Arena, the US pharmaceutical research company behind failed drug candidate Lorcaserin has announced that it is cutting 66 staff at its San Diego base in order to conserve cash and focus on getting Lorcaserin approved in the US. The FDA had rejected Lorcaserin because of concerns about tumours found in the breasts of female rats during phase 1 trials. The same issue was not replicated in the human trials but the FDA is understandably concerned to exclude the possibility that Lorcaserin would affect humans in the same way. There are a number of drugs that are already approved that produced the same results in trials on rodents that have not been replicated in humans so Arena is confident that it can meet these concerns. The FDA advisory committee was also concerned about potential depression and memory loss so these areas will also have to be addressed.
Although 2010 was not a great year for new obesity drug candidates, we do believe that they will fare better in 2011 – even if the year did not start well with the rejection of Contrave and the request for a full cardiovascular risk study. It is our view that both Lorcaserin and Qnexa will be licensed in 2011, filling the gap in the market left after the withdrawal if Sibutramine.