Eye dis­ease biotech rais­es $46.9M in Se­ries B; Jour­ney Med­ical Cor­po­ra­tion shells out $20M up­front for der­ma­tol­ogy fran­chise

ONL Ther­a­peu­tics — an Ann Ar­bor, MI biotech that got its ini­tial back­ing from No­var­tis in a 2017 Se­ries A for its lead can­di­date Fas in­hibitor ONL1204 — just got its next cash in­fu­sion.

The biotech an­nounced this morn­ing that it closed on its sec­ond tranche of a Se­ries B round, rais­ing a to­tal of $46.9 mil­lion. Quite a few in­vestors tagged on­to the fi­nanc­ing — Bios Part­ners led the round along­side new in­vestors John­son & John­son In­no­va­tion – JJDC, Inc, Kaitai Cap­i­tal, PSQ Cap­i­tal, and Michi­gan Cap­i­tal Net­work Ven­ture Fund III. Re­turn­ing in­vestors in­clud­ed In­Fo­cus Cap­i­tal Part­ners, ExSight Ven­tures, the Uni­ver­si­ty of Michi­gan’s Michi­gan In­vest­ment in New Tech­nol­o­gy Star­tups (MINTS) pro­gram, West­ern Michi­gan Uni­ver­si­ty’s Bio­sciences Re­search & Com­mer­cial­iza­tion Cen­ter, and the Cap­i­tal Com­mu­ni­ty An­gels.

In ad­di­tion to com­plet­ing Phase I stud­ies across mul­ti­ple eye-re­lat­ed in­di­ca­tions (open-an­gle glau­co­ma, ge­o­graph­ic at­ro­phy as­so­ci­at­ed with dry mac­u­lar de­gen­er­a­tion and reti­nal de­tach­ment), the sec­ond tranche of fi­nanc­ing will back ONL’s reg­u­la­to­ry plans to prep for Phase II tri­als in the US.

ONL Ther­a­peu­tics CEO David Es­pos­i­to ex­pressed grat­i­tude in a state­ment, say­ing that the biotech had hit its goals for the year by ad­vanc­ing the can­di­date in­to clin­i­cal tri­als for open-an­gle glau­co­ma and ge­o­graph­ic at­ro­phy.

And for next year, the biotech is look­ing to ex­pand its de­vel­op­ment in­to two chron­ic in­di­ca­tions.

Jour­ney Med­ical Cor­po­ra­tion shells out $20M up­front for der­ma­tol­ogy fran­chise

Fortress Biotech sub­sidiary Jour­ney Med­ical Cor­po­ra­tion just made it­self a deal — ac­quir­ing a drug plat­form, two prod­ucts and a de­vel­op­ment-stage pro­gram in a po­ten­tial $475 mil­lion deal.

The deal, an­nounced ear­li­er this morn­ing, was made with Vyne Ther­a­peu­tics for its “Mol­e­cule Sta­bi­liz­ing Tech­nol­o­gy” (MST) fran­chise, which in­cludes FDA-ap­proved prod­ucts Amzeeq and Zilxi, FCD105, a drug can­di­date in de­vel­op­ment — and the MST pro­pri­etary plat­form.

The agree­ment, which stip­u­lat­ed for $20 mil­lion up­front and $5 mil­lion af­ter one year, al­so in­cludes $450 mil­lion in mile­stone pay­ments: $150 mil­lion per prod­uct, and the first year that an­nu­al net sales each reach $100 mil­lion, $200 mil­lion, $300 mil­lion, $400 mil­lion and $500 mil­lion, Jour­ney will pay Vyne a one-time pay­ment of $10 mil­lion, $20 mil­lion, $30 mil­lion, $40 mil­lion and $50 mil­lion.

Amzeeq and Zilxi are top­i­cal foams con­tain­ing minocy­cline, an an­tibi­ot­ic that’s been pre­scribed for skin is­sues such as ac­ne and oth­er skin in­fec­tions. Those drugs have been ap­proved for ac­ne and rosacea, a chron­ic skin con­di­tion.

Ac­cord­ing to Jour­ney, Amzeeq and Zilxi gen­er­at­ed ap­prox­i­mate­ly $4 mil­lion in net sales in the US in Q3 2021.

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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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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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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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.

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.