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GENTA PLANNING FIVE DERMATOLOGY IND FILINGS IN 1992

Executive Summary

GENTA PLANNING FIVE DERMATOLOGY IND FILINGS IN 1992, a sign of Genta's extended aim beyond the start-up company's original antisense technology program. Although Genta's primary interest continues to be the development of Anticode oligonucleotides, the firm has acquired rights to five non-oligonucleotide dermatologicals that are less likely to require lengthy FDA review. The target date for getting one of the five dermatologicals on the market is 1994, the firm disclosed in a preliminary prospectus for an initial public offering. The non-oligonucleotide dermatologicals under development include Prodrug G-101 and Prodrug G-201, which are intended as topical treatments for acne and inflammation, respectively. A Phase II clinical for G-101 on 50 patients in France suggests that the compound may "represent a significant advance in acne therapy," Genta contends. The three other dermatology products are topical methotrexate for the treatment of psoriasis and two "steroid wipes" -- betamethasone for psoriasis and fluocinonide for treating atopic dermatitis. The individual wipes are designed to better maintain the applied drug on the skin. Genta acquired the dermatologics firm Virna Pharmaceuticals in May and appointed Virna founder William Bliss president and chief operating officer. Genta expects to file its second Anticode IND in 1992 for a product to treat a dermatological inflammatory disease. The firm has a topical psoriasis therapeutic in preclinical development as well as an atopic dermatitis treatment. Anticode oligonucleotides are designed to block production of disease-related proteins by binding to messenger RNA ("antisense" mechanism) or DNA ("triple-strand" mechanism). The Anticode R&D program at Genta is divided into four areas -- cancer, inflammatory diseases, infectious diseases and cardiovascular. The company has a total of 17 products in the discovery or preclinical phase. Genta is hoping to begin Phase I/II trials for its lead Anticode product, a systemic therapy for chronic myelogenous leukemia, in 1992. The trial, pending FDA approval, will be conducted at the University of Texas M.D. Anderson Cancer Center with approximately 10 CML patients. Genta believes the IND for G- 1128, submitted in August, is the first for an antisense therapy ("The Pink Sheet" Aug. 19, p. 8). Chugai has an option to acquire exclusive worldwide rights to G-1128 in exchange for fully funding development. The Japanese firm also has the option to acquire such rights to any Genta oligonucleotide product for the treatment or prevention of Epstein-Barr virus, cytomegalovirus, HIV, and all leukemias and lymphomas. Another potential licensee is Procter & Gamble, which recently made a $ 5 mil. equity investment and a first-year research payment of $ 3 mil. for development of treatments for "certain infectious and inflammatory diseases" based on Anticode technology. The September agreement with P&G provides three years of funding and may be extended on an annual basis for an additional five years. Genta's Nov. 25 IPO filing for 2.5 mil. shares proposes an initial offering price between $ 9 and $ 11. Proceeds are tentatively designated as: $ 14 mil. for R&D; $ 6 mil. for marketing and general/administrative expenses; and $ 4 mil to expand facilities. The firm, founded in February 1988, previously has raised $ 25.8 mil. and expects that the anticipated proceeds will be sufficient to fund operations through 1993. Underwriters are Montgomery Securities and Alex. Brown.

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