EDMONTON, Sept. 23 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) today
announced a change to the anticipated timetable for the start of its planned
BLP25 Liposome Vaccine (L-BLP25) phase 3 study in the treatment of non-small
cell lung cancer (NSCLC). The change will allow the Company and its
collaborator on L-BLP25, Merck KGaA of Darmstadt, Germany, to address an
accelerated stability issue discovered during the manufacturing process.
As a result, the start of the trial, which was planned to start at the
end of 2005, is now expected to move into 2006.
An accelerated stability study of a vaccine lot manufactured to test
phase 3 manufacturing processes and equipment indicated a stability problem,
which may have been due to excess moisture in the product. Accelerated
stability studies are intended to provide data to predict long-term product
stability under normal storage conditions. The Companies, working with the
contract manufacturer, are focused on resolving this issue as quickly as
possible.
"An article published in the prestigious Journal of Clinical Oncology
(JCO) this month underlined our confidence in the potential of L-BLP25 and the
clinically important results seen with the product to date in the treatment of
non-small cell lung cancer," said Dr. Alex McPherson, MD, PhD, President and
CEO of Biomira. "We are working with Merck KGaA and others to discover the
cause of the problem now evident during the manufacturing process and to take
corrective action as quickly as possible."
About Lung Cancer
In 2004, approximately 174,000 new cases of lung cancer were diagnosed in
the U.S. Approximately 160,000 people are estimated to have died of this
disease in the U.S. alone in 2004. NSCLC accounts for approximately 75 to
80 per cent of all primary lung cancers. At the time of diagnosis, only
25 per cent of patients are potentially curable by surgery.
The Companies
Biomira's collaboration in developing therapeutic cancer vaccines is with
Merck KGaA. Merck is a global pharmaceutical and chemical company with sales
of EUR 5.9 billion in 2004, a history that began in 1668, and a future shaped
by 28,600 employees in 54 countries. Its success is characterized by
innovations from entrepreneurial employees. Merck's operating activities come
under the umbrella of Merck KGaA, in which the Merck family holds a
73 per cent interest and free shareholders own the remaining 27 per cent. The
former U.S. subsidiary, Merck & Co., has been completely independent of the
Merck Group since 1917. Merck KGaA has built a strategic oncology portfolio by
developing and in-licensing product candidates in four areas -- monoclonal
antibodies, therapeutic vaccines, immunocytokines and angiogenesis inhibitors.
EMD Pharmaceuticals Inc., the U.S. affiliate of Merck KGaA, is a fully
integrated pharmaceutical company with an initial emphasis on launching new
products in oncology. Located in Durham, N.C., EMD focuses on meeting patient
and physician needs with pioneering pharmaceutical products and services.
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.
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This release may contain forward-looking statements. Various factors
could cause actual results to differ materially from those projected in
forward-looking statements, including those predicting the timing of the
L-BLP25 phase 3 trial or the Company's ability to resolve vaccine
manufacturing issues in a reasonable timeframe. Although the Company believes
that the forward-looking statements contained herein are reasonable, it can
give no assurance that the Company's expectations are correct or that the
Company will have sufficient resources to fund clinical trials. All forward-
looking statements are expressly qualified in their entirety by this
cautionary statement.
