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ROCHE/CETUS EUROPEAN ROFERON-A/PROLEUKIN CO-PROMOTION AGREEMENT

Executive Summary

ROCHE/CETUS EUROPEAN ROFERON-A/PROLEUKIN CO-PROMOTION AGREEMENT provides Roche with additional European marketing support for its recombinant alpha interferon product Roferon-A, and gives Cetus' EuroCetus subsidiary an additional anti-cancer product to promote while the biotech firm benefits from Roche's detail force muscle behind its recombinant interleukin-2 product Proleukin. Each company will pay the other an undisclosed commission. The agreement, announced April 23, covers Switzerland and the European Community, except Denmark and Greece. In a same-day press release, Immunex said that it expects to receive royalties on sales of IL-2 by Roche and Cetus. "Under agreements with Roche dating back to 1982, Immunex is entitled to receive royalties on all sales of IL-2 by Roche and its sublicensees, including Cetus," the Seattle-based biotech firm noted. Roche's Roferon-A is said to be lagging behind its direct competitor, Schering's Intron A. Schering's product, which the company predicted last year would have sales of $85 mil., is estimated to control 40% of the world market, with Roferon-A and Burroughs Wellcome's Wellferon splitting the remainder. Roferon-A is approved in Europe for six indications: hairy cell leukemia, chronic myeloid leukemia, Kaposi's sarcoma in AIDS, renal cell cancer and chronic active hepatitis B and hepatitis C. Proleukin currently is approved in six European countries for a single indication, renal cell carcinoma, and is backed by a marketing force of about 60. In the U.S., Cetus filed the Proleukin PLA for renal cancer in late November 1988 ("The Pink Sheet" Dec. 12, 1988, T&G-2). Cetus has predicted that Proleukin may be approved by FDA as early as the middle of this year. The product is awaiting assignment to an FDA advisory committee and a hearing date, a spokesperson said. The April 23 agreement marks a further deepening of the companies' collaborative relationship. The deal is also interesting as evidence of Roche's widening net of international biotech ties -- witness the pending purchase of 60% of Genentech -- and entry into new fields such as the home infusion therapy market last year ("The Pink Sheet" July 3, T&G-6). Last year alone, Roche and Cetus entered into three collaborative agreements. The last covers the development of ras oncogenes ("The Pink Sheet" Oct. 9, T&G-9). That deal was preceded by a February agreement for Cetus' GeneAmp polymerase chain reaction (PCR) technology and a late 1988 agreement not to challenge each other's patents on recombinant alpha interferon, Roche's IL-2 and Cetus' PEG-IL-2 ("The Pink Sheet" Jan. 2, 1989, T&G-5). While Roche will receive a boost from Cetus' marketing force, the deal could also be indicative of difficulties with its own IL-2 product, Teceleukin. Roche Labs, the Swiss firm's U.S. subsidiary, was reportedly in the final stages of preparing its PLA for melanoma and renal cell carcinoma in 1988; one has yet to be filed. Roche licenses its IL-2 from Ajinomoto and has a co-development agreement with Immunex. In addition to the co-promotion arrangement, both Roche and Cetus have agreed to collaborate on the clinical development of IL-2 for other potential cancer and non-cancer uses. Roche will pay Cetus an undisclosed initial payment and share in the ongoing expenses for the development of the additional therapeutic indications. The companies also plan to collaborate on the clinical development of Roferon-A and Proleukin as a combination therapy for cancer and other diseases. Roche will fund the development work. In the U.S., Cetus is in clinicals with IL-2 for a number of uses, including combinations with its own tumor necrosis factor for advanced cancer and with AZT for AIDS, ARC and Kaposi's sarcoma. Cetuss's PEG-IL-2 is being investigated for advanced renal cell cancer and as an orphan treatment for symptomatic primary immunodeficiency in children. Roferon-A is also under study for a variety of cancer indications, including as an orphan treatment for chronic myelogenous leukemia, for non-Hodgkins lymphoma, lupus, viral hepatitis, skin cancer, genital warts, mycosis fungoides and superficial bladder cancer. Additionally, Roche is looking at the product in combination with fluorouracil for esophogeal carcinoma, also an orphan indication, and with Teceleukin as a cancer immunotherapeutic.
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