No­var­tis to pay near­ly $178M in law­suit over BRAF drug — and will be on the hook for roy­al­ty

Af­ter a four-year bat­tle over a can­cer drug patent, No­var­tis has been or­dered by a Cal­i­for­nia judge to pay a Dai­ichi Sankyo sub­sidiary $177.8 mil­lion.

Plexxikon filed a law­suit against the phar­ma gi­ant in 2017, alledg­ing that Tafin­lar, a ri­val to its melanoma drug Zelb­o­raf that was brought to mar­ket in col­lab­o­ra­tion with Roche, has stepped on its in­tel­lec­tu­al prop­er­ty. The ju­ry ruled in its fa­vor, adding that the in­fringe­ment is in fact will­ful.

On top of get­ting com­pen­sat­ed for the past in­fringe­ments, Plexxikon says it will re­ceive “ad­di­tion­al roy­al­ty pay­ments for fu­ture sales of Tafin­lar in the Unit­ed States through the life of the patents.”

Sales for Tafin­lar and Mekin­ist, the MEK in­hibitor it was ap­proved with, hit $672 mil­lion in 2016. Fast for­ward to 2020 and the duo gen­er­at­ed $1.5 bil­lion in rev­enue. In 2021, the com­bo has raked in $818 mil­lion in the first half of the year alone for No­var­tis, a num­ber that is al­ready up 11% from last year. Com­par­a­tive­ly, Roche re­port­ed $218 mil­lion in sales of Zelb­o­raf in 2016, and rev­enue was not re­port­ed in its most re­cent mid-year up­date.

The Plexxikon patents are for com­pounds that re­duce can­cer cell growth by block­ing V600E mu­tat­ed BRAF. Patents were filed as ear­ly as 2005.

No­var­tis and GSK car­ried out a swap of its vac­cine and can­cer drugs back in 2015. GSK paid $5.25 bil­lion to No­var­tis for its vac­cine busi­ness, and No­var­tis sent $16 bil­lion for GSK’s on­col­o­gy pro­grams. Tafin­lar and Mekin­ist had al­ready been grant­ed FDA ap­proval at the time of that deal, and as a part of that deal, No­var­tis agreed to di­vest its own BRAF and MEK in­hibitors to avoid cre­at­ing a mo­nop­oly.

Ac­cord­ing to Plexxikon, GSK sci­en­tists were on­ly able to make Tafin­lar af­ter talks with Plexxikon about a po­ten­tial part­ner­ship; al­though those talks nev­er turned in­to a li­cens­ing deal, GSK ap­par­ent­ly chan­neled that in­for­ma­tion and cre­at­ed a ri­val drug.

The suit says that while BRAF ki­nase in­hibitors ex­ist­ed pri­or to Plexxikon’s dis­cov­er­ies, they were not se­lec­tive, and Plexxikon’s have a core mol­e­c­u­lar struc­ture that al­lows them to bind se­lec­tive­ly to ki­nase cre­at­ed by the BRAF mu­ta­tion. That al­lows for high­er dos­es to be ad­min­is­tered.

“The ju­ry was care­ful and award­ed us what we’d asked for down to the pen­ny,” Plexxikon’s lawyer Dar­a­lyn Durie told Bloomberg af­ter the ver­dict came down.

The ju­ry unan­i­mous­ly ruled in Plexxikon’s fa­vor on all sev­en ques­tions, in­clud­ing that No­var­tis has not proved the spec­i­fi­ca­tion of the patent was full and clear enough to en­able a per­son of “or­di­nary skill” to make and use the in­ven­tion.

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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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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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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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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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