Cel­gene joins the PD-1 check­point club, bag­ging BeiGene drug with $413M down and $1B on the ta­ble

Cel­gene is join­ing the fast grow­ing PD-1 club.

John Oyler, BeiGene

The big biotech $CELG has tak­en a lead po­si­tion in the sec­ond wave of PD-1 check­points in the clin­ic, bag­ging rights to BeiGene’s $BGNE can­di­date for sol­id tu­mors in a $1.4 bil­lion deal, with $263 mil­lion of that paid up­front in a li­cens­ing fee, $150 mil­lion for an eq­ui­ty stake and $980 mil­lion more in mile­stones.

It’s a rich deal for this stage of the game, aimed at the rich­est health­care mar­kets on the plan­et. Cel­gene gets the US and Eu­ro­pean mar­kets and every­thing else out­side of Asia, which the Chi­nese com­pa­ny is keep­ing for it­self, along with glob­al de­vel­op­ment rights on hema­to­log­i­cal ma­lig­nan­cies. Two years ago, Cel­gene paid As­traZeneca $450 mil­lion up front to part­ner on their PD-L1 for heme.

The move was an­nounced the same day as Mer­ck’s com­bi­na­tion stud­ies match­ing its PD-1 drug Keytru­da with Cel­gene’s Revlim­id and Po­m­a­lyst were put on hold by the FDA — a month af­ter in­ves­ti­ga­tors flagged a high­er rate of death in the check­point arm. This was one of the rare in­stances where a check­point was linked to a po­ten­tial­ly lethal safe­ty is­sue. So far, their abil­i­ty to spur an im­mune sys­tem at­tack on can­cer cells has been carv­ing out bil­lions in new rev­enue, with hun­dreds of com­bi­na­tion stud­ies un­der­way to match the im­muno-on­col­o­gy ap­proach with tar­get­ed ther­a­pies.

BeiGene, which is in late-stage stud­ies in Chi­na, is al­so get­ting Cel­gene’s com­mer­cial op­er­a­tions in the mas­sive Asian mar­ket, with ex­clu­sive rights to com­mer­cial­ize Revlim­id, Abrax­ane and Vi­daza. BeiGene al­so gets rights to Cel­gene’s C-122, a next-gen CelMOD cur­rent­ly in de­vel­op­ment for lym­phoma and he­pa­to­cel­lu­lar car­ci­no­ma. And BeiGene is com­mit­ted to beef­ing up its man­u­fac­tur­ing op­er­a­tions to sup­port the part­ner­ship in Asia.

The PD-(L)1 crew al­ready has 5 ther­a­pies on the US mar­ket. Mer­ck and Bris­tol-My­ers Squibb led the way, fol­lowed by Roche, Pfiz­er/Mer­ck KGaA and As­traZeneca. But they keep com­ing. Cel­gene’s check­point will start a piv­otal glob­al pro­gram next year, mak­ing it a dis­tinct­ly late en­try in the field.

While the ba­sic bi­ol­o­gy of the PD-1 drugs is well un­der­stood at this point, mak­ing the clin­i­cal risk rel­a­tive­ly mod­est, there have still been plen­ty of sur­pris­es as new pro­grams push ahead. Bris­tol-My­ers found that out with its mis­step in lung can­cer, which has cost the com­pa­ny dear­ly. There are some big de­bates go­ing on now on whether PD-1 is in­her­ent­ly more po­tent than PD-L1 in dis­man­tling a can­cer cell’s stealth mech­a­nism. That dis­cus­sion was sharp­ened af­ter Roche’s PD-L1 Tecen­triq failed a cru­cial late-stage study, but it’s nowhere close to be­ing re­solved.

For its part, BeiGene says that its PD-1 just might be bet­ter than the rest, point­ing to some added en­gi­neer­ing in the Fc re­gion of the an­ti­body. And Chi­na once again ben­e­fits from news that points to the boom­ing coun­try as a hot spot in drug de­vel­op­ment.

Cel­gene is bring­ing in the PD-1 as the com­pa­ny con­tin­ues one of the most am­bi­tious pipeline cam­paigns in the in­dus­try, beef­ing up its R&D group with a deal spree that has now con­tin­ued for years. For BeiGene, Cel­gene’s quest is their op­por­tu­ni­ty to part­ner up with one of the most ag­gres­sive biotechs in the busi­ness.

“This strate­gic part­ner­ship with Cel­gene is a trans­for­ma­tion­al event for BeiGene, tran­si­tion­ing us in­to a com­mer­cial-stage com­pa­ny and prepar­ing us well for the fu­ture po­ten­tial launch of our in­ter­nal­ly de­vel­oped com­pounds, some of which are al­ready in piv­otal tri­als in Chi­na,” said John Oyler, CEO and co-founder of BeiGene.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

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