Drugmakers chase Novartis, radiopharmaceutical race heats up | Wilnesh News

Drugmakers are betting that delivering radiation directly to tumors will be the next big breakthrough in cancer.

Bristol-Myers Squibb, AstraZeneca, Eli Lilly and Company and other pharmaceutical companies have spent about $10 billion to acquire or partner with radiopharmaceutical manufacturers. They acquired smaller upstarts to acquire technologies that could treat many types of cancer in their infancy.

“Any major company that does business in oncology or views oncology as an important therapeutic category will likely need to be involved in this space in some way,” said Michael Schmidt, an analyst at Guggenheim Securities.

Novartis has launched two radiopharmaceuticals. By Schmidt’s count, dozens more are in development. He said it’s difficult to estimate the total market opportunity because the drugs treat a wide range of possible cancers.

If the technology remains limited to treating a few types of cancer, including prostate cancer and neuroendocrine tumors, the category could grow to the low end of $5 billion, Schmidt predicts. If proven to be true, it could reach tens of billions Effective against more cancers.

These drugs work by attaching a radioactive substance to a target molecule, which seeks out and attaches to specific markers on cancer cells. The trick is to find the mark Found on cancer cells but not on healthy cells. This allows the treatment to deliver radiation to the cancer cells and shields other parts of the body from radiation levels. Damage caused by many cancer drugs.

Proving that the technology can work scientifically and economically will take time. The first radiopharmaceuticals were approved in the early 2000s. But interest from big pharmaceutical companies has only recently picked up.

Making drugs requires complex manufacturing and logistics, two major drawbacks. Radioactive materials degrade quickly, so patients need to be treated within a few days of treatment.

Pharmaceutical companies have proven they can administer complex, time-sensitive drugs, such as CAR-T drugs to treat blood cancers or gene therapies to treat rare diseases. Novartis then showed that these strategies could be applied to radiopharmaceuticals.

The Swiss pharmaceutical giant won approval in 2018 for a radioactive drug called Lutathera to treat a rare form of pancreatic and gastrointestinal cancer. Then in 2022, Novartis’ Pluvicto was approved again for the treatment of prostate cancer. Sales of these drugs are expected to reach about $4 billion by 2027, according to FactSet consensus estimates.

These successes sparked broader interest in radiopharmaceuticals.

“We looked at all of those factors and thought we should do something, we needed to do a deal here,” said Jacob Van Naarden, president of Eli Lilly’s oncology business.

Eli Lilly acquired radiopharmaceutical maker Point Biopharma last year for about $1.4 billion and has signed a number of partnerships with companies developing treatments. Van Naerden said one of the most important factors in Eli Lilly’s initial search process was whether the company was ready to produce the drugs. Making radiopharmaceuticals is not easy, and Eli Lilly wants to ensure that any initial acquisitions can produce the drugs in-house rather than outsourcing the work.

RayzeBio President Ben Hickey said manufacturing is also a key component of Bristol Myers Squibb’s $4.1 billion acquisition of RayzeBio. At the time of the acquisition, RayzeBio was nearing completion of a facility in Indiana and had secured its own supply of radioactive materials needed to develop the experimental drugs in its pipeline.

“This is obviously one of the criteria to ensure that we take our destiny into our own hands,” Hickey said.

Novartis has demonstrated why this is important, as the company initially struggled to produce sufficient doses of Pluvicto. The company will invest more than $300 million to open and expand a radiopharmaceutical manufacturing site in the United States so that it can produce the drug and deliver it quickly to patients. The company is now able to meet treatment demand, which requires careful planning of distribution.

Each dose comes with a GPS tracker to ensure it gets to the right patient at the right time, said Victor Bulto, president of Novartis’ U.S. operations. Bulto said Novartis is shipping doses to destinations within nine hours of the plant to minimize the risk of disruption from the storm.

Physicians and patients on the receiving end are also feeling the complexity.

Dr. Timothy Korytko, chief radiation oncologist at Bassett Healthcare Network in upstate New York, needs to take Lutathera and Pluvicto before using it. Upgrade its medical license to handle radioactive materials. Intravenous medications need to be administered by a certified specialist.

It can take several weeks from the time a radiopharmaceutical is prescribed to when it is administered. For Pluvicto, patients come in every six weeks for up to six treatments.

Radiopharmaceuticals begin to decay once they are made, so they are only effective for a few days.

Ronald Coe knew how important it was to attend his appointment. Coy, a retired firefighter who has been battling prostate cancer since 2015, drove more than an hour across upstate New York to meet Pruevik in Bassett. Coy hasn’t had any problems so far, but he worries a snowstorm could derail one of his appointments between now and the end of January.

“Hopefully we don’t get any big storms between now and then, or even if we do, I won’t be able to leave for a week,” Coy said.

When Coy returns home from treatment, he needs to take precautions, such as staying away from his wife, Sharon, to avoid exposing her to radiation. He drinks lots of water to rid his body of excess radiation. He didn’t mind a minor inconvenience for a few days if it meant fighting cancer.

Bulto said it would be worthwhile for Novartis to invest in the infrastructure to produce and distribute radiopharmaceuticals for both Pluvicto and Lutathera. But it is more attractive because of its potential to treat more cancers. He gave the example of Novartis developing a marker drug This phenomenon has been found in 28 different tumors, including breast, lung and pancreatic cancer.

“If we can apply all this knowledge gained from manufacturing distribution to serve lung cancer patients, breast cancer patients and potentially show these meaningful levels of efficacy and tolerability, then we’re talking about a very good treatment. method.

At this point, it’s still what if. Executives say the field is still in its early stages of development, and radiopharmaceuticals have yet to be proven in their current applications beyond cancer treatment.

“If we can successfully expand the target and tumor type repertoire, this could be a very large drug class,” Eli Lilly’s Van Naarden said. He added that it was difficult to say at this point whether the class was “super important” or “just important.” “.

Robert Plenge, chief research officer at Bristol-Myers Squibb, said one opportunity Bristol-Myers Squibb sees is combining radiopharmaceuticals with existing cancer drugs, such as immunotherapies. AstraZeneca shares the same vision.

Earlier this year, AstraZeneca acquired Fusion Pharmaceuticals for $2 billion. Susan Galbraith, the company’s executive vice president of oncology research and development, pointed to existing treatments that combine immunotherapy with radiation therapy.

How big AstraZeneca’s radiopharmaceutical portfolio ends up being depends on its initial prostate cancer program and other undisclosed targets already in the works, Galbraith said. But she believes the technology will become an important part of anti-cancer drugs over the next decade.

Because many experimental drugs are still in the early stages of development, it may take years to understand the technology’s true potential. Guggenheim analyst Schmidt said an open question is whether other radiopharmaceuticals will be as safe and well-tolerated as Novartis’ Pluvicto, especially those that use other types of radioactive materials.

Big Pharma is eager to join the race. Coy’s story encourages them to believe that hard work pays off.

For nearly 10 years, Coy underwent multiple treatments for prostate cancer, which had spread to his bones. Earlier this year, after a Pluvicto treatment, blood tests showed Coy’s cancer levels plummeted.

Not everyone responded so well to Pluvicto, and things could always change for Coy. But for now, Coy feels lucky that he’s among the group that responded well to Pluvicto. It was worth it to him.

“I feel very lucky every day, and right now, I’m a part of The Third, which is really good for me,” he said.

—CNBC Leanne Miller contributed to this report.