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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Esperion’s executive team spent years insisting that they had found the sweet spot in the market for their cholesterol drug. But that strategy has soured badly, and after struggling to sell its heart disease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.

Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.