Protalix has signed an exclusive agreement with Sarcomed for the treatment of respiratory diseases – the capital market

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Protalix
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Reports that it has signed an exclusive agreement with the American company Sarcomed for the development of Alidornase Alpha for the treatment of a disease or condition in the respiratory tract in humans: sarcoidosis, pulmonary fibrosis and related diseases, through inhalation.

Alidornase alpha is a chemically adapted, recombinant form of human deoxyribonuclase I (DNase I). Sarcomad is trying to investigate whether the DNase I compound may affect chronic pneumonia observed in patients with pulmonary sarcoidosis.

According to the report, in accordance with the agreement between the companies, Sarcomed will be responsible for identifying and selecting pharmaceutical candidates as well as for the clinical research and development of these candidates. Protalix will be entitled to an initial cash payment of approximately $ 3.5 million, additional payments in accordance with regulatory and commercial milestones as well as royalties in respect of the net sales of products that will be traded under the terms of the license.

In the next two months the companies will negotiate and the American company will be able to cancel the licensing agreement if the parties fail to sign such a supply agreement.

Among the company’s investors are Marius Nacht, one of the founders of Check Point, which this week increased its holdings in the company to 10% in the company, the Hebrig Fund and the Psagot Investment House also own about 10% of the company each, and City-Group which owns 2.7% of the company. Protalix is ​​involved in the development of plant-based protein-based drugs. It is a foreign company, incorporated in the United States, and its shares are traded on both the AMEX and the Tel Aviv Stock Exchange.

Currently, the company is at a loss, although it is a company with a product that has undergone FDA for Gaucher disease and has two products that are expected to receive a response from the FDA in the coming year. In 2017, it recorded revenues of NIS 73 million and lost NIS 290 million, in 2018 the company recorded revenues of NIS 128 million and lost NIS 100 million, and in 2019 the company recorded revenues of NIS 189 million and a net loss of NIS 189 million. NIS 63 million. The company’s reports for the first three quarters of 2020 were lukewarm, the company recorded revenues of NIS 152 million and a net loss of NIS 35 million. In the first quarter alone the company entered as in the next two quarters, probably due to the corona plague.

In July 2020, the US Food and Drug Administration (FDA) approved the status of an orphanedron alpha orphan drug for the treatment of sarcoidosis, which is approved for drugs or biologicals designed to treat or prevent rare diseases or conditions that affect less than 200,000 people in the United States.

Dror Bashan, President and CEO of Protelix: “Most patients with pulmonary sarcoidosis do not show symptoms and are unaware of their disease until it is in advanced stages. The treatment alternatives available today vary significantly from patient to patient and in general, treatments focus on controlling symptoms or improving patient lung function. “We believe that the PRX-110 has the potential to become an exciting therapeutic alternative. We believe that this transaction is a further validation and thickens the line of drug products that can be developed and can be manufactured using ProCellEx.”

Significant improvement in renal function
At the end of 2020, Protalix published the results of a trial of the drug for Fabry disease. The results showed a significant improvement in kidney function. The study is in Phase 3 as an open-label clinical trial, with patients being treated with a PRX 102 drug that is supposed to replace existing treatment.

The results of the experiment belong to the BRIDGE experiment, which is the first of three experiments. Next in line are BALANCE and BRIGHT. 22 patients took the drug for a year and showed improvement in renal function, a major cause of mortality among Fabry patients. Most patients who replaced the drug, from an existing drug to PRX showed improvement. Two patients withdrew from the trial as a result of symptoms they developed following taking the drug. The initial results of the study were reported in May 2020. Within the company’s stock, there is a 0.5% increase in trading on Wall Street.

Fabry disease is a lysosomal storage disease. It is a hereditary and rare genetic disease in which there is a decrease in the level of activity of the enzyme alpha-galactosidase. As a result, the breakdown of a fatty-sugar substance called globutriozylceramide (GL-3) is damaged, which accumulates and accumulates in various cells in the body, including the endothelial cells of the blood vessels (the cells lining the internal space of the blood vessels), cardiomyocytes Of the heart, heart valves, nerve cells, various cells in the kidney and more.