Brasofensine NeuroSearch.

Brasofensine (NS-2214) is a dopamine reuptake inhibitor under development by NeuroSearch for the potential treatment of Parkinson's disease (PD) [178224]. The compound entered phase II trials in Denmark in November 1996, and phase I trials in the US in January 1996 [195505], [206604]. Bristol-Myers Squibb (BMS) had been codeveloping the compound until June 1999, when it decided to withdraw from the collaboration due to financial restraints of further regulatory requirements (such as additional toxicology documentation) [318365], [329665]. NeuroSearch was seeking licensing agreements with one or more international pharmaceutical companies to accelerate the development and marketing of brasofensine [187758] and had plans to meet with new potential partners for discussions concerning brasofensine licensing in late 1999 [337221]. A more complete evaluation of the effects of brasofensine was anticipated to be obtained through controlled trials, of at least 3 months duration, comparing it with a placebo and the marketed anti-Parkinson's drug, L-DOPA [317406]. In addition, further animal (monkey) tests were planned in order to document the safety of the drug in long-term treatment. These studies were expected to be discussed with the US FDA in October 1999 and, if satisfactory, the 3-month clinical trials were planned to commence in mid-2000 [337221]. At a meeting with the FDA during 1999, NeuroSearch presented plans for developing brasofensine alone. These were found to be satisfactory on condition that further preclinical studies were performed prior to any more clinical development [371542]. In August 2000, Lehman Brothers predicted worldwide sales of US $45 million in 2002 and US $175 million in 2003 [389229]. In February 1999, Lehman Brothers predicted the drug had a 35% probability of reaching market, with an estimated first launch date in 2002. The analysts predicted peak sales would occur in 2009, with sales of $250 million at that time [319225].