As­traZeneca sells off more as­sets from its is­land of mis­fit drugs in $1.6B Pfiz­er deal

As­traZeneca has com­plet­ed an­oth­er stage in its sys­tem­at­ic re­treat from the an­tibi­otics busi­ness, sell­ing a port­fo­lio of mar­ket­ed and ex­per­i­men­tal small mol­e­cule an­tibi­otics to an ac­quis­i­tive Pfiz­er for $725 mil­lion in cash and an­oth­er $850 mil­lion in mile­stones.

As­traZeneca CEO Pas­cal So­ri­ot

The first stage in the re­treat start­ed in 2014, as it be­gan to wind down its ear­ly-stage an­tibi­otics re­search group in Waltham, MA, which had 175 staffers when Pas­cal So­ri­ot took over as CEO at the phar­ma gi­ant. In­dus­try sources at the time tipped me off to the com­pa­ny’s de­ci­sion to see if it could find a buy­er for the group. But when no deal emerged, As­traZeneca de­cid­ed to spin out a small group of sur­vivors in a new ven­ture dubbed En­ta­sis, with a $40 mil­lion round to get it set up.

This new deal gives Pfiz­er Za­v­icef­ta, Zin­foro and Mer­rem, with a pair of ex­per­i­men­tal pro­grams – a Phase III-ready CXL, an in­jectable bac­te­ri­ci­dal β-lac­tam/β-lac­ta­mase in­hibitor com­bi­na­tion of Zin­foro and Avibac­tam (AVI, NXL104) and ATM-AVI, a bac­te­ri­ci­dal, in­jectable com­bi­na­tion of aztre­on­am (ATM) and a β-lac­ta­mase in­hibitor, Avibac­tam (AVI, NXL104). Just a few weeks ago As­traZeneca flagged a suc­cess­ful Phase III ef­fort for Za­v­icef­ta  (cef­tazidime-avibac­tam), which fol­lowed close on the heels of an ap­proval in Eu­rope. Al­ler­gan has been part­nered with As­traZeneca on the ef­fort and holds North Amer­i­can rights.

Not in­clud­ed: A fi­nal group of bi­o­log­ics un­der Med­Im­mune’s ban­ner in Mary­land as well as its stake in En­ta­sis.

As­traZeneca has been run­ning a brisk busi­ness in sell­ing off as­sets it ei­ther no longer sees as a good fit for So­ri­ot’s core drug strat­e­gy or drugs that have lost a con­sid­er­able amount of lus­ter. The sales in­clude a deal to hive off anes­thet­ics to As­pen for up to $770 mil­lion. The re­jects ex­iled to its is­land of mis­fit as­sets in­clude lesin­u­rad and bro­dalum­ab, which pro­duced mixed da­ta in the clin­ic and were then li­censed out. And now there’s a ques­tion whether selume­tinib might wind up at the bar­gain base­ment as well af­ter back-to-back late-stage fail­ures.

There has been some in­ter­est in an­tibi­otics among the phar­ma ma­jors, wit­nessed by Mer­ck’s ac­qui­si­tion of Cu­bist. But Mer­ck al­so shut­tered ear­ly stage ef­forts there and Big Phar­ma in gen­er­al has been deeply skep­ti­cal of a field that typ­i­cal­ly de­liv­ers on­ly small mar­gins. An­tibi­ot­ic re­sis­tance, mean­while, has on­ly grown worse around the globe.

As­traZeneca has been beef­ing up weak rev­enue with these deals as it con­tin­ues a years-long ef­fort to re­tool in a turn­around aimed at adding bil­lions of dol­lars in new sales. The phar­ma gi­ant sees its can­cer pipeline, in­clud­ing the re­cent­ly ap­proved Tagris­so as well as the late-stage check­point dur­val­um­ab, as its best chance for a come­back. Pfiz­er, on the oth­er hand, has been buy­ing, pur­su­ing an ac­qui­si­tion strat­e­gy high­light­ed by its $14 bil­lion buy­out of Medi­va­tion.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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