Dai­ichi Sankyo shuts down Plexxikon sub­sidiary to stream­line En­her­tu, ADC de­vel­op­ment

Dai­ichi Sankyo is say­ing good­bye to one of its long­time sub­sidiaries.

The multi­na­tion­al phar­ma com­pa­ny an­nounced Wednes­day it will shut down all op­er­a­tions of Plexxikon, which it ac­quired in a $935 mil­lion buy­out back in 2011. In a re­lease, Dai­ichi said it’s clos­ing Plexxikon’s of­fices to “max­i­mize its R&D in­vest­ment” in its ma­jor can­cer drug En­her­tu as well as two oth­er ADC pro­grams, Da­to-DXd and HER3-DXd.

Plexxikon will re­main op­er­a­tional un­til the end of March, Dai­ichi added. The sub­sidiary has about 60 em­ploy­ees, all of whom will “tran­si­tion from em­ploy­ment” from Plexxikon, Dai­ichi spokesper­son Masashi Kawase told End­points News in an email.

Kawase added the com­pa­ny couldn’t com­ment on whether the em­ploy­ees would be re­tained in oth­er po­si­tions at Dai­ichi.

Found­ed in 2001, Plexxikon has pushed two can­cer ther­a­pies to FDA ap­proval in its 21 years: Zelb­o­raf, part­nered with Roche for melanoma, and Tu­ralio for tenosyn­ovial gi­ant cell tu­mors. The lat­ter, a CSF1R in­hibitor, faced a bit of a bumpy road in its de­vel­op­ment path as liv­er tox­i­c­i­ty spurred clin­i­cal holds on two sep­a­rate oc­ca­sions. Ul­ti­mate­ly, the drug was ap­proved in Au­gust 2019.

The drugs on­ly gen­er­ate mod­est sales, how­ev­er, as Zelb­o­raf reached a peak of about $200 mil­lion per year — far be­low an­a­lyst ex­pec­ta­tions of $700 mil­lion. Tu­ralio is in a sim­i­lar boat, as it is in­di­cat­ed on­ly for a rare tu­mor type and not an­tic­i­pat­ed to pull in big sales.

En­her­tu, mean­while, con­tin­ues to be a mon­ey­mak­er for both Dai­ichi and part­ner As­traZeneca, which paid $1.35 bil­lion up­front in 2019 to col­lab­o­rate on the drug in a deal that could ul­ti­mate­ly be worth $6.9 bil­lion.

The pair has po­si­tioned En­her­tu as the next big breast can­cer drug, get­ting ap­provals in sec­ond- and third-line breast can­cer set­tings, as well as for cer­tain types of HER2-pos­i­tive gas­tric can­cer. In Sep­tem­ber, new da­ta showed En­her­tu blew Roche’s Kad­cy­la out of the wa­ter in a head-to-head study for some sec­ond-line breast can­cer pa­tients, cut­ting the risk of dis­ease pro­gres­sion or death by 72%.

But As­traZeneca and Dai­ichi are al­so col­lab­o­rat­ing on datopotam­ab derux­te­can, or da­to-DXd, agree­ing to a deal worth up to $6 bil­lion back in Ju­ly 2020. For that pro­gram, the com­pa­nies are chas­ing Gilead’s Trodelvy, which got FDA ap­proval in April to treat metasta­t­ic TNBC pa­tients in the sec­ond line or lat­er as well as an ac­cel­er­at­ed nod in urothe­lial car­ci­no­ma the same month.

En­sur­ing these three AD­Cs flour­ish is one of Dai­ichi’s main growth strate­gies through the first half of the 2020s, the com­pa­ny not­ed in its re­lease Wednes­day.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.