Radiopharmaceuticals are one of the most dynamic segments of BioPharma. Here is a deep dive into some notable deals, and how the biggest companies are approaching the space.

Novartis is the current leader in the space, with two approved treatments, Lutathera and Pluvicto, which are on track to exceed $2B in combined sales in 2024.

Radiopharmaceuticals are a key area of focus for Novartis, which has named them one of its five core technology platforms. The company is focused on building on its early lead, and has bolstered its pipeline with several additional acquisitions, most recently with Mariana Oncology.

The Mariana deal diversified Novartis's pipeline by adding actinium-based products to Novartis's two lutetium products.

Novartis is planning to file for an expanded label for Pluvicto in earlier treatment lines of Prostate Cancer in the second half of 2024. If approved, it would more than double the addressable patient population for the medicine.

While Novartis has achieved a strong early position, others are moving quickly to keep pace.

Bristol Myers Squibb completed a $4.1B acquisition of RayzeBio in February, whose lead program, RYZ-101, is in phase 3 trials.

Meanwhile, Eli Lilly and Company has struck a series of deals, including a $1.4B deal for Point Biopharma, as well as collaboration deals with Radionetics Oncology ($140M upfront + option to acquire), Aktis Oncology ($60M upfront + equity).

AstraZeneca entered the space through its $2.1B acquisition of Canada-based Fusion pharmaceuticals in March.

Fusion’s lead program is focused on prostate cancer and uses alpha emitters, which could potentially offer a more localized delivery of radiation to cancer cells compared to the beta emitters used in both Pluvicto and Lutathera, but it’s yet to be seen how that translates into later-stage clinical efficacy.

AstraZeneca also picked up valuable manufacturing capabilities through the deal, including a secured supply of actinium, the radioisotope used in its medicines, which is notable given recent supply issues.

That hints at one of the biggest issues facing radiopharmaceutical development today, which is manufacturing and timely supply.

The key radioisotopes involved have relatively short half lives: ~6 days for Lutetium, and ~10 days for Actinium, meaning companies must have efficient logistics networks to get the medicines to patients in a timely way.

Novartis ran into supply issues with Pluvicto in a New Jersey facility last fall, forcing it to re-route production through an Italian facility and resulting in negative impacts to both sales and patient enrollment.

Arguably, radiopharmaceuticals are today where ADCs were ~5 years ago, so the coming years will be critical to see 1) Does clinical efficacy prove out 2) Can a wider range of targets/indications be treated beyond SSTR2 and PSMA, and 3) Can supply be reliable and unconstrained.