Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Bio­gen de­fends slow roll­out of new Alzheimer's drug, crit­i­cizes neg­a­tive me­dia at­ten­tion

As Bio­gen ex­ecs be­moaned the neg­a­tive me­dia cov­er­age around Aduhelm’s ap­proval a month ago, the biotech isn’t gain­ing much trac­tion yet in us­ing its new drug, large­ly due to a lack of in­sur­ance cov­er­age, ac­cord­ing to an earn­ings call Thurs­day.

Man­age­ment in­di­cat­ed that of the near­ly 900 sites that were prepped and ready fol­low­ing Aduhelm’s ap­proval, 325 of those, or about 35%, have com­plet­ed a pos­i­tive phar­ma­cy and ther­a­peu­tics (P&T) re­view or won’t re­quire one. The re­view is a step some hos­pi­tals or health sys­tems take pri­or to us­ing a new drug. Some ma­jor sites, how­ev­er, have said they won’t par­tic­i­pate.

Bio­gen’s top re­search chief Al San­drock al­so said on the call that he wel­comed a for­mal re­view in­to the in­ter­ac­tions be­tween FDA and Bio­gen, as “a bet­ter un­der­stand­ing is good for every­one in­volved.” He al­so of­fered an open let­ter on Thurs­day to “cor­rect some of the mis­in­for­ma­tion” around the ap­proval. For in­stance, San­drock took is­sue with the idea that ad­u­canum­ab’s tri­al re­sults are “post hoc,” al­though the com­pa­ny did stop the tri­als due to fu­til­i­ty. He al­so stressed that the ac­cel­er­at­ed ap­proval path­way, while not­ing that col­lab­o­ra­tion be­tween in­dus­try and reg­u­la­to­ry agen­cies is com­mon, ap­pro­pri­ate and ben­e­fi­cial.

A for­mer se­nior FDA of­fi­cial told End­points that any dis­cus­sion at a con­fer­ence be­tween agency of­fi­cials and a com­pa­ny on an ap­pli­ca­tion’s de­tails or tim­ing, is im­prop­er and should not hap­pen. Both STAT News and NYT al­so con­firmed sep­a­rate­ly that FDA’s neu­ro­science head Bil­ly Dunn met pri­vate­ly at a con­fer­ence to dis­cuss Aduhelm’s ap­pli­ca­tion.

San­drock al­so seemed to blame the con­tro­ver­sy around the Aduhelm ap­proval on neg­a­tive me­dia at­ten­tion. Jay Ol­son, a re­search an­a­lyst at Op­pen­heimer, opened the call’s ques­tion­ing with one about all of the “neg­a­tive me­dia” cov­er­age, which CEO Michel Vounatsos thanked him for ask­ing and said he agreed with.

Vounatsos said he does ex­pect re­gion­al Medicare MAC/Ad­van­tage plans will pro­vide cov­er­age while Medicare’s NCD re­view is on­go­ing. But the NCD will over­ride any of those lo­cal Medicare plan de­ci­sions that are in­sti­tut­ed pri­or to the NCD, said Al­isha Alaimo, pres­i­dent of Bio­gen’s US or­ga­ni­za­tion. That NCD de­ci­sion from CMS isn’t ex­pect­ed for an­oth­er 9 months.

But, ac­cord­ing to one Bio­gen em­ploy­ee, that re­gion­al cov­er­age has not hap­pened yet, and com­mer­cial in­sur­ers have been hes­i­tant to cov­er the new drug. The com­pa­ny said it brought in $2 mil­lion in quar­ter­ly Aduhelm sales, but Vounatsos said to as­sume that a “big chunk” of that $2 mil­lion is in­ven­to­ry and does not re­veal how many pa­tients have been treat­ed.

Bio­gen ex­pects “mod­est” sales in 2021 but did not pro­vide any fi­nan­cial es­ti­mates.

“It’s still ear­ly days,” Vounatsos said. “Over­all, it’s a bit slow­er than what we as­sumed, but we’re mak­ing progress.”

Al San­drock

Alaimo said Bio­gen is mak­ing every ef­fort to get in front of these lo­cal Medicare de­ci­sion mak­ers and there’s a “high lev­el of in­ter­est” in Bio­gen’s pro­gram where it pays for a test that can iden­ti­fy be­ta amy­loid in po­ten­tial pa­tients.

She not­ed that al­though no in­sur­ers have come out with a cov­er­age pol­i­cy yet, so there are no man­dates on find­ing amy­loid be­ta yet, “that’s the ex­pec­ta­tion.” There are sev­er­al ar­eas of the coun­try where ac­cess to amy­loid PET is not avail­able, she said, not­ing that Bio­gen has re­quest­ed PET and CSF tests, but the com­pa­ny is work­ing on gain­ing PET re­im­burse­ment through CMS.

Vounatsos al­so promised that Bio­gen will pub­lish its Phase III tri­al re­sults for Aduhelm in a peer-re­viewed jour­nal. Those da­ta are im­por­tant as some ex­perts are now rais­ing ques­tions about what the FDA re­leased along­side the ac­cel­er­at­ed ap­proval, and as three ad­comm mem­bers have now re­signed from the FDA pan­el.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Although it’s exceedingly rare for the FDA to rescind a breakthrough designation once it’s granted, there has been a recent uptick — as in 2020 and 2021 combined, the agency rescinded 17 BTDs, compared to just 18 rescinded from 2015 to 2019 combined.

Protagonist Therapeutics saw this reality up close and personal in April after a clinical hold lifted on its experimental blood cancer drug, as the company revealed that the FDA sought to revoke the BTD. The decision, Protagonist says, stems from “observed malignancies” related to the hold, initially imposed in September 2021.

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