News brief­ing: No­var­tis hands off NASH drug to biotech col­lab­o­ra­tor, al­so plans to build new Basel pro­duc­tion unit

Robert Arm­strong

Af­ter build­ing up its work on NASH, No­var­tis is hand­ing over one of its can­di­dates to Boston Phar­ma­ceu­ti­cals.

The pri­vate biotech, which didn’t dis­cuss terms, gets the new­ly dubbed BOS-580, an FGF21 drug. And they get to launch a clin­i­cal for­ay in­to a field marked by mul­ti­ple set­backs over the last 2 years.

“No­var­tis has de­signed the BOS-580 prod­uct can­di­date with a dif­fer­en­ti­at­ed pro­file,” says Boston Phar­ma­ceu­ti­cals CEO Robert Arm­strong, who grabbed 3 can­di­dates from No­var­tis back in 2018. Boston Phar­ma­ceu­ti­cals will now jump in­to a NASH niche that in­cludes Akero $AKRO and 89bio $ETNB. — John Car­roll

No­var­tis to build new pro­duc­tion unit near head­quar­ters

No­var­tis is ex­pand­ing its foothold in its home coun­try.

The Swiss phar­ma an­nounced Tues­day that it is spend­ing about $77.5 mil­lion to con­struct a new pro­duc­tion unit on the out­skirts of Basel, Switzer­land, where it is head­quar­tered. No­var­tis’ in­vest­ment will go to­ward two new pro­duc­tion lines for the man­u­fac­tur­ing of “com­plex ac­tive in­gre­di­ents” in ex­per­i­men­tal med­i­cines, the com­pa­ny said.

Cur­rent plans call for the re­fur­bish­ment of ex­ist­ing build­ings in the area’s in­dus­tri­al sec­tor. The pro­duc­tion lines will be com­mis­sioned some­time around the end of 2021.

Tues­day’s news comes af­ter No­var­tis an­nounced the clos­ing of an API plant in Ire­land last Oc­to­ber, which had been open since 1994. That move cut about 320 jobs, and prod­ucts man­u­fac­tured at the site are be­ing trans­ferred to ex­ter­nal sup­ply part­ners with the goal of be­ing fin­ished by mid-2022.

No­var­tis is not the on­ly ma­jor phar­ma to re­struc­ture its API plans, as Sanofi has been work­ing on spin­ning out its busi­ness in the sec­tor. The French phar­ma has been met with heavy re­sis­tance in the face of the Covid-19 pan­dem­ic threat­en­ing sup­ply chains, how­ev­er, as French pres­i­dent Em­manuel Macron per­son­al­ly pledged to keep drug pro­duc­tion in France. — Max Gel­man

As­traZeneca’s Imfinzi wins ap­proval for ES-SCLC in­di­ca­tion 

Dave Fred­er­ick­son

As­traZeneca’s Imfinzi won ap­proval in the EU as a first-line treat­ment for ex­ten­sive-stage small cell lung can­cer in com­bi­na­tion with chemother­a­py.

The PD-L1 in­hibitor is al­ready ap­proved for Stage III non-small cell lung can­cer af­ter chemo in the US, Japan and Chi­na, and across the EU, and for pre­vi­ous­ly treat­ed pa­tients with ad­vanced blad­der can­cer in some coun­tries, in­clud­ing the US.

Imfinzi’s ES-SCLC ap­proval was based on the com­pa­ny’s Phase III CASPI­AN tri­al, in which the drug re­duced pa­tients’ risk of death by 27% com­pared to chemother­a­py alone. Ac­cord­ing to an up­dat­ed analy­sis, pa­tients’ mean over­all sur­vival af­ter a two-year fol­low-up was 12.9 months, ver­sus 10.5 months for those on chemo on­ly. Imfinzi can be used with a va­ri­ety of chemother­a­pies: etopo­side, plus ei­ther car­bo­platin or cis­platin.

“This is the first im­munother­a­py reg­i­men to of­fer both a sus­tained sur­vival ben­e­fit and an im­proved re­sponse rate, as well as a choice of chemother­a­pies and con­ve­nient dos­ing every four weeks dur­ing main­te­nance,” Dave Fredrick­son, EVP of As­traZeneca’s on­col­o­gy busi­ness unit, said in a state­ment. — Nicole De­Feud­is 

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.