Biosim­i­lars go 2-0 in an FDA dou­ble-head­er fa­vor­ing No­var­tis, Am­gen

Now that the FDA ad­vi­so­ry com­mit­tee brought to­geth­er on biosim­i­lars has had a chance to brush up on the agency’s reg­u­la­to­ry frame­work and ob­jec­tives, the out­side ex­perts had lit­tle trou­ble reach­ing for an­oth­er unan­i­mous de­ci­sion en­dors­ing No­var­tis’s copy­cat of En­brel.

The vote was 20-0 in fa­vor, re­flect­ing the agency’s in­sid­er opin­ion that No­var­tis—which scored the first ap­proval for a biosim­i­lar in the U.S. and has a whole line­up be­ing prepped for an OK—has per­fect­ed the de­vel­op­ment process. Com­ing swift­ly on the heels of an­oth­er bright green light yes­ter­day for Am­gen’s biosim­i­lar of Ab­b­Vie’s $14 bil­lion fran­chise drug Hu­mi­ra, there’s con­sid­er­ably less mys­tery about what man­u­fac­tur­ers need to do to win ap­provals in this new but fast grow­ing field.

Mon­day’s vote marked progress for Am­gen in its quest to field the first of sev­er­al knock­offs aimed at Hu­mi­ra. But iron­i­cal­ly the same com­pa­ny was on de­fense Tues­day as it sought to guard against a com­peti­tor that will like­ly be ap­proved for all in­di­ca­tions now al­lowed En­brel, a $9 bil­lion gold mine for Am­gen and its part­ners.

There’s been a lot of pub­lic op­po­si­tion to ex­trap­o­la­tion—tak­ing da­ta on one dis­ease and ap­ply­ing it for all the con­di­tions which the orig­i­nal de­vel­op­er had to win one at a time. The key is the sim­i­lar­i­ty of the drugs. Once the biosim­i­lar man­u­fac­tur­er has pegged that with con­vinc­ing late-stage da­ta, the rest falls in­to place—at least among these orig­i­nal play­ers. And fight­ing ex­trap­o­la­tion ap­pears to be a los­ing strat­e­gy for any­one play­ing de­fense.

Far less cer­tain, though, are the in­tense rear guard fights that com­pa­nies are wag­ing in the courts. Ab­b­Vie has plans to de­lay any di­rect com­peti­tor to Hu­mi­ra for years, and oth­ers are tak­ing the same le­gal ap­proach, ready to make vir­tu­al­ly any ar­gu­ment to pre­vent a low­er priced drug from reach­ing the mar­ket­place.

Nev­er­the­less, you can be sure that every­one play­ing in this space, a group of multi­na­tion­als that in­cludes Pfiz­er, Mer­ck and Sam­sung, are pay­ing close at­ten­tion to every word spo­ken over the past 48 hours. The first new en­try among biosim­i­lars is un­like­ly to cut the ini­tial price much. These old­er drugs have been priced steadi­ly high­er in the lead up to the loss of patent pro­tec­tion, leav­ing the pi­o­neers in search of a block­buster mar­ket share. But as more biosim­i­lars for the same prod­uct pile in, that price is ex­pect­ed to fall steadi­ly.

Now the in­dus­try will wait, per­haps for some time, to see if No­var­tis CEO Joe Jimenez is right, and that the price of these new drugs will even­tu­al­ly slash the whole­sale price as much as 75%.

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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Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.

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.