YM BioSciences’ TheraCIM Granted US Orphan Drug Status
11/30/2004 Mississuaga, Ontario, Canada Press release Yahoo! Finance YM BioSciences Inc. the cancer drug development company with an advanced-stage portfolio, and its majority-owned subsidiary CIMYM Inc., today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to their EGF receptor monoclonal antibody, TheraCIM hR3, for the treatment of glioma (brain cancer). The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Orphan Drug Designation is granted to products that treat conditions affecting fewer than 200,000 people in the U.S. Orphan Drug Designation provides eligibility for a special seven-year period of market exclusivity at marketing approval, potential tax credits for research, potential grant funding for research and development, the possibility of reduced filing fees for marketing applications and, particularly, assistance with the review of clinical trial protocols. TheraCIM hR3 is currently undergoing two Phase II trials in Europe and is expected to become a Phase III candidate in early 2005. The Company's European licensee, Oncoscience AG, is enrolling children in a trial for pediatric brain cancer; and another trial is underway in metastatic pancreatic cancer. Oncoscience also expects to initiate the Phase III trial in adult glioma in early 2005. Orphan Drug Designation for glioma in Europe has already been conferred. "TheraCIM is currently undergoing a robust clinical program in Europe, which we anticipate will be paralleled by additional North American trials that [...]