Biogen has bagged $250 million to advance a key pipeline prospect. Royalty Pharma is providing the cash to bankroll phase 3 development of a lupus candidate that Biogen has named in a bunch of assets with potential peak sales of $14 billion.
The candidate, the anti-BDCA2 antibody litifilimab, is in phase 3 development in systemic and cutaneous lupus erythematosus (SLE/CLE). There is unmet need in both diseases. SLE patients have limited choices, with GSK’s Benlysta and AstraZeneca’s Saphnelo the only options, but that is rich pickings compared to CLE. Physicians have been waiting decades for an advance in the treatment of the cutaneous disease.
Biogen believes litifilimab can address the unmet needs. But, with a pipeline of other programs—including two other lupus assets—to develop, the biotech has opted to seek external money to fund phase 3 trials in SLE and CLE.
Royalty is providing the money, agreeing to drip-feed Biogen $250 million over six quarters in exchange for regulatory milestones and mid-single-digit royalties on annual worldwide sales. Royalty, a buyer of biopharmaceutical royalties, already receives a cut of the sales of Biogen’s Tysabri and Spinraza. The firm secured those royalties through deals with Ionis and Perrigo rather than directly from Biogen.
Biogen has prioritized its pipeline under CEO Christopher Viehbacher, helping it cut R&D spending by 17% last year. The Royalty deal supports ongoing cost management while still allowing Biogen to attempt to bring litifilimab to market.
Viehbacher talked up litifilimab’s prospects on an earnings call in October, including the asset among a clutch of candidates that the CEO said could collectively generate peak sales of $9 billion to $14 billion. CLE is an untapped opportunity. Litifilimab will face competition if it comes to market in SLE, potentially from Biogen’s own dapirolizumab, but Viehbacher sees room for multiple molecules.
“This is a complex disease that affects different organs at a time,” Viehbacher said at the J.P. Morgan Healthcare Conference last month. “I think it's going to be a little like MS. You're really going to decide which product is best at which point in time for every patient. And so I don't think this is one product for the whole disease.”
Dapirolizumab inhibits the CD40 ligand to reduce activation of B and T cells and downregulate interferon. With litifilimab, Biogen is going after the type 1 interferon signature by inhibiting BDCA2 in the plasma delta. The biotech is aiming to file for approval of litifilimab in SLE and CLE from 2027 to 2029.