CETUS-BEN VENUE METHOTREXATE IS A $600,000 PRODUCT IN FOUR MONTHS
Executive Summary
CETUS-BEN VENUE METHOTREXATE IS A $600,000 PRODUCT IN FOUR MONTHS on the market, Cetus Exec VP Hollings Renton reported at the Industrial Biotechnology Association's annual financial meeting in Key Biscayne, Florida on Feb. 5. Launched in October, the generic methotrexate product was the joint venture's first ANDA approval. Seven ANDAs are currently pending at FDA, and the company plans four additional filings this month, Renton noted. "In addition, we will be expanding our venture with Ben Venue to include other generic products that are used in the treatment of cancer patients . . . like antiemetics and analgesics," he added. "To market the products, Cetus has put in place a sales and marketing organization of 14 people, with about half of those people directly involved in the field." Discussing Cetus' proprietary drug development program, Renton identified four therapeutics scheduled to begin U.S. clinicals in 1987 -- two immunotoxins, one for breast cancer and one for ovarian cancer, a human monoclonal antibody for gram negative bacteria and colony stimulating factor 1. Both immunotoxins have been shown efficacious in animal models, Renton said. "We have taken the time to do extensive safety studies in primates, and we are satisfied that the products that we have are safe and effective," he added. "We will be filing our IND this month for the breast immunotoxin." Both the immunotoxin for ovarian cancer and the human monoclonal for gram negative bacteria should reach clinicals by mid-year, Renton predicted, with an IND filing for CSF-1 planned for the second half of 1987.
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