Xavier Becerra, HHS Secretary (Greg Nash/Pool via AP Images)

HHS lines up No­var­tis, Lil­ly, As­traZeneca and 3 oth­er drug­mak­ers for fines due to drug dis­count vi­o­la­tions

As drug­mak­ers con­tin­ue to bat­tle Pres­i­dent Biden’s HHS in court over al­leged 340B drug dis­count vi­o­la­tions, HHS sent let­ters on Wednes­day to six com­pa­nies in­form­ing them that their vi­o­la­tions have been re­ferred to the HHS Of­fice of the In­spec­tor Gen­er­al, which can levy $5,000 fines each.

At is­sue is whether the com­pa­nies have to of­fer dis­count pric­ing to safe­ty-net providers through cer­tain con­tract phar­ma­cy part­ner­ships. The com­pa­nies, in­clud­ing No­var­tis, Eli Lil­ly, As­traZeneca, No­vo Nordisk, Sanofi, and Unit­ed Ther­a­peu­tics, have raised con­cerns that the 340B drug dis­count pro­gram has grown be­yond what it was ini­tial­ly tasked to do, and now lines the pock­ets of cov­ered hos­pi­tals and oth­er providers. The com­pa­nies al­so de­cid­ed to stop of­fer­ing the low­ered prices to some con­tract phar­ma­cies.

In May, HHS told the com­pa­nies to com­ply with its 340B statu­to­ry oblig­a­tions and to im­me­di­ate­ly be­gin of­fer­ing cov­ered out­pa­tient drugs at the 340B ceil­ing price to cov­ered en­ti­ties. But Lil­ly, No­vo Nordisk, and No­var­tis sub­se­quent­ly sued HHS, claim­ing the statute doesn’t re­quire them to work with such con­trac­tors.

Lil­ly spokesper­son An­toinette Forbes told End­points News: “We are dis­ap­point­ed to see HRSA’s con­tin­ued at­tempt to cir­cum­vent the le­gal process.”

“Noth­ing in the statute con­tem­plates — let alone re­quires — that man­u­fac­tur­ers agree to ship drugs nom­i­nal­ly pur­chased by cov­ered en­ti­ties di­rect­ly to ‘con­tract phar­ma­cies’ for dis­pens­ing to both pa­tients and non-pa­tients of the cov­ered en­ti­ty alike. And yet that is pre­cise­ly what HRSA has pur­port­ed to man­date here,” No­var­tis said in its suit.

No­var­tis spokesper­son Caryn Mar­shall al­so told End­points that it’s “con­fi­dent” its 340B pol­i­cy “is in full com­pli­ance with the 340B statute and all bind­ing reg­u­la­tions.”

But HHS is push­ing ahead with the fines re­gard­less, con­clud­ing these ac­tions vi­o­late the 340B statute, and the OIG now will de­ter­mine whether the com­pa­nies are li­able for “know­ing­ly and in­ten­tion­al­ly” over­charg­ing 340B hos­pi­tals and oth­er providers.

Oth­ers that re­ceived the let­ters main­tain that they’re act­ing in com­pli­ance with the law.

Nico­las Kress­mann, spokesman for Sanofi, told End­points the com­pa­ny has been look­ing in­to 340B-priced claims since Oc­to­ber 2020 and that it will pay Med­ic­aid and oth­er in­sur­ers’ re­bate in­voic­es ac­cu­rate­ly. “We con­tin­ue to be­lieve this in­tegri­ty ini­tia­tive com­plies with the 340B statute,” he said.

Michael Bach­n­er, spokesper­son for No­vo Nordisk, added that his com­pa­ny “dis­agrees with the claims made by HRSA in its let­ter, which are al­so the sub­ject of pend­ing lit­i­ga­tion com­menced by No­vo Nordisk and sev­er­al oth­er man­u­fac­tur­ers. We stand be­hind the poli­cies we have put in place to ad­dress the sig­nif­i­cant and well-doc­u­ment­ed abus­es in the 340B pro­gram, re­sult­ing in pro­gram in­ter­me­di­aries such as for prof­it con­tract phar­ma­cies prof­it­ing at the ex­pense of pa­tients.”

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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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.

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.

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.