An Israeli biotechnology firm based in Be’er Tuvia in southern Israel has developed a new-generation fertility treatment through the manipulation of human cells, creating a hormone that can be personalized to boost the chances of patients who seek to get pregnant.
The medication, called Rekovelle, was launched last year by Ferring, a privately held Swiss multinational pharmaceutical company, which in 2005 acquired Bio-Technology General (Israel) Ltd. (BTG). The Israeli firm has been a pioneer in creating medications by genetically modifying bacteria and cells.
“The first baby has already been born with this new medication,” Tal Levy, the general manager of BTG, said in an interview at the company’s offices and manufacturing plant in Be’er Tuvia.
The firm, which both develops its products and manufactures them on site, is already planning to scale up production capabilities of the drug to meet market demand.
The follicle stimulating hormone (FSH), secreted by the gonadotropic cells of the anterior pituitary gland, regulates puberty maturation and the reproductive processes of the body. The hormone, originally extracted by pharma giant Serono from the urine of menopausal nuns in Italy with the blessing of the Pope Pius XII, has been used for years as part of in-vitro fertilization treatments to stimulate follicles in the ovaries of women who fail to get pregnant.
BTG, however, has managed to genetically engineer human cell cultures to get them to emit FSH, which is then collected and transformed into an active pharmaceutical ingredient, explained Levy. “It took us 10 years to develop the drug in its current form.”
Ferring combined its Rekovelle hormone therapy with a diagnostic test that enables physicians to predict how women will respond to the hormone — according to their age, weight and the amount of hormones they already have in their bodies. This allows doctors to calculate each patients’ recommended daily dosage, instead of updating treatment according to their reaction to the drugs, as is done today.
“This helps lower the side effects they can have, like hyper-stimulation of the ovaries. The dosage can be better targeted to patients,” explained Levy.
In May, Ferring said it would invest $15 million to expand the production facilities at BTG over the next three years, focusing on developing additional fertility medications based on human cell cultures.
“It has been a successful acquisition. We provide them with our ideas and we learn from them,” said Levy, the general manager of BTG, of the company’s strong relationship with Ferring. “We are their bridge to the biological world.”
BTG, one of Israel’s pioneering biotech firms, was set up in October 1980 by Professor Haim Aviv and colleagues from the Weizmann Institute of Science to develop and leverage what was then the new science of genetic engineering.
The firm provides end-to-end services, from developing technologies in-house or licensing them from academia, to manufacturing the products at its plants in Be’er Tuvia and shipping them to customers globally.
BTG creates medications using biological methods. “We use micro-organisms like cells or bacteria, and genetically engineer them to generate proteins that are similar to those of humans, which the company then harvests” and uses to create medications, Levy explained.
At the plant in Be’er Tuvia, huge sterile metal tanks, working around the clock, cultivate the bacteria and the cells under ideal conditions, while workers in white lab coats pour over their pipettes and vials. In a separate section of the plant machines package the medications, preparing them for shipment globally.
BTG was one of the first companies in the world to manufacture and sell a genetically engineered growth hormone for children. The hormone was developed by genetically manipulating the E. coli bacteria, whereas previously the growth hormone had to be extracted from corpses and injected into the children.
Another flagship product of the company is hyaluronic acid, which BTG uses for eye treatments, in cataract surgery and to prevent knee erosion. The acid used to be produced from the crests of roosters, but BTG develops the substance by genetically manipulating streptococcal fermentation.
“We were one of the first companies in the world that managed to produce this acid via a biological process,” Levy said. “Our hyaluronic acid is the most similar to that of the human body.”
This acid can also be used to treat chemical burns, for example from radiation. The company believes the acid could also be used in the field of cosmetics and aesthetics.
Growing an ecosystem
In the interview with The Times of Israel, Levy spoke about the difficulties of being a biotechnology firm that both develops and manufactures its products while most startups sell off their developments to multinationals who then develop the products themselves, often outside Israel.
“We hope our activities in Israel, together with Ferring, will help create an ecosystem for other companies like ours to thrive,” he said. “The State of Israel should promote the creation of an biotech industry here, making it possible for startups to grow locally and not just be a hub for research and development activity.”
To create such an industry locally – that both develops and manufactures its products – more professional and technical training is needed, as well as regulatory stability and a clear taxation policy, and increased investment and tax benefits, he said.
If all of that were in place, more multinationals like Ferring would be drawn to manufacture their products in Israel, he said.
Israel is seeking to become a global hub for both digital health and personalized medications,which target diseases based on the patient’s genetic profile.
There are some 1,487 life science companies operating in Israel, which have raised some $13.5 billion in 1997-2017, according to Tel Aviv-based IVC Research Center, which tracks Israel’s tech sector.
The country has set up a National Digital Health plan that aims to create a digital database of some 9 million residents’ medical files and make them available to researchers and enterprises. Israel speculates it could nab some 10% of the $6 trillion digital health sector.
At a recent conference in Tel Aviv, Prime Minister Benjamin Netanyahu said that personalized medicine is “potentially the biggest industry of all,” and Israel is hoping to lead the way in this field, just as it has in cybersecurity.