Chi­na bans GSK from drug pro­cure­ment ac­tiv­i­ties through April 2024

Fol­low­ing an in­spec­tion of GSK’s CD­MO Poz­nan, Poland-based site that iden­ti­fied ques­tion­able prac­tices, Chi­na has de­cid­ed to ban the com­pa­ny from par­tic­i­pat­ing in its cen­tral­ized drug pro­cure­ment pro­gram through April 29, 2024, ac­cord­ing to an Eng­lish trans­la­tion of a re­cent gov­ern­ment post­ing.

The plant in ques­tion is a GSK con­tract man­u­fac­trur­er’s, which sup­plies the uri­nary re­ten­tion drug du­tas­teride, and Chi­na’s State Food and Drug Ad­min­is­tra­tion found the com­pa­ny did not con­duct batch-by-batch and full-item in­spec­tions of the prod­ucts ex­port­ed to Chi­na, as well as iden­ti­fied de­fi­cien­cies in the pre­ven­tion and con­trol of mi­cro­bial con­t­a­m­i­na­tion risks.

GSK sold the man­u­fac­tur­ing site to French CD­MO Del­pharm in Oct. 2020 as the British drug­mak­er sold oth­er as­sets too. Com­ment­ing on the lat­est dis­rup­tion, GSK said in a state­ment:

GSK’s vol­ume-based pro­cure­ment agree­ment with Chi­na for the sup­ply of Avo­dart (du­tas­teride) ex­pired on 30 Oc­to­ber. Due to a re­view of man­u­fac­tur­ing process­es fol­low­ing an in­spec­tion of our con­tract man­u­fac­tur­er, sup­ply of Avo­dart to Chi­na is cur­rent­ly on hold. For this rea­son, GSK will not be el­i­gi­ble to take part in the next vol­ume-based pro­cure­ment agree­ment for this prod­uct. This ex­clu­sion on­ly ap­plies to Avo­dart – no oth­er GSK prod­ucts are sup­plied to Chi­na through a vol­ume-based pro­cure­ment pro­gramme.

Chi­na’s SF­DA said it sus­pend­ed the im­port, sale and use of GSK du­tas­teride soft cap­sules, and all drug im­port ports in Chi­na have sus­pend­ed the is­suance of im­port cus­toms clear­ance forms.

GSK ac­quired the Pol­ish site in 1998 and, ac­cord­ing to a 2018 re­port, spent around $500 mil­lion there over 20 years, with the pro­duc­tion of 8.7 mil­lion tablets and 1.3 mil­lion cap­sules every day for 130 coun­tries.

In March 2019, the drug­mak­er an­nounced plans for a fi­nan­cial hub in Poz­nań, which will stay in GSK’s hands mov­ing for­ward, the com­pa­ny said in a re­lease. The hub em­ploys be­tween 200 and 300 em­ploy­ees, GSK said pre­vi­ous­ly.

“The com­pre­hen­sive as­sess­ment of the pro­duc­tion qual­i­ty man­age­ment of this va­ri­ety does not meet the re­quire­ments of Chi­na’s ‘Good Man­u­fac­tur­ing Prac­tice for Drugs’ (re­vised in 2010). On Oc­to­ber 31, 2022, the State Drug Ad­min­is­tra­tion is­sued an an­nounce­ment to sus­pend the im­port, sale and use of this prod­uct from now on,” Chi­na’s SM­PA wrote on its web­site.

The de­ci­sion to ban GSK came af­ter the col­lec­tive de­lib­er­a­tion of the rel­e­vant mem­bers of the state-or­ga­nized Drug Joint Pro­cure­ment Of­fice, with the SM­PA writ­ing that the com­pa­ny’s qual­i­fi­ca­tion to par­tic­i­pate in the cen­tral­ized drug pro­cure­ment ac­tiv­i­ties or­ga­nized by the state from to­day to April 29, 2024, will be sus­pend­ed.

“In view of the fact that the pro­cure­ment cy­cle of du­tas­teride ends at the end of Oc­to­ber, and the re­place­ment pro­ce­dure will no longer be ini­ti­at­ed, all lo­cal­i­ties are re­quest­ed to pay at­ten­tion to the sup­ply of this drug in the fol­low-up work af­ter the pro­cure­ment cy­cle ex­pires, and do a good job in con­nec­tion work to en­sure a sta­ble drug sup­ply,” the gov­ern­ment added, ac­cord­ing to an Eng­lish trans­la­tion.

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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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; 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.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.