`2001 WLNR 13137035
`
`Chicago Sun Times (IL)
`Copyright © 2001 Inc.
`
`August 14, 2001
`
`Section: NEWS
`
`Thalidomide substitute could be disease fighter
`
`Jim Ritter
`
`Thalidomide, a drug once banned because it caused horrific birth defects, has become something of a miracle drug.
`
`About 10,000 patients in the United States--including former House member and vice presidential candidate Geraldine
`Ferraro--are taking thalidomide for cancer, arthritis, lupus, leprosy, AIDS symptoms and other conditions.
`
`Now, researchers are developing thalidomide substitutes that could provide the benefits of the dangerous drug, without
`the terrible side effects.
`
`"We hope very soon to retire thalidomide forever and replace it with better drugs," said Dr. Azra Raza of Rush-
`Presbyterian-St. Luke's Medical Center.
`
`Raza is beginning a clinical trial of a thalidomide substitute called Revimid for patients with a rare blood disorder called
`myelodysplastic syndrome, or MDS. The disease causes anemia and fatigue, and develops into leukemia in about one-
`third of patients.
`
`In an earlier study, Raza reported that 16 of 83 MDS patients were helped significantly by thalidomide. Among them
`is Charlene Brown of Gary.
`
`Brown, 67, was so fatigued and anemic she required repeated blood transfusions. Since going on thalidomide two years
`ago, Brown said, she hasn't needed further transfusions, and her fatigue "has subsided quite a bit."
`
`Thalidomide was a popular treatment in the late 1950s and early 1960s for pregnant women suffering from insomnia
`and nausea. More than 10,000 babies in 46 countries were born with defects--often grotesque--attributed to thalidomide.
`Some had no arms or legs. Others had flappers extending from their shoulders or toes extending from their hips. They
`also had missing ears, genital abnormalities and heart and kidney problems.
`
`In 1998, the Food and Drug Administration approved thalidomide for leprosy sores, and since then, doctors have been
`prescribing the drug "off label" for other conditions. Thalidomide also is being studied in more than 200 clinical trials.
`It costs about $10,000 for one year's worth
`
`DR. REDDY’S LABS., INC. EX. 1014 PAGE 1
`
`
`
`Any thalidomide patient capable of becoming pregnant must have a pregnancy test before starting the drug and use two
`contraceptive methods or not have intercourse. Male patients must use condoms.
`
`Thalidomide also can cause drowsiness, dizziness, constipation and tingling or numbness in hands and feet that could
`be permanent.
`
`Celgene Corp., which sells thalidomide under the brand name Thalomid, has developed three substitutes by slightly
`altering the chemical structure of thalidomide. In preliminary clinical trials, Revimid appears to be more potent than
`thalidomide and does not cause drowsiness. And unlike thalidomide, Revimid does not cause birth defects in rabbits.
`
`For information on the Rush-Presbyterian trial, call (312) 563-2538.
`
`---- Index References ----
`
`Company: MEDICAL CENTER OF SHERMAN LLC; MHI DIGITAL SYSTEM CO LTD; MDS MOVING DOOR
`SYSTEM AND COMPONENTS; MEDIENGRUPPE M DUMONT SCHAUBERG GMBH AND CO KG; MDS;
`PT MILLENIUM DANATAMA SEKURITAS; CELGENE CORP; MERCURIES DATA SYSTEMS LTD; MDS
`SGPS SA
`
`Region: (North America (1NO39); Americas (1AM92); USA (1US73))
`
`Language: EN
`
`Other Indexing: (AIDS; CELGENE CORP; FOOD AND DRUG ADMINISTRATION; MDS; MEDICAL
`CENTER) (Azra Raza; Brown; Charlene Brown; Geraldine Ferraro; Male; Raza; Revimid)
`
`Keywords: Thalidomide Revimid clinical trial FDA (HEALTH - MEDICAL); (NEWS)
`
`Word Count: 404
`
`End of Document
`
`DR. REDDY’S LABS., INC. EX. 1014 PAGE 2
`
`