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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

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Pa­tient re­port finds con­sti­pa­tion con­di­tion not well-man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

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