Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Re­gen­eron faced a sub­stan­tial slump in over­all rev­enue last year, but the fo­cus still re­mains on some of its biggest block­busters.

The phar­ma with sev­er­al high-pro­file part­ner­ships — Sanofi and Bay­er among them — said Fri­day that Q4 rev­enue was down 31% for the quar­ter, and down 24% for the en­tire year. How­ev­er, that won’t stop block­buster ex­pan­sion plans.

One of those is Eylea, the Bay­er-part­nered eye dis­ease drug that has been in ma­jor com­pe­ti­tion with Roche’s Vabysmo. While Eylea is cur­rent­ly on­ly ap­proved in a 2 mg dose, the com­pa­ny re­cent­ly filed for ap­proval to give a 8 mg dose, in hopes of mak­ing a longer-last­ing treat­ment.

Vabysmo, on top of block­ing the same VEGF re­cep­tor as Eylea, al­so in­hibits a growth reg­u­la­tor called an­giopoi­etin-2. Plus, Vabysmo can be dosed once every 16 weeks, com­pared to Eylea’s once every eight weeks once past the load­ing dose sched­ule.

CEO Len Schleifer told an an­a­lyst who asked about Eylea plans to “give us a sec­ond, we’ll dis­con­nect all the Roche peo­ple on the call so we can get you our strat­e­gy,” amid a chuck­le in the back­ground.

“There’s a lot of thought that’s go­ing to go in — be­tween now and what we hope will be our late Au­gust ap­proval — on pric­ing, on roll­out, on tar­get­ing, on strat­e­gy, etc, etc.,” Schleifer said. “But we’re work­ing on that. We have to get our la­bel, we have to get it ap­proved and we’ll have every­thing else ready to go. The ini­tial launch will be with a vial, and then we hope down the road not too far with a pre­filled sy­ringe.”

Eylea record­ed just un­der $1.5 bil­lion in sales in the last quar­ter, down ap­prox­i­mate­ly $51 mil­lion quar­ter over quar­ter.

Dupix­ent, the Sanofi-part­nered IL-4 and IL-13 tar­get­ing ther­a­py, brought in just short of $2.5 bil­lion last quar­ter.

CSO George Yan­copou­los said Fri­day on the earn­ings call that a read­out of the Phase III BORE­AS tri­al in COPD is ex­pect­ed in the first half of 2023. The pri­ma­ry end­point of that tri­al is the an­nu­al­ized rate of acute, mod­er­ate and se­vere COPD ex­ac­er­ba­tions.

Q4 earn­ings over­all showed a 31% drop in rev­enue com­pared to Q4 in 2021, pulling in $3.4 bil­lion. When ex­pand­ed to the year, 2022 rev­enue was $12.2 bil­lion, a 24% drop com­pared to 2021.

How­ev­er, Re­gen­eron not­ed the drop was the re­sult of de­clin­ing sales of Covid prod­ucts RE­GEN-COV and Ron­apreve, the mon­o­clon­al an­ti­body cock­tail that went by dif­fer­ent names in the US and in Eu­rope. The EUA for RE­GEN-COV was pulled ear­ly last year when the ther­a­py was found to be in­ef­fec­tive against the Omi­cron vari­ant.

This fol­lows a trend men­tioned on Re­gen­eron’s pre­vi­ous earn­ings call, where ex­ecs point­ed to a 15% drop in rev­enue that quar­ter com­pared to the year be­fore — cit­ing lost rev­enue from Covid-re­lat­ed mAbs.

De­spite the drop, Re­gen­eron was quick to point out that out­side Covid, rev­enue was up for both the quar­ter and the year: 14% and 17% re­spec­tive­ly.

An­a­lysts with Cowen wrote af­ter the con­fer­ence call Fri­day that they “were com­fort­ed to hear mgmt’s com­ments with re­spect to com­pet­i­tive mar­ket dy­nam­ics for Eylea ahead of the HD Eylea launch. The Dupi per­for­mance was very strong (yet again), and COPD da­ta could come around April. The Y/Y ex­pense in­crease was large­ly an­tic­i­pat­ed. We re­it­er­ate our Out­per­form as the fun­da­men­tals for REGN re­main strong.”

Shares of $REGN went up 4% af­ter the mar­ket opened, up $30 a share and con­tin­u­ing an up­ward trend of over 25% in the last year.

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.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.