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

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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