Merck assumes development costs of Biomira's cancer vaccine

By Lisa Kerner

Erie, Pa., Jan. 26 - Biomira Inc. said it signed a letter of intent to amend the licensing agreement between Biomira BV and Merck KGaA for BLP25 Liposome Vaccine (L-BLP25), currently in development for the treatment of non-small cell lung cancer (NSCLC).

Merck KGaA will take over administrative and financial responsibility for the development and commercialization of L-BLP25, according to a company news release. This includes the planned phase 3 trial in non-small cell lung cancer, which is expected to enroll patients in mid 2006.

Merck also plans to investigate the use of L-BLP25 to treat other types of cancer. L-BLP25 is a synthetic MUC1 peptide vaccine and a biological response modifier.

All future development, regulatory, commercialization and marketing costs for L-BLP25 (excluding the Canadian territory) will be the sole responsibility of Merck KGaA effective March 1.

Biomira will receive royalties at a specified rate as well as milestone payments. The company will retain responsibility for manufacturing L-BLP25. Biomira remains responsible for the Canadian territory.

"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," Dr. Alex McPherson, Biomira president and chief executive officer, said in the release.

In October, Biomira said median survival for patients with stage 3B locoregional NSCLC who received L-BLP25 in a phase 2b study had an average survival of 30.6 months in the vaccinated group compared with 13.3 months for the unvaccinated group.

Biomira announced in November the interim results of a phase 2 non-small cell lung cancer single-arm, multi-center, open label study of L-BLP25. Results showed that, in terms of safety, the new formulation of the vaccine for the phase 3 trial was not different from the previous formulation, the company said.

The reformulated vaccine incorporated manufacturing changes intended to secure the future commercial supply of the vaccine. Pending completion of testing, it is expected that manufacturing for the phase 3 trial will resume in the first quarter of this year.

Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. The company is based in Edmonton, Alberta.

Merck KGaA is a global pharmaceutical and chemical company with its headquarters in Darmstadt, Germany.

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