In the world of pharma dealmaking, radiopharma companies are increasingly the belles of the ball.
Radiopharma’s value became more apparent after Novartis’ 2018 acquisition of Endocyte paved the way for it to launch its blockbuster cancer drug Pluvicto. Since then, Novartis’ competitors have raced to also team up with radiopharma companies, with Bristol Myers Squibb snapping up RayzeBio, AstraZeneca acquiring Fusion Pharmaceuticals, Eli Lilly snagging Point Biopharma, and both Roche and Sanofi developing products with Orano Med.
Regeneron has also sought to find its path into radiopharma, and began a search process that felt like a “beauty pageant” for attractive applicants, according to Christian Behrenbruch, founder and CEO of Telix Pharmaceuticals, which was eventually crowned with a partnership. During the dealmaking process with Regeneron, Telix’s manufacturing platform stood out, Behrenbruch said.
“They liked the fact we weren't just a VC-backed pipeline on paper trying to discover how things work,” Behrenbruch said. “We actually had experience in scaling up and running multicenter clinical trials with biologic-based radiopharma, and also regulator experience globally. It’s a very complementary relationship.”
Regeneron and Telix struck a 50/50 cost- and profit-sharing deal in April that could eventually net the Australia-based radiopharma company up to $2.1 billion.
Under the deal, Regeneron will gain access to Telix’s manufacturing platform for four initial therapeutic programs in cancer, including multiple solid tumor targets from Regeneron’s portfolio of antibodies. The companies will also develop radio diagnostics.
Telix is a commercial stage company with a deep, late-stage pipeline of its own.
“We have easily the largest radiopharma pipeline in the industry … [including] three phase 3 trials running in renal, prostate and brain cancer,” Behrenbruch said.
Telix’s next approval win could be with Pixclara, a glioma imaging agent with a Sept. 11 FDA decision date. But it’ll be Telix’s second attempt at approval for Pixclara, which the agency rejected last year, asking for “additional confirmatory clinical evidence.”
Behrenbruch believes Telix’s strength in the radiopharma space comes from three factors. First is that Telix combines therapeutic drug development with diagnostics.
Telix has also concentrated on building pipeline depth in specific disease areas, since “not all areas of solid tumors are going to be perfect for radioactive drugs,” he said.
And the company has vertically integrated its isotope supply chain and manufacturing, which Behrenbruch said is “pretty unusual for a small biopharma.”
Here, Behrenbruch explains how the Regeneron deal could help both companies innovate and what’s helped Telix succeed on the market.
This interview has been edited for brevity and style.
PHARMAVOICE: How has the radiopharma space evolved and what kinds of innovations will the Regeneron matchup allow you to explore?
CHRISTIAN BEHRENBRUCH: One of the earliest things that we learned about IgGs [immunoglobulin G] and how they work came from radiopharma because you could study where an injected antibody went into your body. So there was this kind of immunotherapy boom in the late 80s and early 90s. People took their antibodies, their Rituximabs and Herceptins, and they radiolabeled them, and they studied them in patients. But there wasn't really any optimization of those targeting agents for radioactivity in terms of the clearance organ, or the serum half-life, or how long the targeting agent stays on the target relative to, say, healthy tissue distribution.
The Regeneron collaboration allows us to do more than just take an antibody and pack some radioactivity onto it and hope for the best. You can start now to really use the whole repertoire of protein engineering approaches that would reflect modern antibody-drug based discovery, bispecifics and engineered formats that have different pharmacologic properties.
Your latest market update touted Telix’s supply chain resilience. Why is that important for the Regeneron deal?
We are going into this relationship with the intention to be a co-development, co-commercialization [partner], which is very unusual for a small biopharma company. We actually have our own commercial team, because selling radioactive drugs is not the same as selling a blister pack or a vial. There's a whole clinical workflow involved. You have to educate the customer about radiation safety,waste management, how to calibrate your scanner, how you dispense it and draw down your dose and administer it into patients.
We have a commercial team as well as a manufacturing and supply chain capability that has the redundancy and the resilience to scale a drug if it actually is commercially successful. To put that into context: Last year, we delivered globally three million patient doses.
[Regeneron was] looking for a partner that … has the infrastructure to be able to scale and deliver [products] globally. And in order to do that, you've got to have a lot of capacity and redundancy in your isotope and manufacturing supply chain.
Telix’s precision medicine unit has had really strong growth in the past year. What’s the strategy there?
That comes down to really building franchise depth. We’ve got two products in prostate cancer imaging, which are very complementary to each other from a reimbursement perspective and also from a supply chain and logistics perspective. Illuccix is really great. It's got a really short shelf life that allows you to do on demand dose delivery in major metropolitan areas.
Gozellix is our more newly introduced product. It got reimbursement just before Christmas. It’s got an extended shelf life, which enables us to transport the drug a lot further and make it a lot more available into the wider community setting.
A lot of innovation went into building the second-generation products. We’ve got kind of a one-two punch strategy there, which is helping us to take market share.
And then coming in behind, we've got the Zircaix product, which is shortly going to have its BLA submission. This is in kidney cancer. It also potentially has some utility in bladder cancer as well.
It’s about really building that pipeline depth and that relationship with the urologists and the urologic oncologists. That's been the success of that business.
What we do as a company is a very high touch approach. It's very science- and clinician-led. We focus on what we can do for the patient.