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.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Ash Shehata, KPMG

As sup­ply chain wor­ries ease up, Big Phar­ma CEOs have a new top con­cern: re­cruit­ing and keep­ing em­ploy­ees

As the industry goes through a boom, Big Pharma’s CEOs seem to have realized one thing above the rest: It’s time to reward the people doing the leg work.

KPMG, a Big Four accounting network, has compiled a business confidence report for pharma CEOs for the past few years, and while 2020’s report had top executives soul-searching for answers and predictions amidst a chaotic time, it appears that some normalcy, coupled with the skyrocketing growth of the industry, has restored confidence levels at the top.

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Kevin Boyle, Ziopharm Oncology CEO

Zio­pharm lays off half its staff af­ter man­u­fac­tur­ing is­sues force de­lays

New Ziopharm CEO Kevin Boyle has only been at the biotech for less than a month, but he’s already engineering major changes.

Late Monday afternoon, Ziopharm announced a sweeping restructuring that involved eliminating more than half its workforce and 60 jobs in total. The layoffs were necessary to help the penny stock player refocus its attention on advancing its TCR program, which saw a setback earlier this year after “unforeseen delays” at a contract manufacturer, Ziopharm said.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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