With the radiopharma field booming, RLS plans to add CDMO services at 8 US sites

The biopharma industry is going nuclear. As major companies—such as Eli Lilly with its $1.4 billion acquisition of Point Biopharma—rush to the radiopharmaceuticals space, they're finding that the field presents new manufacturing challenges. 

Seizing an opportunity to leverage its expertise is RLS Radiopharmacies. The Florida-based company, which runs a network of 31 radiopharmacies in 18 states, is expanding its operations and adding contract development and manufacturing services.

RLS will provide services from eight of its 31 facilities, dedicating roughly 10,000 square feet at each of the sites to the development and manufacture of radiotherapies.

The CDMO facilities are near major population centers spread throughout the U.S. RLS intends to get all eight of its sites staffed and production ready by the end of the first quarter of next year.

Because the radioactive components in these drugs have a very short shelf-life and must be produced in a customized fashion, there is a growing demand for regional manufacturing and same-day delivery services, according to RLS.

“Having the ability to be closer to your end user has always been the advantage. That’s how radiopharmacies were built—to maximize that closeness to each individual hospital,” Trey Bankston, RLS’s chief operating officer, said in an interview. “Because of issues manufacturers have had in the past, they’re all coming to realize that having one centralized location and trying to distribute to the entire United States can be problematic.”

Compared to Big Pharma, RLS can look like a “ma and pop” organization with its relatively small facilities, Bankston said. But there is a de-risking advantage to operating out of smaller, spread out sites, RLS CEO Stephen Belcher added during the interview.

There are roughly 400 radiopharmaceutical products in biopharma company pipelines, Bankston said. And even as large drugmakers flex their muscles in the space, private equity companies and biotechs are increasingly active in funding and advancing these drugs.

An example came last week, when Nucleus RadioPharma said it had attracted $56 million in a series A investment round that will fund new facilities in the U.S. for the development, manufacture and distribution of radiopharmaceuticals.

Private equity firm RLS recognized the potential in 2020 when it purchased the radiopharmacy network from General Electric. Belcher said he has heard from roughly 70 companies that are interested in taking advantage of RLS’ expertise.

Among large drugmakers, Novartis has been at the forefront of the radiopharma field. The company's prostate cancer therapy Pluvicto won FDA approval last year and has been rapidly growing sales. But, along the way, the company had to pause new patient starts to get a handle on manufacturing issues.