Róbert Wessman, Alvotech chairman and founder

Ice­landic bil­lionare's biosim­i­lar com­pa­ny rais­es $450M, preps for Nas­daq launch with SPAC merg­er

As Ice­landic bil­lion­aire Róbert Wess­man tries to take down Ab­b­Vie’s megablock­buster Hu­mi­ra in court, he’s al­so tak­ing his biosim­i­lar up­start to the big time with a $2.25 bil­lion SPAC merg­er, Nas­daq launch and $450 mil­lion raise an­nounced ear­ly Tues­day.

While Wess­man’s Alvotech has not won FDA ap­proval for any of its biosim­i­lar can­di­dates yet, the com­pa­ny was the first to file with the FDA for ap­proval of its high-con­cen­tra­tion Hu­mi­ra biosim­i­lar and to have suc­cess­ful­ly con­duct­ed a switch­ing study in sup­port of a high­ly-cov­et­ed in­ter­change­abil­i­ty des­ig­na­tion. But oth­er com­pa­nies like Am­gen, Boehringer In­gel­heim and Pfiz­er have since caught up ahead of the launch­es of their own Hu­mi­ra biosim­i­lar com­peti­tors in 2023.

“So when those biosim­i­lar com­pa­nies en­ter in 2023, we ex­pect that on­ly 10% of Hu­mi­ra sales in the US – around 15 to 16 bil­lion, on­ly 10% will be [the low­er con­cen­tra­tion] 50 mg. We, on the oth­er hand, were the first to get fil­ing ac­cep­tance [with the FDA] of the high­er con­cen­tra­tion, so we can fo­cus on 90% of the mar­ket when we come out,” Wess­man pre­vi­ous­ly told End­points News.

But the high­er con­cen­tra­tion ver­sion of a Hu­mi­ra biosim­i­lar may be a moot point, as BI said in a re­cent cit­i­zen pe­ti­tion to FDA that the agency has yet to weigh in on:

In Boehringer In­gel­heim’s view, these biosim­i­lar prod­ucts, in­clud­ing Cyl­te­zo, should be con­sid­ered to have the same ‘strength’ as the cor­re­spond­ing OC [orig­i­nal con­cen­tra­tion] and HC [high­er con­cen­tra­tion] ver­sions of Hu­mi­ra be­cause they con­tain the same to­tal drug con­tent per con­tain­er (e.g., 40 mg), re­gard­less of the vol­ume of ex­cip­i­ents.

What’s more, if Alvotech proves to be suc­cess­ful in de­feat­ing Ab­b­Vie in court, Ab­b­Vie CEO Rick Gon­za­lez said re­cent­ly in an earn­ings call that al­though he thinks such an out­come is doubt­ful, all of the oth­er FDA-ap­proved Hu­mi­ra biosim­i­lars would come to mar­ket too along­side Alvotech’s biosim­i­lar, po­ten­tial­ly in late 2022.

Mean­while, Alvotech’s pipeline al­so in­cludes biosim­i­lar can­di­dates to Ste­lara (ustek­inum­ab), Eylea (afliber­cept), Pro­lia/Xge­va (deno­sum­ab) and Sim­poni/Sim­poni ARIA (goli­mum­ab).

And Alvotech’s part­ners, in­clud­ing Te­va in the US and Sta­da in the EU, have li­censed prod­ucts in ex­change for mile­stone pay­ments and roy­al­ties. As of June 30,  Alvotech said it had re­ceived li­cense fee com­mit­ments of up to $1.15 bil­lion un­der these part­ner­ships, ap­prox­i­mate­ly 80% of which are still to be col­lect­ed.

“Alvotech has built a high­ly at­trac­tive plat­form with a long-term view to lead the biosim­i­lars mar­ket,” said Zaid Parde­si, man­ag­ing di­rec­tor at Oak­tree and CFO of Oak­tree Ac­qui­si­tion Corp II, which is work­ing with Alvotech on the SPAC merg­er. “The Com­pa­ny’s di­verse pipeline and unique ca­pa­bil­i­ties, in com­bi­na­tion with its world-class dis­tri­b­u­tion part­ners, set the stage for mean­ing­ful val­ue cre­ation and ac­cel­er­at­ed growth go­ing for­ward.”

As part of the SPAC, Alvotech is ex­pect­ed to get $450 mil­lion in cash — $250 mil­lion from the SPAC’s trust, $150 mil­lion from a PIPE fi­nanc­ing and a $50 mil­lion eq­ui­ty com­mit­ment. The merg­er is ex­pect­ed to close in the first half of 2022.

Alexander Lefterov/Endpoints News

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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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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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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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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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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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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