Iloperidone (Novartis)

Iloperidone (HP-873) is a mixed 5-HT(2a)/(D2) antagonist under development by Novartis for the potential treatment of schizophrenia. Phase III trials started in 1998 and the company had predicted a filing in 2001, with a possible launch in 2002 [295127], [342937], [364082]. By February 2001, the company had revised its predicted launch date to 2003 [400976]. This was further revised in November 2001, and NDA filing was anticipated for mid-2003 with launch expected in mid-2004 [429516], [431614]. Novartis was also developing a depot formulation, with the aim of providing 1 month of treatment; by March 2001, this was in phase II trials [389740], [402747]. The compound was previously being developed by its originator, Hoechst Marion Roussel, for the potential treatment of schizophrenia and psychosis. It had reached phase II trials. In May 1996, the company announced that it had discontinued further development, and in January 1997, it licensed the compound to Titan Pharmaceuticals on a worldwide exclusive basis [229500], [216445]. Subsequently, Titan granted Novartis worldwide development, manufacturing and marketing rights, excluding Japan [270037]. In April 2001, Titan executed a further development and commercialization agreement with Novartis, granting the latter rights to iloperidone in Japan [407075]. In October 2001, Lehman Brothers predicted a 60% chance of iloperidone reaching the market. The analysts predicted that launch would take place in 2004, with sales of 50 million US dollars, rising to peak sales of 400 million US dollars in 2011 [429750].