In­cyte nabs 2nd ever ap­proval ahead of sched­ule as FDA in­sists it can still re­view on time

Al­most a full year af­ter In­cyte broke off a trou­bled part­ner­ship with Eli Lil­ly to fo­cus on its own in­ter­nal en­gine, one of the drugs from that en­gine will en­ter the mar­ket.

Pemi­ga­tinib, now brand­ed as Pe­mazyre, ob­tained FDA ap­proval as a sec­ond-line treat­ment for a rare form of can­cer known as cholan­gio­car­ci­no­ma, or bile duct can­cer. For In­cyte, a biotech that rose to promi­nence on the strength of a sin­gle drug — Jakafi — and a slew of Big Phar­ma part­ner­ships, the ap­proval marks the first of what they hope will be a se­ries of in­ter­nal suc­cess­es and the first sign of a new phase for the com­pa­ny, al­beit one that is un­like­ly to make a huge com­mer­cial splash.

The ap­proval came a month be­fore the May 30 PDU­FA date and on the same day that a Seat­tle Ge­net­ics drug was cleared four months ahead of its date. FDA of­fi­cials, hav­ing been hound­ed for over a month with ques­tions about how the Covid-19 cri­sis would af­fect the re­view process for non-Covid drugs, were clear about what the reg­u­la­to­ry an­nounce­ments should sig­nal.

“This ap­proval demon­strates that while we con­tin­ue to fo­cus our ef­forts on ad­dress­ing the COVID-19 pan­dem­ic, the FDA re­mains com­mit­ted to the im­por­tant work of re­view­ing treat­ments for pa­tients with can­cer and oth­er se­ri­ous con­di­tions,” Richard Paz­dur, CDER’s top on­col­o­gy of­fi­cial, said in a state­ment.

For all its con­fi­dent state­ments and now mul­ti­ple ear­ly ap­provals, though, the agency ac­knowl­edged last week that with staff in­creas­ing­ly fo­cused on re­view­ing Covid-19 work, “it is pos­si­ble that we will not be able to sus­tain our cur­rent lev­el of per­for­mance in­def­i­nite­ly.”

The In­cyte drug had re­ceived both break­through ther­a­py sta­tus and pri­or­i­ty re­view. Af­ter ES­MO last year, Eval­u­ate pegged peak sales for the drug at $127 mil­lion across in­di­ca­tions.

Pem­ga­tinib is an in­hibitor of FGFR, or fi­brob­last growth fac­tor, the same ki­nase tar­get­ed by J&J’s blad­der can­cer drug erdafi­tinib. In Phase II tri­al da­ta re­leased last year, In­cyte showed the drug led to a pro­gres­sion-free sur­vival of 6.9 months and over­all sur­vival of 21.1 months in pa­tients with an FGFR2 mu­ta­tion. Two oth­er small­er co­horts with dif­fer­ent forms of FGFR lived for 6.7 months and 4.0 months, in line with the dis­ease’s stan­dard prog­no­sis. The fi­nal du­ra­tion of re­sponse re­sult was 9.1 months.

In­cyte hopes to soon show ef­fec­tive­ness in blad­der can­cer, test­ing the drug in sev­er­al Phase II tri­als for that in­di­ca­tion, along with tri­als for pa­tients with any tu­mors that have FGFR mu­ta­tions, ir­re­spec­tive of type. Op­er­at­ing in re­verse, J&J is now test­ing their drug against bile duct can­cer, while In­cyte push­es to show ef­fi­ca­cy as a first-line treat­ment. Agios al­so has an ex­per­i­men­tal bile duct treat­ment that tar­gets the en­zyme IDH1.

If the FDA keeps up its rapid pace, In­cyte could soon see an­oth­er big can­cer ap­proval. No­var­tis’ cap­ma­tinib, which the Swiss gi­ant li­censed from In­cyte back in 2009, has al­so been grant­ed break­through sta­tus and pri­or­i­ty re­view for MET-14 breast can­cer, with a PDU­FA date in Au­gust. That deal pro­vid­ed for over $500 mil­lion in mile­stones if No­var­tis suc­cess­ful­ly de­vel­oped the drug, plus 12-14% of sales.

The ap­proval could help shore up in­vestors’ testy faith in In­cyte’s abil­i­ty to ex­pand be­yond Jakafi. The com­pa­ny’s stock has swung wild­ly over the past year, par­tic­u­lar­ly af­ter the with­draw­al from the strug­gling Lil­ly drug baric­i­tinib and, in Jan­u­ary, a large Phase III fail­ure for a graft-ver­sus-host-dis­ease drug. It was up 4.54% from Thurs­day’s mar­ket close, to a flat $100.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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