YM BioSciences’ EGFr antibody receives EU orphan drug designation through Oncoscience AG, its European partner
Oncoscience | August 10th, 2004
10.08.2004 – Mississauga.
YM BioSciences Inc., the cancer drug development company with an advanced-stage portfolio, and its majority-owned subsidiary, CIMYM Inc., announced that their anti-cancer drug TheraCIM hR3 has been designated an Orphan Drug by the European Medicines Agency for the Evaluation of Medical Products (EMEA) for the treatment of glioma. This designation was obtained by Oncoscience AG, the Company’s European development partner for the drug. TheraCIM hR3 is licensed to YM’s subsidiary CIMYM Inc. by the Center for Molecular Immunology.
“Orphan drug status provides TheraCIM hR3 with up to ten years of market exclusivity in Europe, greatly enhancing this product’s commercial potential,” said David Allan, Chairman and CEO of YM BioSciences. “It also ensures that assistance in meeting European regulatory requirements is provided, strengthening our regulatory position for this important cancer drug.”
TheraCIM hR3, a humanized monoclonal antibody, is licensed as “Theraloc” to Oncoscience AG for Europe and is currently in a Phase I/II trial in paediatric glioma, a form of brain cancer, for which the first patients were recruited in June 2004. Oncoscience is proposing to initiate several additional studies for TheraCIM hR3, including a Phase III registration trial in adult glioma that is anticipated to start in Q4, 2004 and a Phase II trial in metastatic pancreatic cancer also anticipated to start in Q4, 2004. Results of a previous Phase I/II trial for TheraCIM hR3 were published in the Journal of Clinical Oncology on May 1, 2004.
“The combination of this orphan drug designation immediately preceding the launch of a Phase III registration trial in the designated indication is highly significant for the development of this drug,” said Ferdinand Bach, CEO of Oncoscience. “We are especially proud to have obtained this designation within only six months thanks to the excellent work of our dedicated team.”
On July 15, 2004, YM BioSciences announced that an agreement between it and CancerVax Corporation of San Diego, CA for two other cancer products it licensed from the Centre of Molecular Immunology was approved by the US Treasury Department.