Pharmaceutical companies believe that delivering radiation directly to tumors will be the next big advance in cancer treatment.
Bristol-Myers Squibb, AstraZeneca, Eli Lilly Pharmaceutical companies have spent roughly $10 billion acquiring or partnering with radiopharmaceutical makers, snapping up smaller startups to get their hands on nascent technologies that could potentially treat many cancers.
“Any large company that operates in oncology or for which oncology is a key therapeutic area will probably need to get into the space in some way,” said Michael Schmidt, an analyst at Guggenheim Securities.
Two Novartis radiopharmaceuticals are already on the market, and Schmidt calculates that dozens more are in development. He said the total market potential is hard to estimate because there are so many types of cancer the drugs could potentially treat.
Schmidt estimates that if the technology is limited to treating a few types of cancer, such as prostate and neuroendocrine tumors, sales in the field could grow to at least $5 billion, and could grow to tens of billions of dollars if the technology proves effective against more cancers.
The drug works by attaching a radioactive substance to a targeted molecule that seeks out and binds to specific markers on cancer cells. The key is to find a marker that is present on cancer cells but not on healthy cells. This allows the treatment to deliver radiation to the cancer cells and spare the rest of the body from the level of damage associated with many anti-cancer drugs.
The technology has taken time to prove its scientific and economic viability: the first radiopharmaceuticals were approved in the early 2000s, but it has only recently attracted interest from big pharmaceutical companies.
Workers at the NSA radiopharmaceuticals factory in Rome, Italy.
Franco O’Riglia | Getty Images
Producing the drug requires complex manufacturing and logistics, which are two major drawbacks: Radioactive material breaks down quickly, so patients need to be treated within a few days of the drug being produced.
Drug companies have proven they can manage complex, time-sensitive drugs like CAR-T for blood cancers and gene therapies for rare diseases, and now Novartis has shown those strategies can be applied to radiopharmaceuticals.
The Swiss pharmaceutical giant received approval for Lutathera, a treatment for rare cancers of the pancreas and gastrointestinal tract, in 2018. Novartis then received approval for Prubixt, a treatment for prostate cancer, in 2022. Combined sales of these two drugs are expected to reach about $4 billion by 2027, according to FactSet consensus estimates.
These successes have led to further interest in radiopharmaceuticals.
“We put all this together and said we need to do something, we need to make a deal here,” said Jacob Van Naarden, president of Eli Lilly’s oncology division.
Lilly acquired radiopharmaceutical maker Point BioPharma last year for about $1.4 billion and has also partnered with several companies to develop treatments. One of Lilly’s biggest priorities in its initial search for potential companies was whether the company was ready to manufacture the drug, Mr. Van Naarden said. Radiopharmaceuticals are not easy to make, and Lilly wanted to ensure that its first acquisition could produce the drugs in-house rather than outsource them.
Ben Hickey, president of RaizBio, said manufacturing was also a key factor in Bristol-Myers Squibb’s $4.1 billion acquisition of RaizBio, which was building a factory in Indiana at the time and had secured supplies of radioactive materials needed to develop experimental drugs in its pipeline.
“One of the criteria was obviously to be confident that our destiny was in our own hands,” Hickey said.
Novartis demonstrated why that’s so important, as it initially struggled to manufacture enough doses of Pulvict. The company has invested more than $300 million to open and expand radiopharmaceutical manufacturing facilities in the U.S. so it can make the drug and get it to patients quickly. The company is now able to meet demand for the treatment, which requires careful planning for distribution.
Each dose is equipped with a GPS tracker to ensure it gets to the right patient at the right time, said Victor Bulut, president of Novartis’ U.S. operations. Novartis transports doses from its factories to destinations within nine hours to minimize the risk of dose interruptions due to storms, Bulut said.
The doctors and patients who receive the treatment also feel the complexity.
Bassett Healthcare Network in upstate New York had to renew its medical licenses to work with radioactive materials before it could administer Lutathera and Pulvict, said Dr. Timothy Koritko, Bassett’s chief radiation oncologist. The drugs, which are administered intravenously, must be administered by a certified medical specialist.
It can take several weeks for the radiopharmaceutical to be prescribed and administered, and with Pluvicto, patients visit the hospital once every six weeks for up to six treatments.
Radioactive medicines begin to break down as soon as they are made, so they can only be used for a few days.
Ronald Coy and his wife, Sharon.
Courtesy of Ronald Coy
Ronald Coy knows how important it is to make those appointments on time. A former firefighter who has been battling prostate cancer since 2015, Coy drives more than an hour across upstate New York to see Prvikt at Bassett. So far, there haven’t been any issues, but he worries a snowstorm could cancel one of his appointments between now and the end of January.
“Hopefully there won’t be any major storms between now and then, and if there are any it’ll be a week before I leave,” Coy said.
When Koi returns home from treatment, he has to take precautions, such as staying away from his wife, Sharon, to avoid exposing her to radiation. To get rid of excess radiation in his body, Koi drinks lots of water. He’s willing to accept a few days of inconvenience if it means he can fight cancer.
For Novartis, investing in infrastructure to manufacture and distribute radiopharmaceuticals is worth it for Pulvict and Lutathera alone, Bulut said. But the potential to treat more cancers makes it even more appealing. He pointed to Novartis’ efforts to develop drugs against markers found in 28 types of tumors, including breast, lung and pancreatic cancer.
“If we can apply all the knowledge we gain from manufacturing and distribution to help lung cancer patients and breast cancer patients and demonstrate meaningful levels of efficacy and tolerability, then this could have a huge impact on cancer care – and of course, it’s also a very promising business,” he said.
For now, it’s all “if”: Executives say the field is still in its early stages, and radiopharmaceuticals still need to be proven to have promise beyond the cancers they currently treat.
“If we’re successful in expanding the repertoire of targets and tumor types, this has the potential to be a very large drug class,” Eli Lilly’s van Naarden said, adding that at this point it’s hard to tell whether the class will be “very important” or “just important.”
One opportunity Bristol-Myers Squibb sees is combining radiopharmaceuticals with existing cancer treatments, such as immunotherapy, said Robert Prange, Bristol’s chief research officer. AstraZeneca shares that vision.
Susan Galbraith, vice president of oncology research and development at AstraZeneca, which acquired Fusion Pharmaceuticals for $2 billion earlier this year, points to an existing treatment that combines immunotherapy with radiation therapy.
How large AstraZeneca’s radiopharmaceutical portfolio ultimately becomes will depend on the company’s early-stage prostate cancer program and other undisclosed targets already in the pipeline, Galbraith said, but he believes the technology will become an important part of cancer drugs over the next decade.
Understanding the technology’s true potential could take years, because many experimental drugs are still in the early stages of development. An open question is whether other radiopharmaceuticals, particularly those that use other kinds of radioactive material, will be as safe and well-tolerated as Novartis’s Pruvic, Guggenheim analyst Schmidt said.
Ronald Coy has been battling prostate cancer for almost 10 years. He started taking Novartis’ Previc earlier this year.
Courtesy of Ronald Coy
Big pharma isn’t waiting around to jump in the race, and stories like Koi’s are encouraging them that hard work will pay off.
Coy has been treated multiple times for nearly a decade for prostate cancer that has spread to his bones, but after just one treatment with Prubict earlier this year, blood tests showed his cancer levels had dropped dramatically.
Not everyone responds well to Pulvikt and Koi’s situation could always change, but for now Koi feels lucky to be in a group that responds well to Pulvikt, and for him it’s worth the drive and precautions.
“I feel so blessed every day to be in that third group where this is really working for me right now,” he said.
—CNBC’s Leanne Miller contributed to this report.