EDMONTON, Aug. 8 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) 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.
"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.
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.
For more information on the START trial, or to find a participating
center and eligibility criteria, log on to www.nsclcstudy.com or
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. MUC1 is over expressed on
many cancers such as lung cancer, breast cancer and colorectal cancer.
Stimuvax is thought to work by stimulating the body's immune system to
identify and destroy cancer cells expressing MUC1.
A randomized Phase IIb trial was conducted in 171 patients with stage
IIIb and IV NSCLC with response or stable disease after first line therapy.
While the overall study results were not statistically significant, in the
randomization stratum of patients with stage IIIb locoregional disease,
Stimuvax showed a median survival of 30.6 months versus 13.3 months in the
control group - an improvement of 17.3 months. In the Phase IIb trial, side
effects were primarily limited to mild-to-moderate flu-like symptoms, GI
disturbances, and mild injection site reactions.
Biomira is a biotechnology company specializing in the development of
innovative therapeutic products for the treatment of cancer. Biomira's goal is
to develop and commercialize novel synthetic vaccines and targeted small
molecules that have the potential to improve the lives and outcomes of cancer
This press release contains forward-looking statements, including,
without limitation, statements related to payments Biomira may expect to
receive; the therapeutic and commercial potential of Stimuvax(R) and other
drug candidates in Biomira's pipeline; future clinical development plans; the
details of the clinical trials; and the anticipated future size of the market
for Stimuvax. Any statements contained in this press release that are not
statements of historical fact may be deemed to be forward-looking statements.
Words such as "believes," "anticipates," "plans," "expects," "will,"
"intends," "potential," "possible" and similar expressions are intended to
identify forward-looking statements. These forward-looking statements are
based upon Biomira's current expectations. Forward-looking statements involve
risks and uncertainties. Various factors could cause actual results to differ
materially from those projected in forward-looking statements, including those
predicting the timing, duration and results of clinical trials, the timing and
results of regulatory reviews, the safety and efficacy of Stimuvax, and the
possibility of future milestone and royalty payments. There can be no
guarantee that the results of earlier trials will be predictive of either
safety or efficacy in future trials. Biomira expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in the
company's expectations with regard thereto or any change in events, conditions
or circumstances on which any such statements are based.
For further information:
For further information: Investor and Media Relations Contact: Stephanie
Seiler, Ph.D., Gemini BioProjects LLC, (206) 713-0124, email@example.com