Samantha Du, Zai Lab CEO

Chi­na's Zai Lab spins 2 more li­cens­ing deals, in­clud­ing a sud­den dive in­to neu­ro­science

Chi­na can­cer spe­cial­ist Zai Lab has made its name in-li­cens­ing West­ern drugs and us­ing its deep knowl­edge of the East Asian mar­ket to churn out re­sults. The biotech has now signed two more li­cens­ing deals for a trio of drugs, in­clud­ing a very sud­den jump in­to the neu­ro­science space.

First, Zai Lab inked a deal Tues­day with Karuna Ther­a­peu­tics for rights in main­land Chi­na, Hong Kong, Macau and Tai­wan to KarXT, an in­ves­ti­ga­tion­al M1/M4-pre­fer­ring mus­carinic ag­o­nist be­ing test­ed to treat a va­ri­ety of psy­chi­atric con­di­tions.

Zai Lab will shell out $35 mil­lion up­front in this one with the po­ten­tial for an ad­di­tion­al $80 mil­lion in de­vel­op­ment and reg­u­la­to­ry mile­stones and $72 mil­lion in sales mile­stones on top of roy­al­ties.

Karuna is eval­u­at­ing KarXT in a slate of late-stage tri­als to treat schiz­o­phre­nia and psy­chosis in Alzheimer’s pa­tients with two Phase III stud­ies for the schiz­o­phre­nia pro­gram ex­pect­ed to read­out in 2022. Mean­while, the com­pa­ny is set to be­gin an ad­di­tion­al Phase III tri­al look­ing at KarXT as an ad­junct ther­a­py for pre­vi­ous­ly treat­ed adults by the end of the year.

Mean­while, an up­com­ing Phase III study for KarXT in psy­chosis in Alzheimer’s is set to kick off by mid-2022.

The deal is sig­nif­i­cant in that it rep­re­sents Zai Lab’s first for­ay in­to neu­ro­science, an­oth­er branch­ing out for the can­cer spe­cial­ist. In a state­ment, CEO Saman­tha Du had this to say about why her team de­cid­ed to make the leap:

Our col­lab­o­ra­tion with Karuna is a sig­nif­i­cant mile­stone for Zai Lab, mark­ing the ex­pan­sion and di­ver­si­fi­ca­tion of our de­vel­op­ment and com­mer­cial port­fo­lio in­to neu­ro­science, our fourth ther­a­peu­tic area. KarXT is well po­si­tioned to serve as the an­chor as­set in our new neu­ro­science fran­chise. Zai Lab’s mis­sion is to de­liv­er in­no­v­a­tive med­i­cines to ad­dress un­met med­ical needs of pa­tients, and we look for­ward to work­ing with Karuna to bring KarXT to pa­tients in need in Greater Chi­na as soon as pos­si­ble.

In a sec­ond pact signed Tues­day, Zai Lab will pay $25 mil­lion up­front and a po­ten­tial ad­di­tion­al $590 mil­lion in down­stream mile­stones for rights to Blue­print Med­i­cines’ in­ves­ti­ga­tion­al EGFR TKI in­hibitors BLU-945 and BLU-701 in Chi­na, Hong Kong, Macau and Tai­wan, the com­pa­nies said Tues­day.

Both drugs are be­ing de­vel­oped specif­i­cal­ly to tar­get drug re­sis­tant mu­ta­tions in EGFR-pos­i­tive lung can­cer pa­tients who do not re­spond to oth­er EGFR in­hibitors. BLU-945 specif­i­cal­ly tar­gets the T790M and C797S and mu­ta­tions while BLU-701 tar­gets C797S with pre­clin­i­cal mod­els show­ing a high de­gree of CNS pen­e­tra­tion, po­ten­tial­ly mak­ing it a good op­tion for pa­tients with brain metas­tases.

Zai Lab sees these drugs as po­ten­tial first-in-class op­tions in Chi­na for EGFR-pos­i­tive NSCLC pa­tients whose dis­ease pro­gress­es with oth­er EGFR in­hibitors, and Blue­print is us­ing the deal as part of a glob­al clin­i­cal ef­fort to see both drugs reach ap­proval in Chi­na and else­where.

If ei­ther drug does get ap­proved in Chi­na, Blue­print will be due tiered roy­al­ties in the “low teens to mid-teens.”

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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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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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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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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