Megablock­buster day for Roche too as MS game-chang­er Ocre­vus gets a green light at the FDA

Sev­erin Schwan, Roche CEO

Tues­day turned out to be the day for a game of megablock­busters. Re­gen­eron and Sanofi snagged an FDA OK for Dupix­ent, a land­mark new eczema ther­a­py, and now Roche came through with a thumbs up for ocre­lizum­ab, which promis­es to remap the land­scape for the mul­ti­ple scle­ro­sis drug mar­ket.

Ocre­lizum­ab — which will now be sold as Ocre­vus — could be used to treat most MS pa­tients, a com­bi­na­tion of re­laps­ing/re­mit­ting and pri­ma­ry pro­gres­sive pa­tients. That’s a unique dis­tinc­tion that is like­ly to make this a key fo­cus among doc­tors who spe­cial­ize in treat­ing MS. And that could be a game change for every­one in the field.

Roche priced this drug for mar­ket pen­e­tra­tion at $65,000 a year, a 25% dis­count to Rebif.

“Ac­cord­ing to the NMSS, MS med­i­cines on av­er­age cost al­most 4 times more to­day than they did 12 years ago,” notes a spokesper­son for Roche. “In fact, Rebif – the 14 year-old stan­dard of care that OCRE­VUS was shown to be clin­i­cal­ly su­pe­ri­or in two RMS tri­als – now costs about $86,000. We feel that the in­dus­try needs to start to re­verse this trend, and be­lieve that pric­ing Ocre­vus 25% less than the com­para­tor in our tri­als is an im­por­tant first step.”

Eval­u­atePhar­ma has pegged con­sen­sus fore­casts of rev­enue for 2022 at $4 bil­lion for this ther­a­py, about a bil­lion dol­lars be­hind where Dupix­ent is ex­pect­ed to land. Its pres­ence in the pipeline, com­bined with a re­cent ap­proval of its check­point Tecen­triq and a few oth­er top prospects, has al­lowed Roche CEO Sev­erin Schwan to large­ly stay out of an M&A mar­ket he has long viewed as over­priced and way too risky.

In­ves­ti­ga­tors say they were able to de­ter­mine the drug in­creased the pro­por­tion of re­laps­ing/re­mit­ting MS pa­tients see­ing the elim­i­na­tion of dis­ease ac­tiv­i­ty by 75% over 96 weeks com­pared to Rebif. Most achieved that sta­tus at the end of 24 weeks of treat­ment with the ther­a­py. And the com­pa­ny al­so out­lined new pos­i­tive da­ta on the elim­i­na­tion of dis­ease pro­gres­sion among pri­ma­ry pro­gres­sive MS pa­tients com­pared to a place­bo.

Bri­an Sko­r­ney, Baird an­a­lyst

The da­ta paves the way for a new con­tender that is en­ter­ing a fast-chang­ing and fu­ri­ous­ly com­pet­i­tive mar­ket. A 40mg gener­ic ver­sion of Te­va’s Co­pax­one may be on the way soon as Bio­gen’s flag­ship drug Tec­fidera con­tin­ues to see its mar­ket de­te­ri­o­rate. That ero­sion has left Bio­gen in­cred­i­bly vul­ner­a­ble to grow­ing crit­i­cism of its busi­ness mod­el.

“Re­call, we’ve ad­vo­cat­ed that Tysabri should be an ob­vi­ous tar­get for Ocre­vus in RMS giv­en the as­so­ci­at­ed safe­ty risks, sim­i­lar­i­ties in ad­min­is­tra­tion, etc,” not­ed Baird’s Bri­an Sko­r­ney. “Docs in­di­cat­ed that about 50% of Ocre­vus pa­tients would like­ly be PPMS pa­tients, with 11% com­ing from Tysabri and an­oth­er 11% switch­es from Tec­fidera. This im­plies an al­most 20% hit to over­all Tysabri de­mand. How­ev­er, when asked about long-term trends, gener­ic 40mg Co­pax­one, and oth­er com­pet­i­tive threats, docs still be­lieve Tec­fidera could see a 20%+ de­cline in scripts by YE18.”

San­dra Horn­ing

“The FDA’s ap­proval of OCRE­VUS is the be­gin­ning of a new era for the MS com­mu­ni­ty and rep­re­sents a sig­nif­i­cant sci­en­tif­ic ad­vance with this first-in-class B cell tar­get­ed ther­a­py,” said San­dra Horn­ing, chief med­ical of­fi­cer and head of Glob­al Prod­uct De­vel­op­ment. “Un­til now, no FDA-ap­proved treat­ment has been avail­able to the pri­ma­ry pro­gres­sive MS com­mu­ni­ty, and some peo­ple with re­laps­ing forms of MS con­tin­ue to ex­pe­ri­ence dis­ease ac­tiv­i­ty and dis­abil­i­ty pro­gres­sion de­spite avail­able ther­a­pies. We be­lieve OCRE­VUS, giv­en every six months, has the po­ten­tial to change the dis­ease course for peo­ple with MS, and we are com­mit­ted to help­ing those who can ben­e­fit gain ac­cess to our med­i­cine.”

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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