Back to MAbs for Pfizer as Dimebon reaches the end of the road in Alzheimer's
This article was originally published in Scrip
Top-line data show that the once-hyped drug Dimebon (latrepirdine) has again failed to improve Alzheimer's disease symptoms, leading to the discontinuation of all development of the drug. Despite this expected setback, Pfizer can look to the monoclonal antibody bapineuzumab in its Alzheimer's disease pipeline with cautious optimism.
You may also be interested in...
Following the failure of two pivotal studies, Alkermes is unlikely to keep ALKS 5461 alive and must instead redefine its strategy, says Datamonitor Healthcare lead analyst Daniel Chancellor.
Ocrelizumab (Roche AG) was the undisputed main attraction of the 2015 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, which was held on Oct. 7–10 in Barcelona, Spain. Roche presented detailed clinical data for the drug from three Phase III trials: OPERA I and II in relapsing-remitting multiple sclerosis (RRMS) patients and ORATORIO in primary progressive multiple sclerosis (PPMS) patients. The CD20 antibody showed impressive efficacy across the entire pivotal clinical trial program, with the PPMS data most notable considering the absence of any approved treatment options in this patient population. With no safety signal yet emerging that might jeopardize its regulatory approval, Datamonitor Healthcare now expects ocrelizumab to be a very competitive drug for RRMS patients, where it will predominantly target the $2bn market segment currently occupied by Biogen's Tysabri (natalizumab). Furthermore, as the first effective drug for PPMS patients, ocrelizumab will provide true growth to the wider market and reinvigorate drug development for this underserved population.
Biogen and Eli Lilly both presented much-anticipated data at the 2015 Alzheimer's Association International Conference (AAIC) in Washington DC for their respective anti-beta amyloid antibodies aducanumab and solanezumab. While these data continue to support the drugs'' clinical profiles and further development – which Biogen and Eli Lilly are already committed to – there was no further information that might help more accurately gauge each drug''s likelihood of success in Phase III and potential commercial opportunity, says Datamonitor Healthcare analyst Daniel Chancellor.