With biosim­i­lar threat un­der con­trol (for now), Roche sa­vors de­mand for its new drugs

Roche $RHB­BY un­veiled a cheer­ful up­date on its per­for­mance in the first nine months of this year, with de­mand for its new­er drugs — pri­mar­i­ly in on­col­o­gy/im­munol­o­gy — dri­ving sales, par­tic­u­lar­ly in Chi­na where can­cer is on the rise. In its press re­lease, the Swiss drug­mak­er men­tioned its pend­ing $4.3 bil­lion ac­qui­si­tion of Spark Ther­a­peu­tics $ONCE, promis­ing the deal — which has seen de­lay af­ter de­lay due to un­re­lent­ing scruti­ny by com­pe­ti­tion reg­u­la­tors — will be con­sum­mat­ed by the end of the year.

The com­pa­ny — the world’s largest can­cer drug­mak­er — lift­ed its full-year sales fore­cast, spurred by a 12% jump to about $36.7 bil­lion in phar­ma­ceu­ti­cal sales. Sales were fu­eled by de­mand for Roche’s mul­ti­ple scle­ro­sis drug Ocre­vus, he­mo­phil­ia treat­ment Hem­li­bra, and its on­col­o­gy prod­ucts: check­point in­hibitor Tecen­triq and mon­o­clon­al an­ti­body Per­je­ta and old­er Avastin — which more than off­set de­clines in the sales of its can­cer drugs Her­ceptin and MabThera/Rit­ux­an.

Sales in Eu­rope were down 1% due to Her­ceptin (-44%) and MabThera/Rit­ux­an (-33%), but the strong growth of new­er treat­ments al­most stead­ied the ship.

Bill An­der­son Roche

“The im­pact of biosim­i­lars (in Eu­rope) is tail­ing off,” not­ed Roche’s head of phar­ma­ceu­ti­cals Bill An­der­son in a post-earn­ings con­fer­ence call on Wednes­day. Her­ceptin biosim­i­lars launched in Eu­rope about two years ago, while MabThera biosim­i­lar ero­sion in the re­gion kicked off last year.

Roche’s three lega­cy on­col­o­gy drugs — Rit­ux­an, Her­ceptin, and Avastin — are ripe for biosim­i­lar com­pe­ti­tion in the Unit­ed States — and ear­li­er this year the com­pa­ny saw the launch of the first Her­ceptin and Avastin biosim­i­lar. (Al­though if oth­er biosim­i­lar launch­es are any kind of barom­e­ter, the ero­sion of drug fran­chis­es in the Unit­ed States is fair­ly mut­ed com­pared to Eu­rope.)

Still, An­der­son preached cau­tion. “We do ex­pect there to be sig­nif­i­cant im­pact from biosim­i­lars in the US, be­cause there will be biosim­i­lars to all three of our lega­cy on­col­o­gy prod­ucts — but al­so be­cause there’s a need for ad­di­tion­al com­pe­ti­tion, and we’ve been ex­pect­ing it.”

He pre­dict­ed the first five biosim­i­lars for Rit­ux­an will come some­time over the next quar­ter, with at least a cou­ple of more Her­ceptin biosim­i­lars in the next six months, and an­oth­er Avastin biosim­i­lar at the end of the year and/or ear­ly 2020.

In­ter­na­tion­al sales grew a healthy 20% main­ly due to a strong up­take in Chi­na, where rates of can­cer are high due to pol­lu­tion and smok­ing. At some point the com­pa­ny will see lim­it­ed biosim­i­lar com­pe­ti­tion in Chi­na, al­though “there may be some ques­tions about the qual­i­ty of some of those ear­ly biosim­i­lars so I think will we see our­selves as able to com­pete,” An­der­son said. “In fact, one of the ways that will be com­pet­ing in Chi­na is get­ting drugs like Per­je­ta and Hem­li­bra added to the na­tion­al drug re­im­burse­ment list.”

As is the tra­di­tion, the com­pa­ny al­so culled a num­ber of ex­per­i­men­tal drugs across its pipeline:

Source: Roche, 2019

Click on the im­age to see the full-sized ver­sion

Sev­erin Schwan Roche

One of the key cuts is pe­tesi­cat­ib (RG7625), which was be­ing de­vel­oped to treat celi­ac dis­ease and au­toim­mune dis­or­ders, in­clud­ing Sjö­gren’s syn­drome and pso­ri­a­sis. The oral com­pound was en­gi­neered to tar­get cathep­sin-S. Years ago, Mer­ck had tout­ed the com­mer­cial po­ten­tial of its cathep­sin-K in­hibitor for os­teo­poro­sis, al­though it was forced to ter­mi­nate the pro­gram af­ter it was linked to an in­creased risk of car­dio­vas­cu­lar events.

At the tail end of the con­fer­ence call, the ques­tion of the Spark ac­qui­si­tion fi­nal­ly cropped up. Roche chief Sev­erin Schwan did not go in­to specifics but re­it­er­at­ed that he was con­fi­dent the deal would be com­plet­ed by year-end.

So­cial im­age: Roche

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Michael Gladstone, partner at Atlas Venture

At­las rais­es new $400M fund amid spree of VC rais­es. Here’s what they’ll spend it on

You can add another few hundred million to the now Montana-sized reservoir of cash biotech VCs have raised since the WHO declared Covid-19 a pandemic.

Atlas Venture, the prominent Kendall Square incubator, has raised $400 million for its twelfth biotech fund, their first in 3 years. After a string of mammoth new raises from other major VCs in April and May, the total pot now stands between $5 billion and $6 billion, depending on how you slice it.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.