Generic Israeli cancer-killing drug approved for marketing by the FDA

The United States FDA approved a complex and innovative generic drug indicated for the treatment of ovarian cancer, multiple myeloma and Kaposi’s sarcoma, according to The Jerusalem Post.

Ayana’s Doxorubicin-HCI Liposomal Injection will now be available in the US market. The drug is a modified chemotherapy treatment that targets cancer cells directly, reducing side effects.

The drug and the company that makes it are located in Jerusalem. It was developed by Professor Yechezkel Barenholz, a world expert in biochemistry, nanotechnology and drug development and winner of the 2020 EMET award for exact sciences.

Barenholz is also the inventor of Doxil, the world’s first nanotechnology drug approved by the FDA in 1995. Doxorubicin-HCI is the generic version of Doxil, which was first produced by Johnson & Johnson.
He has written more than 420 scientific publications and holds more than 55 patents.

Treatment takes advantage of the drug dodoxorubicin, a cytotoxin or chemotherapy drug, encapsulated in a closed lipid sphere called a liposome.

A liposome can be thought of as a small “ball” the size of a virus, Barenholz explained. The ball is made of a shell made of special “fat” molecules with a watery solution inside.
These balls are known as nano-liposomes.

“We load the toxic agent into these balls and inject them into the patient’s bloodstream once a month,” he said.

“These balls of nano-liposomes travel through the bloodstream to the cancerous tissue and there, through tiny pores in the blood vessels, they exit the bloodstream and accumulate in the cancerous tissue.

“Unlike healthy cells, cancer cells produce ammonia, and this ammonia releases the active toxic agent [doxorubicin] from nano-liposome balls in the vicinity of cancer cells, leading to the death of cancer cells. ”Barenholz explained.

Specific technology helps solve one of the biggest challenges in chemotherapy: side effects. Treatment reduces hair loss, gastrointestinal problems, and other results of chemotherapy, which attacks all cells equally, both healthy and cancerous.

“When a patient doesn’t have as many side effects, the compliance rate is much better and the patient is much easier to treat,” said Gal Cohen, Ayana’s CEO.

Barenholz founded Ayana in 2012 at the request of various oncologists and cancer patients when J&J was struggling to make Doxil. A generic drug is also much less expensive, making it more accessible to those who need it.

It was necessary from the end of 2012 until now to obtain FDA approval after developing the capacity to produce Doxorubicin-HCI in Israel in accordance with Good Manufacturing Practices and meeting all other FDA requirements for the marketing authorization of USA

Cohen, who joined Ayana in late 2020, led the team in obtaining FDA approval and preparation for commercial launch.

During the past decade, as the company worked on the treatment, other novel treatments for cancer have also been developed.

This includes, for example, monoclonal antibodies. But Cohen said that many of these new treatments inhibit costs and don’t work for everyone. Chemotherapy remains the most effective treatment for cancer.

The drug will be available through a strategic partnership with Padagis, which Altaris recently acquired for $ 1.55 billion from Perrigo, a company it has been operating since 1887.

Padagis offers hundreds of topical and specialty pharmaceuticals to its major markets in the US and Israel, has annual sales of about $ 1 billion, and employs more than 1,300 people worldwide.

The companies are ready for the commercial launch of the drug. Although Ayana is a small company of only 12 employees, Cohen said he has a portfolio of other products that he is working on, also focused on the use of nanotechnology.

“We believe this is state-of-the-art technology and that many people could benefit from treatment through this delivery system,” Cohen said.

He did not indicate which diseases could be the next target, but said that not all of the company’s drugs will be used for cancer.