Gilead­'s sto­ried hep C fran­chise will now in­clude a gener­ic drug op­er­a­tion

Faced with a dwin­dling stream of rev­enue for its he­pati­tis C fran­chise amid an on­go­ing na­tion­al de­bate on drug pric­ing, Gilead has come up with an un­con­ven­tion­al plan.

Through a new sub­sidiary named Asegua Ther­a­peu­tics, Gilead will sell gener­ic ver­sions of the he­pati­tis C com­bo drugs Ep­clusa and Har­voni at a price of $24,000 — a frac­tion of the list prices of the drugs, which cost $75,000 and $94,500 re­spec­tive­ly for a 12-week reg­i­men.

John Mil­li­gan

While pro­vid­ing a pain­less cure for he­pati­tis C was a ma­jor suc­cess in biotech, it turned out to be a bit of a mixed sto­ry for Gilead, which saw the huge, prof­itable mar­ket quick­ly shrink as the pa­tient pop­u­la­tion got small­er and cheap­er ri­vals emerged from Mer­ck and Ab­b­Vie. Chair­man John Mar­tin and CEO John Mil­li­gan — the duo cred­it­ed for ex­e­cut­ing this break­through — al­so en­dured end­less crit­i­cism for their ag­gres­sive strat­e­gy, which trig­gered a con­tro­ver­sy that nev­er re­al­ly went away.

Nei­ther Mil­li­gan nor Mar­tin will over­see the launch of these gener­ic drugs, sched­uled for Jan­u­ary of 2019, as they are both step­ping down at the end of the year. But to hear Mil­li­gan tell it, this ini­tia­tive is an at­tempt to solve a com­plex prob­lem they have ob­served for the past five years: Even though re­bates have shaved more than 60% off the av­er­age price paid for their hep C cures, these dis­counts are “ef­fec­tive­ly in­vis­i­ble” and “ac­cess to these cures has been lim­it­ed.”

Over the past sev­er­al months, we have searched for a vi­able path to re­duce the list price of our brand­ed HCV med­ica­tions so that their cost to pay­ers is more eas­i­ly un­der­stood. Un­for­tu­nate­ly, ex­ist­ing con­tracts with in­sur­ers, to­geth­er with laws as­so­ci­at­ed with gov­ern­ment pric­ing poli­cies, make it un­ac­cept­ably dif­fi­cult to quick­ly low­er the list price to re­flect the dis­count­ed cost of our med­ica­tions.

Set­ting up their own gener­ic op­er­a­tion, Mil­li­gan writes, is “the fastest way to low­er list prices for our HCV cures with­out sig­nif­i­cant dis­rup­tion to the health­care sys­tem and our busi­ness, as a bridge to longer term so­lu­tions aimed at re­duc­ing pa­tients’ out-of-pock­et med­ica­tion costs.”

Specif­i­cal­ly, this could save Medicare pa­tients up to $2,500 in out-of-pock­et costs in the Part D set­ting, as well as “sub­stan­tial sav­ings” to state man­aged Med­ic­aid plans.

Ep­clusa and Har­voni both con­tain so­fos­bu­vir, the orig­i­nal hep C med­i­cine that Gilead sells as So­val­di. In the first half of 2018, their com­bined sales reg­is­tered at $1.7 bil­lion, com­pared with $4.8 bil­lion dur­ing the same pe­ri­od in 2017.

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.