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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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