Seattle Genetics’ drug gets FDA nod

  • Herald staff and Associated Press
  • Tuesday, August 24, 2004 9:00pm
  • Business

BOTHELL – Seattle Genetics Inc. said the U.S. Food and Drug Administration has granted an “orphan drug” designation to another of the company’s experimental cancer drugs.

The Bothell-based company’s SGN-40 is an antibody-based drug designed to treat multiple myloma, a cancer of plasma cells in the blood that often results in destruction of bone mass.

It’s undergoing phase 1 clinical trials for that condition and could be tested for other cancers later this year.

“This orphan drug designation is an important component of our SGN-40 development strategy and provides us with a number of potential financial and marketing benefits,” Clay Siegall, Seattle Genetics’ president and chief executive officer, said in a statement.

The Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 people in the United States. With the designation, Seattle Genetics can now receive federal funding to defray the costs of clinical trials, tax credits for research costs, a potential waiver of the FDA’s application user fee, and seven years of exclusivity on the market if the drug is approved.

The company’s SGN-30, another experimental cancer drug, already has received two such “orphan drug” designations in the past year.

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