Vifor CEO Abbas Hussain

Days af­ter buy­out news, Vi­for out­lines plan to of­fload 'non-core' fin­ished drug man­u­fac­tur­ing wing

Aus­tralian firm CSL paid a steep price ear­li­er this week for Vi­for Phar­ma and its pipeline of iron and kid­ney drugs. Look­ing to en­sure it starts its next phase as bat­tle-ready as pos­si­ble, Vi­for will now dump its “non-core” man­u­fac­tur­ing busi­ness as it slims down be­fore the merge.

Vi­for Phar­ma will of­fload its fin­ished drug man­u­fac­tur­ing wing to Swiss CD­MO Cor­den­Phar­ma in a deal de­signed to stream­line the biotech’s busi­ness as it awaits reg­u­la­to­ry ap­proval for a $11.7 bil­lion buy­out by CSL an­nounced ear­li­er this week.

The di­ves­ture will see Cor­den­Phar­ma as­sume con­trol of Vi­for man­u­fac­tur­ing op­er­a­tions in Fri­bourg and Et­tin­gen, Switzer­land, and Lis­bon, Por­tu­gal, and con­tin­ue man­u­fac­tur­ing drugs cur­rent­ly pro­duced on site. Mean­while, Vi­for will hold on to its pro­duc­tion fa­cil­i­ty in St. Gallen, Switzer­land, where it will fo­cus on pro­duc­ing the API nec­es­sary to make its iron ther­a­pies, the com­pa­ny said.

Vi­for will hold on to the com­mer­cial teams as­so­ci­at­ed with those three sites, the com­pa­ny said.

“In sup­port of our am­bi­tious growth strat­e­gy, op­ti­miz­ing our man­u­fac­tur­ing foot­print will en­able us to build an even stronger, more ef­fi­cient or­ga­ni­za­tion fo­cus­ing on core ca­pa­bil­i­ties in nephrol­o­gy, and to max­i­mize and lever­age our mar­ket-lead­ing ex­per­tise and in­tel­lec­tu­al prop­er­ty in iron de­fi­cien­cy,” Vi­for CEO Ab­bas Hus­sain said in a state­ment.

Ear­li­er this week, CSL un­veiled plans to ac­quire Vi­for for $11.7 bil­lion — a steep pre­mi­um for an emerg­ing drug­mak­er with a re­cent his­to­ry of set­backs but one the Aus­tralian firm saw as a mean­ing­ful ad­di­tion to its broad­en­ing port­fo­lio. On top of its iron ther­a­pies, Vi­for has a li­cense-heavy pipeline of drugs in the works, in­clud­ing part­nered kid­ney drug ANG-3777, which has failed mul­ti­ple mid-stage tests.

Talks be­tween CSL and Vi­for re­port­ed­ly be­gan in March, but ru­mors ger­mi­nat­ed ear­li­er this month when Aus­tralian out­lets such as The Aus­tralian and the Aus­tralian Fi­nan­cial Re­view re­port­ed CSL and Vi­for were in ne­go­ti­a­tions for a po­ten­tial deal.

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

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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.

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.

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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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.