Dirloctocogene samoparvovec is a Gene Therapy owned by Spark Therapeutics, and is involved in 3 clinical trials, of which 2 are ongoing, and 1 is planned.

RG-6357 (SPK-8011, SPK-FVIII) acts by activating the factor VIII which is an essential blodd clotting protein. This activated factor VIII converts factor X to the activated form Xa. Activated factor X converts prothrombin into thrombin which is responsible for the conversion of the fibrinogen into fibrin and leads to clot formation.

The revenue for Dirloctocogene samoparvovec is expected to reach a total of $4.8bn 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. View the complete picture with the Dirloctocogene samoparvovec NPV Report.

Dirloctocogene samoparvovec was originated by Children’s Hospital of Philadelphia and is currently owned by Spark Therapeutics. F. Hoffmann-La Roche is the other company associated in development or marketing of Dirloctocogene samoparvovec.

Dirloctocogene samoparvovec Overview

RG-6357 (SPK-8011, SPK-FVIII) is under development for the treatment of hemophilia A. It is administered through intravenous route. The therapeutic candidate constitues of Adeno-associated virus (AAV) encoding coagulation factor VIII (Factor VIII). The drug candidate is a new molecular entity.

F. Hoffmann-La Roche Overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

The company reported revenues of (Swiss Francs) CHF62,801 million for the fiscal year ended December 2021 (FY2021), an increase of 7.7% over FY2020. In FY2021, the company’s operating margin was 28.9%, compared to an operating margin of 31.8% in FY2020. In FY2021, the company recorded a net margin of 22.2%, compared to a net margin of 24.5% in FY2020.

Quick View – Dirloctocogene samoparvovec

Report Segments
  • Innovator
Drug Name
  • Dirloctocogene samoparvovec
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Hematological Disorders
Key Companies
Highest Development Stage
  • Phase III

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.