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Dow Jones Newswires -- June 2, 1998
FDA Panel Backs Seragen's Ontak For Lymphoma
By Otesa Middleton
WASHINGTON (Dow Jones)--Seragen Inc. (SRGN) received an endorsement from a federal advisory panel for its drug Ontak, which could be the first drug approved for treating cutaneous T-cell lymphoma.
The final decision rests with the U.S. Food and Drug Administration, which usually clears products recommended by its expert panels.
Cutaneous T-cell lymphoma is a rare disease, which afflicts 5,000 to 10,000 Americans. It is a non-Hodgkin's lymphoma that usually causes frequent skin infections, disfigurement, severe itching, pain and ultimately death. Treatment for the disease includes topical therapies, radiation, interferon-alpha and chemotherapy.
Hopkinton, Mass.-based Seragen studied the drug in 456 patients. To show the drug's effectiveness, Seragen looked at 143 patients.
The company said 30% of patients showed a partial response, which is at least a 50% reduction in tumor size, and 10% had a complete response.
Most patients reported adverse reactions ranging from nausea to mental problems to cardiac events when taking Ontak, with seven deaths occurring during the trial. FDA reviewer Dr. Bernard Parker said it's hard to determine whether Ontak contributed to any of the deaths.
The company applied to the FDA last December, and the agency agreed to accelerate its review to make a decision within six months of Seragen's filing. FDA has also designated Ontak an "orphan drug," which gives companies incentives to encourage the development of drugs to treat rare diseases.
-Otesa Middleton: 202-862-6654
The committee said the drug should be approved for patients with advanced disease who have relapsed or patients in the early stages of the disease who have failed after using other therapies. The panel also urged the company to continue the trials.
"We need another drug for this disease," said Dr. Wilma Bergfeld, a dermatologist and consultant to the FDA committee.
Panelist Dr. Edward A. Sausville, a director at the National Cancer Institute, said no one can deny Ontak is active against the disease but said the benefits don't last as long as some other agents.
"This disease is almost biblical in its symptoms and disfigurement."
Ira Loss, an analyst who follows the pharmaceuticals industry for HSBC Washington Analysis, said the panel's recommendation "seals the deal" for Ligand Pharmaceuticals Inc. (LGND) to purchase Seragen. "If the committee didn't recommend the drug for approval, (Ligand) shareholders might have objected to the purchase."
As reported May 11, Ligand Chairman David Robinson said the company signed a definitive agreement to acquire Seragen for $67 million in cash and stock, of which $37 million is contingent upon final regulatory approval of Ontak. |
