Immuno-oncology drug Libtayo is Regeneron Pharmaceuticals’ lead cancer asset, marketed under an alliance with Sanofi to treat lung and skin cancers. Regulatory decisions in multiple markets later this year could further expand the drug’s use with chemotherapy as a first-line lung cancer treatment.With Libtayo’s growth prospects looming, Regeneron wants all of those financial benefits, and the company has agreed to pay Sanofi $900 million regain full global rights to partner drugs.
Under a preliminary agreement reached in 2015, Regeneron and Sanofi shared the commercialization of Libtayo in the United States, while Sanofi was responsible for an equal share of global profits from commercialized Libtayo sales outside the United States. The terms of the new agreement announced Thursday require Sanofi to transfer global rights to Regeneron. The pharma giant will receive an 11% royalty on the drug’s global sales, as well as milestone payments. The first $100 million milestone is tied to regulatory approval of Libtayo in the U.S. or Europe as part of first-line treatment in combination with chemotherapy for certain non-small cell lung cancer patients. Sanofi could earn up to $100 million in additional revenue tied to sales milestones over the next two years.
Libtayo was originally developed in Regeneron’s lab. The antibody blocks PD-1, a checkpoint protein on T cells that prevents them from recognizing and targeting cancer cells. First approved in 2018, FDA-authorized indications cover advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced non-small cell lung cancer. Libtayo’s global sales in 2021 were $458.2 million, up 31% from the previous year. But the drug lags behind its peers in reaching the market. Merck, Bristol-Myers Squibb and Roche all have blockbuster checkpoint inhibitors approved for a range of indications, so Libtayo has some work to do.
in a Investor introduction, Regeneron said that securing full control over Libtayo would give the company flexibility in terms of assets, speeding up decision making and development timelines. This control extends to exploring plans for a combination therapy with Libtayo, including potential pairings with drug candidates in Regeneron’s pipeline.
“This strategic acquisition is an important step toward Regeneron’s goal of becoming a global oncology leader, centered on Libtayo, as an important option as a PD-1 inhibitor as a monotherapy, and it is exciting to partner with us Differentiated and diversified pipeline of potential new combined oncology assets,” Regeneron CEO Leonard Shriver said in a prepared statement.
Recent M&A transactions mark a combination that Regeneron is exploring. In April, Regeneron agrees to pay $250 million to acquire Checkmate Pharmaceuticals, a clinical-stage biotechnology company whose lead program is vidutolimod, is a locally administered immunotherapy designed to activate the innate immune system to fight tumors. In addition to studies as a monotherapy, Checkmate has also explored potential combinations of its assets with checkpoint inhibitors, including Libtayo.
In an investor presentation, Regeneron said the joint Libtayo/vidutolimod study is expected to produce data in 2024. Another ongoing combination study is evaluating the pairing of Libtayo and REGN5678, an antibody drug for the treatment of advanced prostate cancer. Data from the study is expected to be released in the second half of this year. Libtayo’s external partners include drug testing combined with assets such as Inovio, Vyriad, Replimmune and BioNTech.
Regeneron’s relationship with Sanofi includes an antibody collaboration that has resulted in products such as blockbuster drug Dupixent. The alliance is asking Regeneron to reimburse Sanofi for development costs associated with the partnered drug. Under the terms of the deal announced Thursday, Regeneron will accelerate the repayment of the balance, which stood at $3.1 billion at the end of March.
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