FDA helps Md. business EntreMed is granted aid in developing thalidomide treatment


August 21, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

The Food and Drug Administration has granted EntreMed Inc. tax credits and other benefits to help it develop thalidomide as a treatment for Kaposi's sarcoma, a skin cancer associated with AIDS, the Rockville company announced yesterday.

The company's thalidomide treatment won "orphan drug" status, an FDA category used to encourage the development of pharmaceuticals for relatively rare ailments such as Kaposi's sarcoma.

Gaining orphan drug status is no guarantee that the treatment will win FDA approval. EntreMed is not at the stage of seeking FDA approval for its treatment, which involves a drug banned in the 1960s because it caused severe birth defects in 48 countries. Thalidomide was not sold in the United States until this year.

Only a few experimental drugs each year win the federal agency's orphan designation, which guarantees a company seven years of exclusive marketing rights, plus tax credits for research and development costs, and a reduction in FDA application fees.

The designation is aimed at encouraging drug research for illnesses that affect fewer than 200,000 people. A 1997 report in the Annals of Pharmacology put the number of acquired immune deficiency syndrome patients in the United States with Kaposi's sarcoma at about 47,800, EntreMed said.

The biotechnology company, which has no drugs on the market, is in the early stages of testing thalidomide on people suffering from Kaposi's sarcoma.

The FDA opened the door to thalidomide's first use in the United States last month when it approved the drug for treating a painful leprosy-related inflammation.

Celgene Corp. of Warren, N.J. has rights to market the drug for the leprosy condition.

Other companies, including Andrulis Pharmaceuticals Inc. of Beltsville, are researching thalidomide's use against AIDS-related ulcers, brain tumors and autoimmune disorders, such as lupus and rheumatoid arthritis.

Winning the orphan drug status was an important milestone in EntreMed's effort toward gaining FDA approval for the cancer treatment, company executives said yesterday.

"This designation will assist EntreMed's research efforts by exempting the company from fees associated with an FDA marketing application, and may additionally provide certain tax credits for research costs," said Dr. John W. Holaday, EntreMed president and chief executive officer.

In early July, researchers for the National Cancer Institute and EntreMed reported on their clinical study involving a small group of Kaposi's sarcoma patients who were treated with thalidomide.

In their report to the 12th World AIDS Conference in Geneva, six of 13 patients in the trial had a 50 percent reduction in nodular skin lesions associated with the disease after receiving 1,000 milligrams a day of thalidomide.

Other patients' conditions stabilized, or their lesions were reduced less than 50 percent, said Dr. Edward Gubish, EntreMed's senior vice president for research and development.

He said the results were "encouraging" and that the company is planning further human studies to explore the use of thalidomide in combination with alpha-interferon, a traditional drug treatment for Kaposi's sarcoma. The company hopes to seek FDA approval for that trial later this year, said Gubish.

Shares in EntreMed, which rose to a high of $85 a share in May after a New York Times article portrayed one of its experimental drugs as a possible cure for cancer, closed yesterday at $23.375, down 12.5 cents.

Pub Date: 8/21/98

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