Hervé Hoppenot, Incyte CEO

In­cyte pays out $70M to get hands on Medicxi-backed vi­tili­go biotech

The M&A wheels keep on turn­ing in biotech — and this time it’s In­cyte that gets to do the deal­mak­ing.

The Delaware biotech put out word on Mon­day morn­ing that it will be shelling out $70 mil­lion in cash to ac­quire Vil­laris Ther­a­peu­tics. In­cyte will not on­ly ac­quire Vil­laris, but al­so ex­clu­sive glob­al rights for Vil­laris’s lead can­di­date au­re­molimab.

Au­re­molimab, cur­rent­ly in IND-en­abling stud­ies, is an an­ti-IL-15Rβ mon­o­clon­al an­ti­body be­ing in­ves­ti­gat­ed in vi­tili­go, with a pos­si­bil­i­ty of oth­er au­toim­mune and in­flam­ma­to­ry in­di­ca­tions. Vil­laris says it is tar­get­ing that path­way af­ter a mouse study showed that do­ing so could be ef­fec­tive at re­vers­ing the dis­ease.

In­cyte said in a state­ment that it ex­pects the drug to en­ter the clin­i­cal de­vel­op­ment phase some­time next year.

Be­yond the $70 mil­lion up­front, Vil­laris share­hold­ers are el­i­gi­ble for an­oth­er $310 mil­lion af­ter cer­tain de­vel­op­ment and reg­u­la­to­ry mile­stones are met. And if com­mer­cial­iza­tion ends up hap­pen­ing, In­cyte al­so in­clud­ed $1.05 bil­lion in com­mer­cial mile­stones based on net sales.

In­cyte CEO Hervé Hop­penot said in a state­ment that the deal com­ple­ments In­cyte’s port­fo­lio, in­clud­ing its top­i­cal cream of rux­oli­tinib, a JAK in­hibitor orig­i­nal­ly in­di­cat­ed to treat atopic der­mati­tis. Rux­oli­tinib, brand­ed as Opzelu­ra, is the first reg­i­men­ta­tion cream to be ap­proved for vi­tili­go. Like oth­er JAK in­hibitors, Opzelu­ra has a black box warn­ing, in­clud­ing in­creased risk of stroke, heart at­tack, cer­tain can­cers, and death.

This is the newest up­date for the com­pa­ny since the FDA OK’d a sec­ond in­di­ca­tion for its bile duct can­cer drug, FGFR1/2/3 in­hibitor Pe­mazyre back in Au­gust. That in­di­ca­tion was for re­lapsed or re­frac­to­ry myeloid/lym­phoid neo­plasms (MLNs) with FGFR1 re­arrange­ment.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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 you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Mene Pangalos, AstraZeneca EVP of BioPharmaceuticals R&D (AstraZeneca via YouTube)

In new deal, As­traZeneca places small bet on 'crit­i­cal but chal­leng­ing' tar­get

AstraZeneca has its eyes on NRF2 as a target for inflammatory and respiratory diseases, and it’s handing out $2 million in cash to pluck a preclinical candidate from a drug discovery shop.

It’s so early that C4X Discovery doesn’t have a name for the oral NRF2 activator program just yet. Including the upfront, the biotech is eligible for a total of $16 million in preclinical payments, after which AstraZeneca will take over for clinical development and commercialization. Those future milestones add up to $385.8 million.

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