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Executive Summary

Internatl. Genetic Engineering is using biotechnology techniques to develop therapeutic products to treat bone and cartilage damage from injury or disease, the company noted in a preliminary prospectus for its initial public offering filed with the Securities and Exchange Commission on April 25. Ingene (Internatl. Genetic Engineering) explained that it "uses genetic engineering and related biotechnologies in the development of commercial products for the pharmaceutical, specialty chemical and food industries." Ingene said it has "isolated proteins which induce bone and cartilage formation in laboratory animals." Ingene's objective is to "develop the proteins into pharmaceutical products for treatment of human bone and cartilage trauma and diagnosis and treatment of bone and cartilage disorders." Based in Santa Monica, Calif., Ingene was founded in December 1980. Specifically, the company noted that it is developing a product "to enhance healing of bone fractures and to promote bone formation after reconstructive surgery, such as the anchoring of prosthetic devices or teeth to bone." Another product is intended "to enhance healing of cartilage in damaged knees or intervertebral discs of the back, and to improve augmentation of soft tissues in procedures such as consmetic facial surgery." In addition, Ingene said it "anticipates generating information which may be used to develop diagnostic products." Ingene noted that in 1982 it began a project on bone repair that was sponsored by Dow for three years. The company said it is "currently conducting discussions with pharmacutical companies regarding a collaborative arrangement for testing, manufacturing and marketing the products" that emerge from the program. Outlining its research in the cancer treatment area, Ingene reported that it is developing products based on "regression associated antigens" which "would stimulate the body's immune system to fight certain common types of cancers, including lung cancer, which respond poorly to currently standard forms of treatment such as surgery, radiation therapy and chemotherapy." In another product development program, Ingene said it is using its proprietary hybrid antibody technology "to combine modules of mouse and human antibody genes to produce TheraMAbs, human-like hybrid antibodies directed at human cancer cells." The company explained that "a TheraMAb contains the variable region of a mouse monoclonal antibody and the constant region of a human antibody." Ingene's technology "can take advantage of the large number of mammalian hybridomas producing antibodies with variable regions directed against specific human cancer antigens," the company stated. Ingene added that it believes TheraMAbs "may avoid or reduce some of the adverse immunological side effects associated with introducing mouse antibodies into cancer patients." Ingene said it entered into a nonbinding letter of intent with Oncogen in March 1985 through which it obtained hybridoma cell lines. The firm said that if anti-cancer TheraMAbs "can be produced in quantities economically feasible for clinical trials," the two companies may form a joint venture to test, manufacture, use and sell the product. Ingene noted that "several health care companies, biotechnology companies and academic institutions have developed mouse hybridomas producing antibodies with variable regions directed to human cancer antigens" and "certain of these parties have approached" Ingene regarding arrangements to use Ingene's hybrid antibody technology. Another area Ingene is currently focusing on is development of the low-calorie sweetener thaumatin. Through a project sponsored by Beatrice, Ingene said it has developed a method to produce the sweetener by fermentation of genetically engineered yeast. Beatrice has sponsored the project since December 1982 and has agreed to fund research and production scale-up studies through December 1986, with the right to cancel on 60 days notice. Among its other agreements, Ingene has developed under the sponsorship of Sandoz "microbial strains for the production of human calcitonin." Ingene said the bacterial strains and production technology were transferred to Sandoz in December 1984. Under the sponsorship of Triton, Ingene said it has "engineered microbial strains for the production of certain mammalian alpha transforming growth factors (alpha-TGFs), proteins which may be useful in wound healing and as diagnostics for certain cancers." The microbial strains and technologies for production of these factors were transferred to Triton in June 1985. Ingene said it is entitled to royalties on sales of any products resulting from the two projects. The company is offering a maximum of $2.7 mil. shares at a proposed price of $6 to $7 per share. At $7, the sale could raise $19.3 mil., at least $10 mil. of which Ingene said will go to support bone healing and cancer treatment projects. Bear, Stearns & Co. and L. F. Rothschild, Unterberg, Towbin are underwriting. Ingene reported product development revenues of $3.1 mil. in 1985, compared with $3.7 mil. the previous year. Net loss was $1.1 mil. in 1985, versus $166,000 in 1984. The company attributes the results to increased expenditures on self-funded projects.

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