EQT Group ac­quires VC firm in $500M+ deal; Sanofi se­lects IPO lead­ers for 2022 API spin­out — re­port

Pri­vate in­vest­ment group EQT an­nounced an agree­ment this morn­ing to buy out Life Sci­ence Part­ners, a Eu­ro­pean VC firm with more than $2.5 bil­lion un­der man­age­ment.

While de­tails are not com­plete, EQT agreed to $520 mil­lion up­front — 25% in cash and 75% in new EQT shares. There is al­so po­ten­tial for a $29 mil­lion earn-out pay­ment, ac­cord­ing to an EQT state­ment.

Michael Bauer, Part­ner and Co-Head of EQT’s Glob­al Health­care sec­tor team, said, “We are tru­ly ex­cit­ed about the op­por­tu­ni­ty to join forces with LSP and form EQT Life Sci­ences. The EQT and LSP teams have com­ple­men­tary skill sets, and the com­bi­na­tion will al­low us to sup­port health­care com­pa­nies and their man­age­ment teams in a unique way.”

EQT plans to close the trans­ac­tion by some­time ear­ly next year.

Sanofi choos­es big bankers to lead API spin­out in 2022 IPO — re­port

Sanofi SA has picked Bank of Amer­i­ca, BNP Paribas and JP­Mor­gan to lead EU­ROAPI to an IPO some­time next year, ac­cord­ing to Bloomberg News.

The French phar­ma wants to raise close to $1.2 bil­lion in the IPO, and more banks could get added to the list­ing ros­ter.

Sanofi an­nounced plans just be­fore the Covid-19 pan­dem­ic to cre­ate a new ac­tive phar­ma­ceu­ti­cal in­gre­di­ents com­pa­ny, hop­ing the spin­out could gen­er­ate around 1 bil­lion eu­ros in sales. The Big Phar­ma said at the time that it planned to re­tain around 30% in the com­pa­ny and would con­sid­er Paris as a list­ing venue.

And this past Jan­u­ary, Sanofi un­veiled EU­ROAPI as the name of the new unit and tapped Karl Rot­thi­er as the first CEO. The spin­out’s ini­tial port­fo­lio will come with more than 200 APIs ap­proved for prod­ucts in 80 in­ter­na­tion­al mar­kets.

Free­line claims ear­ly win in Fab­ry dis­ease pro­gram

UK gene ther­a­py biotech Free­line Ther­a­peu­tics gave in­vestors an up­date this morn­ing on its in­ves­ti­ga­tion­al Fab­ry dis­ease treat­ment FLT190, cur­rent­ly in a Phase I/II clin­i­cal tri­al, say­ing the can­di­date proved durable in the sec­ond pa­tient test­ed.

Fab­ry dis­ease is an in­her­it­ed me­tab­o­lism dis­or­der — re­sult­ing from the ab­sent or marked­ly de­fi­cient ac­tiv­i­ty of lyso­so­mal en­zyme α-galac­tosi­dase A, or α-Gal A.

“En­zyme ex­pres­sion da­ta from the sec­ond pa­tient in our Phase I/II dose-find­ing tri­al of FLT190 are high­ly en­cour­ag­ing, with ex­pres­sion of al­pha-galac­tosi­dase A reach­ing near-nor­mal lev­els and the pa­tient thus far re­main­ing off en­zyme re­place­ment ther­a­py since dos­ing,” said Free­line CEO Michael Pari­ni. Ac­cord­ing to a com­pa­ny state­ment, the pa­tient was last dosed more than 16 weeks ago.

A third pa­tient will be dosed some­time ear­ly next year.

The biotech al­so an­nounced that it is work­ing with reg­u­la­to­ry au­thor­i­ties to up­date study pro­to­cols for FLT180a for he­mo­phil­ia B to in­clude ad­di­tion­al da­ta col­lec­tion, and that it will ini­ti­ate a Phase I/II tri­al on the in­ves­ti­ga­tion­al can­di­date by Q1 next year.

Wednes­day’s up­date comes af­ter the com­pa­ny an­nounced a two-year de­lay on a piv­otal tri­al for he­mo­phil­ia B in Feb­ru­ary to work on CMC feed­back from the FDA. The pro­gram was ini­tial­ly slat­ed to en­ter a piv­otal Phase IIb/III study be­fore the end of the year.

In the same state­ment, Free­line an­nounced they are adding a new CMO in Pamela Foulds, who joins the biotech just a few months af­ter now-for­mer CEO There­sa Heg­gie spent on­ly a year at the helm.

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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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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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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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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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.

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.