FDA Approves Pacis BCG For Treatment Of Bladder Cancer
LAVAL, QC -- March 9, 2000 -- BioChem Pharma
Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its
immunotherapy against bladder cancer, Pacis(R) BCG, Live, for sale in the
U.S.
Pacis will be distributed in the
U.S. by UroCor, Inc. an Oklahoma City-based company with a focus on urological
disorders, including prostate and bladder cancer, and provides products and
services for many of the office-based urologists in the U.S. BioChem will
continue to manufacture the drug in its Quebec- based
facilities.
Pacis is indicated for
the treatment of carcinoma in situ of the urinary bladder. The recommended
course of treatment in the U.S. is a single dose, once per week, for six weeks,
usually administered in a urologist's office. As with all BCG Live products, the
following warnings are required:
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Pacis (R) contains live, attenuated mycobacteria. Because
of the
potential risk for transmission,
it should be prepared, handled and
disposed of as a biohazardous material.
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Already approved for use in several other countries,
including Canada, the product features the original Armand-Frappier strain of
Bacillus Calmette-Guerin (BCG), which has been in clinical use for a number of
years worldwide.
"We are pleased that
we have been able to successfully bring Pacis through the U.S. regulatory
approval process, which underscores the capabilities of our vaccine
operations,'' said Jacques R. Lapointe, BioChem's President and Chief Operating
Officer.
According to the American
Cancer Society, bladder cancer is the sixth most common cancer in the U.S. This
year, it estimates that more than 53,000 people will be diagnosed with bladder
cancer, and more than 12,000 people will die from the
disease.
BioChem Pharma is an
international biopharmaceutical company dedicated to the research, development
and commercialization of innovative products for the prevention and treatment of
human diseases with a focus in the anti-infective and anticancer
areas.
Related Link: BioChem Pharma
Inc.
