It’s over: Eli Lil­ly shares tank af­ter its huge gam­ble on Alzheimer’s drug solanezum­ab ends in fail­ure

Eli Lil­ly CEO John Lech­leit­er

Eli Lil­ly’s mon­u­men­tal ef­fort to prove once and for all that solanezum­ab could work in de­lay­ing Alzheimer’s has end­ed in to­tal fail­ure. The phar­ma gi­ant an­nounced this morn­ing that the drug failed its third Phase III ef­fort at Lil­ly, send­ing its stock in­to a tail­spin.

Back in 2012, in­ves­ti­ga­tors for Lil­ly con­vinced the top ex­ecs at the com­pa­ny that they had seen re­al, tan­gi­ble ben­e­fits for ear­ly-stage pa­tients tak­ing the drug, de­signed to elim­i­nate de­posits of amy­loid be­ta in the brain. The da­ta, they felt, war­rant­ed an­oth­er clin­i­cal odyssey in Phase III, even though that study had failed. And CEO John Lech­leit­er was a stout ad­vo­cate through­out, will­ing to in­vest heav­i­ly in the study. But in the end, the drug of­fered noth­ing but false hope to mil­lions of pa­tients, fail­ing to bend the curve on cog­ni­tive de­clines or the abil­i­ty of pa­tients to func­tion bet­ter.

Lil­ly will take a mod­est $150 mil­lion charge in the fourth quar­ter — just a frac­tion of what it has spent on this drug.

Its shares plunged 14% on the news. And the dam­age ex­tend­ed to oth­er com­pa­nies pur­su­ing the amy­loid be­ta the­o­ry. Bio­gen, which has pro­mot­ed the prospect of ad­u­canum­ab, watched its stock plunge 10% in pre-mar­ket trad­ing. And Ax­o­vant, a com­pa­ny that nabbed a failed Alzheimer’s drug from GSK and put it back in­to the clin­ic, saw its shares drop 18%, even though their drug goes af­ter a com­plete­ly dif­fer­ent tar­get.

The fail­ure here casts a par­tic­u­lar pall over the amy­loid be­ta the­o­ry. The tox­ic pro­tein clus­ters in pa­tients’ brains are con­sid­ered the most like­ly sus­pect for trig­ger­ing the dis­ease, which af­flicts mil­lions. Mer­ck, Bio­gen, Lil­ly and oth­ers all have oth­er pro­grams in the pipeline that look at var­i­ous ways to re­duce the lev­el of amy­loid be­ta in the brain. And those pro­grams will con­tin­ue, along with the de­bate over what tar­gets should be used in fu­ture stud­ies.

Not­ed Leerink’s Sea­mus Fer­nan­dez:

This re­sult will no doubt cast a shad­ow over LLY’s Alzheimer’s Dis­ease (AD) pipeline port­fo­lio, which is heav­i­ly based on the be­ta amy­loid hy­poth­e­sis. Oth­er com­peti­tors’ pro­grams based on this hy­poth­e­sis will prob­a­bly con­tin­ue, but this will like­ly have neg­a­tive read-through on these re­sults in the short term.

The fail­ure at Eli Lil­ly al­so un­der­scores the dis­as­trous record that Alzheimer’s drugs over­all have had in the clin­ic for more than a decade, with a near-uni­ver­sal fail­ure rate. Eli Lil­ly has had one of the longest run­ning R&D ef­forts in Alzheimer’s, with some jaw-drop­ping set­backs along the way. It al­so tried to go af­ter Alzheimer’s with sema­gace­s­tat, on­ly to find that the drug ap­par­ent­ly in­creased the risk of the dis­ease. In­ves­ti­ga­tors and ex­ecs, though, have been steadi­ly lured on by the prospect of mega-block­buster sales, of­ten cru­el­ly tout­ing the po­ten­tial of a ther­a­py, on­ly to ad­mit fail­ure in the end.

“The re­sults of the solanezum­ab EX­PE­DI­TION3 tri­al were not what we had hoped for and we are dis­ap­point­ed for the mil­lions of peo­ple wait­ing for a po­ten­tial dis­ease-mod­i­fy­ing treat­ment for Alzheimer’s dis­ease,” said Lech­leit­er. “We will eval­u­ate the im­pact of these re­sults on the de­vel­op­ment plans for solanezum­ab and our oth­er Alzheimer’s pipeline as­sets.”

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

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Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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