Costa Saroukos, Takeda CFO (Takeda)

Pay­ing down more debt, Take­da of­floads pre­scrip­tion drug port­fo­lio for $562 mil­lion

It’s been two years since Take­da’s $62 bil­lion Shire buy­out, and the Tokyo biotech is still re­struc­tur­ing.

The com­pa­ny struck a deal with Ger­many-based Chep­lapharm to di­vest some non-core pre­scrip­tion prod­ucts for an up­front pay­ment of $562 mil­lion. The port­fo­lio — which in­cludes car­dio­vas­cu­lar, meta­bol­ic and an­ti-in­flam­ma­to­ry drugs sold most­ly in Eu­rope and Cana­da — doesn’t fit in with Take­da’s post-Shire vi­sion. The biotech has since shift­ed its fo­cus to gas­troen­terol­o­gy (GI), rare dis­eases, plas­ma-de­rived ther­a­pies, on­col­o­gy and neu­ro­science.

Giles Plat­ford

“These di­vest­ments rep­re­sent an­oth­er im­por­tant mile­stone in our port­fo­lio sim­pli­fi­ca­tion and op­ti­miza­tion strat­e­gy as we po­si­tion Take­da for con­tin­ued suc­cess across our five key busi­ness ar­eas … ” Giles Plat­ford, pres­i­dent of Take­da’s Eu­rope & Cana­da busi­ness unit (EU­CAN), said in a state­ment.

While the Shire buy­out made Take­da a top 10 in­ter­na­tion­al drug com­pa­ny, it al­so sad­dled the com­pa­ny with a re­port­ed $48 bil­lion in net debt. The biotech planned to shed $10 bil­lion in non-core as­sets to bal­ance it out.

Just a few months ago, Take­da an­nounced plans to of­fload some of EU­CAN’s non-core over-the-counter prod­ucts to Ori­farm Group for up to $670 mil­lion. Chep­lapharm, on the oth­er hand, is set to swal­low a port­fo­lio of pre­scrip­tion prod­ucts that gen­er­at­ed $260 mil­lion in net sales last year.

No em­ploy­ees are trans­fer­ring in con­nec­tion with the Chep­lapharm deal, ac­cord­ing to Take­da.

Last month, Take­da en­tered an agree­ment to sell its over-the-counter unit Take­da Con­sumer Health­care Com­pa­ny to US pri­vate eq­ui­ty firm Black­stone Group for about $2.3 bil­lion. It was Take­da’s fourth di­vest­ment deal this year.

In ad­di­tion to the Ori­farm deal, the biotech al­so agreed to di­vest as­sets in the Asia-Pa­cif­ic to Cell­tri­on for up to $278 mil­lion in June; and to Latin-Amer­i­can Hy­pera Phar­ma for $825 mil­lion in March. In Au­gust, Take­da be­gan of­fer­ing ear­ly re­tire­ment to Japan­ese em­ploy­ees.

Take­da ex­pects to close the Chep­lapharm deal by the end of this year.

“While the trust­ed prod­ucts in­clud­ed in the sale ad­dress key pa­tient needs in these coun­tries, they are out­side of our core busi­ness ar­eas of fo­cus. We are con­fi­dent that Chep­lapharm is the right part­ner to en­sure pa­tients con­tin­ue to have ac­cess to these prod­ucts,” CFO Cos­ta Saroukos said in a state­ment.

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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Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: 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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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: 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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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.