Roche forced to concede another flop for Alzheimer's program

You can score another setback for Roche's ($RHHBY) star-crossed attempt to develop a new drug for Alzheimer's. Roche partner Evotec reported that their drug sembragiline failed a Phase IIB study.

Sembragiline is a MAO-B inhibitor, a class of drugs which is currently used to treat Parkinson's disease. The drug is designed to safeguard dopamine by targeting an enzyme--monoamine oxidase type B, or MAO-B--that breaks it down. But investigators say the drug failed to demonstrate a cognitive benefit in patients after 52 weeks of therapy.

These were just headline results--no actual data were included in the statement from Evotec. The German biotech added that Roche plans to consider secondary endpoints in the study as it ponders all of its options.

Roche's R&D team took a nasty hit with the failure late last year of gantenerumab, an antibody aimed at toxic clusters of amyloid beta. The drug flopped against a placebo in Phase III, putting this program on a likely path to extinction. But then Biogen Idec reported an early-stage success with its amyloid program, inspiring some renewed hope at Roche as they consider whether to put their treatment back into the clinic.

Roche has taken several shots at Alzheimer's. The pharma giant is also pursuing studies of crenezumab, which showed mixed results in a mid-stage trial a year ago. And Roche isn't alone in the losers box. Eli Lilly ($LLY) and J&J ($JNJ) led the two pioneering Phase III studies for solanezumab and bapineuzumab, with their failures spurring considerable debate over investigators' still limited understanding of the memory-stealing disease that afflicts millions.

Even though there's a long history of failures to consider, drugmakers remain determined to keep plugging away, and investors appear ready to lend a hand. When Axovant grabbed a discarded Alzheimer's drug from GlaxoSmithKline ($GSK) for a mere $5 million, the biotech mounted the industry's biggest IPO by touting the megablockbuster potential for any new drug that makes it to the regulatory finish line. With millions of desperate patients, any new drug that offers some hope is likely to generate massive sales numbers.

Evotec CEO Werner Lanthaler

For now, it looks like sembragiline won't make the cut.

"Clearly disappointing news that sembragiline didn't reach its primary endpoint but Alzheimer's is one of the biggest medical challenges of our times, and will remain a priority for Evotec and our partners," says Evotec CEO Werner Lanthaler. "Strategically, this program represents one out of more than 70 product opportunities within our portfolio in the fields of CNS and pain, metabolic diseases, oncology and anti-infectives."

- here's the release

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