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Executive Summary

SMITHKLINE's SOLUBLE T4 WILL BE PRODUCED BY INVITRON under a manufacturing collaboration announced by the two firms Sept. 6. Under the agreement, Invitron will produce recombinant soluble T4 (also known as CD4) and other undisclosed biopharmaceutical products at its St. Louis manufacturing facility. In addition, SmithKline will also have "non-exclusive rights to Invitron's proprietary biopharmaceutical manufacturing technology" in exchange for a cash payment and "subsequent additional license payments," the two companies said in a joint release. SmithKline will pay $ 15 mil. for 1.5 mil. shares of newly issued Invitron stock, representing 9.6% of the firm's outstanding common stock. The agreement further calls for subsequent license payments upon FDA approval of "certain SmithKline Beckman cell culture products," the release explains. In addition to the common stock, SmithKline will also obtain warrants to purchase 217,000 additional shares of Invitron at $ 10.35 a share. If exercised, the warrants could bring SmithKline's equity in Invitron to 10.9%. The total value of the collaboration is approximately $ 21 mil. SmithKline said that its soluble T4 development program "continues on target." The company said it expects "to begin clinical trials late this year or early next." Invitron will provide product for clinical studies. The SmithKline agreement, anticipated by some industry observers since the spring of this year, calls for a separate SmithKline operation within Invitron. Invitron will modify its St. Louis manufacturing facility during the next two years to "create an isolated dedicated unit for SmithKline Beckman's products," according to the release. The modification, "which should not affect Invitron's ongoing manufacturing operations, will result in an increase in the facility's efficiency while maintaining the plant's flexibility to accommodate multiple clients simultaneously." SmithKline will be the first unrelated party to hold an equity position in Invitron. The biotech firm also has a supply agreement with Rorer covering recombinant Factor VIII. However, agreements with Searle covering TPA and azurophil-derived bastericidal factor have been terminated. Searle's parent company, Monsanto, will continue to hold a controlling interest in Invitron. Following the SmithKline deal, Monsanto will directly hold 8.7% of outstanding Invitron stock and 80% of Alofi Venture, which owns 57.8% of Invitron. SmithKline is one of several companies preparing for clinicals with a recombinant soluble T4 for the treatment of AIDS. The National Cancer Institute announced Aug. 10 that it had begun clinical study of recombinant soluble T4 using Genentech's product. Biogen is targeting initiation of clinicals with its recombinant product by the end of this year. Genelabs is also working on a recombinant CD4.

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