Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

Dutch VC For­bion is hop­ping on the ever-length­en­ing SPAC train.

To be led by Jasper Bos, who joined For­bion Growth as a gen­er­al part­ner back in May just af­ter the fund closed at $428 mil­lion, For­bion Eu­ro­pean Ac­qui­si­tion will tar­get late-stage op­por­tu­ni­ties in the life sci­ences in­dus­try in Eu­rope to merge with and bring on­to Nas­daq.

Cyril Less­er, se­nior con­troller at For­bion, will be the CFO while Bos serves as CEO.

Af­ter a record year for biotech SPACs, the craze for blank check com­pa­nies ap­pears to be in a bit of a lull re­cent­ly, al­though it’s clear­ly not stop­ping ex­pe­ri­enced in­vestors who think they will be able to spot a de­cent pri­vate com­pa­ny to flip pub­lic.

As is stan­dard with these types of deals, For­bion Eu­ro­pean Ac­qui­si­tion is pen­cil­ing in a $100 mil­lion raise by sell­ing shares at $10 apiece — a pitch cen­tered around the man­age­ment team’s ex­pe­ri­ence, net­work and ex­per­tise. It may raise an­oth­er $20 mil­lion “at the clos­ing of an ac­qui­si­tion,” the com­pa­ny added. — Am­ber Tong

Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

On­col­o­gy biotech Kro­nos Bio an­nounced da­ta from its on­go­ing Phase I/II clin­i­cal tri­al of its oral CDK9 in­hibitor KB-0742, which is be­ing de­vel­oped to treat MYC-am­pli­fied sol­id tu­mors.

Among the 12 pa­tients treat­ed in the tri­al, KB-0742 had a ter­mi­nal half-life of 24 hours, with ap­prox­i­mate­ly 2 to 2.5-fold ac­cu­mu­la­tion be­tween days 1 and 10. Ac­cord­ing to Kro­nos, this long plas­ma half-life sup­ports the biotech’s ap­proach to defin­ing a ther­a­peu­tic win­dow for CDK9 in­hi­bi­tion.

Fur­ther dose es­ca­la­tion — the first part of the two-stage tri­al — is re­quired to reach de­sired lev­els of CDK9 in­hi­bi­tion.

The na­ture and sever­i­ty of the ad­verse events ob­served have been con­sis­tent with what is typ­i­cal­ly seen among heav­i­ly pre­treat­ed pa­tients with ad­vanced can­cer in Phase I tri­als, and Kro­nos Bio is con­tin­u­ing to en­roll in the tri­al.

“These ear­ly da­ta are en­cour­ag­ing, and we look for­ward to con­tin­u­ing the tri­al and es­tab­lish­ing a rec­om­mend­ed Phase II dose,” said Kro­nos Bio CEO and pres­i­dent Nor­bert Bischof­berg­er.

While the first stage is de­ter­min­ing safe­ty of the drug and find­ing a dosage lev­el for pa­tients, the sec­ond stage of the tri­al will en­roll pa­tients with MYC-am­pli­fied or over-ex­press­ing tu­mors, as well as oth­er tran­scrip­tion­al­ly ad­dict­ed tu­mor types, to as­sess the an­ti-tu­mor ac­tiv­i­ty of KB-0742 at the rec­om­mend­ed Phase II dose. — Paul Schloess­er

Gilead goes with Ama­zon Web Ser­vices as its cloud provider

Gilead had de­cid­ed on Ama­zon for its cloud ser­vices.

Gilead an­nounced this morn­ing that it is go­ing with Ama­zon Web Ser­vices as its cloud provider — cit­ing AWS’s on­line port­fo­lio for in­fra­struc­ture and oth­er ser­vices.

Ac­cord­ing to Gilead, AWS’ ca­pa­bil­i­ties in ma­chine learn­ing and an­a­lyt­ics fu­el de­ci­sion mak­ing across the phar­ma — from bio­mark­er dis­cov­ery to man­u­fac­tur­ing and clin­i­cal tri­al re­cruit­ment.

“With AWS as our pre­ferred cloud provider, our re­searchers can use AWS’s port­fo­lio of ser­vices to gain the in­sights, agili­ty, and se­cu­ri­ty need­ed to de­liv­er new med­i­cines at speed,” said Gilead SVP and CIO Marc Berson in a pre­pared state­ment.

In ad­di­tion, Gilead has moved more than 50% of its da­ta cen­ter foot­print to AWS over the past year through an ac­cel­er­at­ed cloud mi­gra­tion pro­gram with AWS Pro­fes­sion­al Ser­vices. The com­pa­ny al­so plans to mi­grate hun­dreds of ap­pli­ca­tions to AWS, which in­clude ap­pli­ca­tions that sup­port in­dus­try good prac­tice guide­lines and reg­u­la­tions in ar­eas like drug man­u­fac­tur­ing, stor­age and dis­tri­b­u­tion.

As a re­sult, Gilead will be ac­cel­er­at­ing its plans to up­grade its IT op­er­a­tions with AWS, while avoid­ing up­front costs to re­fresh hard­ware and the sus­tained costs of run­ning an “al­ways on,” on-premis­es IT land­scape pro­vi­sioned for peak use. — Paul Schloess­er

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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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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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.

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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