Enzon and Schering-Plough Collaborate on Phase III Clinical Trials for PEG-INTRON and Rebetol Combination Therapy

Strategic Insights -

Enzon, Inc. has announced that Schering-Plough Corporation has initiated Phase III clinical trials for a combination therapy of PEG-INTRON and Rebetol (ribavirin) for the treatment of hepatitis C. This collaboration marks a significant step in the development of PEG-INTRON, a modified form of INTRON A, which has been developed using Enzon's proprietary PEG technology to enhance its therapeutic properties.

Key Takeaways:

  • Schering-Plough has initiated Phase III clinical trials for a combination therapy of PEG-INTRON and Rebetol (ribavirin) for the treatment of hepatitis C, with Enzon entitled to royalties for product sales and milestones.
  • PEG-INTRON is a modified form of INTRON A, developed using Enzon's proprietary PEG technology to have longer-acting properties and an improved side-effect profile.
  • Under the licensing agreement, Enzon has the option to exclusively manufacture PEG-INTRON in the U.S.
  • Schering-Plough is continuing development of PEG-INTRON as a monotherapy for hepatitis C and is conducting Phase III clinical trials for two cancer indications: malignant melanoma and chronic myelogenous leukemia (CML).
  • PEG-INTRON is also in early stage trials for various solid tumors, including dosing once a week for CML, as opposed to a daily regimen.
  • Enzon has two products on the market using its PEG-modification technology: ONCASPAR, for acute lymphoblastic leukemia (ALL), and ADAGEN, for severe combined immunodeficiency disease (SCID).
  • Enzon's research focuses primarily on oncology, with several products in various stages of clinical development, including PEG-INTRON, in collaboration with Schering-Plough.

Statistics:

  • 1997: Phase III clinical trials for PEG-INTRON began for the treatment of hepatitis C.
  • 1999: Enzon announced the initiation of Phase III clinical trials for PEG-INTRON and Rebetol combination therapy.

Sources:

  • Business Wire. (1999, February 1). Enzon, Inc. Announces Schering-Plough's Initiation of Phase III Clinical Trials for Combination Therapy of PEG-INTRON and Rebetol for the Treatment of Hepatitis C.
  • Enzon, Inc. (1999). Enzon, Inc. Announces Schering-Plough's Initiation of Phase III Clinical Trials for Combination Therapy of PEG-INTRON and Rebetol for the Treatment of Hepatitis C.