Remestemcel-L is a Cell Therapy owned by Mesoblast, and is involved in 31 clinical trials, of which 24 were completed, 6 are ongoing, and 1 is planned.

Remestemcel-L (Prochymal, Temcell) is a stem cell therapy that constitutes mesenchymal stem cells. MSCs express intermediate to low levels of HLA Class I, low levels of HLA Class II, and low levels of costimulatory molecules to avoid self-recognition by the immune system. Systemic administration of MSCs helps in decreasing the accumulation of collagen, fibrosis and levels of matrix metalloproteinases. Prochymal reduces the inflammation and promotes crypt regeneration. 

The drug candidates ability to reduce production of damaging pro-inflammatory cytokines, which are central to tissue damage in both ARDS and acute GVHD, provides a unifying mechanism of action for remestemcel-L in the treatment of such diseases.

The revenue for Remestemcel-L is expected to reach a total of $5.5bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Remestemcel-L NPV Report.

Remestemcel-L was originated by Case Western Reserve University and is currently owned by Mesoblast. JCR Pharmaceuticals is the other company associated in development or marketing of Remestemcel-L.

Remestemcel-L Overview

Remestemcel-L (Prochymal, Temcell) is a stem cell drug therapy. It is formulated as solution for intravenous route of administration. Remestemcel-L is indicated in the management of acute Graft versus Host Disease (aGvHD) in pediatric patients. Temcell is indicated for treatment in children and adults with acute Graft Versus Host Disease in Japan. Prochymal is an intravenous formulation of mesenchymal stem cells (MSCs). The stem cells are obtained from the bone marrow of healthy adult donors. Mesenchymal stem cells (MSCs) are nonhematopoietic stem cells of mesodermal origin, with the capacity to differentiate into both mesenchymal and nonmesenchymal lineages likewise bone, cartilage and muscle, tendon, fat and liver.

Prochymal is under development for the treatment of  ulcerative colitis, Crohn's disease, cutaneous ulcers, hypoxic-ischemic encephalopathy. It is administered through intravenous and subcutaneous routes. The therapeutic candidate is developed based on mesenchymal precursor cell (MPC) technology platform.

It was also under development for the treatment of acute steroid refractory graft versus host disease (GvHD) in adults and pediatrics as first line therapy and for acute epidermolysis bullosa, type 1 diabetes, chronic obstructive pulmonary disease (COPD), myocardial infarction and acute radiation syndrome (ARS), osteoarthritis, cartilage repair.

It is also under development for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19).

Mesoblast Overview

Mesoblast is a regenerative medicine company that develops regenerative cell-based products. Its most advanced candidate remestemcel-L is in phase III trials under the brand name RYONCIL for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). Mesoblast is advancing rexlemestrocel for localized inflammatory diseases including advanced heart failure, end-stage ischemic heart failure, and MPc-06-ID (rexlemestrocel) for the treatment of chronic low back pain. The company employs its proprietary technology platform, mesenchymal lineage adult stem cells (MLCs), to discover and treat cardiac diseases, and hematological diseases, spine and musculoskeletal disorders and immune-mediated and inflammatory conditions. The company has operations in the US, Australia, and Singapore. Mesoblast is headquartered in Melbourne, Victoria, Australia.

The company reported revenues of (US Dollars) US$10.2 million for the fiscal year ended June 2022 (FY2022), an increase of 37% over FY2021. The operating loss of the company was US$74.1 million in FY2022, compared to an operating loss of US$85.2 million in FY2021. The net loss of the company was US$91.4 million in FY2022, compared to a net loss of US$98.8 million in FY2021.

Quick View – Remestemcel-L

Report Segments
  • Innovator (NME)
Drug Name
  • Remestemcel-L
Administration Pathway
  • Intracoronary
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Dermatology
  • Gastrointestinal
  • Immunology
  • Infectious Disease
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Respiratory
  • Toxicology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.