FDA tar­gets prod­ucts false­ly claim­ing to treat Alzheimer’s dis­ease

De­vel­op­ing treat­ments for Alzheimer’s dis­ease has been no­to­ri­ous­ly dif­fi­cult, and now the FDA is crack­ing down on com­pa­nies fraud­u­lent­ly claim­ing that their di­etary sup­ple­ments can help treat, pre­vent or even cure the dis­ease.

The FDA on Mon­day re­leased 12 warn­ing let­ters and five ad­vi­so­ry let­ters to for­eign and do­mes­tic com­pa­nies that are il­le­gal­ly sell­ing more than 58 un­ap­proved new drugs and/or mis­brand­ed drugs that claim to pre­vent, treat or cure Alzheimer’s dis­ease and a num­ber of oth­er se­ri­ous dis­eases and health con­di­tions.

“To­day’s ac­tions are part of the FDA’s larg­er ef­fort to ad­dress the boom­ing growth of the di­etary sup­ple­ment in­dus­try through the im­ple­men­ta­tion of mod­ern reg­u­la­to­ry ini­tia­tives that will en­able the agency to pre­serve the bal­anced vi­sion of the Di­etary Sup­ple­ment Health and Ed­u­ca­tion Act (DSHEA), en­act­ed by Con­gress 25 years ago,” FDA Com­mis­sion­er Scott Got­tlieb said.

In­creased Reg­u­la­tion

Got­tlieb al­so out­lined sev­er­al ways in which the FDA is look­ing to move its reg­u­la­tion of di­etary sup­ple­ments for­ward, par­tic­u­lar­ly as in the 25 years since Con­gress passed the Di­etary Sup­ple­ment Health and Ed­u­ca­tion Act (DSHEA), the law that en­abled the FDA’s au­thor­i­ty to reg­u­late di­etary sup­ple­ments, the di­etary sup­ple­ment mar­ket has grown sig­nif­i­cant­ly.

“What was once a $4 bil­lion in­dus­try com­prised of about 4,000 unique prod­ucts, is now an in­dus­try worth more than $40 bil­lion, with more than 50,000 – and pos­si­bly as many as 80,000 or even more,” Got­tlieb said.

As far as up­com­ing changes, the FDA is ex­plor­ing new ways to com­mu­ni­cate more quick­ly when con­cerns arise that an in­gre­di­ent is un­law­ful and po­ten­tial­ly dan­ger­ous and should not be mar­ket­ed in di­etary sup­ple­ments. He al­so not­ed how the FDA is push­ing to­ward the sub­mis­sion of new di­etary in­gre­di­ent (NDI) no­ti­fi­ca­tions so the FDA could eval­u­ate the safe­ty of a new in­gre­di­ent be­fore it be­comes avail­able.

“We’re con­tin­u­ing to de­vel­op guid­ance for prepar­ing NDI no­ti­fi­ca­tions to en­sure FDA can thor­ough­ly re­view the safe­ty of these in­gre­di­ents. In con­junc­tion with this ef­fort, we’re plan­ning to up­date our com­pli­ance pol­i­cy re­gard­ing NDIs,” he said.

The agency is al­so plan­ning a pub­lic meet­ing this spring on the top­ic of re­spon­si­ble in­no­va­tion in the di­etary sup­ple­ment in­dus­try, open­ing the pos­si­bil­i­ty for a broad­er con­ver­sa­tion on whether cer­tain changes to the DSHEA might be help­ful.

For ex­am­ple, some stake­hold­ers have sug­gest­ed that the statute should be amend­ed to es­tab­lish av­enues for di­etary sup­ple­ment ex­clu­siv­i­ty and add a prod­uct list­ing re­quire­ment. A manda­to­ry list­ing re­quire­ment could al­so pro­vide sig­nif­i­cant ben­e­fits by im­prov­ing trans­paren­cy in the mar­ket­place and pro­mot­ing risk-based reg­u­la­tion, Got­tlieb said.

The Coun­cil for Re­spon­si­ble Nu­tri­tion, a trade as­so­ci­a­tion for the di­etary sup­ple­ment and func­tion­al food in­dus­try, ap­plaud­ed the moves by Got­tlieb and the FDA, and called on Con­gres­sion­al ap­pro­pri­a­tors to al­lo­cate to the FDA the fund­ing re­quired to ad­e­quate­ly po­lice sup­ple­ments and fol­low through on en­force­ment.

First pub­lished here and syn­di­cat­ed in part­ner­ship with RAPS. 

Im­age: Scott Got­tlieb. AP IM­AGES

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Roger Perlmutter, Merck R&D chief (YouTube)

Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

Once a gem, now just a rock, Take­da punts PhI­II IBD drug as ri­vals mus­cle ahead

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.