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VIAGENE SEEKING $27 MIL. FROM REACTIVATED INITIAL PUBLIC OFFERING; THREE GENE THERAPY TRIALS ARE ONGOING: HIV IN VIVO IMMUNOTHERAPEUTIC IS NOW MAIN FOCUS

Executive Summary

Viagene is seeking to net $27 mil. in an initial public offering filed Oct. 29 of 2.5 mil. shares at an estimated price of $11 to $13 per share. San Diego-based Viagene first filed for the offering in February ("The Pink Sheet" Feb. 15, In Brief). Viagene has been exploring the public offering market since early 1992. Underwriters for the offering are Alex. Brown, CS First Boston and Nomura Securities. Completion of the public offering would substantially increase Viagene's cash reserves. The company reported $2.9 mil. in cash and equivalents as of Sept. 30, down from $4.7 mil. as of Dec. 31, 1992. Viagene estimates that proceeds from the offering coupled with revenues from its corporate agreements "will be adequate to satisfy its capital needs through 1996," the prospectus states. A number of private start-up companies that missed the last cycle of public financings are preparing to take advantage of the next open window for new offerings. Several firms, including Viagene, are already testing the waters in light of the recent upturn in the public biotech market. Pending or recently completed offerings include: Alpha-Beta, Cell Genesys, Incyte, Cor Therapeutics, Shaman Pharmaceuticals and Texas Biotechnology. Viagene is involved in three ongoing gene therapy trials. The company's first, an ex vivo AIDS therapy, began in April 1993. "Four patients are being treated with the ex vivo product," the prospectus states. "To date, no adverse effects which the company believes could be attributable to the ex vivo HIV ImmunoTherapeutic have been observed in the four patients in the Phase I clinical trial." Viagene has stopped enrolling patients in that first trial to concentrate on development of its in vivo HIV ImmunoTherapeutic because "the company believes that the direct vector method will have broader clinical use," the prospectus states. The in vivo trial began in August ("The Pink Sheet" June 14, p. 6). Viagene has a third HIV protocol coming up for review by the National Institutes of Health Recombinant DNA Advisory Committee. Viagene is also supplying vectors for an ongoing investigator- sponsored melanoma trial ("The Pink Sheet" Aug. 16, p. 2). Other areas of research for Viagene include: hepatitis B, herpes simplex virus and human papilloma virus immunotherapeutics; a malaria vaccine; a cancer drug activation therapeutic; and a Factor VIII gene therapy. Japan's Green Cross Corp. is funding Viagene's FHV gene therapy research. Under the deal, Green Cross has made a $5.5 mil. equity investment in Viagene (1.2 mil. shares or 13% post- offering) and paid $11.9 mil. in research funding in 1991 and 1992, with another $8 mil. committed for 1993, the prospectus states. In January, Viagene signed a three-year, $9 mil. agreement with Bayer/Miles for development of a Factor VIII gene therapy for hemophilia A. Viagene "has filed 20 U.S. patent applications and certain corresponding international patent applications directed, in part, toward the use of recombinant retroviruses to stimulate a specific immune response to a pathogenic agent, such as a virus, and to methods for producing recombinant retroviruses which are capable of delivering vector constructs to susceptible target cells," the prospectus states. The firm's patent applications also cover "methods for destroying selected tumor cells and methods for treating hepatitis B and hepatitis C infections." Gensia Chairman and CEO David Hale serves as Viagene's chairman. Gensia owns 450,000 Viagene shares it was issued in 1987 "in exchange for the right, title and interest in all property relating to retroviral vector and gene therapy technologies developed or owned by Gensia," the prospectus states. Former NeoRx CEO Russell Abbott, PhD, is CEO. Another former NeoRx exec, Donald Longenecker, PhD, is senior VP-operations. Fortner Lederle-Praxis exec Stephen Mento, PhD, is VP-R&D. VP- Clinical Development & Regulatory Affairs Bruce Merchant, MD/PhD, is a former Hybritech exec and a former FDA Center for Biologics Evaluation & Research staffer. CFO Jefferson Works previously was with Cetus. Viagene has 111 employees.
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