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(COMTEX) B: FDA grants fast track status for BLP25 Liposome Vaccine ( Cana
a NewsWire )
B: FDA grants fast track status for BLP25 Liposome Vaccine ( Canada NewsWire )

EDMONTON, AB, Sep 29, 2004 (Canada NewsWire via COMTEX) -- Biomira Inc.
(Nasdaq: BIOM) (TSX: BRA) and Merck KGaA of Darmstadt, Germany today announced
that the U.S. Food & Drug Administration (FDA) has granted Fast Track status to
the investigation of BLP25 Liposome Vaccine (L-BLP25) for its proposed use in
the treatment of non-small cell lung cancer (NSCLC).

The FDA's Fast Track programs are designed to facilitate the development and
expedite review of drugs that are intended to treat serious or life-threatening
conditions and that demonstrate the potential to address unmet medical needs.
With Fast Track designation, there may be more frequent interactions with the
FDA during the development of a product and eventually a company may be eligible
to file a U.S. biologics license application (BLA) on a rolling basis as data
becomes available. This permits the FDA to review a filing as it is received,
rather than waiting for the entire document prior to commencing the review
process. Due to the nature of these types of products, BLAs filed with Fast
Track status are generally eligible for priority review, which could decrease
the typical review period.

Biomira submitted a Fast Track application to the FDA, which included
encouraging results from a controlled, randomized Phase IIb study in Stage IIIB
and IV NSCLC patients. Results from the Phase IIb study will be presented at the
European Society of Medical Oncology meeting (ESMO) to be held in Vienna,
Austria, on November 1.

A recent letter received from the FDA stated, "We have reviewed your request and
concluded that it meets the criteria for the Fast Track designation. Therefore,
we are designating as a Fast Track Drug Product development program the
investigation of Liposomal Vaccine in the extension of survival among patients
with unresectable stage 3a and locoregional stage 3b non-small cell lung cancer
following first line chemotherapy. We look forward to working with you to
expedite the development and review of this promising proposed use of the
product."

"Fast Track designation for L-BLP25 for the treatment of these patients is an
important step in the development of this product candidate and may help us
bring this potentially promising drug to patients more quickly," said Alex
McPherson, MD, PhD, President and CEO of Biomira. "This is a significant
milestone for the Company, highlighting the importance of product candidates
such as L-BLP25 to one day address a sizeable unmet need in this patient
population. We believe our vaccine will be able to provide a new treatment
option for men and women with NSCLC that has the potential to both extend and
improve the quality of their lives."

L-BLP25 is a synthetic MUC1 peptide vaccine, designed to induce an immune
response to cancer cells. L-BLP25 incorporates a 25-amino acid sequence of the
MUC1 cancer mucin, encapsulated in a liposomal delivery system. The liposome
enhances recognition of the cancer antigen by the immune system and facilitates
better delivery.

Biomira and Merck KGaA continue to explore opportunities for early registration
for this product candidate with other regulatory agencies. Plans are also
underway for a confirmatory Phase III study.

About Lung Cancer

Lung cancer is the leading cause of cancer-related mortality for both sexes in
North America. In 2004, approximately 174,000 new cases of lung cancer will be
diagnosed in the U.S. - 54 per cent of them in men and 46 per cent in women.
Approximately 160,000 people will die of this disease in the U.S. alone in 2004.
In Canada, the mortality percentages are slightly higher for men - 57 per cent
of deaths from lung cancer will occur in men and 43 per cent will be in women.
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 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. We are The Cancer Vaccine
People(TM).

Merck is a global pharmaceutical and chemical company with sales of EUR 7.2
billion in 2003, a history that began in 1668, and a future shaped by 28,300
employees in 56 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 74 per cent interest and free
shareholders own the remaining 26 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.

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 or attainment of regulatory or
product approvals and whether or not the timing may be expedited, the timing of
clinical trials approvals, the timing of clinical trials, the efficacy of
products or the availability of capital. 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. All forward-looking
statements are expressly qualified in their entirety by this cautionary
statement.

VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION:
http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=76826


CONTACT: For further information: Biomira Company Contacts: Bill Wicks
n,
Manager, Public Relations, [phone]; Jane Tulloch, Dire
tor, Investor
Relations, [phone]; U.S. Media Contact: Daniel Budwick
BMC
Communications, [phone] X14;
To request a free copy of this organization's annual report,
lease go to
http://www.newswire.ca and click on reports(at)cnw.

News release via Canada NewsWire, Calgary 403-269-7605

Copyright (C) 2004 CNW, All rights reserved

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KEYWORD: EDMONTON, AB
INDUSTRY KEYWORD: MTC
BIO
HEA
SPM

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