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Executive Summary

CONNAUGHT LABS' THERACYS (BCG, LIVE) WILL BE LAUNCHED in approximately three months, after scale-up of the product is completed. Theracys was approved for bladder carcinomain situ, a form of cancer found in 20-30% of the 45,000 cases of bladder cancer diagnosed in the U.S. annually, FDA said in a May 21 press release. The product, Bacillus Calmette Guerin Live (intravesical), involves a live but weakened bacteria that is administered at a high dosage directly into the bladder via a urethral catheter. The bacteria "cause an inflammatory reaction that eliminates many of the cancer cells," FDA said. The patient retains the product about two hours before urinating. The procedure is repeated once a week for six weeks and then monthly for six to 12 months. FDA noted that BCG Live "may be used alone or following surgical scraping to remove visible tumor growth." FDA's May 21 approval of TheraCys came about one month later than originally anticipated ("The Pink Sheet" April 23, "In Brief"). The agency explained that discussions about the product's labeling, specifically about whether or not to call it a vaccine, were the cause of the delay. A different formulation and concentration of BCG is licensed in the U.S. and elsewhere for use as a tuberculosis vaccine. However, TheraCys is not approved for use as a vaccine. The approval was based on a controlled study sponsored by the National Cancer Institute in which 74% of patients with CIS of the bladder responded to treatment compared to 42% receiving Adria's Adriamycin (doxorubicin). "Patients treated with BCG had a median time for recurrence of the cancer of four years," FDA said. Flu-like symptoms such as fever, chills and nausea, and discomfort related to inflammation of the bladder were the most common side effects following therapy, FDA noted. Labeling warns physicians "to watch for and treat any spread of BCG organism throughout the body, which has been associated with two deaths," the agency added. In a same-day release, Connaught Labs President David Williams commented: "We're very pleased that our first entry into cancer therapeutics and urology has such potential for [carcinoma in situ] patients."

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