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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.