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Biotech / Medical : Celgene-CELG -- Ignore unavailable to you. Want to Upgrade?

To: margie who wrote (304)	5/10/1999 10:21:00 AM
From: Abuckatatime	Read Replies (1) \| Respond to of 804

NORD HONORS CELGENE CORPORATION for Development of THALOMID(R) (thalidomide) WASHINGTON, May 10 /PRNewswire/ -- The National Organization for Rare Disorders, Inc.(R) (NORD) will honor Celgene Corporation for its development of the orphan drug THALOMID(R) (thalidomide) to treat leprosy at its 16th Annual Tribute Banquet on Monday evening, May 10th at the Capital Hilton Hotel in Washington, D.C. "The gala celebrates the strong partnership between the patient community, medical researchers, health-related industries, and the federal government to promote development of new treatments for rare diseases," said NORD President Abbey S. Meyers. Celgene's first product, THALOMID(R) (thalidomide), was approved by the U.S. Food and Drug Administration (FDA) for marketing in 1998 for the treatment of erythema nodosum leprosum (ENL), a severe and debilitating condition associated with leprosy. Leprosy is an orphan disease in the United States, but is much more prevalent in developing countries such as Brazil and India. THALOMID(R) has also received orphan drug designation for multiple myeloma, Crohn's disease, mycobacterial infections, cachexia and ulceration in AIDS, Kaposi's sarcoma and glioblastoma. Thalidomide has extraordinary significance in the history of medicine. The drug was initially developed in the 1950's and marketed in Europe and Canada as a tranquilizer, but was never approved for sale in the U.S. because it was suspected to cause severe side effects. It was found that pregnant women who took the drug gave birth to babies with severe birth defects. Curious scientists wanted to understand why thalidomide caused severe birth defects in fetuses. An Israeli doctor who gave thalidomide to his male leprosy patients as a sedative unexpectedly noticed that their lesions and mouth ulcers disappeared. Further study indicated the drug blocks a protein that stimulates the immune system, and also inhibits growth of blood vessels, a process known as angiogenesis. Because of the drug's history, it required extraordinary courage for Celgene to move ahead toward regulatory approval of this drug. THALOMID(R)'s approval by the FDA was accompanied by unprecedented distribution restrictions to guard against pregnancy of patients. A major safety initiative undertaken by Celgene in this regard was development of the STEPS (System for Thalidomide Education and Prescribing Safety) program, which incorporates numerous safeguards for pregnancy prevention. Today, the promise of THALOMID(R) is finally coming to fruition, not only for leprosy but other diseases as well. There are approximately 60 clinical investigations in progress to study THALOMID(R)'s effectiveness as an antiangiogenic agent in treating numerous forms of cancer including glioblastoma (brain cancer), multiple myeloma, non-small cell lung cancer, and head and neck cancer; autoimmune diseases such as rheumatoid arthritis and Bechet's disease; and, inflammatory bowel diseases such as Crohn's disease. "The members of NORD salute Celgene for its extraordinary courage and fortitude in bringing this orphan drug to market," said Nancy Harris, chair of the NORD board of directors. Today THALOMID(R) stands as a very important lesson that good things can evolve out of a terrible tragedy when scientific curiosity impels a search for answers." "Celgene is proud to be recognized by NORD as a corporate leader in orphan drug development," said Sol J. Barer, Ph.D., president and chief operating officer. "We are continuing to investigate THALOMID(R)'s therapeutic effectiveness toward the objective of saving and improving the lives of patients with rare orphan diseases who may have few treatment options." The NORD Annual Tribute Banquet honors outstanding individuals, government leaders and corporations that have enhanced the lives of people with rare "orphan diseases." The 1999 honorees are: U.S. Senator Dianne Feinstein (D-Calif.); FDA Commissioner Jane Henney, M.D.; Agnes Varis, president, Agvar Chemicals, Inc.; Curt Engelhorn, president, European Foundation for the Advancement of Medicine; Celgene Corporation; Centocor, Inc.; and, Cephalon, Inc. SOURCE National Organization for Rare Disorders, Inc.