Jeff Marrazzo, Spark CEO (Credit: Endpoints News)

FTC to Roche: OK, go ahead and com­plete your $4.3B Spark buy­out — we're con­vinced now this is­n't an­ti­com­pet­i­tive

Af­ter putting Roche through mul­ti­ple de­lays dur­ing a 10-month re­view, the FTC has de­ter­mined that Roche isn’t spend­ing $4.3 bil­lion to buy Spark so it can de­stroy a po­ten­tial com­peti­tor, or use it to re­place one of their new block­busters. And the phar­ma gi­ant fol­lowed up soon af­ter to say that it had 60.4% of Spark’s stock and will for­mal­ly wrap the buy­out to­day.

The FTC an­nounced Mon­day evening that the com­mis­sion­ers vot­ed 5 to 0 to close the in­ves­ti­ga­tion af­ter de­ter­min­ing the ev­i­dence “did not in­di­cate that Roche would have the in­cen­tive to de­lay or ter­mi­nate Spark’s de­vel­op­men­tal ef­fort for its he­mo­phil­ia A gene ther­a­py, or that the ac­qui­si­tion would af­fect Roche’s in­cen­tives re­gard­ing [its he­mo­phil­ia treat­ment drug] Hem­li­bra.”

In a state­ment, the FTC ex­plained that they need­ed to as­sure them­selves that Roche was ac­tu­al­ly sin­cere. Their ri­vals in he­mo­phil­ia A helped con­vince them that com­pe­ti­tion would on­ly dri­ve Roche faster — some­thing that might seem ob­vi­ous to any­one even ca­su­al­ly ac­quaint­ed with bio­phar­ma.

Among oth­er things, Spark is on­ly one of sev­er­al com­pa­nies cur­rent­ly de­vel­op­ing a gene ther­a­py treat­ment for he­mo­phil­ia A. As the oth­er com­pa­nies en­deav­or to bring their gene ther­a­pies to mar­ket, Roche would have the in­cen­tive to ac­cel­er­ate, rather than de­cel­er­ate the de­vel­op­ment of Spark’s gene ther­a­py in or­der to com­pete for gene ther­a­py pa­tients.

For much of the year the FTC kept the bio­phar­ma in­dus­try guess­ing on what its con­cerns were, amp­ing up con­cerns af­ter the two De­mo­c­ra­t­ic ap­pointees in­di­cat­ed a ba­sic prob­lem with all kinds of M&A deals in the drug in­dus­try.

Spark CEO Jeff Mar­raz­zo told End­points News they hadn’t ex­pect­ed the pro­tract­ed de­lay, and it set­back some of their work.

“It was ob­vi­ous­ly a process that we thought would con­clude ear­li­er,” he said.  “We’re dis­ap­point­ed we weren’t able to go about in­vest­ing in re­search and de­vel­op­ment.”

The move comes just hours af­ter the UK’s chief reg­u­la­to­ry group for M&A of­fered its own green light, leav­ing the phar­ma gi­ant free to com­plete what they al­ways in­sist­ed was a sim­ple buy­out aimed at cre­at­ing a new cen­ter for gene ther­a­py R&D. And Spark’s he­mo­phil­ia pro­gram is go­ing up against ri­vals at Bio­Marin and Sang­amo/Pfiz­er.

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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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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#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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