Merck KGaA signed a binding letter of intent with Biomira Inc. to amend the licensing agreement for BLP25 liposome vaccine (L-BLP25), currently in development for the treatment of non-small cell lung cancer (NSCLC). 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, Merck and Biomira shared rights in the United States and Canada and Merck had exclusive rights in the rest of the world. Under the letter of intent, Merck will take over full responsibility, both administrative and financial, for development and commercialisation of L-BLP25, including the planned phase III trial in NSCLC, which remains on schedule with expected initiation of the trial in mid-2006. Merck is also considering the investigating the use of L-BLP25 to treat other types of cancer. In return, Biomira's co-promotion interest in US sales will be converted to a specified royalty rate. The royalty and other arrangements with respect to the rest of the world will remain generally unchanged. Similarly, the milestone payments to be made by Merck pursuant to the collaboration will remain essentially the same, claims the company release.
Biomira will retain responsibility for manufacturing L-BLP25, both for clinical trials and following any marketing approval.
"Merck is pleased that it has the opportunity to develop what appears to be a very promising treatment for non-small cell lung cancer, which is one of the most prevalent and deadly of all cancers," said Elmar Schnee, Merck deputy executive board member with responsibility for pharmaceuticals.
Dr. Alex McPherson, president and CEO of Biomira Inc. said, "This agreement will ensure the fastest possible initiation of the phase III programme in NSCLC as well as the possibility of exploring L-BLP25's potential in other forms of cancer. We are delighted by the strong and continued commitment that Merck has shown to this innovative and promising product. Merck's decision to take over the full cost of the trials will enable Biomira to focus our efforts and resources on our follow-on cancer vaccine, BGLP40, and on building our pipeline by acquiring new products."
L-BLP25 is a synthetic MUC1 peptide vaccine and is a biological response modifier with a chemically synthesised peptide of a cancer-associated protein antigen widely expressed on common cancers. It is designed to induce an immune response to both the synthetic antigen and the natural corresponding antigen as expressed on the cancer.
In 2005, approximately 172,000 new cases of lung cancer were diagnosed in the US. Approximately 163,000 people are estimated to have died of this disease in the US alone in 2005. NSCLC accounts for approximately 75 to 80 per cent of all primary lung cancers.
Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. Biomira's commitment to the treatment of cancer currently focuses on the development of synthetic vaccines and novel strategies for cancer immunotherapy.