The amended agreement gives Merck global development and marketing rights to the vaccine except in Canada, where the companies share rights to the vaccine. Previously the companies shared rights in the US and Canada and Merck had exclusive rights in the rest of the world.
Merck will now take over full responsibility for the development and commercialization of L-BLP25, including the planned phase III trial in non-small cell lung cancer (NSCLC), which remains on schedule with expected initiation of the trial in mid-2006. Merck is also considering the use of L-BLP25 to treat other types of cancer.
Under the terms of the amended agreement between the companies, Biomira will now receive royalties on Merck’s US sales of the drug. Merck will also continue to make payments to Biomira upon achievement of milestones.
Biomira will retain responsibility for manufacturing L-BLP25, both for clinical trials and following any marketing approval.
“This agreement will ensure the fastest possible initiation of the phase III program in NSCLC as well as the possibility of exploring L-BLP25’s potential in other forms of cancer,” said Dr Alex McPherson, president and CEO of Biomira.