-- Positive Opinion from EU Advisory Committee Could Mark the Return of Thalidomide to Europe --
North Hollywood, CA and Würzburg, Germany, January 30, 2008 – The International Myeloma Foundation (IMF) – supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians – today said the positive opinion from the European Medicines Agency (EMEA) could clear the way for a new treatment regimen in Europe. The decision recommends approval of Thalidomide Pharmion® in combination with melphalan and prednisone for newly diagnosed patients over 65.
"Thalidomide is the first of what are called the Novel Therapies that - along with VELCADE® and REVLIMID® - have changed the outlook for myeloma patients," said Susie Novis, president and co-founder of the IMF. "Thalidomide is available in the United States, Australia, New Zealand and elsewhere now, and we would like all patients to have safe access to its demonstrated benefits.
The combination of melphalan and prednisone (MP) was once the standard of care for myeloma in Europe, but recent studies have shown the combination is greatly improved by the addition of the Novel Therapies: This positive opinion for thalidomide MP is based on a multi-center clinical trial showing average survival of more than 4 years, a year and a half more than MP without thalidomide. Studies have also shown improved response adding VELCADE to MP and adding REVLIMID to MP.
The recommendation sets the stage for the return of thalidomide to Europe with safe distribution for an important indication. Thalidomide, developed as THALOMID® from the Celgene Corporation, was approved for patients in the United States in 2006. Although once associated with an epidemic of birth defects when prescribed for pregnant women, a proprietary risk management system in the United States has seen more than 100-thousand prescriptions without a single birth defect, demonstrating the drug can be used safely.
German hematologist Ralph Naumann, of the University Clinic in Dresden, Germany prescribes thalidomide for his patients even though he personally has experienced the effects of thalidomide since his own mother took it when she was pregnant. He has stated: "Thalidomide is not a bad drug, it's just a drug that was badly used, and for the many myeloma patients today who are benefiting from thalidomide, that's a crucial distinction."
Myeloma, also called multiple myeloma, is a cancer of the bone marrow that affects production of red cells, white cells and stem cells. It affects an estimated 750,000 people worldwide, and in industrialized countries it is being diagnosed in growing in numbers and in increasingly younger people. There is no cure, but by using therapies in combination and in sequence doctors are moving myeloma toward becoming a chronic disease.
The positive recommendation could lead to marketing authorization for thalidomide-melphalan-prednisone in the EU within two to three months.
ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 165,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses on four key areas: research, education, support and advocacy. To date, the IMF has conducted more than 100 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF can be reached at +1818-487-7455. The global Website is www.myeloma.org with a companion Website in Spanish at www.myelomala.org.
Stephen Gendel, BioCom Partners, New York
+1 212 918 4650