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CETUS/BEN VENUE JOINT VENTURE HAS ANDAs ON FILE AT FDA COVERING SEVEN ANTICANCER GENERICS; FIRST PRODUCT METHOTREXATE IS MARKETED BY TWELVE MAN SALES GROUP

Executive Summary

Cetus' generic cancer drug joint venture with Ben Venue currently has ANDAs pending at FDA for seven generic drug products and 20 dosage forms, the biotech firm recently reported. In its fiscal 1986 annual report, Cetus called the venture an "opportunity to create near term profits for Cetus in advance of the introduction of our proprietary drugs developed through biotechnology." Cetus announced the formation of the 50/50 joint venture with Ben Venue, the largest contract manufacturer of single dosage I.V. drugs, a year ago ("The Pink Sheet" Sept. 30, 1985, p. 5). Explaining its reasons for entering the joint venture agreement, Cetus predicted it "ultimately will be advantageous to be able to market both chemical and biotechnology-based products because many of these anticancer drugs may be used together in combination therapy." Cetus-Ben Venue is marketing its first therapeutic product, methotrexate, via a twelve person salesforce following approval of four dosage forms of the generic anticancer agent Sept. 16. Cetus indicated it will increase its sales force over the next six to nine months as more generic drugs are approved. Cetus-Ben Venue is targeting a salesforce of approximately 30-40 detailmen by the time Cetus' recombinant interleukin-2 product, Proleukin, nears approval. By the end of 1988-early 1989, Cetus expects to have a salesforce in the 75-100 person range. The company noted in the annual report that it is currently "building a hospital sales force and marketing capabilities and establishing an image for Cetus in the medical community." Cetus' closest biotech compound to the market is Proleukin, which is now in Phase II clinicals but is expected to enter Phase III before the year's end. Cetus reported that Proleukin is currently being studied in 60-70 centers involving 70 protocols in approximately 1000 patients. Included in these trials is the Proleukin/LAK (lymphokine activated killer) cell study conducted by the National Cancer Institute's Steven Rosenberg, MD, which has been expanded to six additional centers. Proleukin is also being studied in combination with Betaseron (recombinant beta interferon) "for treating kidney and skin cancers," the annual report notes. In later trials, Cetus said, Proleukin will be combined with the company's tumor necrosis factor analog "for skin and lung cancers." Future trials will involve combining Proleukin with monoclonal antibodies and gamma interferon, the annual report notes. Betaseron, also in late Phase II study, is currently being tested in 40 centers for cancers, Cetus said. "Clinical responses have been seen in patients with melanoma, hairy cell leukemia, superficial bladder cancer, and Kaposi's sarcoma," the annual report states. "Promising results have also been recorded in trials against genital warts, viral hepatitis, and rhinovirus," Cetus added. Cetus said it is the only company with a beta interferon product in clinicals. The development of Betaseron is a joint venture between Cetus and Triton Biosciences. The third human protein developed by Cetus, tumor necrosis factor, is now being tested in three Phase I clinical trials. A combination trial with Proleukin will begin after the Phase I trials with tumor necrosis factor are completed, Cetus said. "In our experimental studies in animals we've been able to demonstrate a very strong synergy between the two compounds," the company commented. Tumor necrosis factor is expected to enter Phase II clinicals by early next year. Cetus reported that it has stepped up production of its colony stimulating factor-1. Cetus President Robert Fildes noted that in preclinical trials with CSF-1 Cetus has "already began to see some interesting results . . . in using CSF-1 to reconstitute the immune system." Cetus said it plans to begin clinical trials with CSF-1 in the first half of 1987. An immunotoxin product combining monoclonal antibodies with potent toxins is scheduled to enter human clinicals shortly, Cetus said. "The first human trials . . . will involve studies using the monoclonal itself to establish its specificity in the human patients and that will then be followed by using the immunotoxin including the toxin shortly after," Fildes stated.

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