Re­gen­eron and Sanofi pull Lib­tayo app in cer­vi­cal can­cer, cit­ing post-mar­ket study dis­agree­ment with FDA

Sanofi and Re­gen­eron on Fri­day said they’ve de­cid­ed to pull their sBLA for their PD-1 Lib­tayo (cemi­plimab-rwlc) in sec­ond-line cer­vi­cal can­cer af­ter the com­pa­nies and the FDA were not able to align on cer­tain post-mar­ket­ing stud­ies that pre­sum­ably would’ve been re­quired had it won ap­proval.

Nei­ther Sanofi nor Re­gen­eron was will­ing to elab­o­rate on this dis­con­nect over the post-mar­ket­ing re­quire­ments, but talks with reg­u­la­tors out­side the US re­main on­go­ing.

“We’re notic­ing a pat­tern with FDA on non-align­ment on post-mar­ket­ing stud­ies, which cre­ates un­cer­tain­ty for drug­mak­ers,” in­vest­ment an­a­lysts at Tru­ist Se­cu­ri­ties said in a note on the an­nounce­ment Fri­day. “FDA is not mak­ing the path for­ward eas­i­er. It could be be­cause there are oth­er drugs com­ing down the pipeline that are po­ten­tial­ly bet­ter and safer, which rais­es the bar.”

Tru­ist al­so not­ed that oth­er com­pa­nies may find chal­lenges in pur­su­ing evolv­ing and com­pet­i­tive ther­a­peu­tic land­scapes such as this one, par­tic­u­lar­ly as “it be­comes more dif­fi­cult to re­cruit for these con­fir­ma­to­ry and post-mar­ket­ing stud­ies in a rea­son­able time,” which com­pa­nies “may think it’s not worth the in­vest­ment.”

Ear­li­er this week, In­cyte said it made the “busi­ness de­ci­sion” to with­draw an NDA for parsaclis­ib, its oral PI3Kδ in­hibitor, af­ter de­cid­ing that run­ning the con­fir­ma­to­ry stud­ies the agency was ask­ing for to sup­port an ac­cel­er­at­ed ap­proval wouldn’t be worth it.

Fri­day’s news for Sanofi and Re­gen­eron came as a sur­prise as the com­pa­nies pre­vi­ous­ly halt­ed a Phase III cer­vi­cal can­cer tri­al ear­ly af­ter Lib­tayo was shown to cut the risk of death by 31% over chemother­a­py, paving the way for this pri­or­i­ty re­view sub­mis­sion (the PDU­FA date was Jan. 30).

A Re­gen­eron spokesper­son con­firmed that the com­pa­ny was not amend­ing its state­ment from March re­gard­ing the tri­al re­sults.

The tri­al win in March fol­lowed a string of two quick ap­provals that came with­in weeks of each oth­er, vast­ly ex­pand­ing Lib­tayo’s la­bel and, for the first time, pit­ting it against Mer­ck’s dom­i­nant PD-1 star Keytru­da.

In­vent­ed with Re­gen­eron’s pro­pri­etary Ve­locIm­mune tech, Lib­tayo has shown sig­nif­i­cant sales growth in re­cent years, as it’s ap­proved for cer­tain pa­tients with ad­vanced basal cell car­ci­no­ma, ad­vanced cu­ta­neous squa­mous cell car­ci­no­ma (CSCC), and ad­vanced non-small cell lung can­cer.

Re­gen­eron, which records net prod­uct sales of Lib­tayo in the US, re­port­ed about $340 mil­lion in Lib­tayo sales in the first nine months of 2021, a 34% in­crease over 2020.

And Sanofi, which records net prod­uct sales of Lib­tayo out­side the US, said sales amount­ed to €59 mil­lion ($66 mil­lion) in the first half of 2021, dri­ven by in­creased de­mand in the treat­ment of metasta­t­ic CSCC and by the launch of the prod­uct for that in­di­ca­tion in new coun­tries.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new details of what needs fixing, Lupin disclosed last week that the FDA recently sent a warning letter to its Tarapur, India-based site.

After an inspection from March 22 to April 4, Lupin disclosed in an April stock filing that it received a Form 483 with four observations, but it didn’t offer any details on the observations.

Similar to comments made in April, the company said last week it does not believe the FDA slap will disrupt its drug supplies or the existing revenues from operations of this facility.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.