Biogen secures $250 million to finance phase 3 study

To forward a significant pipeline opportunity, Biogen has secured $250 million. The firm has identified a lupus candidate among a group of assets with potential peak sales of $14 billion, and Royalty Pharma is contributing the funds to finance the phase 3 development of this candidate.
Systemic and cutaneous lupus erythematosus (SLE/CLE) is being treated with litifilimab, an anti-BDCA2 antibody in phase 3 development. Both illnesses have unmet needs. Only GSK’s Benlysta and AstraZeneca’s Saphnelo are available to SLE patients, which is a small selection, but it’s better than CLE. For decades, doctors have been waiting for a breakthrough in managing the skin condition.
Litifilimab, according to Biogen, can meet the unmet demands. However, the biotech has chosen to look for outside funding to support phase 3 studies in SLE and CLE since it has a pipeline of other medicines to advance, including two more lupus assets.
By agreeing to drip-feed Biogen $250 million over six quarters in exchange for regulatory milestones and mid-single-digit royalties on yearly global sales, Royalty is supplying the funding. A portion of the sales of Biogen’s Tysabri and Spinraza are already given to Royalty, a buyer of biopharmaceutical royalties. Instead of obtaining such royalties directly from Biogen, the company obtained them through agreements with Ionis and Perrigo.

Under CEO Christopher Viehbacher, Biogen emphasized its pipeline, which helped the company reduce R&D expenditures by 17% last year. The royalty agreement enables Biogen to continue managing costs while attempting to commercialize litifilimab.
During an October earnings call, Viehbacher praised litifilimab’s prospects, citing it as one of many potential possibilities that the CEO claimed might collectively produce peak sales of $9 billion to $14 billion. CLE represents an unexplored potential. Viehbacher believes there is space for more than one molecule, but Litifilimab will face competition if it makes it to market in SLE, maybe from Biogen’s dapirolizumab.
Dapirolizumab lowers interferon and decreases B and T cell activation by blocking the CD40 ligand. Biogen is targeting the type 1 interferon signature by blocking BDCA2 in the plasma delta with litifilimab. Between 2027 and 2029, the biotech hopes to submit applications for litifilimab approval in SLE and CLE.