Kite Pharma founder, chairman, president, and CEO Prof. Arie Belldegrun has kept mum since the sale of his company was announced. Belldegrun, who is responsible for the biggest ever exit of a biotech company whose product has not yet been approved, is usually happy to share his ideas and insights. This time, however, it appears that even he regards what has happened as exceptional.
Kite Pharma, founded in 2009, just an instant ago in terms of drug development, will provide the basis for Gilead Sciences' oncology division. Gilead Sciences searched the entire globe for a company that could provide it with the advantage needed in order to begin activity in the sector, and found what it wanted in Kite Pharma.
"The big companies sat on the fence"
In his first media interview since his company was sold, Belldegrun tells "Globes" about founding Kite Pharma and the deal, and shares his forecasts for the future of cancer treatment and his personal future. He is the same man as he was before the event, raised to the hundredth power: more ambitious and more enthusiastic, with a broader vision and bigger than ever dreams about the future.
"Globes": Kite Pharma is now one of the leading companies in treatment with living cells. How was it founded, and what were the challenges?
Belldegrun: "The seed for founding Kite Pharma was planted just over a decade ago. The US National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), conducted a pioneering study in T cell engineering for fighting cancer. The academic world had already realized the potential, but the NCI lacked the resources to examine and test the cells in clinical trials, and also lacked the knowledge for carrying out the scale-up of a patient treatment system - something that is very complicated, compared with a non-cell treatment drug. The NCI therefore offered the technology to anyone who could pick up the ball and run with it. The major companies, however, preferred to sit on the fence. I am a former colleague of NCI researcher Steven Rosenberg, and I saw the potential where everyone else saw mainly risk. The NCI invested less than $1 million in the technology over two decades. We immediately realized that a lot more had to be invested."
As of now, Kite Pharma has spent over $500 million on bringing the product to market. The ability to move forward was based on Belldegrun's personal wealth and on the name he had already made for himself among medical industry investors after selling two companies, Cougar Biotechnology and Agensys, for a combined total of $1.5 billion. Kite Pharma held its IPO in 2014.
It was a bright period for IPOs by young biotech companies, and Kite Pharma raised $127.5 million at a company valuation of $612 million, even though its product had been tested on only a few dozen patients at the time. Testing on this scale is considered mere anecdotal evidence in other drug development spheres, but the US Food and Drug Administration (FDA) was impressed by the potential, and decided to introduce special registration tracks for Kite Pharma and other ground breaking cancer treatment companies. The trials required for these tracks are shorter, and involve fewer patients.
In 2014, Kite Pharma said that its product was likely to reach the market in late 2017. This was regarded at the time as dangerously optimistic, but thanks to Belldegrun's reputation as a man capable of achieving ambitious goals, the market chose to believe him, and it now appears that the plan is very likely to materialize. Kite Pharma is waiting for the FDA's answer on the product in late November. In less than a year, investors have already received a return far beyond what they expected.
"The company value rose 2,300% between the IPO and the sale," Belldegrun says with pride. "The share price rose 960%." Unlike other managers, who hesitate even to talk about their success and put it in numbers, Belldegrun appears to enjoy it. "Within 27 months of the beginning of a Phase I trial, we submitted the product for FDA approval. Kite Pharma's product will soon be the first and only Chimeric Antigen Receptor (CAR) T-Cell therapy product for treating adults with non-Hodgkin's lymphoma (the competitor, Novartis, initially aimed at the pediatric market, G.W.). The drug will give hope to the 7,000 people who die of this disease annually in the US alone. We hope that Europe will join in the first half of 2018," he says.
"The solution is just around the corner"
How did Kite Pharma become the market leader against its competitors, some of whom dropped out of the race completely, while the others were left behind?
"We didn't regard the process as a competition, although the market frequently portrayed it as one. We didn't focus on others; we put our heads down and concentrated on our work. We didn't let what the competitors were doing distract us."
Thus it was that even when Juno Therapeutics, a close competitor, suddenly announced the deaths of two patients in its clinical trial of a technology similar to that of Kite Pharma, Belldegrun's stance was that the events were not related to Kite Pharma in any way, a message accepted by both the market and the FDA. The storm passed with no damage to Kite Pharma.
"Our base was strong," Belldegrun says. "It included years of research and processes developed by the NCI. This created a company that now has a leading pipeline and the best production processes in the business. In the clinical trials, we are succeeding in bringing the cells to the patient in the shortest time."
How convinced are you that the cells will work well even on solid tumors?
"That's a fair question, because solid tumors are responsible for 95% of cancer fatalities, while blood cancer is responsible for 5%. This problem is therefore in urgent need of a solution. Our approach could be suitable for solid tumors as well, and trials have already been conducted proving its feasibility, but we haven't yet achieved success rates as high as with blood cancer. In our opinion, it's only a matter of time, because the technology is developing, including here at Kite Pharma, at a very rapid pace.
"T-cells reach every organ in the body, and can penetrate both small and large tumors. Unfortunately, as of now, they are paralyzed by materials that the cancer emits. The big challenge is to overcome this immunosuppression within the tumor, but we're working on it. Rosenberg recently showed that T-cells that have been engineered to identify specific markers on the tumor can completely destroy large tumors and large secondary tumors of the deadliest cancers, such as cancer of the breast, bowel, and cervix. We're cooperating in testing this technology on other cancers, such as pancreatic cancer. There's a lot to do in solid tumors, but I believe that the solution is just around the corner."
Are you afraid that what happened to Juno Therapeutics could happen to you?
"Developing a cancer drug means taking risks. Kite Pharma advanced very cautiously, and to this day, the quality of our risk-benefit profile has been demonstrated. Later this year, we'll get the figures for over 100 patients after a year of treatment, and I believe that the technology's real potential will be demonstrated, because without the treatment, their average life expectancy is six months or less. Today, 40% of them have no sign of cancer after just one treatment with our product."
What is the future of cell therapy?
"The future is very rosy. Many companies are active in the field, and others are being founded, and we're confident that progress will be dramatic. The beauty of this technology is the combination with new technologies, such as the combination of our product with immune checkpoint products, and we're considering other combinations.
"We're also developing the new generation of cell therapy using synthetic biology (creating cells, the genome sequence of which is artificially created), and planning to launch a 'remote control' for T-cells next year that can increase or decrease their activity after the cells are already within the body, in order to increase their effectiveness and reduce side effects. In this way, we can give the treatment to more patients, and it can be administered outside hospitals. These are only the first of many possibilities in cell therapy. Other possibilities will be revealed in the coming years. This treatment is not going away."
Cooperation with General Electric
What is your wildest dream for Kite Pharma?
"At Kite Pharma, we always knew that we were pioneers in the new era of cell therapy. I believe that a decade from now, chemotherapy and other technologies that destroy the immune system in order to treat cancer will be regarded as outmoded. Future generations will read in history books how cancer was treated in the past, and how it was regarded as a death sentence that destroyed families, but they won't have firsthand knowledge of it.
"Two years ago, when we met at a medical industry conference in Israel, I and my head of business development Helen Kim met with Michael Idelchik, who is VP of advanced technology programs at General Electric, and I formed with him a historic partnership for joint development of automated technology for creating cells in a closed system. We are testing this technology now, and hope to commercialize it next year, thereby revolutionizing the field: one box can also produce our cells in small and medium-sized clinics throughout the world"
"The successes will enable us to fund the future of science"
When Gilead Sciences was courting you, did you really not want to sell Kite Pharma?
"Gilead Sciences examined every cell therapy technology for a year or longer, and concluded that we were in the right place to lead the industry. After a long process of discussions, I was convinced that Gilead Sciences' senior management, including CEO Dr. John Milligan and chairman John Martin, were committed to developing our technology, to cancer, and to other spheres. We spent many hours together, and I felt that they were the right match for Kite Pharma."
Would you have been able to compete with Novartis had you remained an independent company?
"The market often regarded Kite Pharma and Novartis as David and Goliath, but just as we succeeded in revolutionizing cell therapy, we also believed totally in in our ability to create the CAR-T market. Even before the sale, we had the best commercial team in the industry, led by Shawn Tomasello, and the best commercial production team, led by Tim Moore. We believe that we could have brought products to the US and European market by ourselves, and to the Japanese and Chinese markets with our partners. Gilead Sciences' support will only add to what was already a leading outfit.
"I'm proud of how we made our way in the Chinese market. We looked for a partner in China for over three years, but the FosunKite ventre is now well established, and I expect our production facility there to open in December. Fosun's senior international executives and those of Fosun Pharma are behind us."
What's the difference between being millionaire who has tens of millions of dollars and being a millionaire with half a billion dollars? Have you thought about what to do with the money?
"I have had the good fortune of working with some of the greatest scientific minds in the world, and the privilege of supporting the people with the scientific vision that may change the world for patients. That was one of my best rewards. Beyond the fact that they are changing the treatment of cancer, they have also become an important engine for business and an inspiration for more scientific discoveries. Even if life does not change for me and for Rebecka, my wife, who is a partner in all the ventures, and for our four children, we are glad to be changing the lives of others. The successes will enable us to fund the future of science."
What does your future dream company look like?
"Kite Pharma was a great journey, and the most significant achievement of my career so far. It will be very difficult to exceed it, but I'm ready for the challenge. I have no intention of stopping here. Stay with us."
Dr. Arie Belldegrun
Family status: Married to Rebecka (sister of billionaire Poju Zabludowicz), and father of four children
Residence: Since 1982, resident in the US
Education: Medical studies at the Hebrew University of Jerusalem, post-graduate studies at the Weizmann Institute of Science, residency at Beilinson Hospital (now Rabin Medical Center), Petah Tikva, and at Harvard Medical School, Boston. Specialized in surgical oncology at the National Cancer Institute, Rockville
Business career: Founded Agensys, which developed monoclonal antibodies to treat cancer, in 1996. Agensys was sold to Japanese company Astellas Pharma in 2007 for $537 million. Founded Cougar Biotechnology, which focuses on oncology, in 2003. The company was sold to Johnson & Johnson in 2009 for nearly $1 billion.
Academic position: Director of the UCLA Institute of Urologic Oncology, Professor of Urology, and Chief of the Division of Urologic Oncology at the David Geffen School of Medicine
Published by Globes [online], Israel Business News - www.globes-online.com - on October 2, 2017
© Copyright of Globes Publisher Itonut (1983) Ltd. 2017