Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi ex­pects its RSV an­ti­body joint­ly de­vel­oped with As­traZeneca will be avail­able next sea­son, ex­ec­u­tive VP of vac­cines Thomas Tri­om­phe an­nounced on the com­pa­ny’s quar­ter­ly call.

Bey­for­tus, al­so known as nir­se­vimab, was ap­proved in the EU back in No­vem­ber and is cur­rent­ly un­der FDA re­view with an ex­pect­ed de­ci­sion com­ing in the third quar­ter of this year. The news comes as the FDA plans to hold ad­vi­so­ry com­mit­tee meet­ings over the next cou­ple months to re­view RSV vac­cines from Pfiz­er and GSK.

Thomas Tri­om­phe

“We’re get­ting ready to launch Bey­for­tus for the next RSV sea­son as soon as we get the li­cense and ACIP rec­om­men­da­tion,” Tri­om­phe said on the quar­ter­ly call. “RSV is cre­at­ing hav­oc this sea­son. It has put heavy bur­den on health­care sys­tems and emo­tion­al strain on fam­i­lies, which re­in­forces the val­ue of Bey­for­tus as a so­lu­tion for an im­por­tant un­met med­ical need.”

Mean­while, Sanofi re­port­ed a rough­ly 42% boost in sales last quar­ter for its block­buster Dupix­ent, to­tal­ing €2.4 bil­lion ($2.6 bil­lion) with sales in the US reach­ing close to €1.9 bil­lion ($2.1 bil­lion). The uptick was dri­ven by strong de­mand in asth­ma and atopic der­mati­tis (AD) as well as a launch in AD for chil­dren as young as six months, Sanofi said.

Over­all, the com­pa­ny pulled in €10.7 bil­lion ($11.6 bil­lion) in sales for the fi­nal quar­ter and close to €43 bil­lion ($46.5 bil­lion) last year.

“The bi­o­log­ic pro­file of Dupix­ent to this day, we be­lieve re­mains the best in its class with ex­cep­tion­al abil­i­ty to bal­ance high ef­fi­ca­cy with com­pelling safe­ty,” CEO Paul Hud­son said on the in­vestor call. “Blaz­ing the trail in mar­kets that are un­der­pen­e­trat­ed in terms of el­i­gi­ble pa­tient pop­u­la­tions, Dupix­ent keeps adding sig­nif­i­cant pa­tient pools through mul­ti­ple ap­provals in dis­eases that are still un­der­served. With­out ques­tion, this method is now a key cor­ner­stone in treat­ing chron­ic type 2 in­flam­ma­to­ry dis­eases.”

How­ev­er, the com­pa­ny did dis­close a few speed bumps. While record­ing €7.2 bil­lion ($7.8 bil­lion) in vac­cines sales for the en­tire year, sales slipped 16% last quar­ter to €1.7 bil­lion ($1.8 bil­lion). Tri­om­phe said on the call that this was due to “stronger pro­duc­tion ex­e­cu­tion” and the ship­ment of large amounts of in­fluen­za vac­cine that took place in Q3. In the quar­ter, flu vac­cines saw a 32% sales de­crease, and po­lio/per­tus­sis/Hib (PPH) vac­cines fell more than 16%.

“PPH sales were low­er com­pared to the same quar­ter last year due to the COVID-19 in­sti­tu­tion in Chi­na dis­rupt­ing the rou­tine in­fant vac­ci­na­tion at the cen­ters of care,” Tri­om­phe said.

For gen­er­al med­i­cines, Sanofi had a 3.7% de­crease for the quar­ter at €3.4 bil­lion ($3.7 bil­lion).

Look­ing at 2023, Sanofi is ex­pect­ing its earn­ings per share (EPS) to grow in the low sin­gle dig­its, ac­cord­ing to CFO Jean-Bap­tiste de Chatil­lon. As for launch­es in 2023, Sanofi is gear­ing up for a read­out of Dupix­ent in COPD as well as launch­es for Al­tuvi­i­io for he­mo­phil­ia A and Bey­for­tus in RSV.

While Sanofi an­nounced last month that it was back­ing out of deal talks with Hori­zon, Chatil­lon said that its strat­e­gy hasn’t changed and that deals done in the past have most­ly been cen­tered on ear­ly sci­ence.

“If we see an op­por­tu­ni­ty where we can cre­ate val­ue for share­hold­ers, we would seize it. It’s not al­ways about the size be­cause Hori­zon at the right price was a great op­por­tu­ni­ty to ac­cel­er­ate our jour­ney to in­vest more in in­no­v­a­tive sci­ence. So, no change of strat­e­gy but al­ways on the look­out to seize an op­por­tu­ni­ty and try to cre­ate val­ue for share­hold­ers,” Chatil­lon said.

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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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.

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.”