Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks in­to his new role at the helm of Te­va Phar­ma­ceu­ti­cal, Richard Fran­cis said it’s time to “get back to growth,” start­ing with a good look at the com­pa­ny’s pri­or­i­ties.

The chief ex­ec­u­tive has kicked off a strate­gic re­view, he an­nounced dur­ing Te­va’s quar­ter­ly call, which will con­tin­ue over the next sev­er­al months and pro­duce re­sults some­time in the mid­dle of 2023. That means some pipeline cuts may be in store, he told End­points News, while de­clin­ing to of­fer much more de­tail.

“When you pri­or­i­tize, it means you de­pri­or­i­tize,” he said in an in­ter­view, adding that “it will be pur­pose­ful and it will be de­ci­sive.”

“Some things we will choose to do and dou­ble down on, and that means oth­er ar­eas, we need to re­duce our re­sources in­to that or step away,” he con­tin­ued.

Best known as a ma­jor gener­ics mak­er, Te­va has been lean­ing more on R&D as part of a promised turn­around. The com­pa­ny’s Hunt­ing­ton’s dis­ease treat­ment Auste­do and mi­graine med Ajovy have been a big part of those ef­forts, and Fran­cis tout­ed a rough­ly 20% full-year sales growth for each prod­uct on Wednes­day, part­ly mak­ing up for Co­pax­one’s falling sales.

Co­pax­one was first ap­proved in 1996 for re­laps­ing-re­mit­ting MS, and Te­va launched a longer-act­ing ver­sion more than a decade lat­er as the drug ap­proached a 2015 patent cliff. The fran­chise raked in $4.2 bil­lion in 2014, a year be­fore San­doz launched the first gener­ic, Glatopa. Last year, Co­pax­one sales topped out at just $691 mil­lion thanks to gener­ic com­pe­ti­tion and the avail­abil­i­ty of oth­er bi­o­log­ics, and Fran­cis ex­pects sales to slip fur­ther this year.

Mean­while, Auste­do and Ajovy brought in around $971 mil­lion and $377 mil­lion last year re­spec­tive­ly, and Fran­cis pre­dicts that the for­mer could soar to $1.2 bil­lion this year.

He al­so tout­ed the com­pa­ny’s Alvotech-part­nered Hu­mi­ra biosim­i­lar. An ex­pect­ed de­ci­sion is com­ing in April, and should it gain ap­proval, Fran­cis hopes for a Ju­ly launch. Te­va said on Wednes­day that the FDA has con­firmed its da­ta pack­age “is suf­fi­cient to sup­port a de­ter­mi­na­tion of in­ter­change­abil­i­ty,” mean­ing that pa­tients could sub­sti­tute the biosim­i­lar for Hu­mi­ra at the phar­ma­cy with­out a doc­tor’s in­ter­ven­tion.

While a slate of Hu­mi­ra biosim­i­lars are ex­pect­ed to launch this year, Fran­cis is look­ing to po­ten­tial in­ter­change­abil­i­ty sta­tus as a key dif­fer­en­tia­tor.

“Let’s not for­get the size of the price here,” he said on the in­vestor call. “This is a big as­set, where I think pay­ers and health­care au­thor­i­ties can gar­ner some sig­nif­i­cant sav­ings.”

Reg­u­la­tors re­ject­ed the biosim­i­lar back in Sep­tem­ber over man­u­fac­tur­ing is­sues at a Reyk­javik fa­cil­i­ty, though Alvotech said at the time that it aimed “to sat­is­fac­to­ri­ly ad­dress the is­sues be­fore the Biosim­i­lar User Fee Act (BS­U­FA) goal date.”

“We need to work close­ly with our part­ners at Alvotech to make sure that the in­spec­tion of their fa­cil­i­ty in Ice­land is a pos­i­tive in­spec­tion… So that’s sort of where our fo­cus is right now,” Fran­cis said on Wednes­day.

For­mer CEO Kåre Schultz stepped down in Jan­u­ary, af­ter guid­ing Te­va through a se­ries of chal­lenges in­clud­ing opi­oid law­suits and gener­ic drug price-fix­ing al­le­ga­tions. Fran­cis, who hails from San­doz, an­nounced on Wednes­day that opi­oid set­tle­ments are mov­ing for­ward with all states ex­cept Neva­da, though he not­ed “that con­ver­sa­tion is pro­gress­ing well.”

Te­va’s rev­enues reached just over $14.9 bil­lion last year, down 6%. This year, Fran­cis an­tic­i­pates rev­enue in the $14.8 bil­lion to $15.4 bil­lion range. The com­pa­ny’s stock $TE­VA was down near­ly 9% on Wednes­day af­ter­noon, trad­ing at around $9.93 per share.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.”