Scoop: VA de­cides against adding Bio­gen's Aduhelm to its for­mu­la­ry as PBM shuns con­tro­ver­sial Alzheimer's drug

The De­part­ment of Vet­er­ans Af­fairs has de­cid­ed to not in­clude Bio­gen’s pricey new Alzheimer’s drug Aduhelm on its for­mu­la­ry, and its PBM even went so far as to rec­om­mend against of­fer­ing it, not­ing “the lack of ev­i­dence of a ro­bust and mean­ing­ful clin­i­cal ben­e­fit and the known safe­ty sig­nal.”

The de­ci­sion, which is one of the first na­tion­wide de­ter­mi­na­tions on whether to cov­er the con­tro­ver­sial new drug, al­so rec­om­mends that if Aduhelm is to be used by ex­cep­tion, then it should be used “on­ly in high­ly se­lect­ed pa­tients by ex­perts and cen­ters that have the nec­es­sary di­ag­nos­tic and man­age­ment ex­per­tise — and on­ly by those with the need­ed re­sources for close mon­i­tor­ing to as­sure safe­ty,” End­points News has learned.

“It is not be­ing added to the VA Na­tion­al For­mu­la­ry due to the risk of sig­nif­i­cant ad­verse drug events and to the lack of ev­i­dence of a pos­i­tive im­pact on cog­ni­tion,” con­firmed a spokesper­son for the VA on Wednes­day, af­ter we re­port­ed the move.

Aduhelm has been un­der con­stant fire since its ap­proval, as two ma­jor health sys­tems — the Cleve­land Clin­ic and Mount Sinai — are now re­fus­ing to ad­min­is­ter the drug, and as af­fil­i­ates of Blue Cross Blue Shield are de­clin­ing to cov­er it while oth­er in­sur­ers re­main in a wait-and-see-what-Medicare-does mode. The HHS in­spec­tor gen­er­al has al­so opened an in­ves­ti­ga­tion in­to the close ties be­tween FDA and Bio­gen, and oth­er con­gres­sion­al in­ves­ti­ga­tions are on­go­ing.

In a list­ing post­ed on the VA web­site, in which the de­part­ment says that ad­u­canum­ab is not on the for­mu­la­ry, the drug is grouped with oth­er Alzheimer’s drugs (VA Drug Class CN900), in­clud­ing some like galan­t­a­mine, which are in­clud­ed on the VA’s for­mu­la­ry.

“We are pleased the De­part­ment of Vet­er­ans Af­fairs (VA) rec­om­men­da­tion will al­low ac­cess to ADUHELM for vet­er­ans who meet the cri­te­ria as pub­lished in the ‘Place in Ther­a­py’ sec­tion of the clin­i­cal mono­graph,” a Bio­gen spokesper­son told End­points News in a state­ment. “Bio­gen re­mains com­mit­ted to en­sur­ing vet­er­ans have ac­cess to the lat­est ther­a­pies for Alzheimer’s and we will con­tin­ue to en­gage close­ly with the VA as they eval­u­ate po­ten­tial up­dates to their guid­ance.”

End­points re­viewed a copy of the mono­graph, which in­cludes the “Place in Ther­a­py” sec­tion, mak­ing clear that the VA PBM rec­om­mends against Aduhelm giv­en the un­clear ev­i­dence and safe­ty con­cerns.

The mono­graph al­so lays out ex­ten­sive safe­ty stan­dards that should be ad­hered to if the drug is used, in­clud­ing en­sur­ing that ApoE geno­type has been ob­tained and doc­u­ment­ed, and the pa­tient has a re­cent brain MRI, meets clin­i­cal cri­te­ria for mild cog­ni­tive im­pair­ment with Alzheimer’s pathol­o­gy or mild AD, and has an amy­loid PET imag­ing that is con­sis­tent with Alzheimer’s pathol­o­gy, and/or CSF analy­sis. It al­so in­cludes a half dozen con­di­tions un­der which Aduhelm should not be ad­min­is­tered.

Bio­gen pre­vi­ous­ly said it was work­ing to fi­nal­ize a mul­ti-year agree­ment in or­der to sup­port ac­cess for vet­er­ans through­out the VHA sys­tem, which in­cludes 9 mil­lion en­rolled vet­er­ans, ap­prox­i­mate­ly 48% of which are over the age of 65. The VA said it es­ti­mates the num­ber of US vet­er­ans with Alzheimer’s de­men­tia in FY 2021 is about 457,000.

The VA’s de­ci­sion to not in­clude Aduhelm on its for­mu­la­ry does not mean that ac­cess to the drug will nec­es­sar­i­ly be re­strict­ed. As VA doc­tors have ex­plained to End­points, every VA fa­cil­i­ty has the abil­i­ty to re­quest ac­cess, elec­tron­i­cal­ly, to a drug not on the for­mu­la­ry. And since all vet­er­ans over the age of 65 are en­rolled in Medicare, the de­ci­sion may be a cost-sav­ing one, es­pe­cial­ly if Medicare de­cides to not cov­er the drug. That 9-month process is on­go­ing.

The VA al­so ex­plains this process for ob­tain­ing a drug not on its for­mu­la­ry, not­ing that such prod­ucts may be ap­proved un­der cer­tain cir­cum­stances, such as if there are no al­ter­na­tive ther­a­pies on the for­mu­la­ry or if a pa­tient has pre­vi­ous­ly re­spond­ed to a non­for­mu­la­ry agent and risk is as­so­ci­at­ed with a change to a for­mu­la­ry agent.

Sep­a­rate­ly, Aduhelm al­so ap­pears to be in­clud­ed in the VA’s Non-Pro­motable List, which is a list of drugs that are not to be pro­mot­ed or de­tailed by phar­ma sales rep­re­sen­ta­tives.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.