Seattle Genetics Receives Orphan Drug Designation for SGN-30

Strategic Insights -

Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its product candidate SGN-30 for T cell lymphomas, a category of non-Hodgkin lymphoma. SGN-30 is a monoclonal antibody currently in phase II clinical trials for the treatment of anaplastic large cell lymphoma and Hodgkin disease. The designation is expected to provide Seattle Genetics with benefits such as grant funding, tax credits, and marketing exclusivity.

Key Takeaways:

  • The FDA granted orphan drug designation to SGN-30 for T cell lymphomas, a category of non-Hodgkin lymphoma, on March 22, 2004.
  • SGN-30 is a monoclonal antibody in phase II clinical trials for the treatment of anaplastic large cell lymphoma and Hodgkin disease.
  • The orphan drug designation provides Seattle Genetics with the opportunity to obtain grant funding from the U.S. government to defray costs of clinical trial expenses.
  • The designation also offers tax credits for clinical research expenses, potential waiver of the FDA's application user fee, and seven years of marketing exclusivity in the event of market approval.
  • Seattle Genetics plans to initiate a phase II study of SGN-30 in cutaneous lymphoma later in 2004.
  • The Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States.

Statistics:

  • SGN-30 is currently in phase II clinical trials for the treatment of anaplastic large cell lymphoma and Hodgkin disease.
  • The orphan drug designation is expected to provide Seattle Genetics with seven years of marketing exclusivity in the event of market approval.
  • The FDA granted orphan drug designation to SGN-30 on one occasion prior to this, in July 2003, for Hodgkin disease.

Sources:

  • NewsRx.com & NewsRx.net (2004 MAR 22)
  • Seattle Genetics, Inc.