[MOL] FDA approves pacis BCG for treatmetn of bladder cancer..... [01853] Medicine On Line


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[MOL] FDA approves pacis BCG for treatmetn of bladder cancer.....



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:

------------------------------------------------------------------------
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.
------------------------------------------------------------------------

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.


Warmly, lillian

 
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