Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen's Michel Vounatsos takes home $18.7M in pay as the com­pa­ny bat­tles to take ad­u­canum­ab to mar­ket

Bio­gen found it­self at the cen­ter of con­tro­ver­sy late last year as it worked with the FDA to grease the wheels for its con­tro­ver­sial Alzheimer’s med ad­u­canum­ab. That back and forth led to ac­cu­sa­tions the agency wasn’t be­ing im­par­tial in its re­view — con­sid­er the ques­tion of whether the drug even works — but for Bio­gen CEO Michel Vounatsos, con­tro­ver­sy proved lu­cra­tive.

Vounatsos bagged an $18.67 mil­lion pay pack­age in 2020 as Bio­gen has pushed to get ad­u­canum­ab over the fin­ish line de­spite push­back from an FDA ad­vi­so­ry com­mit­tee and con­sumer ad­vo­cates, ac­cord­ing to an SEC fil­ing.

It’s a slight bump from the $18.16 mil­lion Vounatsos took home in 2019, most­ly tied to a big bump in stock awards. Vounatsos’ salary jumped to $1.49 mil­lion with $13.89 mil­lion in stock awards and $2.57 mil­lion in non-eq­ui­ty in­cen­tives.

In terms of perks, Vounatsos bagged about $455,000, most­ly tied to con­tri­bu­tions in­to a re­tire­ment ac­count.

The sto­ry of 2020 for Bio­gen re­volved around the tra­vails of ad­u­canum­ab, a con­tro­ver­sial drug that faced an FDA ad­comm fir­ing line and spurred ac­cu­sa­tions that the drug­mak­er and agency have been far too cozy dur­ing the reg­u­la­to­ry process.

In No­vem­ber, that ad­comm gave a ma­jor­i­ty thumbs down against ad­u­canum­ab’s ap­pli­ca­tion for Alzheimer’s ar­gu­ing the drug didn’t show “pri­ma­ry ev­i­dence of ef­fec­tive­ness” de­spite the FDA’s full-throat­ed sup­port for the drug on the mer­its. FDA neu­ro head Bil­ly Dunn — who con­sumer ad­vo­cates would lat­er ac­cuse of fa­vor­ing Bio­gen’s po­si­tion dur­ing the re­view process — said the agency was us­ing “in­no­v­a­tive think­ing” in sup­port­ing ad­u­canum­ab’s ap­proval.

Crit­ics, how­ev­er, ac­cused the agency of skew­ing the ad­comm’s ques­tions in fa­vor of sup­port­ive an­swers and cher­ry-pick­ing da­ta to sup­port a case for ap­proval.

The case has be­come a stick­ing point for the FDA as it con­tin­ues to seek a per­ma­nent head amid the Biden ad­min­is­tra­tion’s takeover of pow­er and a cau­tion­ary tale for drug­mak­ers. But that doesn’t mean it won’t get ap­proved. Just last week, Vounatsos ef­fec­tive­ly or­dered full speed ahead on prep­ping a com­mer­cial launch for ad­u­canum­ab in an­tic­i­pa­tion of the FDA’s June 7 PDU­FA date.

Ac­cord­ing to a pre­sen­ta­tion the com­pa­ny gave to an­a­lysts, Bio­gen has iden­ti­fied some 600 sites in the US where pa­tients could be as­sessed, dosed and mon­i­tored, while work­ing with sci­en­tists, physi­cians and pa­tients to lay the ground­work for the roll­out. And then there’s the glob­al cam­paign un­der­way, with ap­pli­ca­tions filed in Brazil, Cana­da, Switzer­land, and Aus­tralia.

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.

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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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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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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.

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.

Pascal Soriot, AstraZeneca CEO (AP Images)

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19. However, follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.