With top-line phase 3 results in sight, Rezolute has stepped up preparations for a planned rare disease launch by appointing Sunil Karnawat as its chief commercial officer.
Rezolute recently completed enrollment in a pivotal trial of ersodetug for the treatment of hypoglycemia in patients with congenital hyperinsulinism (HI), a milestone that put the biotech on track to report data in December. Facing potential competition from companies including Zealand Pharma, Rezolute has hired an executive with experience guiding multiple launches to prepare for the commercialization of ersodetug.
Karnawat joins Rezolute from Cytokinetics, where he spent just over a year as vice president of global value, access and distribution. Cytokinetics hired Karnawat shortly after striking a financing deal that positioned the company, once reportedly a takeover target for Novartis, to commercialize a heart drug itself. Karnawat’s departure from Cytokinetics comes months before the drug’s recently delayed PDUFA date.
Before joining Cytokinetics, Karnawat made his name during a seven-year spell at Ultragenyx. He was involved in the launches of four ultra-rare disease products at Ultragenyx, including the rollout of Crysvita in X-linked hypophosphatemia and tumor-induced osteomalacia. Crysvita sales hit $410 million last year and are on course to rise again in 2025.
Prior to that, Karnawat had stints on commercial teams at Myriad Genetics, Vivus Pharmaceuticals and Novo Nordisk, where he headed up analytics and commercial operations groups to support the launch of Victoza in the U.S.
In a statement, Rezolute CEO Nevan Charles Elam cited Karnawat’s “proven track record of successfully bringing therapies to patients across multiple therapeutic areas” as a driver of his appointment. To Elam, that track record indicates commercial expertise that will be instrumental as the company prepares to launch ersodetug and builds out its commercial organization.
Patients with hypoglycemia caused by HI currently have limited options. Diazoxide is approved in the indication but, with response rates ranging from 40% to 74%, there is room to improve on the treatment. Zealand is preparing to refile for approval of dasiglucagon, a glucagon analog that it already sells as Zegalogue in other settings, in congenital HI after suffering two rejections in recent years.
Rezolute sees barriers to the use of dasiglucagon in congenital HI, though, telling (PDF) investors that the utility in chronic use is unproven and predicting that Zealand is likely to need to combine the drug with other therapies.
Amylyx Pharmaceuticals, meanwhile, acquired an HI candidate last year, but Rezolute expects use to be limited to post-bariatric hypoglycemia, one of several indications on the roadmap for ersodetug.