Omisirge is the world’s 1st U.S. FDA approved product that is a expanded umbilical cord blood cell therapy.
It is also the only allogeneic stem cell therapy approved by the U.S. FDA on the basis of a global randomized Phase 3 trial.
Rapid onboarding of transplant centers and significant payer coverage demonstrate strong launch progress.
Boston, MA, September 27, 2023 –– Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, announced that the first patient has received a stem cell transplant with Omisirge (omidubicel-onlv). “This is a significant milestone for Gamida Cell, advancing our mission of delivering potentially curative therapies to patients with cancer,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. “This patient will be the first of many who have new hope for a cure thanks to the availability of Omisirge as a new stem cell transplant donor source. This is why we do the work that we do – to make a difference for people with cancer.”
Omisirge was approved by the U.S. FDA in April 2023 for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Gamida Cell has already exceeded its 2023 launch goals, with 15 transplant centers onboarded across the United States and confirmed coverage with payers that cover 90% of commercial lives. Gamida Cell is actively engaged with more than 90% of the top 70 transplant centers, which conduct approximately 80% of transplants. An increasing number of patients are being enrolled in Gamida Cell Assist®, which signals a transplanter’s intent to use Omisirge as the donor source.
“The launch of Omisirge is progressing very well in terms of payer coverage, transplant center onboarding and transplanter interest in using Omisirge as a donor source,” said Michele Korfin, Chief Operating and Chief Commercial Officer of Gamida Cell. “We recognize the importance of making sure eligible patients can access Omisirge. To appropriately manage our cash, we launched with a limited investment and field footprint. The positive launch progress and strong interest from transplant centers now warrant expanding that investment and the team from four to eight account managers by the start of 2024. We are encouraged by transplanter feedback that Omisirge may both increase the number of patients able to access an appropriate donor source and address some limitations of other donor sources.”
Approximately 8,000 stem cell transplants are performed in the U.S. each year in patients with hematologic malignancies1 and another 1,700 patients are estimated to be eligible for transplant but unable to find a donor.2 The ability to find a donor is historically more challenging for racially and ethnically diverse populations than for patients who are white.3 Gamida Cell market analyses indicate that Omisirge has the ability to capture approximately 20% of allogeneic stem cell transplant market share by ~2028.
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies.
Source: Gamida Cell Ltd.