News brief­ing: Ex­elix­is rolls the dice with 2 ADC deals tied to $35M cash up­fronts; A rare an­tibi­ot­ic win for promi­nent­ly-backed Spero

Pe­ter Lamb

Catal­ent’s Red­wood Bio­science sub­sidiary is tak­ing the lead role in de­vel­op­ing AD­Cs for Ex­elix­is $EX­EL. In one of 2 deals an­nounced this morn­ing, Ex­elix­is is turn­ing to Catal­ent to do the dis­cov­ery work on the AD­Cs, which will em­ploy their SMARTag site-spe­cif­ic bio­con­ju­ga­tion plat­form tech­nol­o­gy us­ing an­ti­bod­ies out of the biotech’s pipeline.

Catal­ent gets $10 mil­lion up­front to trig­ger the deal, with Ex­elix­is hold­ing world­wide de­vel­op­ment rights on any­thing it choos­es.

In a sep­a­rate ADC de­vel­op­ment deal, Ex­elix­is is turn­ing to NBE-Ther­a­peu­tics for an­oth­er pact that could steer more prod­uct can­di­dates its way. In this deal Ex­elix­is is pay­ing $25 mil­lion up­front to get a 2-year al­liance un­der­way.

“Ex­elix­is is pur­su­ing both in­ter­nal drug dis­cov­ery and ex­ter­nal busi­ness de­vel­op­ment ap­proach­es to build a pipeline with the po­ten­tial to make a dif­fer­ence for pa­tients with can­cer,” said Pe­ter Lamb, the CSO at Ex­elix­is. – John Car­roll

Spero her­alds Phase III an­tibi­ot­ic suc­cess

Back in the days when in­vestors thought there was still good busi­ness to be made in an­tibi­otics, Spero raised a fair bit of cap­i­tal: a $30 mil­lion Se­ries A and B led by At­las Ven­tures, a $51.7 mil­lion Se­ries C led by GV, and a $77 mil­lion IPO. In 2018, they re­ceived an up to $54 mil­lion con­tract with BAR­DA too.

The mar­ket for an­tibi­otics has since soured, but that cash has al­lowed Spero to get through Phase III with its lead drug. And on Tues­day they an­nounced pos­i­tive re­sults, show­ing in a 1,372-per­son study that their oral an­tibi­ot­ic tebipen­em was non-in­fe­ri­or to the ap­proved IV an­tibi­ot­ic er­tapen­em in treat­ing pa­tients with com­pli­cat­ed uri­nary tract in­fec­tions and acute pyelonephri­tis.

Ankit Ma­hade­via

The drug, said tri­al in­ves­ti­ga­tor Kei­th Kaye, will give cU­TI pa­tients a new oral op­tion af­ter evolv­ing mi­cro­bi­ot­ic re­sis­tance had left them with on­ly the IV drug.

“Due to the in­creas­ing preva­lence of an­tibi­ot­ic-re­sis­tant bac­te­ria, many pa­tients with cU­TI now re­ceive in­tra­venous an­tibi­otics as their on­ly avail­able treat­ment op­tion,” Kaye, who is al­so di­rec­tor of re­search in the di­vi­sion of in­fec­tious dis­eases at the Uni­ver­si­ty of Michi­gan Med­ical School, said in a state­ment. “The much-an­tic­i­pat­ed da­ta from this head-to-head com­par­i­son against an IV stan­dard-of-care car­bapen­em an­tibi­ot­ic sug­gest that in many in­stances oral, out­pa­tient treat­ment of these com­pli­cat­ed bac­te­r­i­al in­fec­tions is a vi­able op­tion.”

Spero CEO Ankit Ma­hade­via said it would be the first oral cU­TI drug ap­proved in 26 years. The com­pa­ny said it plans to start a rolling NDA and com­plete it by the sec­ond quar­ter of 2021.

An ap­proval would be a ma­jor boon to any biotech, but when it comes to an­tibi­otics, reg­u­la­to­ry suc­cess doesn’t nec­es­sar­i­ly trans­late in­to com­mer­cial suc­cess. Melin­ta and Achaoe­gen are well proof of that.  — Ja­son Mast

A UK biotech bro­kers an in­ter­con­ti­nen­tal AI deal

A UK-based biotech is buy­ing out­right a soft­ware de­vel­op­er in Brook­lyn, NY, in or­der to bring ar­ti­fi­cial in­tel­li­gence to its di­ag­nos­tics tools.

APIS As­say Tech­nolo­gies an­nounced the ac­qui­si­tion of Beoge­nomics on Fri­day, hop­ing to use da­ta-min­ing process­es to iden­ti­fy bio­mark­er tar­gets in on­col­o­gy, as well as in­flam­ma­to­ry, au­toim­mune and in­fec­tious dis­eases. The tech­nol­o­gy from Beoge­nomics, which has been de­vel­op­ing both on-prem and se­cure cloud-based da­ta analy­sis so­lu­tions, will help sup­port the launch of a new pro­pri­etary ser­vice line. APIS main­ly works in R&D and di­ag­nos­tics, de­vel­op­ing new tests for the pre­dic­tion, pre­ven­tion, and di­ag­no­sis of dis­ease from dis­cov­ery to reg­u­la­to­ry ap­proval.

The com­pa­ny’s busi­ness mod­el fo­cus­es on three as­pects: bio­mark­er di­ag­nos­tics de­vel­op­ment, mol­e­c­u­lar di­ag­nos­tic con­tract de­vel­op­ment, and ap­plied bioin­for­mat­ics. — Max Gel­man

NIH hands out $9.4. M con­tract for re­search on dif­fer­ent virus

In­travacc, a Dutch vac­cines com­pa­ny, land­ed an up to $9.4 mil­lion con­tract from NI­AID to de­vel­op a vac­cine for en­terovirus D68, a res­pi­ra­to­ry virus that can cause paral­y­sis and has be­come in­creas­ing­ly com­mon in Amer­i­ca, Eu­rope and Asia over the last few years.

The small biotech, which al­so has pro­grams for RSV, gon­or­rhea and of course Covid-19, will de­vel­op an in­ac­ti­vat­ed virus vac­cine in Vero cells. The con­tract is for ear­ly prod­uct se­lec­tion through Phase I. — Ja­son Mast

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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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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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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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.

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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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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.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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