Giovanni Caforio, Bristol Myers Squibb CEO (Pablo Martinez Monsivais/AP Images)

Star­ing at a down quar­ter for Op­di­vo, Bris­tol My­ers keeps its eyes on price com­pe­ti­tion po­ten­tial in packed PD-1 mar­ket

De­spite its stand­ing as one of the best­selling an­ti-PD-1s, Bris­tol My­ers Squibb can ill af­ford a down quar­ter for its lead­ing I/O amid a packed — and grow­ing — class. With Covid-19 al­ready nip­ping at sales, the drug­mak­er is al­so keep­ing close watch for a po­ten­tial dis­count­ed dis­rupter in the PD-1 class, which could come soon­er rather than lat­er.

Bris­tol My­ers’ an­ti-PD-1 Op­di­vo post­ed dis­ap­point­ing sales for Op­di­vo in the first quar­ter, down 3% from the same time pe­ri­od last year at $1.72 bil­lion, ac­cord­ing to earn­ings re­leased Thurs­day.

The drug­mak­er tied that dip to Covid-19 dis­rup­tions at in­fu­sion cen­ters and be­lieves the drug will turn it around for the rest of the year, ex­ec­u­tives told an­a­lysts on a Thurs­day call. How­ev­er, Op­di­vo’s poor per­for­mance stands in con­trast to Mer­ck’s mar­ket-lead­ing Keytru­da, which post­ed 19% growth on the quar­ter to a whop­ping $3.9 bil­lion.

Op­di­vo’s stum­ble comes as the an­ti-PD-1 mar­ket wel­comes its sev­enth en­trant — Glax­o­SmithK­line’s Jem­per­li — and casts in­to stark re­lief a lack of price com­pe­ti­tion in that class. Ear­li­er this month, Bern­stein an­a­lyst Ron­ny Gal is­sued an open let­ter to Re­gen­eron CEO Len Schleifer call­ing on the drug­mak­er to be the first drug in the class to jump­start a dis­count­ing strat­e­gy for Lib­tayo. His ar­gu­ment goes like this:

While some of your peers may not be too hap­py with your strat­e­gy at first, you will be do­ing the in­dus­try a fa­vor. The strongest ar­gu­ment in fa­vor of gov­ern­ment in­ter­ven­tion in drug pric­ing is that mar­ket forces are fail­ing. There are now six ap­proved PD-1s [sev­en with Jem­per­li], none have done a head-to-head tri­al, and they are all rais­ing prices every year. The best thing you can do for the in­dus­try is to demon­strate that mar­ket forces work. This is an op­por­tu­ni­ty for Re­gen­eron to tru­ly lead in phar­ma as the com­pa­ny has his­tor­i­cal­ly led biotech.

Chris Boern­er

An­a­lysts quizzed Bris­tol My­ers CCO Chris Boern­er on the pos­si­bil­i­ty of any one of Op­di­vo’s an­ti-PD-(L)1 com­peti­tors — and even more are on the way — tak­ing a dis­count­ing path, which if Gal is cor­rect could steal some mar­ket share away from the big­ger com­peti­tors. His re­sponse? We’re go­ing to keep churn­ing out da­ta and ap­provals and see what hap­pens.

“While we’re al­ways a bit para­noid about new en­trants, we have a good po­si­tion to man­age com­pe­ti­tion,” Boern­er said. “In terms of risk, we ab­solute­ly think it’s some­thing we need to stay on top of. The ar­eas where we see the great­est risk don’t over­lap with our biggest mar­kets, at least to­day … (but) this is an area that’s very dy­nam­ic, and we’re pay­ing very close at­ten­tion to it.”

With hopes that Op­di­vo will make a turn­around, Bris­tol My­ers spent much of the call field­ing ques­tions on re­latlimab, the drug­mak­er’s LAG-3 mol­e­cule be­ing test­ed along­side Op­di­vo in first-line melanoma. You’ll re­mem­ber the drug­mak­er read out topline da­ta from that com­bo in March show­ing sig­nif­i­cant ben­e­fit over Op­di­vo alone in the Phase III REL­A­TIV­I­TY-047 tri­al.

Bris­tol My­ers is gear­ing up to re­veal more da­ta from that study at this year’s AS­CO, and it clear­ly has high hopes for the drug, most­ly as a com­bo ther­a­py with Op­di­vo. The drug­mak­er will need it, too, as a se­ries of patent cliffs in 2025 puts a big bur­den on the strength of the drug­mak­er’s pipeline.

Fac­ing those cliffs, CEO Gio­van­ni Caforio hint­ed that M&A will be a big part of Bris­tol My­ers’ strat­e­gy mov­ing for­ward, de­spite some un­knowns around a sud­den­ly steely FTC.

“It’s re­al­ly dif­fi­cult to spec­u­late at this point what the evolv­ing po­si­tion of the FTC will be,” Caforio told an­a­lysts. “I feel there are plen­ty of op­por­tu­ni­ties to strength­en our port­fo­lio across all of the ar­eas in our port­fo­lio where we have ex­per­tise.”

Bris­tol My­ers post­ed $11.1 bil­lion in sales on the quar­ter, a 3% in­crease from the same time pe­ri­od last year.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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