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 $707m 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).

JCR Pharmaceuticals Overview

JCR Pharmaceuticals (JCR) manufactures, sells, buys, imports, and exports pharmaceutical products, regenerative drugs and drug substances. It provides biopharmaceuticals in the field of regenerative medicine for the treatment of rare diseases. The company offers pharmaceuticals to treat growth hormone deficiency, Turner syndrome, adult growth hormone deficiency, small for gestational age, renal anemia in dialysis patients, and anemia of prematurity; and a regenerative medical product for acute graft-versus-host disease and other disorders. JCR is also involved in the purchasing, selling, import and export of medical devices and laboratory instruments. It operates subsidiaries in Japan, Brazil, Switzerland, and the US. JCR is headquartered in Ashiya, Hyogo, Japan.

The company reported revenues of (Yen) JPY51,082 million for the fiscal year ended March 2022 (FY2022), an increase of 69.8% over FY2021. In FY2022, the company’s operating margin was 36.9%, compared to an operating margin of 28.1% in FY2021. In FY2022, the company recorded a net margin of 28.4%, compared to a net margin of 22.9% in FY2021. The company reported revenues of JPY5,975 million for the second quarter ended September 2022, a decrease of 37.8% over the previous quarter.

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.