In a deal worth up to $1.8 billion, Biogen Inc. is buying Human Immunology Biosciences Inc. (Hibio) to bolster its late-stage immune-disease treatment portfolio. The massive amount comprises $1.15 billion up front and as much as $650 in potential milestone payments. The deal in rare diseases brings Biogen phase III-ready felzartamab, a fully human monoclonal antibody that selectively depletes CD38-positive plasma cells and natural killer cells. Hibio’s lead asset has breakthrough therapy and orphan drug designations from the U.S. FDA for primary membranous nephropathy and orphan drug designation for antibody-mediated rejection in kidney-transplant patients. Phase II studies in both indications are complete and another phase II, this one in IgA nephropathy is in progress.

Interchangeable exclusivity not limited to first-to-file

In lieu of pending guidance, the U.S. FDA’s approval Monday of Biocon Biologics Ltd.’s Yesafili and Samsung Bioepis Co. Ltd.’s Opuviz as interchangeable biosimilars to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) provides further insight into how the agency is approaching the market exclusivity the Biologics Price Competition and Innovation Act awards to the first approved interchangeable for any given biologic. By approving the two interchangeables at the same time, the FDA granted them both first interchangeable exclusivity, even though Biocon submitted its BLA in 2021, more than a year earlier than Samsung. “Yesafili and Opuviz were approved on the same day because that was the earliest possible day we were allowed to approve those applications” due to Eylea’s regulatory exclusivities, a spokesperson for the FDA’s Center for Drug Evaluation and Research told BioWorld.

Rezolute’s oral diabetic macular edema drug hits phase II goal

Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. Handok shares (KOSPI:002390) on the Korea Exchange (KRX) rose 8.73% from the day prior to close at ₩14,700 (US$10.77). Rezolute stock (NASDAQ:RZLT) also climbed 6.76%, or 19 cents, to close at $3 on May 21. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME, a severe and systemic complication of diabetic retinopathy characterized by swelling of the retina and thickening of the macula that could impair vision.

Contera’s JM-101 misses phase IIb endpoint in Parkinson’s

Hørsholm, Denmark-based Contera Pharma A/S’ lead asset for levodopa-induced dyskinesia in Parkinson’s disease, JM-010, failed to meet its primary endpoint in the late-stage phase IIb Astoria trial. JM-010 is a novel drug formulation and 5-HT receptor modulator that combines existing medications of immediate-release buspirone and extended-release zolmitriptan. Both South Korea’s Bukwang Pharmaceutical Co. Ltd. and its Danish central nervous system-focused subsidiary announced the news of JM-010 on May 21. Shares of Bukwang (KOSPI:003000) on the Korean stock market fell nearly 9% on market open May 22, closing at ₩5,950 ($US4.37).

In HIV, vaccine-induced broadly neutralizing antibodies, and paths to more of them

In a paper published in the May 17, 2024, online issue of Cell, investigators from the Duke Human Vaccine Institute reported that a sequence of three immunizations in the HVTN-133 trial was sufficient for the development of heterologous or broadly neutralizing antibodies that protected against several strains of HIV. The findings are “a real beachhead,” according to Barton Haynes, the director of the Duke Human Vaccine Institute and the senior author of the paper.

Also in the news

Actio, Aligos, Alligator, Anavex, Amorchem, Antion, Aslan, Atalanta, Avalyn, Biocon, Biodexa, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Cantex, Captain T Cell, Celltrion, Cingulate, Dermavant, Durect, Dyne, Edgewood Oncology, Eli Lilly, Erasca, Exavir, Faron, Ferring, GSK, Imvax, Innocare, Innovent, Insmed, Invivyd, Ironwood, Johnson & Johnson, Kodikaz, Larimar, Molecure, Neophore, Oragenics, Oruka, OSE, Otsuka, Ractigen, Remegen, Roche, SAB, Samsung Bioepis, Sanofi, Sixpeaks, Sonnet, Telix, Transposon, Vantai, Vedanta, Viiv