Sanofi CEO Paul Hudson made it clear earlier this year that his mission to reshape the company would involve some pipeline pruning. For the right price that apparently includes Libtayo, mere months ahead of an expected FDA decision on lung cancer.
Regeneron is putting down a whopping $ 900 million upfront for the full rights to Libtayo, their partnered PD-1 treatment that earned Regeneron $ 306 million last year, up 13% from the year before.
The Tarrytown, NY-based company is sweetening the deal with an 11% royalty on worldwide net sales. Plus, there’s another $ 100 million on the line if the drug wins approval in the US or EU in combination with chemotherapy for non-small cell lung cancer patients, and $ 100 million in potential sales-related milestones over the next two years.
The move is in line with Hudson’s warning earlier this year that some serious program cuts are on the way, this latest one signaling a shift to next-gen cancer meds.
“Our early steps with Libtayo in immuno-oncology provided a strong foundation for our revitalized oncology efforts. Now, we are focused on leveraging our internal capabilities and advancing a new generation of oncology medicines, ”Sanofi’s EVP of specialty care and North America president Bill Sibold said in a news release.
“We continue to maintain a strong partnership with Regeneron in immunology, and will work closely with them on the seamless transition of Libtayo to ensure there is no impact for patients,” Sibold added.
Prior to the deal, Sanofi and Regeneron co-commercialized Libtayo in the US, while Sanofi held the rights everywhere else. Regeneron CEO Leonard Schleifer spelled out “several compelling reasons” for pursuing global rights, perhaps most importantly the freedom to explore combination opportunities.
“You can look at what Merck and others are doing, and it sort of gives you a window to where the world is going,” he said on a call with investors. “They are well aware of the loss of exclusivity that might confront them, and they are looking to combine the drug, Keytruda for example, or others, with other agents that will improve the benefit to patients while simultaneously extending the exclusivity.”
Regeneron highlighted a series of potential Libtayo combinations, including with CD3 bispecifics, CD28 bispecifics, and other immune-modulating agents like fianlimab, its anti-LAG-3 candidate. LAG-3 is an immune checkpoint receptor associated with therapeutic resistance to anti-PD-1 therapy. Therefore, scientists believe it could enhance the anti-tumor effect in melanoma patients when combined with Libtayo.
“We believe fianlimab is the first in a series of Libtayo combinations that we can develop to improve treatment for cancer patients,” CSO George Yancopoulos said on the call while noting that new data from that combination won’t be available until at least 2024. .
Libtayo was first approved in 2018 for a type of skin cancer called metastatic cutaneous squamous cell carcinoma, and last year won its second and third approvals in advanced basal cell carcinoma and as a monotherapy for certain advanced NSCLC patients. It has a Sept. 19 PDUFA date in combination with chemo as a first-line treatment for advanced NSCLC, and the EC is expected to decide in the second half of this year.
Earlier this year, Sanofi and Regeneron pulled an application for Libtayo in second-line cervical cancer after the companies and the FDA were unable to align on certain post-marketing studies.
Sanofi and Regeneron’s partnership dates back to 2003. Over the last 19 years, the duo brought a handful of drugs to market in a collaboration that Hudson once called “one of the most productive in the industry.”
With the global rights to Libtayo, CFO Robert Landry said Regeneron isn’t afraid to explore opportunities outside of its own pipeline.
“We will continue to explore ways to bolster and complement our own research capabilities with externally sourced innovation,” he said, pointing to the company’s recent $ 250 million all-cash Checkmate Pharmaceuticals buyout as an example.
And it certainly has the cash to work with. Sales last year increased 89% to $ 16.07 billion, $ 6.19 billion of which was attributable to the company’s Covid-19 monoclonal antibody REGEN-COV.
“We’re not just doing this internally,” Schleifer said. “We’re open for business.”