John Oyler, Founder & CEO of BeiGene, at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018; Credit: Endpoints News, PharmCube

BeiGene scores first Chi­na OK with PD-1 — to be man­u­fac­tured by Boehringer In­gel­heim

On De­cem­ber 17, 2018, Jun­shi Bio­sciences notched the land­mark ap­proval for a made-in-Chi­na PD-(L)1 check­point in­hibitor by Chi­nese reg­u­la­tors. Bare­ly a year lat­er, the fourth home­grown PD-1 is mak­ing its way to a mar­ket that has since seen sev­er­al more firsts even whilst get­ting crowd­ed.

The ap­proval for BeiGene’s tislelizum­ab just be­fore 2019 end­ed is al­so mark­ing a new his­toric event: the first time a for­eign part­ner will be pro­duc­ing the mar­ket­ed drug un­der a re­formed con­tract man­u­fac­tur­ing reg­u­la­to­ry sys­tem. Boehringer In­gel­heim, a part­ner since 2013, will be sup­ply­ing the PD-1 an­ti­body for com­mer­cial use us­ing a Shang­hai fa­cil­i­ty.

“This is an im­por­tant mile­stone, not on­ly to en­sure the sup­ply of med­i­cines for pa­tients in Chi­na, but al­so for the rapid­ly emerg­ing Chi­nese bio­phar­ma­ceu­ti­cal Re­search & De­vel­op­ment land­scape,” said BeiGene CEO John Oyler in a state­ment.

In 2014 Chi­na’s drug reg­u­la­tor — since re­named the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion — be­gan pi­lot­ing a new Mar­ket­ing Au­tho­riza­tion Hold­er sys­tem un­der which drug­mak­ers with­out man­u­fac­tur­ing ca­pa­bil­i­ties can still ap­ply for mar­ket­ing ap­proval. This move opened up the op­tion of en­list­ing con­tract man­u­fac­tur­ers and sig­ni­fied a com­plete break from the pre­vi­ous sys­tem, where de­vel­op­ers must have man­u­fac­tur­ing au­tho­riza­tion to mar­ket a drug.

While BeiGene does have its own bi­o­log­ics man­u­fac­tur­ing plant in Guangzhou, it’s al­so inked a sep­a­rate deal with Catal­ent to pro­duce its first com­mer­cial drug, zanubru­ti­nib (re­cent­ly chris­tened Brukin­sa in the US).

SVB Leerink an­tic­i­pates BeiGene will launch tislelizum­ab in ear­ly 2020. The ini­tial in­di­ca­tion is third-line re­lapsed/re­frac­to­ry Hodgkin’s lym­phoma, fa­mil­iar ter­rain for any­one who’s been fol­low­ing In­novent’s Tyvyt or Jiang­su Hen­grui’s cam­re­lizum­ab. But BeiGene will have top-line Chi­nese da­ta in non-small cell lung can­cer com­ing lat­er this year, and is plot­ting sup­ple­men­tal OKs for urothe­lial can­cer, he­pa­to­cel­lu­lar car­ci­no­ma and more.

“This is BeiGene’s first in­ter­nal­ly dis­cov­ered drug ap­proved in Chi­na,” the an­a­lysts not­ed. “The ap­proval was based on re­sults from a sin­gle-arm piv­otal Phase 2 tri­al, in which tislelizum­ab demon­strat­ed a 76.9% ob­jec­tive re­sponse rate (ORR) via in­de­pen­dent re­view com­mit­tee (IRC) as­sess­ment, in­clud­ing a 61.5% com­plete re­sponse (CR) rate.”

Their mod­el es­ti­mates $85 mil­lion in 2020 Chi­na rev­enue for tislelizum­ab, part­ly from “mean­ing­ful off-la­bel sales” — as the re­cent Na­tion­al Re­im­burse­ment Drug List up­date fea­tured In­novent’s PD-1 for Hodgkin’s lym­phoma (at about $1,100 per month) but not oth­er check­points in larg­er in­di­ca­tions.

At one point Cel­gene was part­nered on this drug as part of a port­fo­lio swap which had BeiGene in charge of mar­ket­ing Abrax­ane, Revlim­id and Vi­daza in Chi­na, but cut it loose as soon as it got gob­bled up by Op­di­vo mak­er Bris­tol-My­ers Squibb. BeiGene’s de­vel­op­ment suc­cess­es bode well for Am­gen, which re­cent­ly paid $2.7 bil­lion for a rough­ly 20% stake in the biotech and en­trust­ed its R&D team with some of its own projects.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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