Bus stop ads from the new UsAgainstAlzheimer's campaign include a QR code (pictured) that links to its advocacy website.

Alzheimer’s group amps pub­lic pres­sure with ad cam­paign as Medicare de­ci­sion looms

A new sev­en-fig­ure ad cam­paign takes aim – again – at Medicare’s pend­ing cov­er­age de­ci­sion on Alzheimer’s dis­ease an­ti-amy­loid drugs.

Us­Again­stAlzheimer’s launched the $1 mil­lion-plus na­tion­al ef­fort Sun­day, in­clud­ing a TV ad that ran across the the day’s morn­ing talk news shows. The group is the lat­est to push back on the Cen­ters for Medicare and Med­ic­aid Ser­vices’ pro­posed de­ci­sion to on­ly cov­er Bio­gen and Ei­sais’s Aduhelm and oth­er po­ten­tial an­ti-be­ta amy­loid drugs for pa­tients in clin­i­cal tri­als. CMS’ fi­nal de­ci­sion is set for re­lease on April 11.

The first Us­Again­stAlzheimer’s TV ad fea­tures a re­al Alzheimer’s pa­tient who talks about his di­ag­no­sis and then says: “There are new treat­ments that could slow the pro­gres­sion of Alzheimer’s. Medicare plans to de­ny cov­er­age for these new treat­ments – and that’s wrong.” A sec­ond TV ad will be­gin run­ning soon.

Dig­i­tal dis­play ads on­line as well as out­door bus stops ad­ver­tis­ing in Bal­ti­more and Wash­ing­ton D.C. al­so are run­ning. Both fea­ture QR codes that when scanned, re-di­rect peo­ple to the Us­Again­stAlzheimer’s Ac­tion web­page where they can opt-in to send a let­ter to Pres­i­dent Joe Biden and their lo­cal Con­gres­sion­al mem­bers. The White House, lo­cal sen­a­tors and rep­re­sen­ta­tives email ad­dress­es au­to pop­u­late based on zip code along with a sug­gest­ed let­ter that can be cus­tomized by the sender.

On so­cial me­dia, physi­cians and re­searchers who op­posed the con­tro­ver­sial Aduhelm ap­proval – and en­su­ing CMS cov­er­age – pushed back on the new Us­Again­stAlzheimer’s cam­paign.

“Alzheimer’s As­so­ci­a­tion and Us­Again­stAlzheimers are not pa­tient groups. The ad­u­canum­ab saga has ex­posed that they are ac­tu­al­ly paid to lob­by groups. Lob­by­ing for a clin­i­cal­ly in­ef­fec­tive drug that has po­ten­tial­ly fa­tal side-ef­fects shows how lit­tle they care for AD pa­tients,” Robert Howard, a pro­fes­sor and old age psy­chi­a­trist at UCL, wrote in a post re­spond­ing to Reuters cov­er­age of the cam­paign.

How­ev­er, Us­Again­stAlze­heimer’s founder George Vraden­burg dis­put­ed that, say­ing they didn’t speak on be­half of fi­nanciers.

“We do have an enor­mous bias – a bias for pa­tients,” he said. “Whomev­er fi­nances us – the in­di­vid­u­als who fi­nance us, the com­pa­nies that fi­nance us, we speak the pa­tients’ truth.”

He point­ed to the group’s own re­search with pa­tients and care­givers re­leased Mon­day. It  asked if new drugs for Alzheimer’s are ap­proved and “rea­son­ably like­ly to have an ef­fect, while stud­ies to be sure about the ef­fect are still go­ing on,” would they take it “even if it might have bad side ef­fects?”

Three-fourths said they would take it. “My dis­ease is fa­tal,” one re­spon­dent liv­ing with Alzheimer’s said. “What could be worse than that?”

Us­Again­stAlzheimer’s new cam­paign is the lat­est in a se­ries of state­ments, events and mar­ket­ing by Alzheimer’s ad­vo­ca­cy groups and or­ga­ni­za­tions that came af­ter CMS an­nounced its pro­posed de­ci­sion in Jan­u­ary. The CMS 30-day win­dow for open com­ments yield­ed al­most 10,000 re­spons­es both for and against cov­er­age.

Im­me­di­ate­ly af­ter the Jan­u­ary de­ci­sion, the Alzheimer’s As­so­ci­a­tion launched a paid so­cial me­dia cam­paign that ac­cused Medicare of “cre­at­ing fur­ther health in­equities” and call the agency’s de­ci­sion “sim­ply un­ac­cept­able.” The As­so­ci­a­tion en­cour­aged peo­ple to lob­by Con­gress and CMS to change course in its fi­nal de­ci­sion, sec­ond­ed by a host of oth­er ad­vo­ca­cy in­flu­encers in­clud­ing PhRMA and BIO.

On Tues­day, the Al­liance for Ag­ing Re­search is plan­ning a ral­ly out­side the De­part­ment of Health and Hu­man Ser­vices “to protest the Medicare draft cov­er­age for FDA-ap­proved Alzheimer’s treat­ments.” Peo­ple who are liv­ing with Alzheimer’s along with fam­i­ly mem­bers, Con­gres­sion­al rep­re­sen­ta­tives and chron­ic dis­ease ad­vo­cate groups will speak.

Glob­al Alzheimer’s Plat­form’s pres­i­dent John Dwyer, an­oth­er out­spo­ken crit­ic of CMS’ pro­pos­al, plans to talk about his con­cern the “pro­pos­al will de­lay treat­ment op­tions for at least an­oth­er 10 years and pos­es a threat to health eq­ui­ty in clin­i­cal tri­als.”

The Alzheimer’s As­so­ci­a­tion said in an email to End­points News that it is not par­tic­i­pat­ing in the Al­liance for Ag­ing’s ral­ly in D.C. nor is it work­ing with the Us­Again­stAlzheimer’s cam­paign. A spokesper­son said the group has been clear about its po­si­tion on the CMS draft de­ci­sion and added that it “con­tin­ues to use all av­enues of com­mu­ni­ca­tion to en­sure those af­fect­ed, the broad­er pub­lic and the ad­min­is­tra­tion tru­ly un­der­stand the ram­i­fi­ca­tions of this draft de­ci­sion.”

The Alzheimer’s groups’ try to dis­tance them­selves from Bio­gen and Ei­sai’s ap­proved drug Aduhelm specif­i­cal­ly. They point to the fact that CMS lumped all an­ti-amy­loid drugs to­geth­er as a prob­lem for fu­ture ap­provals’ pay­out. Eli Lil­ly and Roche along with an­oth­er Bio­gen can­di­date are ad­vanc­ing through stud­ies in the same an­ti-amy­loid class.

Eli Lil­ly and Roche joined the CMS re­ply cho­rus with let­ters to CMS ask­ing for it to re­verse its rul­ing re­strict­ing Aduhelm cov­er­age to pa­tients in clin­i­cal stud­ies.

Ed­i­tor’s note: The sto­ry has been up­dat­ed with com­ments from the Alzheimer’s As­so­ci­a­tion.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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Photo: Clara Bui for Endpoints News

#Can­nes­Lions2022: Phar­ma and health mar­keters lose spot­light at cre­ativ­i­ty ad fest, but does it mat­ter?

Pharma advertising has long been considered second-tier when compared to the rest of the advertising industry. And there are some legitimate reasons why. Nike sneakers and Coca-Cola soda ads will likely always be more entertaining or exciting than regulated campaigns for diabetes and heart disease.

Still, the Cannes Lions advertising festival of creativity was pharma and healthcare advertising’s annual chance to shine. For the past eight years, pharma agencies and clients stood side by side with consumer companies and agency hotshots on the biggest advertising award stage in the world at the Palais in Cannes, France.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.