BIOM - Biomira and Merck KGaA sign amended and restated collaboration and supply agreements related to Stimuvax(R)
Last Update: 8:00 AM ET Aug 8, 2007
EDMONTON, Aug 08, 2007 /PRNewswire-FirstCall via COMTEX/ -- Biomira Inc. (BIOM : biomira inc com
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BIOM0.96, -0.01, -1.0%) (CA:BRA: news, chart, profile) today announced the signing of amended and restated collaboration and supply agreements related to Stimuvax(R) with Merck KGaA of Darmstadt, Germany. The amended agreements restructure the agreements originally signed in 2001, and are based upon the letter of intent signed in January 2006. Stimuvax is an innovative investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. Merck KGaA currently is conducting a global Phase 3 trial of Stimuvax in patients with unresectable Stage III non-small cell lung cancer (NSCLC).
Under the terms of the restated agreements, Merck will have world wide marketing rights to and will be entirely responsible for the further clinical development of Stimuvax. Biomira is entitled to development and sales-based milestone payments and a royalty on net sales. Biomira retains responsibility for the manufacture of Stimuvax, including process development and scale-up for commercial manufacturing. Merck will exclusively purchase Stimuvax from Biomira; with respect to purchases for commercial sales, the purchase price will be subtracted from Biomira's royalty. The restated agreements provide Biomira with revised payments based on certain milestones related to manufacturing scale-up and process transfer. Biomira also will receive a payment of U.S. $2.5 million upon clearance of the transaction with the U.S. anti-trust authorities.
"We are pleased to conclude these revised agreements with Merck, enhancing our relationship for this exciting product," said Dr. Robert L. Kirkman, M.D., President and Chief Executive Officer of Biomira. "Given the significant clinical and commercial potential for Stimuvax, we believe that Merck KGaA's expertise and resources in global clinical development, sales and marketing will help to bring this innovative vaccine to as many patients as possible. Merck KGaA has demonstrated its ability to bring important new cancer therapies to market, and we believe this collaboration will enable robust and efficient development of Stimuvax in NSCLC and, potentially, several additional cancer indications."
Merck KGaA and its U.S. affiliate, EMD Serono, Inc., currently are conducting a Phase 3 trial of Stimuvax in patients with unresectable Stage III NSCLC. This global trial, known as START (Stimulating Targeted Antigenic Responses To NSCLC) is expected to enroll more than 1,300 patients in approximately 30 countries. The trial is designed to assess survival in patients receiving best supportive care and Stimuvax compared with patients receiving best supportive care alone.
Financial Guidance
Biomira believes the following financial guidance to be correct as of the date provided. We are providing this guidance as a convenience to investors, and we assume no obligation to update it.
Based on the terms of the restated and amended supply and collaboration agreements with Merck announced herein, Biomira is updating its prior financial guidance. The restated agreements provide for near-term payments which Biomira believes are sufficient to fund its operations at current levels for approximately an additional six months. Biomira currently anticipates receiving a substantial portion of these milestones before the end of 2008. As a result, the Company believes that it currently has sufficient cash resources to last through the end of fiscal 2008.
About the START Trial
The START trial is a randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum based chemo-radiotherapy. The study has been designed considering scientific advice from the European Medicines Agency (EMEA/CHMP) and has been agreed upon with the U.S. Food and Drug Administration (FDA) through a Special Protocol Assessment (SPA). Data from a randomized Phase IIb trial described below encouraged the initiation of the Phase III program.
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