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Merck KGaA Acquires Full U.S. Rights to BLP25 Liposome Vaccine |
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27 Jan 2006 |
Merck to commence Phase III clinical trial in non-small cell lung cancer in mid- 2006. Merck to assume development costs and will pay royalties to Biomira Inc.
Darmstadt, DE | Jan. 26, 2006 | Merck KGaA today announced the signing of a binding letter of intent with Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) 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 commercialization 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 U.S. 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.
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. “We believe this new agreement is not only beneficial for both companies but also for patients.”
Dr. Alex McPherson, President and CEO of Biomira Inc., commented: “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. 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.”
About L-BLP25
L-BLP25 is a synthetic MUC1 peptide vaccine and is a biological response modifier with a chemically synthesized 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 October, 2005 Biomira announced that median survival for patients with Stage IIIB locoregional non-small cell lung cancer who received L-BLP25 in a Phase IIb study had been determined. These results demonstrated an average survival of 30.6 months in the vaccinated group compared with 13.3 months for the unvaccinated group. A more comprehensive analysis of these data is expected in the first quarter of this year. In November, 2005 Biomira announced the interim results of a Phase II NSCLC single-arm, multi-center, open label study of L-BLP25. The results showed that the new formulation of the vaccine to be used in the Phase III clinical trial program is not different from the previous formulation from a safety perspective. The reformulated vaccine incorporated manufacturing changes intended to secure the future commercial supply of the vaccine.
About Lung Cancer
In 2005, approximately 172,000 new cases of lung cancer were diagnosed in the U.S. Approximately 163,000 people are estimated to have died of this disease in the U.S. alone in 2005. NSCLC accounts for approximately 75 to 80 percent of all primary lung cancers. At the time of diagnosis, only 25 percent of patients are potentially curable by surgery.
About Biomira Inc.
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.
SOURCE: Merk |
