Af­ter promis­ing Trump new US jobs, Eli Lil­ly sets out to chop 200 R&D staffers

David Ricks, Lil­ly

Eli Lil­ly is bring­ing out the cor­po­rate ax and aim­ing it at its R&D op­er­a­tions.

Just weeks af­ter the com­pa­ny an­nounced plans to lay off 485 staffers that had been in­volved in the failed solanezum­ab pro­gram, the com­pa­ny spread word on Fri­day that it’s look­ing for 200 re­searchers to take a “vol­un­tary ex­it.”

A spokesper­son for Lil­ly tells me that this amount to about 3% of the com­pa­ny’s to­tal re­search staff. And the cuts aren’t be­ing aimed at any par­tic­u­lar unit.

“Lil­ly is fo­cus­ing its in­vest­ment in new R&D ca­pa­bil­i­ties to en­sure port­fo­lio sus­tain­abil­i­ty,” she added. “We plan to in­crease our in­vest­ment and hire in strate­gic ar­eas, in­clud­ing mol­e­cule-mak­ing ca­pa­bil­i­ties, im­munol­o­gy and Alzheimer’s dis­ease, across our U.S. re­search sites lat­er this year.”

In re­sponse to a fol­lowup query, the spokesper­son said that this is not a buy­out and that it won’t tar­get ex­ec­u­tives, then said she had no oth­er in­for­ma­tion to of­fer in re­ply to my query whether any fur­ther lay­offs are be­ing planned.

The cuts were an­nounced in­ter­nal­ly two days af­ter Lil­ly CEO Dave Ricks as­sured Pres­i­dent Trump that Lil­ly is in a hir­ing mode on the man­u­fac­tur­ing front — a big is­sue for the new ad­min­is­tra­tion. “We’re hir­ing man­u­fac­tur­ing jobs as I speak,” Ricks told Trump. “Some of the poli­cies you’ve sug­gest­ed — tax, dereg­u­la­tion — those are things that could re­al­ly al­low us to ex­pand op­er­a­tions.”

But Ricks and his Big Phar­ma brethren have be­come ex­perts at rein­ing in em­ploy­ment over the last five years, rather than adding head count. And there’s noth­ing un­usu­al about these kinds of R&D re­align­ments in Big Phar­ma. As­traZeneca, No­var­tis and Mer­ck, among oth­ers, have been do­ing the same thing over the past year. And Pfiz­er said years ago that it ex­pects to see a con­stant chang­ing line­up as it fo­cus­es on new pro­grams and drops its duds.

Lil­ly an­nounced dur­ing its Q4 call late last week that it is shut­ter­ing Ex­pe­di­tion Pro, its sole re­main­ing Phase III study for the one-time megablock­buster hope­ful solanezum­ab. Solanezum­ab failed Ex­pe­di­tion 3, mark­ing a painful­ly ex­pen­sive flop — the third straight clin­i­cal fail­ure. Ex­pe­di­tion Pro, said Ricks, was head­ed for yet an­oth­er fail­ure. The phar­ma gi­ant en­dured a se­ries of set­backs dur­ing a long and painful R&D drought, but it’s been re­ward­ed by some ma­jor ap­provals in the last cou­ple of years. And this year an­a­lysts have high hopes that baric­i­tinib will fol­low up with an ap­proval on its way to block­buster sta­tus.

At the end of 2015, Eli Lil­ly em­ployed 41,275 peo­ple, in­clud­ing ap­prox­i­mate­ly 23,425 em­ploy­ees out­side the US. But it’s al­so been ship­ping jobs over­seas. Five years ear­li­er Lil­ly em­ployed 40,360 peo­ple, in­clud­ing ap­prox­i­mate­ly 20,300 em­ploy­ees out­side the Unit­ed States.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.