AstraZeneca/Targacept: Another nail in the coffin for TC-5214
This article was originally published in Scrip
Executive Summary
The latest Phase III data for AstraZeneca and Targacept's TC-5214 in major depressive disorder (MDD) are likely to spell the end for the product, say analysts at Datamonitor. Earlier this week, the two companies released top-line data from the second Phase III trial from their clinical programme, RENAISSANCE 2, showing that it did not meet its primary endpoint, change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214, as compared to placebo (scripintelligence.com, 20 December 2011).
You may also be interested in...
COMMENT: Alkermes Needs New Strategy In Wake Of Trial Failures
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 Shines At ECTRIMS With Standout Data
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.
Beta amyloid market prospects still no clearer after AAIC analyses
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.