Pfiz­er bags an FDA OK for PARP play­er ta­la­zoparib — now the hard part be­gins

Pfiz­er has picked up an ap­proval for ta­la­zoparib, its PARP in­hibitor for a ge­net­i­cal­ly de­fined line of breast can­cer. And now the phar­ma play­er can jump in­to a crowd­ed mar­ket where As­traZeneca’s ri­val Lyn­parza is way out in front of the pack.

The Pfiz­er drug, which is hit­ting the mar­ket as Talzen­na, fig­ured promi­nent­ly in Pfiz­er’s $14 bil­lion Medi­va­tion buy­out. The then Medi­va­tion CEO David Hung pitched ta­la­zoparib as a block­buster-to-be as Sanofi stepped up first with an of­fer. Now Pfiz­er gets to find out just how much it can make as the fourth en­try in the field, be­hind Clo­vis and Tesaro as well.

The ap­proval from the FDA marks the 46th new drug ap­proval from CDER this year, ty­ing the record for all of last year and leav­ing the agency poised to surge to an all-time record high well be­fore the end of the year. The FDA help­ful­ly pro­vid­ed a snap run-through for Pfiz­er, putting the drug on a pri­or­i­ty re­view path.

The PARP crowd works along sim­ple lines, dis­rupt­ing DNA mech­a­nisms for self re­pair and putting can­cer cells on a path to de­struc­tion. And this new en­try for BR­CA-mu­tat­ed can­cer won an OK with a mean pro­gres­sion free sur­vival rate of 8.6 months com­pared to 5.6 months for a chemo arm.

That’s all well and good, ex­plain­ing the drug’s pres­ence on CEO Ian Read’s list of late-stage rea­sons why he was con­fi­dent in Pfiz­er’s pipeline. But the OK comes 4 years af­ter As­traZeneca pro­vid­ed the mar­ket-lead­ing OK for a PARP in the US. Since then, it’s al­lied with Mer­ck and con­tin­ued to ex­pand the drug’s la­bel. 

As­traZeneca has al­ready of­fered sim­i­lar risk re­duc­tion fig­ures for breast can­cer, which will make Pfiz­er’s job that much tougher.

In a few days As­traZeneca and Mer­ck will be putting the SO­LO-1 da­ta on dis­play at ES­MO, high­light­ing its ac­tiv­i­ty in ovar­i­an can­cer. And the gi­ant part­ners have more stud­ies un­der­way as they con­tin­ue to build the block­buster in new mar­kets, in­clud­ing Chi­na. 

Bio­Marin, which sold the drug to Medi­va­tion, is get­ting a $15 mil­lion mile­stone pay­ment with the ap­proval to­day.

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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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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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