Flemming Ørnskov, Galderma CEO

UP­DAT­ED: Gal­der­ma drug pass­es PhI­II in rare skin dis­ease, set­ting the stage for ap­proval re­quest

Der­ma­tol­ogy be­he­moth Gal­der­ma is one step clos­er to reg­u­la­tors’ doorsteps for a mon­o­clon­al an­ti­body it li­censed from Chugai Phar­ma­ceu­ti­cal af­ter a Phase III read­out Wednes­day.

The for­mer Nestlé Skin Health unit said that the drug, named nemolizum­ab, passed muster in one of two Phase III tri­als in the rare skin dis­ease pruri­go nodu­laris. The drug, test­ed on its own, was able to clear most skin le­sions and re­duce itch­ing in pa­tients with the rare skin dis­ease.

The Cetaphil mak­er will pack­age the re­sults and sub­mit to reg­u­la­tors once gath­er­ing da­ta from the sec­ond Phase III study, CEO Flem­ming Ørn­skov told End­points News in an email. The for­mer Shire CEO de­clined to dis­close when the sec­ond part of the OLYMPIA piv­otal pro­gram would read out in the rare in­flam­ma­to­ry dis­ease, which is de­void of any ap­proved ther­a­pies.

“If ap­proved, nemolizum­ab would be a con­ve­nient ther­a­py with a month­ly in­jec­tion as op­posed to some of the ex­ist­ing bi­o­log­ic ther­a­pies which re­quire bi­week­ly in­jec­tions,” the CEO said.

Gal­der­ma is al­so test­ing nemolizum­ab in atopic der­mati­tis. The Phase III AD tri­als, un­der the clin­i­cal pro­gram um­brel­la AR­CA­DIA, are ex­pect­ed to com­plete in late 2022 or the first half of 2023, Ørn­skov said. An­oth­er long-run­ning biotech work­ing to get in­to the AD space re­ceived FDA ap­proval last De­cem­ber, as Leo Phar­ma won a nod for an IL-13-tar­get­ing drug, named Ad­bry.

Af­ter 16 weeks of treat­ment, 38% of pa­tients treat­ed with Gal­der­ma’s in­ves­ti­ga­tion­al med saw skin le­sion clear­ance or al­most-clear­ance as com­pared to 11% in the place­bo group. On the itch­ing im­prove­ment, Gal­der­ma’s med led to a four-point re­duc­tion or greater in itch­ing in 56% of nemolizum­ab-treat­ed pa­tients com­pared to 21% in the con­trol co­hort.

All key sec­ondary end­points were al­so achieved, the Swiss der­ma­tol­ogy com­pa­ny said Wednes­day. Pa­tients re­ceived two sub­cu­ta­neous in­jec­tions at base­line and then ei­ther one or two in­jec­tions, de­pend­ing on weight, every four weeks across 16 weeks.

Gal­der­ma is al­so in­ves­ti­gat­ing the drug in mul­ti­ple mid- and late-stage tri­als in atopic der­mati­tis.

Orig­i­nal­ly de­vel­oped by Chugai Phar­ma­ceu­ti­cal, the an­ti-IL-31 mAb re­ceived ap­proval in Japan in March for treat­ing pru­ri­tus (itch­ing) as­so­ci­at­ed with atopic der­mati­tis. Japan­ese biotech Maruho is mar­ket­ing the drug as Mitch­ga. Maruho has Japan and Tai­wan rights to the Chugai drug and Gal­der­ma has the ex­clu­sive glob­al li­cense else­where un­der a Ju­ly 2016 deal, for which fi­nan­cials were not dis­closed.

The Phase III re­sults prop up the strat­e­gy be­hind Gal­der­ma’s in­creased fo­cus on R&D since spin­ning out of Nestlé. With “dis­rup­tive po­ten­tial,” nemolizum­ab is cen­tral to the com­pa­ny’s bi­o­log­ics fu­ture, Ørn­skov said.

Ed­i­tor’s note: This sto­ry was up­dat­ed to clar­i­fy that Leo Phar­ma’s Ad­bry is an IL-13 and Gal­der­ma’s mon­o­clon­al an­ti­body tar­gets IL-31.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Susan Galbraith, AstraZeneca EVP, oncology R&D

Catch­ing up with Bris­tol My­ers and Mer­ck, As­traZeneca de­clares neoad­ju­vant win for PD-L1/chemo com­bo

When AstraZeneca started the Phase III AEGEAN trial for Imfinzi in 2018, it was, alongside several Big Pharma brethren, hoping to push the use of PD-(L)1 therapies into earlier lines of treatment. Three and a half years later, the British drugmaker has nabbed promising data in a type of lung cancer.

Topline results from an interim analysis showed that adding Imfinzi to chemotherapy before surgery spurred a “statistically significant and meaningful” improvement in pathologic complete response for patients with resectable non-small cell lung cancer compared to chemotherapy alone.

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Nassim Usman, Catalyst Biosciences CEO

Fac­ing set­backs for months and an ac­tivist at­tack, Cat­a­lyst Bio­sciences pre­pares to call it quits

After downsizing for several months, Catalyst Biosciences is getting ready to tap out.

The San Francisco biotech announced Wednesday that it would be liquidating and distributing cash back to shareholders, with total proceeds expected to reach $65 million. Catalyst intends to return the money “as soon as practicable,” the company said, as it has ceased all R&D activities, CEO Nassim Usman said in a statement.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

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Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.