Drugmakers are betting that delivering radiation directly to tumors will be the next cancer breakthrough.
Bristol Myers Squibb, AstraZeneca, Eli Lily and other pharmaceutical companies have spent some $10 billion on bids to acquire or work with manufacturers of radiopharmaceuticals. He had created a smaller startup to acquire technology that, while still young, could cure many cancers.
“Any large company that has a business in oncology or for which oncology is an important therapeutic category may need exposure to this area in other ways,” said Guggenheim Securities analyst Michael Schmidt.
Two radiopharmaceuticals from Novartis are already available. Several dozen more are under development, according to Schmidt’s count. It is difficult to estimate the total market opportunity because there are many possibilities of cancer drugs can cure, he said.
Schmidt predicts that the category could grow to as little as $5 billion if the technology remains limited to treating certain types of cancer such as prostate and neuroendocrine tumors, so many up to tens of billions if indicated effective in other cancers.
The drug works by attaching a radioactive substance to a target molecule that looks for and sticks to a specific marker in the cancer cell. The trick is to find the sign which is present in cancer cells but not in healthy cells. That can allow treatment to send radiation to cancer cells and spare the rest of the body from the level of damage that comes with many cancer drugs.
Proving the technology works scientifically and financially will take time. Radiopharmaceuticals were first approved in the early 2000s. But interest from large pharmaceutical companies did not rise until recently.
Workers work at the NSA radiopharmaceutical factory in Aedea Rome, Italy.
Franco Origlia Getty Images
Making these drugs requires complex manufacturing and logistics, two major drawbacks. Radioactive materials break down quickly, so patients must be treated within a few days after treatment.
Pharmaceutical companies are proving that they can manage complex and time-sensitive drugs like CAR-T for blood cancer or gene therapy for rare diseases. Then Novartis showed that the strategy could be applied to radiopharmaceuticals.
The Swiss pharmaceutical giant won approval in 2018 for a radiopharmaceutical drug called Lutathera for a rare type of cancer in the pancreas and digestive tract. Then in 2022, Novartis won another approval in the treatment of Pluvicto for prostate cancer. Combined, the drugs are expected to generate sales of about $4 billion by 2027, according to consensus estimates from FactSet.
Its success led to a wider interest in radiopharmaceuticals.
“We took it all in and thought, we’ve got to do something, we’ve got to do a deal 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 entered into several partnerships with companies developing the treatment. One of the most important factors in Lilly’s initial search was whether the company was ready to produce the drug, Van Naarden said. Radiopharmaceuticals are not easy to make, and Lilly wanted to ensure that early acquisitions could produce the drugs themselves rather than outsourcing them.
Manufacturing is also a key component in Bristol Myers Squibb’s $4.1 billion acquisition of RayzeBio, said Ben Hickey, president of RayzeBio. At the time of the acquisition, RayzeBio was nearing completion of its factory in Indiana and had acquired its own supply of radioactive materials needed to develop experimental drugs in the pipeline.
“This is clearly one of the criteria to ensure that we have our destiny in our own hands,” Hickey said.
Novartis has shown why it’s so important, as the company has since struggled to make enough doses of Pluvicto. It is investing more than $300 million to open and expand a radiopharmaceutical manufacturing site in the US so that it can produce the drug and deliver it to patients as quickly as possible. Companies are now able to meet the demand for such care, which involves careful planning for distribution.
Each dose carries a GPS tracker to ensure it’s the right patient at the right time, according to Victor Bulto, president of Novartis’ US business. Novartis drives the dose to the destination within nine hours of the factory to minimize the risk of disruption from the storm, Bulto said.
Doctors and patients at the receiving end also feel the complexity.
Bassett Healthcare Network in upstate New York needs to renew its medical license to handle radioactive materials before administering Lutathera and Pluvicto, said Dr. Timothy Korytko, Bassett’s chief of radiation oncology. A certified specialist must administer the drug, which is administered intravenously.
It takes several weeks from the radiopharmaceutical prescription to administration. For Pluvicto, patients come every six weeks for six treatments.
Radiopharmaceuticals begin to decay once they are made, 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 make that appointment. Coy, a retired firefighter who has been battling prostate cancer since 2015, drove more than an hour through New York to receive Pluvicto in Bassett. Coy hasn’t had any problems so far, but he’s worried a snowstorm could ruin one of his appointments between now and the end of January.
“I hope we don’t get a big storm between now and now, or if we do, the week before I leave,” Coy said.
When Coy comes home from treatment, he has to be careful to stay away from his wife Sharon so she doesn’t get exposed to radiation. He drank a lot of water to remove the extra radiation from his body. He doesn’t remember the unpleasant situation for a few days if it means fighting cancer.
For Novartis, the investment in infrastructure to produce and distribute radiopharmaceuticals will be beneficial for Pluvicto and Lutathera, Bulto said. But it is even more attractive because of its potential to treat other cancers. He gave the example of Novartis’ work to develop drugs for markers found in 28 different tumors, including breast, lung and pancreatic cancer.
“If we can apply all the studies that have been developed from the manufacturing distribution in the service of lung cancer patients, breast cancer patients, and potentially show a useful level of efficacy and tolerance, we are talking about a very large potential impact on cancer treatment and, of course , a very viable business,” he said.
At this point, it is still if. The field is in its infancy, executives say, and the promise of radiopharmaceuticals beyond the cancers currently being treated remains to be proven.
“If we succeed in developing a target and tumor-type repertoire, this could be a very large class of drugs,” said Eli Lilly’s Van Naarden, adding that at this point it is difficult to say whether the class will become “super important”. or “just important.”
One opportunity Bristol Myers Squibb sees is combining radiopharmacy with existing cancer drugs like immunotherapy, said Robert Plenge, Bristol’s chief researcher. AstraZeneca shares that 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 an existing regimen that combines immunotherapy with radiation.
How big AstraZeneca’s radiopharmaceutical portfolio ultimately will depend on the early prostate cancer program and other unknown targets it has pursued, Galbraith said. But he thinks the technology will become an important part of cancer medicine in the next decade.
It will take years to realize the true potential of the technology, as many experimental drugs are still in the early stages of development. One outstanding question is whether other radiopharmaceuticals are as safe and tolerated as Novartis’ Pluvicto, especially those that use other types of radioactive materials, said Guggenheim analyst Schmidt.
Ronald Coy has been battling prostate cancer for almost 10 years. He started taking Novartis’ Pluvicto earlier this year.
Courtesy: Ronald Coy
Big pharmaceutical companies are not waiting to jump into the race. Stories like Coy’s encourage that the work will pay off.
Over the course of 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 tests showed Coy’s cancer levels were down.
Not everyone responds well to Pluvicto, and things may change for Coy. But now, Coy feels lucky that he is among the group that responded well to Pluvicto. It is worth the drive and precautions for him.
“I feel lucky every day – like now – I’m in the third part where this works well for me,” he said.
– CNBC’s Leanne Miller contributed to this report.
