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Executive Summary

SHELL OIL SEEKING BUYER FOR TRITON BIOSCIENCES, the petrochemical giant's wholly-owned pharmaceutica biotechnology subsidiary. Shell announced April 19 that it is in the "very early stages" of exploring a sale of Alameda, California-based Triton and will pursue the matter in a "deliberate and orderly fashion so as to preserve Triton's value and to support the company's continuing progress in its projects." Shell is not putting a valuation on the biotech firm, saying instead that it would be "imprudent" to do so before negotiations determine a fair price. Triton Biosciences was established in 1983 as an outgrowth of Shell's 1980 entry into medical products, a development partnership with Cetus for interferons. Now, however, the Houston-based oil company said that Triton is "not sufficiently related to its to retain it for the long term." * To date, Shell has supported Triton with more than $100 mil. in funding for R&D, clinical evaluation and preparation for product commercialization. The petrochemical giant recently turned over to Triton a database of more than 80,000 organic compounds (originally developed by Shell's agricultural researchers) to be screened for biological activity. Triton's most advanced project is Fludara I.V. (fludarabine phosphate), an orphan drug for chronic lymphocytic leukemia (CLL), licensed by Triton from the federal government in 1984. The NDA for Fludara was filed in November 1989, two days after the drug received Treatment IND/Group C approval ("The Pink Sheet" Dec. 4, T&G-2). Fludara has been rated a "1A" drug by FDA. CLL is diagnosed in about 9,600 U.S. patients (mostly elderly) each year and affects 25,000 Americans at any one time, according to Triton. * In preparation for the launch of Fludara, Triton now has in place an oncology marketing and sales organization for North America. When Shell decided to sell Triton, the company halted negotiations with foreign companies to outlicense the drug in Europe in anticipation that a new parent would want the rights, a spokesperson said. Next furthest along in the pipeline is Betaseron, recombinant beta interferon developed by the Cetus-Triton partnership Tritus, which was established in late 1985. Betaseron is currently in Phase III trials for multiple sclerosis ("The Pink Sheet" Nov. 14, 1988, T&G-2). The trials are scheduled to conclude in mid-1991. Triton's MS database includes more than 3,000 patients. The product is also in an expanded Phase III trial in combination with AZT as an orphan drug for AIDS and ARC patients (Sept. 11, 1989, "In Brief") and in Phase II for anticancer indications. Triton's second drug for HIV is ADZU (azidouridine or CS-87), a nucleoside analog similar to AZT, which began Phase I studies in mid-June at Triton and is also being studied in conjunction with the National Institute for Allergy and Infectious Diseases. Two Triton products are expected to enter clinical evaluations next year: FEAU, a nucleoside analog/antiviral agent for herpes and hepatitis B, and TGF-alpha (biosynthetic transforming growth factor-alpha) for wound healing and cancer therapy. Triton has co-exclusive worldwide rights to TGF-alpha under a cross-licensing arrangement with Bristol-Myers Squibb. Pharmacia controls the ophthalmic license rights for the product. Also in earlier stages of development are an oral form of Fludara -- human clinicals have recently begun -- and TAB 250, an oncogene protein antibody with potential as an anticancer agent. Triton's diagnostic focus is centered on cancer, specifically bladder, colorectal, lung, breast and adult T-cell leukemia cancers and melanoma. Triton's partnership with Technicon Instruments, called TriTech, plans to launch its second product next year, the TECHNICON IMMUNO-1 automated assay system. The first product, DPA-1, a serum protein analysis test, was launched in late 1988.

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