Say what? Al­ler­gan just agreed to pay a 6X cash pre­mi­um for To­bi­ra and its trou­bled PhI­II NASH drug

A cou­ple of months af­ter a tri­al set­back crushed To­bi­ra’s share price, Al­ler­gan $AGN has swooped in to buy the com­pa­ny for $29.35 a share and up to $49.84 a share in con­tin­gent val­ue rights if its late-stage NASH drug turns out to be a hit.

Brent Saun­ders, Al­ler­gan

That cash price is more than six times what To­bi­ra’s bat­tered stock $TBRA closed at yes­ter­day, a vir­tu­al­ly un­heard of pre­mi­um in a mar­ket that is al­ready ap­ply­ing high val­ues to biotech as­sets. The to­tal val­ue for the com­pa­ny will range up to $1.7 bil­lion. The com­pa­ny stock trad­ed for $4.74 at the close yes­ter­day, with a mar­ket cap of $89 mil­lion.

The buy­out stun­ner comes cour­tesy of Al­ler­gan CEO Brent Saun­ders, who has been on a deal spree that in­cludes the Vi­tae ac­qui­si­tion a few days ago. These kind of bolt-on ac­qui­si­tions are a tempt­ing tar­get for Al­ler­gan’s CEO, es­pe­cial­ly since its merg­er with Pfiz­er fell through. Al­ler­gan re­cent­ly closed on a pact to sell a gener­ics unit to Te­va, leav­ing it with a hefty sum in cash re­serves for deals like this.

An­a­lysts had to do a dou­ble take on the num­bers in­volved.

“In our rec­ol­lec­tion, the up­front alone places the high­est pre­mi­um we’ve ever seen on a deal, and not just in biotech,” not­ed Baird’s Bri­an Sko­r­ney. “Not to men­tion, the val­u­a­tion placed on some of the mile­stones is, in our opin­ion, ex­ces­sive. To­bi­ra has in­di­cat­ed plans to ini­ti­ate a Phase III tri­al next year, on which Al­ler­gan has agreed to pay $13.68 per CVR for en­roll­ment of the first pa­tient.”

The deal al­so marks a big bet on NASH, or fat­ty liv­er dis­ease, which has been grow­ing at an epi­dem­ic pace around the world. Al­ler­gan is adding ceni­crivi­roc and evogliptin to its pipeline, and the com­pa­ny says it will look for ad­di­tions to beef up its new NASH ef­fort.

David Nichol­son, Al­ler­gan

Ceni­crivi­roc flunked a Phase IIb study for NASH in Ju­ly, but the South San Fran­cis­co-based biotech said it got enough pos­i­tive da­ta on a sec­ondary end­point to war­rant a move in­to a piv­otal Phase III pro­gram. To­bi­ra’s shares were crushed by the news, plung­ing 64%.

The pri­ma­ry end­point in the study, which reg­is­tered 289 pa­tients, was a drop in a score for dis­ease ac­tiv­i­ty in NASH. On that point, the drug flopped. It al­so failed a sec­ondary end­point for com­plete res­o­lu­tion of steato­hep­ati­tis.

But To­bi­ra vowed that it had a good rea­son to launch a late-stage pro­gram, look­ing for an im­prove­ment in fi­bro­sis with­out any wors­en­ing of steato­hep­ati­tis. The da­ta for the in­tent-to-treat pop­u­la­tion in Phase IIb was 20% for the drug vs. 10% for place­bo af­ter a year of treat­ment, p=0.02; in oth­er words, twice as many pa­tients on drug had a marked im­prove­ment for fi­bro­sis, but it was a small group.

Still, it was big enough to en­cour­age Al­ler­gan to leap in.

Said Al­ler­gan R&D chief David Nichol­son:

“Im­por­tant­ly, NASH treat­ment may well re­quire a mul­ti-ther­a­peu­tic ap­proach to ad­dress the mul­ti­ple fac­tors of the dis­ease. CVC has been shown in clin­i­cal tri­als to pro­vide sig­nif­i­cant im­prove­ment in liv­er fi­bro­sis, the hall­mark of NASH. Liv­er fi­bro­sis is as­so­ci­at­ed with key long-term out­comes, in­clud­ing over­all mor­tal­i­ty, liv­er trans­plan­ta­tion and liv­er-re­lat­ed events.  Evogliptin, in pre­clin­i­cal mod­els, has been shown to de­crease he­pat­ic glu­cose pro­duc­tion, im­prove he­pat­ic triglyc­eride con­tent and steato­sis, and re­duce his­to­log­ic mark­ers of in­flam­ma­tion of the liv­er. To­geth­er, these pro­grams pro­vide a high­ly com­ple­men­tary po­ten­tial ther­a­peu­tic ap­proach to ad­dress the in­flam­ma­to­ry, meta­bol­ic and fi­brot­ic el­e­ments of NASH that the med­ical com­mu­ni­ty will need to treat this con­di­tion.”

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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Deborah Dunsire. Lundbeck

Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation for a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month.

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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.