No­var­tis nabs pri­or­i­ty re­view for a block­buster-to-be aimed at NSCLC niche — de­light­ing In­cyte ex­ecs

In­cyte fi­nal­ly has some good news to share about one drug it’s dis­cov­ered that’s not Jakafi — al­beit one that doesn’t be­long to it any­more.

FDA reg­u­la­tors have ac­cept­ed cap­ma­tinib, an or­phan and “break­through” MET in­hibitor, for pri­or­i­ty re­view. The hon­or tech­ni­cal­ly goes to No­var­tis, which li­censed world­wide de­vel­op­ment and com­mer­cial­iza­tion rights to the drug back in 2009.

But that didn’t stop In­cyte from brag­ging about it in a re­lease, re­mind­ing in­vestors that if every­thing goes well, it’s el­i­gi­ble for $500 mil­lion-plus in mile­stones as well as roy­al­ties up to 14% of glob­al sales.

Shav­ing four months off the re­view time­line — as­sum­ing there aren’t hic­cups — helps en­sure that No­var­tis can score an ap­proval with­in this year. The phar­ma gi­ant had des­ig­nat­ed cap­ma­tinib (for­mer­ly INC280) as one of four ma­jor launch­es of 2020, pre­dict­ing a block­buster fu­ture for a drug ini­tial­ly aimed at a sub­type of non-small cell lung can­cer.

NSCLC pa­tients who har­bor a MET ex­on-14 skip­ping mu­ta­tion cur­rent­ly have no ap­proved tar­get­ed ther­a­py. A No­var­tis-spon­sored Phase II tri­al showed that cap­ma­tinib in­duced an over­all re­sponse rate of 67.9% among treat­ment-naïve pa­tients (du­ra­tion of re­sponse 11.14 months) and 40.6% among pre­vi­ous­ly treat­ed ones (DOR 9.72 months).

Those 97 pa­tients had EGFR wild­type, ALK-neg­a­tive tu­mors, and took 400 mg cap­ma­tinib tablets twice a day.

“ME­Tex14 mu­ta­tions oc­cur in 3-4% of new­ly di­ag­nosed ad­vanced NSCLC cas­es and is a rec­og­nized onco­genic dri­ver,” No­var­tis not­ed in a state­ment.

Mer­ck KGaA and Pfiz­er al­so an­gling for this un­tapped niche; both have been grant­ed break­through ther­a­py des­ig­na­tions, though theirs on­ly cov­er sec­ond-line ther­a­py fol­low­ing plat­inum-based chemo. While tepo­tinib from the Ger­man drug­mak­er was en­gi­neered as a se­lec­tive MET in­hibitor, the drug Pfiz­er has put for­ward is Xalko­ri, orig­i­nal­ly tar­get­ed at ALK and ROS1 mu­ta­tions.

Mean­while, in Chi­na, Chi-Med is al­so test­ing As­traZeneca’s MET in­hibitor, savoli­tinib, in a Phase II reg­is­tra­tional tri­al among pa­tients who have pro­gressed fol­low­ing pri­or sys­temic ther­a­py or are un­able to re­ceive chemo.

A com­pan­ion di­ag­nos­tic will like­ly be key to the adop­tion of any of these treat­ments. No­var­tis has teamed up with Foun­da­tion Med­i­cine — now a Roche sub­sidiary — to in­clude tu­mor tis­sue and liq­uid biop­sy di­ag­nos­tics on its flag­ship prod­ucts.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Alarmed by side ef­fect, FDA slaps clin­i­cal hold on Sarep­ta's next-gen Duchenne drug

Sarepta Therapeutics’ next-gen Duchenne muscular dystrophy drug has been hit with a clinical hold after investigators flagged a serious case of low magnesium levels in one patient’s blood.

Screening and dosing will be halted in what is known as Part B of the Phase II MOMENTUM study, which has enrolled about half of the planned patients. Sarepta said it will be submitting information on all cases of the condition, known as hypomagnesemia, per the FDA’s request and proposing some changes to the risk mitigation and safety monitoring plan.

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When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Although it’s exceedingly rare for the FDA to rescind a breakthrough designation once it’s granted, there has been a recent uptick — as in 2020 and 2021 combined, the agency rescinded 17 BTDs, compared to just 18 rescinded from 2015 to 2019 combined.

Protagonist Therapeutics saw this reality up close and personal in April after a clinical hold lifted on its experimental blood cancer drug, as the company revealed that the FDA sought to revoke the BTD. The decision, Protagonist says, stems from “observed malignancies” related to the hold, initially imposed in September 2021.

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FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.