Boehringer In­gel­heim beefs up vet port­fo­lio with GST buy­out; No­var­tis, Aus­tria to in­vest €150M in Eu­ro­pean man­u­fac­tur­ing deal

One year af­ter the Eu­ro­pean launch of Ar­ti-Cell Forte — a stem cell prod­uct used to treat lame­ness in hors­es — Boehringer In­gel­heim has ac­quired Bel­gian vet­eri­nary biotech com­pa­ny Glob­al Stem cell Tech­nol­o­gy (GST) with an eye to ex­pand­ing its port­fo­lio of an­i­mal health drugs.

Boehringer ranked as the world’s sec­ond largest an­i­mal health com­pa­ny in 2019, be­hind New Jer­sey-based Zoetis, with about €19 bil­lion (or $21.7 bil­lion) in to­tal net sales. It ini­tial­ly part­nered with GST in 2018, and the re­sult­ing Ar­ti-Cell Forte was the first vet­eri­nary stem cell med­i­cine to gain mar­ket au­tho­riza­tion from the Eu­ro­pean Com­mis­sion.

Er­ic Haaks­ma

Boehringer hopes the ac­qui­si­tion will lead to an ac­cel­er­at­ed de­vel­op­ment pipeline and ex­pand­ed vet­eri­nary port­fo­lio. Last year, the com­pa­ny pumped €3.5 bil­lion (or $4.1 bil­lion) in­to R&D. The 2 com­pa­nies are keep­ing the terms of the deal un­der wraps.

“This de­ci­sion is ful­ly aligned with our re­cent­ly re­fo­cused strate­gic di­rec­tion,” Boehringer In­gel­heim An­i­mal Health head of glob­al in­no­va­tion Er­ic Haaks­ma said in a pre­pared state­ment. “Stem cell re­search ar­eas and re­gen­er­a­tive med­i­cine of­fer an ex­cit­ing po­ten­tial for the next wave of in­no­va­tion we are ac­tive­ly pur­su­ing. In ad­di­tion, strength­en­ing ex­ter­nal part­ner­ships to ac­cel­er­ate our in­no­v­a­tive ef­forts and growth is one of the key el­e­ments of our strat­e­gy.”

Ear­li­er this month, Boehringer des­ig­nat­ed $507.9 mil­lion to build a new Ex­ter­nal In­no­va­tion Hub in Shang­hai. It al­so be­gan col­lab­o­rat­ing with Num­ab Ther­a­peu­tics to de­vel­op drugs for lung and gas­troin­testi­nal can­cers, and ge­o­graph­ic at­ro­phy.

No­var­tis and Aus­tri­an gov­ern­ment nav­i­gate pro­posed deal to boost an­tibi­ot­ic man­u­fac­tur­ing

Seek­ing a long-term com­pet­i­tive edge in an­tibi­ot­ic man­u­fac­tur­ing, No­var­tis and Aus­tria’s gov­ern­ment plan is to in­vest more than €150 mil­lion over the next five years to boost the com­pa­ny’s pro­duc­tion of ac­tive in­gre­di­ents used in peni­cillin prod­ucts.

No­var­tis’ San­doz site in Kundl, Aus­tria

San­doz, a di­vi­sion of No­var­tis fo­cused on gener­ics and biosim­i­lars, cur­rent­ly man­u­fac­tures 300 mil­lion packs of an­tibi­otics an­nu­al­ly, and claims to pro­duce enough peni­cillin prod­ucts to meet all of Eu­rope’s de­mand. The funds would sup­port new man­u­fac­tur­ing tech­nol­o­gy for ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) and fin­ished dosage forms (FDFs) at No­var­tis’ Kundl, Aus­tria, fa­cil­i­ty, which was es­tab­lished in 1946 to man­u­fac­ture peni­cillin. No­var­tis would com­mit to peni­cillin API pro­duc­tion in Eu­rope for 10 years, de­spite stiff price com­pe­ti­tion from Chi­na.

The Aus­tri­an gov­ern­ment  — look­ing to ramp up Eu­ro­pean pro­duc­tion of es­sen­tial med­i­cines as on-shoring man­u­fac­tur­ing ini­tia­tives grow around the world — would kick in €50 mil­lion to fund new process tech­nol­o­gy for pro­duc­ing APIs. While the agree­ment has yet to be for­mal­ly ap­proved by ei­ther side, the two par­ties are ex­pect­ed to seal the deal by the end of this year.

Richard Saynor No­var­tis

“This plan is a great ex­am­ple of gov­ern­ment and the pri­vate sec­tor work­ing close­ly to­geth­er to pro­tect the long-term in­ter­ests of pa­tients in Eu­rope and be­yond. An­tibi­otics are the back­bone of mod­ern med­i­cine and our Kundl fa­cil­i­ty in Aus­tria is the hub and cen­ter of the last re­main­ing in­te­grat­ed pro­duc­tion chain for an­tibi­otics in the west­ern world. This joint in­vest­ment will help to keep it that way,” San­doz CEO Richard Saynor said in a re­lease.

Cen­to­gene and Mol­e­c­u­lar Health to use da­ta to ac­cel­er­ate or­phan drug de­vel­op­ment

Cen­to­gene and Mol­e­c­u­lar Health have joined forces to ac­cel­er­ate and im­prove the de­vel­op­ment of or­phan drugs through the Re­al-life da­ta and In­no­v­a­tive Bioin­for­mat­ic Al­go­rithms (RI­BA) project, with epilep­sy as the first in­di­ca­tion. The com­pa­nies will look to large, re­al-life da­ta sets, ar­ti­fi­cial in­tel­li­gence and com­pu­ta­tion­al al­go­rithms to re­duce the time and risk as­so­ci­at­ed with pro­duc­ing an or­phan drug. The da­ta are glob­al­ly sourced from 500,000 con­sent­ing pa­tients, ac­cord­ing to Cen­to­gene CEO Arndt Rolfs. The com­pa­nies didn’t dis­close how the project will be fund­ed.

Friedrich von Bohlen

“To­geth­er with Cen­to­gene, Mol­e­c­u­lar Health’s deep sci­en­tif­ic, med­ical, and com­pu­ta­tion­al ex­per­tise will lay the fun­da­ment for per­son­al­ized health­care op­tions in rare dis­eases to ful­fill the promise of pre­ci­sion med­i­cine,” Mol­e­c­u­lar Health CEO Friedrich von Bohlen said in a re­lease.

Caris­ma to en­ter Phase I tri­al with drug to treat HER2 over­ex­press­ing sol­id tu­mors

With FDA clear­ance, Caris­ma Ther­a­peu­tics will be­gin a Phase I hu­man tri­al of its lead can­di­date, CT-0508, an an­ti-hu­man epi­der­mal growth fac­tor re­cep­tor 2 (HER2) tar­get­ed chimeric anti­gen re­cep­tor macrophage. The “ground-break­ing mile­stone” moves Caris­ma from the pre­clin­i­cal dis­cov­ery stage to the clin­i­cal de­vel­op­ment stage, pres­i­dent and CEO Steven Kel­ly said.

HER2 is over­ex­pressed in a va­ri­ety of can­cers, in­clud­ing breast, gas­troe­sophageal, non-small cell lung, col­orec­tal, blad­der, and pan­cre­at­ic. The clin­i­cal tri­al, to take place at the Uni­ver­si­ty of Penn­syl­va­nia and Uni­ver­si­ty of North Car­oli­na, will in­clude pa­tients with re­cur­rent or metasta­t­ic can­cers with HER2 over­ex­press­ing sol­id tu­mors.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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