Eli Lil­ly part­ner Ab­Cellera ac­quires bis­pe­cif­ic plat­form; Te­va faces more law­suits, this time over opi­oid mar­ket­ing

An Eli Lil­ly part­ner help­ing de­vel­op a lead­ing Covid-19 project has just scored a new ac­qui­si­tion.

Tim Ja­cobs

Ab­Cellera, a small but well-con­nect­ed biotech out of Van­cou­ver, an­nounced it has pur­chased a plat­form from Du­a­log­ics called Or­thomab, which en­gi­neers pro­teins to cre­ate IgG-like bis­pe­cif­ic an­ti­bod­ies from any two an­ti­body se­quences. The trans­ac­tion fur­thers the deal­ings be­tween the two com­pa­nies, as Du­a­log­ics CTO Tim Ja­cobs joined Ab­Cellera in ear­ly Au­gust.

Thurs­day’s agree­ment gives Ab­Cellera full rights to the Or­thoMab plat­form while Du­a­log­ics re­tains the abil­i­ty to de­vel­op ex­ist­ing pro­grams and com­plete ex­ist­ing part­ner­ships.

The biotech emerged from rel­a­tive ob­scu­ri­ty dur­ing the Covid-19 pan­dem­ic thanks to its “lab-on-a-chip” tech­nol­o­gy that iso­lates an­ti­body-pro­duc­ing cells from blood sam­ples and us­es ma­chine learn­ing to pro­cure the best ones. Af­ter ob­tain­ing a sam­ple from a Covid-19 sur­vivor in Feb­ru­ary, Ab­Cellera part­nered with Eli Lil­ly the next month and then pulled in a hefty $105 mil­lion Se­ries B fundraise.

They’re not de­vel­op­ing a vac­cine, but Ab­Cellera has made waves with their po­ten­tial treat­ment, pick­ing up steam in Busi­ness­week and MIT Tech­nol­o­gy Re­view. Vir and Re­gen­eron are al­so work­ing on sim­i­lar clin­i­cal stud­ies.

New York sues Te­va and Al­ler­gan over roles in opi­oid epi­dem­ic

On the heels of fed­er­al pros­e­cu­tors ac­cus­ing Te­va of de­fraud­ing the Medicare sys­tem, the Is­raeli drug­mak­er is fac­ing more le­gal pro­ceed­ings.

New York State has launched its own in­quiry in­to Te­va’s deal­ings re­gard­ing the opi­oid cri­sis, gov­er­nor An­drew Cuo­mo’s of­fice an­nounced Tues­day, al­leg­ing that the com­pa­ny “know­ing­ly fur­thered false nar­ra­tives” in or­der to boost sales of its drugs. Cuo­mo al­so in­clud­ed Al­ler­gan, which was left out of the fed­er­al com­plaint, in the state’s law­suit. A hear­ing will take place on Oc­to­ber 26.

Among the most se­ri­ous al­le­ga­tions is that Te­va mis­rep­re­sent­ed the risks of fen­tanyl and mar­ket­ed such drugs for off-la­bel use. The law­suit cites the FDA ap­proval of Ac­tiq in can­cer pa­tients as proof this strat­e­gy suc­ceed­ed, boost­ing sales of the drug from $16 mil­lion in 2000 to $590 mil­lion by 2006.

The com­plaint al­so dinged the com­pa­nies for uti­liz­ing key opin­ion lead­ers to im­prop­er­ly dis­sem­i­nate mis­in­for­ma­tion about opi­oids in med­ical in­for­ma­tion cours­es and pam­phlets, tar­get­ing pa­tients and pre­scribers.

Tues­day’s fed­er­al suit dealt with price fix­ing, as the gov­ern­ment said Te­va paid hun­dreds of mil­lions of dol­lars to two foun­da­tions to boost sales for the mul­ti­ple scle­ro­sis drug Co­pax­one.

Evotec ex­pands deal with Cen­to­gene to in­clude Gauch­er re­search

Ger­man drug dis­cov­ery com­pa­ny Evotec is ex­pand­ing an ex­ist­ing part­ner­ship with a com­pa­ny fo­cused on min­ing da­ta from pa­tients with rare dis­eases.

The scope of the col­lab­o­ra­tion with Cen­to­gene, based in Cam­bridge, MA, will broad­en in­to pro­duc­ing treat­ments for Gauch­er dis­ease, a ge­net­ic dis­or­der caused by mu­ta­tions in the glu­co­cere­brosi­dase gene. Re­searchers will look to tar­get GBA by com­bin­ing Evotec’s stem cell plat­form with Cen­to­gene’s rare dis­ease plat­form.

The two com­pa­nies orig­i­nal­ly en­tered in­to the part­ner­ship in 2018 with the goal to de­vel­op ther­a­pies for rare hered­i­tary meta­bol­ic dis­eases.

Gauch­er dis­ease is an in­her­it­ed dis­or­der and can af­fect the cen­tral ner­vous sys­tem. Signs and symp­toms can vary wide­ly among af­fect­ed in­di­vid­u­als, rang­ing from the en­large­ment of the liv­er and spleen, ane­mia and lung dis­ease in Type 1 to seizures and brain dam­age in Types 2 and 3.

The most com­mon of the lyso­so­mal dis­eases, Gauch­er is of­ten treat­ed with imiglucerase, a re­com­bi­nant form of the de­fi­cient en­zyme, al­though sev­er­al new treat­ments have been ap­proved in re­cent years.

Proces­sa li­cens­es gas­troin­testi­nal can­di­date from South Ko­re­an phar­ma

A South Ko­re­an phar­ma is li­cens­ing out a lead­ing gas­troin­testi­nal treat­ment to a US part­ner.

Yuhan Corp will sell ex­clu­sive glob­al de­vel­op­ment and com­mer­cial­iza­tion rights, with the ex­cep­tion of Ko­rea, to Proces­sa Phar­ma­ceu­ti­cals for YH12852. The deal nets Yuhan up to $415 mil­lion and $2 mil­lion in Proces­sa shares as a down pay­ment.

Cur­rent­ly, the can­di­date is be­ing eval­u­at­ed for the treat­ment of dys­pep­sia and con­sti­pa­tion, but a Phase II study in Ko­rea was sus­pend­ed last Sep­tem­ber with Yuhan need­ing to re­con­fig­ure its dosage.

YH12852 works by stim­u­lat­ing the 5-HT4 re­cep­tor, which plays an es­sen­tial role in the reg­u­la­tion of in­testi­nal move­ment. The com­pa­ny hopes it can com­pete with cis­apride-based drugs in gas­troin­testi­nal in­di­ca­tions, aim­ing to show few­er car­dio­vas­cu­lar side ef­fects than cur­rent­ly li­censed drugs.

Proces­sa is plan­ning its own Phase II study for oth­er gas­troin­testi­nal motil­i­ty dis­eases, such as post­op­er­a­tive in­testi­nal ob­struc­tion or opi­oid-in­duced con­sti­pa­tion, be­gin­ning in 2021 pend­ing guid­ance from the FDA.

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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