Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long bat­tle for biosim­i­lars in the can­cer space be­gin.

Am­gen has launched its Avastin and Her­ceptin copy­cats — li­censed from the pre­de­ces­sors of Al­ler­gan — al­most two years af­ter the FDA had stamped its ap­proval on Mvasi (be­va­cizum­ab-awwb) and three months af­ter the Kan­jin­ti OK (trastuzum­ab-anns). While the biotech had been field­ing biosim­i­lars in Eu­rope, this marks their first for­ay in the US — and the first on­col­o­gy biosim­i­lars in the coun­try.

The part­ners are set­ting the WAC, or whole­sale ac­qui­si­tion cost, of both drugs 15% low­er than their ref­er­ence prod­ucts: $677.40 / 100 mg and $2,709.60 / 400 mg for Mvasi and $3,697.26 / 420 mg for Kan­jin­ti. The WAC, of course, rarely ends up be­ing the fi­nal price; re­bates, dis­counts and as­sis­tance pro­grams of­ten cut a big slice off be­fore mon­ey ex­changes hands. Am­gen and Al­ler­gan at­tempt­ed to take that in­to ac­count by look­ing at the av­er­age sell­ing price (ASP); on that front Mvasi is still 12% cheap­er than Avastin and Kan­jin­ti 13% be­low Her­ceptin.

“We note that the launch of these prod­ucts is slight­ly ahead of our 2020 as­sump­tion for both prod­ucts,” Cred­it Su­isse an­a­lyst Evan Seiger­man wrote in a note. “Still de­spite some un­knowns about the com­mer­cial­iza­tion of these as­sets, we are en­cour­aged with this progress and see >$500M across these two prod­ucts alone in the US.”

Bil­lions more are on the line. An­oth­er biosim­i­lar for Rit­ux­an, the fi­nal of Roche’s block­buster can­cer trio, is com­ing; Cred­it Su­isse fore­cast more than $3 bil­lion in to­tal sales at peak, much of which will go to Am­gen while Al­ler­gan — soon to be swal­lowed by Ab­b­Vie — col­lects roy­al­ties and mile­stones.

If they can con­vince physi­cians and pay­ers to switch, that is. No­tably, while Kan­jin­ti is ap­proved to treat every dis­ease on Her­ceptin’s la­bel, Mvasi is on­ly ap­proved for five of Avastin’s sev­en in­di­ca­tions.

Aside from the dis­counts, Seiger­man notes that the com­pa­nies will like­ly adopt oth­er strate­gies to com­pete with the brand-name prod­ucts:

We note that Am­gen ap­pears to be of­fer­ing pa­tient as­sis­tance pro­grams for these as­sets, es­sen­tial­ly sell­ing them more like a brand­ed prod­uct vs. a tra­di­tion­al gener­ic. We think that con­tract­ing/ ac­cess in ad­di­tion to pol­i­cy around J-codes (will dif­fer­ent biosim­i­lars to a spe­cif­ic prod­uct have one J-code or mul­ti­ple) and in­ter­change­abil­i­ty will al­so im­pact up­take curves.

It won’t be fast, com­ment­ed Scott Got­tlieb, who cheered on Mvasi’s ap­proval dur­ing his tenure at the FDA.

So­cial im­age cred­it: Am­gen

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.