Gamida Cell says its two-pronged strategic approach includes accomplishing a successful commercial strategy with FDA approved Omisirge and pursuing partnerships.
In April, the US Food and Drug Administration (FDA) approved Gamida’s Omisirge (omidubicel), an allogeneic cell therapy for patients with blood cancers who are set to undergo stem cell transplantation.
Omisirge is a modified allogeneic cord blood-based cell therapy to quicken the recovery of neutrophils and reduce the risk of infection. It is intended for use in patients with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen, such as radiation or chemotherapy.
During its Q1 2023 earnings call, CEO Abbey Jenkins told shareholders the company “is positioned like never before” to bring the cell therapy to patients with hematologic malignancies who need a stem cell transplant.
Jenkins said Gamida has taken a “two-pronged strategic approach” and this “approach includes successfully executing our commercial strategy with Omisirge, now FDA approved and launching, while pursuing strategic partnerships that will accelerate our ability to provide this important cell therapy to patients in need of a new option.”
To successfully complete its commercial plan for launching Omisirge in the US, Jenkins said the firm aims “to onboard 10 to 15 transplant centers” by the end of this year. To support this goal, Gamida is also pursuing strategic partnerships with biopharmaceutical companies to expand transplant center on-boarding to accelerate patient access to Omisirge.”
Jenkins added: “I’m pleased to share that we are making positive progress on both fronts.”
The road to approval has been relatively rocky for Gamida. The FDA asked for more information regarding the manufacturing process and facility used to make omidubicel in November 2021, and – last year – delayed the approval process by a further three months. Meanwhile, Gamida has twice undergone cost-cutting measures, cutting 10% of its workforce in January 2022 and 17% of its staff just in March.
However, in terms of the launch, Jenkins said the team was ready to do this before the cell therapy received FDA approval. Because of this, “we were able to move swiftly to initiate on-boarding of transplant centers and secure payer coverage in order to make Omisirge available to appropriate patients in need of a stem cell transplant. As of today, we are on track to complete the goal of on-boarding 10 to 15 of the top 70 transplant centers in 2023.”