Pharmacists are betting that delivering radiation directly to tumors will become the next big breakthrough in cancer.
Bristol Myers Squibb, AstraZeneca, Eli Lilly and other pharmaceutical companies have spent about $10 billion on deals to acquire or partner with radiopharmaceutical manufacturers. They have created smaller startups to get their hands on technology that, while still in its infancy, could cure many cancers.
“Any large company that has a business presence in oncology or for which oncology is an important therapeutic category will probably need exposure to this area in one way or another,” said Guggenheim Securities analyst Michael Schmidt.
Two Novartis radiopharmaceuticals are already available. Dozens more are under development, by Schmidt’s count. It’s hard to estimate the overall market opportunity because there are so many potential cancers the drugs could treat, he said.
Schmidt predicts the category could grow to a low of $5 billion in revenue if the technology remains limited to treating a few types of cancer such as prostate and neuroendocrine tumors, tens of billions if it turns out to be effective in most cancers.
The drugs work by attaching radioactive material to a targeting molecule that seeks out and attaches to a specific marker on cancer cells. The trick is to find pointers that are present in cancer cells but not in healthy cells. This can allow the treatment to deliver radiation to the cancer cells and rid the rest of the body of its level damage that accompanies many anticancer drugs.
It took time to prove that the technology could work both scientifically and economically. The first radiopharmaceuticals were approved in the early 2000s. But interest from big pharmaceutical companies didn’t pick up until recently.
An employee works at the NSA radiopharmaceutical plant in Aedea, Rome, Italy.
Franco Origlia | Getty Images
Manufacturing the drugs requires complex manufacturing and logistics, two major drawbacks. The radioactive material breaks down quickly, so patients must be treated within days of starting treatment.
Drug companies proved they could manage complex, time-sensitive drugs like CAR-T for blood cancers or gene therapies for rare diseases. Novartis then showed that these strategies could be applied to radiopharmaceuticals.
The Swiss pharmaceutical giant won approval in 2018 for a radiopharmaceutical called Lutathera for a rare type of pancreatic and gastrointestinal cancer. Then, in 2022, Novartis secured another approval for its prostate cancer treatment Pluvicto. Combined, the drugs are expected to reach about $4 billion in sales by 2027, according to consensus estimates from FactSet.
These successes sparked a wider interest in radiopharmaceuticals.
“We took all of this together and thought, we have to do something, we have to make deals here,” said Jacob Van Naarden, president of Eli Lilly’s oncology business.
Lilly acquired radiopharmaceutical maker Point Biopharma last year for about $1.4 billion and has also signed a few partnerships with companies developing the treatments. One of the most important factors during Lilly’s initial investigation was whether the companies were ready to make the drugs, Van Naarden said. Radiopharmaceuticals are not easy to make, and Lilly wanted to make sure that any initial acquisition could produce the drugs themselves rather than outsourcing the work.
Manufacturing was also a key element in Bristol Myers Squibb’s $4.1 billion acquisition of RayzeBio, said Ben Hickey, RayzeBio’s president. At the time of the acquisition, RayzeBio was nearing completion of a plant in Indiana and had secured its own supply of radioactive material necessary to develop the experimental drugs in its pipeline.
“It was clearly one of the criteria to make sure we had our destiny in our own hands,” Hickey said.
Novartis showed why this is so important, as the company initially struggled to produce enough doses of Pluvicto. It is investing more than $300 million to open and expand radiopharmaceutical manufacturing sites in the U.S. so it can produce the drug and get it to patients quickly. The company is now able to meet demand for the treatment, which includes careful planning for distribution.
Each dose carries a GPS tracker to ensure it goes to the right patient at the right time, according to Victor Bulto, president of Novartis’ US business. Novartis drives doses to destinations within nine hours of the plant to minimize the risk of storm disruptions, Bulto said.
Doctors and patients on the receiving end also feel the complexity.
Bassett Healthcare Network in upstate New York needed to upgrade its medical license to handle radioactive material before administering Lutathera and Pluvicto, said Dr. Timothy Korytko, Bassett’s chief radiation oncologist. A certified specialist is needed to administer the drugs, which are administered intravenously.
It can take a few weeks from when a radiopharmaceutical is prescribed to when one is given. For Pluvicto, patients come in once every six weeks for up to six treatments.
Radiopharmaceuticals begin to decay as soon as they are prepared, so they are only good for a few days.
Ronald Coy and his wife Sharon.
Courtesy: Ronald Coy
Ronald Coy knows how important it is to do this on his dates. Coy, a retired firefighter who has been battling prostate cancer since 2015, drives more than an hour to upstate New York to see Pluvito in Bassett. Coy hasn’t had any problems so far, but he’s worried a snowstorm could derail one of his dates between now and the end of January.
“Hopefully we don’t get any big storms between now and then or if we do, it’s a week before I leave,” Coy said.
When Coy returns home from treatment, he must take precautions such as staying away from his wife Sharon to avoid exposure to radiation. He drinks plenty of water to flush the extra radiation from his body. He doesn’t mind a little discomfort for a few days if it means fighting his cancer.
For Novartis, the investment in infrastructure to manufacture and distribute radiopharmaceuticals would be worth it for Pluvicto and Lutathera alone, Bulto said. But it is even more attractive because of the potential to treat more cancers. He gives the example of Novartis’ work to develop a drug for an indicator found in 28 different tumors, including breast, lung and pancreatic cancers.
“If we were able to put all of this knowledge that we’ve developed from a manufacturing distribution into the service of lung cancer patients, breast cancer patients, and potentially show these levels of meaningful efficacy and tolerability, we’re talking about a very large potential impact on cancer care and, of course, a very sustainable business,” he said.
At this point, it’s still an if. The field is in its early days, executives say, and the promise of radiopharmaceuticals beyond the current cancers they treat has yet to be proven.
“If we can succeed in expanding the target repertoire and tumor types, this could be a very large class of drugs,” Eli Lilly’s Van Naarden said, adding that at this point it is difficult to say whether the class will is “super important”. or “just important”.
One opportunity Bristol Myers Squibb sees is combining radiopharmaceuticals with existing cancer drugs such as immunotherapy, said Robert Plenge, Bristol’s principal investigator. AstraZeneca shares this vision.
AstraZeneca spent $2 billion to acquire Fusion Pharmaceuticals earlier this year. Susan Galbraith, the company’s executive vice president of oncology research and development, points to existing regimens that combine immunotherapy with radiation.
How big AstraZeneca’s radiopharmaceutical portfolio eventually becomes depends on its initial prostate cancer program and other unseen targets already in the works, Galbraith said. But he believes the technology will become an important part of cancer drugs in the next decade.
It could take years to understand the true potential of the technology, as many experimental drugs are still in the early stages of development. An outstanding question is whether other radiopharmaceuticals are as safe and well-tolerated as Novartis’ Pluvicto, especially those that use other types of radioactive material, Guggenheim analyst Schmidt said.
Ronald Coy had been battling prostate cancer for almost 10 years. He started taking Novartis’ Pluvicto earlier this year.
Courtesy: Ronald Coy
Big pharma isn’t waiting to get into the fray. Stories like Coy’s encourage them that the work will pay off.
For nearly 10 years, Coy has undergone multiple treatments for prostate cancer that has spread to his bones. After just one Pluvicto treatment earlier this year, blood work showed Coy’s cancer level had plummeted.
Not everyone responds so well to Pluvicto, and things could always change for Coy. But for now, Coy feels lucky to be among the group responding well to Pluvicto. It’s worth the moves and precautions for him.
“I feel very lucky every day that I’m – as it is now – I’m part of the third where it works really well for me,” he said.
— The CNBC Leanne Miller contributed to this report.
