today (Wednesday) “Globes” learned that the drug did not receive the approval, and as a result ceased activity.
Dan Telman, who was the CEO of the company: “We submitted the marketing application in November 2020 and in September 2021 we received from theFDA Letter of completion. We filed an appeal, and in February 2022 theFDA Please answer for another experiment, which was supposed to last another few more years. It was inapplicable to us. The experiment was supposed to cost us tens of millions of dollars and take five years to complete. The market for our product is relatively small, it is an orphan drug, so there was no economic justification in terms of funds to invest the amount needed for another trial before marketing. It was decided to close the company.
“In our opinion, the results obtained by the experiment were good enough to register it for marketing, or at least register it in a conditional registration and require another post-approval experiment. But theFDA Think differently. there’s nothing to do. We have already gone through the period of mourning. “
What will happen to the product? And about the company’s technology that can yield more products?
“Other potential investors will encounter the same problem of an experiment that makes the product worthless. Even for a large pharma company that has the money to invest in such an experiment, the market is simply too small. The other products developed by the company based on the same technology are at least two years away from human experiments. “Spirituality exists, I wish someone else would do something with it, but at the moment it does not seem reasonable.”
It is difficult to know for sure, but Telman guesses that the tightening of the requirementsFDA Related to the criticism she received for the approval of the drug Adholm for Alzheimer’s, made by the Biogen company. God-FDA Approved the product according to an experiment that did not examine improvement in disease symptoms, but an alternative measure that critics believe is not properly validated. Despite the approval of theFDAThe state-owned insurance company Medicar refused to finance its customers the product, it was sold in small quantities, and was recently taken off the shelves.
Telman: “Since then we have seen some change in the policy of theFDA. “Products for rare diseases that have no other solution, such as our product, as well as cancer products, no longer necessarily receive such shortened routes as in the previous two or three years.”
There is no product for a carnivorous bacterium
Estox, established in 2003, has developed a drug to prevent systemic collapse in people aged 12 and over who suffer from a predatory bacterial infection. The product acts on the immune system to prevent its overreaction, which can itself be fatal to the patient.
In a trial conducted by the company, it was found that 48.6% of the patients in the trial group improved, compared with 39.9% of the control group. This was the main variable, and these results were not significant, which is probably why another experiment was needed. However, the company demonstrated significance in two other variables, which were defined as secondary variables of the experiment. Usually theFDA Indeed does not accept products based on experiments that have not met their primary goal, but Etox as stated believed that it could obtain approval on that basis, due to the significant need for the product, lack of alternative, and precedents like that of Biogen. “I believe our results were better,” says Talman.
Whether Atox was indeed part of this trend or whether its results were simply not impressive enough for theFDAThe average lengthening of drug approval schedules could hit the biotech market hard, which is already suffering from declining markets.
Atox was established in 2003 and raised about $ 30 million, from investors including Orbimed Israel, the SR1 fund of the medical device company GlaxoSmithKline, the investment fund of the pharmaceutical company Lundbeck and the Integra fund that invests in technology-based companies at the Hebrew University.
Until 2009 the company focused mainly on a joint project with BARDA, the American organization in charge of medical innovation related to protection against military attacks, epidemics or natural disasters, which dealt with protection against a certain toxin that was known to be collected in large quantities by Saddam Hussein. Although Hussein was caught in 2003, it was not yet clear what would happen to the toxin, and BARDA also funded the company with about $ 12 million. In 2009, when Telman joined the company, he turned its activities into the civilian field.
Telman was appointed a partner inIBF
Today, Telman is the active chairman of Tamrix Pharma, and recently announced that he will join the fund as a partner IBF, To a team that includes Ido Tzairi, Dr. Yuval Kabili and Dr. David Sidransky. Telman started his career in the marketing team of Amgen’s Enbrel drug, managed the business development of the Israeli company Pharmos, founded and managed the company Pain Reform And then the Bio Etox. “Even though we did not receive a permit,” he says, “we brought a product until it was submitted for approval, and I can now bring this experience to the Israeli companies.”
IBF stated that: “Dan will work closely with the fund’s portfolio companies that are in their infancy, assist and advise them in various stages of product development, fundraising and optimal management. Our second fund focuses much of its investments in early-stage companies, licensing existing products from academia and industry and establishing “New Israeli companies for the purpose of developing them. We see great importance in this type of activity in Israel, while providing close companionship to companies by experienced people from the industry, such as Dan Telman.”