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Drug Names(s): delmitide acetate

Description: RDP58 (rationally designed peptide) is an anti-inflammatory peptide consisting of nine D-amino acids and glycine, developed by computer-aided rational design using artificial intelligence. RDP58 targets the TRAFYK complex, inhibiting the synthesis of TNF-alpha, gamma-interferon, IL-2 and IL-12 in various animal models through its crucial role in regulating the p38, JNK and IKK signal transduction pathways. In addition, RDP58 causes up-regulation of heme oxygenase (HO-1) expression in vivo. Up-regulation of HO-1 has been associated with inhibition of inflammation. All of these activities may contribute to RDP58's therapeutic effects.

TNF-alpha, gamma interferon, IL-2 and IL-12 are pro-inflammatory cytokines that are often elevated in autoimmune disorders and are important in the activation of immune responses and inflammation. RDP58 is orally active and different from injectable anti-TNF-alpha agents such as Enbrel(R) and Remicade(R) in that it inhibits the synthesis of multiple specific inflammatory cytokines at the intra-cellular level, as opposed to neutralizing a single circulating cytokine, TNF-alpha. Also, because RDP58 does not appear to be absorbed into the bloodstream, SangStat believes that oral administration of RDP58 may reduce these pro-inflammatory cytokines in the intestines with little or no effect elsewhere in the body. In contrast, subcutaneous or intravenous administration of anti-TNF-alpha, anti-gamma interferon, and anti-IL-12 agents appears to suppress these cytokines in a broad and unspecific way.

Deal Structure: RDP58 was originally developed by SangStat, although Acti:map [sic], a technology developed by the French comapny Synt:em [sic], was used for the development of RDP58. In August 2003, Genzyme acquired SangStat and in November 2004, Sonus acquired Synt:em.

In April 2004, Genzyme and Procter & Gamble announced an agreement under which P&G will develop and market RDP58 for the treatment of gastrointestinal and other disorders. Under the agreement, Genzyme will grant P&G an exclusive worldwide license to develop, manufacture, and commercialize RDP58, in exchange for an upfront fee, milestone payments, and royalties on product sales. Genzyme will retain development and commercialization rights to RDP58 in pulmonary and other disorders not specifically licensed to P&G. Genzyme will also retain co-promotion rights with P&G in oncology-related disorders, such as chemotherapy-induced diarrhea.

In May 2008, Sonus Pharmaceuticals and OncoGenex Technologies jointly announced the signing of...See full deal structure in Biomedtracker

Partners: OncoGenex Pharmaceuticals, Inc. Allergan plc

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