Fierce Biotech February 26, 2015 | By John Carroll Boehringer...

Fierce Biotech
February 26, 2015 | By John Carroll
Boehringer Ingelheim has put a hold on its Phase I work with a BACE inhibitor for Alzheimer's, marking the latest in a series of missteps for this category of therapeutics, which has emerged as one of the key arenas in the field.

....Vitae CEO Jeff Hatfield told FierceBiotech last fall that investigators were looking for the right dose to lower amyloid beta, a hotly pursued theory that has engaged a lineup of biopharma companies following the Phase III failures of solanezumab (Lilly) and bapineuzumab (J&J and Pfizer).

The potential payoff--if it works--would be enormous, which is one reason why so many developers are willing to invest in the field. AstraZeneca estimated its BACE program could earn up to $5 billion a year--just before it licensed out rights to Eli Lilly for an upfront fee that amounted to 1% of that figure.
Off-target toxicity was the likely culprit behind the death of Eli Lilly's (LLY) BACE program for LY2886721. That failure pushed Lilly to ink a $500 million deal--$50 million upfront--with AstraZeneca to take charge of its BACE drug--AZD3293. Roche (RHHBY) also killed off an early-stage effort, though it has yet to attempt to explain why. Astellas, meanwhile, backed out of its $760 million deal with CoMentis on another early-stage BACE drug.

Merck (MRK), meanwhile, has emerged as the leader in the BACE race, accelerating a late-stage study of its own BACE drug--MK-8931--after clearing a safety hurdle in the clinic. Biogen Idec (BIIB) recently partnered with Eisai on E2609. And Novartis is positioning its own BACE inhibitor for the clinic, targeting pre-symptomatic patients.