Richard Gonzalez, AP Images

Ab­b­Vie puts an end to Botox trade se­crets suit, im­pos­es roy­al­ty, li­cense deal on com­peti­tor Evo­lus

The crown jew­el of Ab­b­Vie’s big-dol­lar ac­qui­si­tion of Al­ler­gan, Botox is one of the most rec­og­niz­able brands in phar­ma — and both drug­mak­ers have worked over­time to pro­tect its ad­van­tage. Af­ter scor­ing a fa­tal blow to Evo­lus’ chances as a ma­jor com­peti­tor late last year, Ab­b­Vie is now putting the ic­ing on the cake.

Look­ing to set­tle once and for all a years-long IP spat, Ab­b­Vie will put a lega­cy Botox trade se­crets case against Evo­lus to rest in re­turn for a roy­al­ty and li­cense deal for fu­ture sales, the Illi­nois drug gi­ant said Fri­day.

Ab­b­Vie and Me­dy­tox, the Al­ler­gan part­ner re­spon­si­ble for de­vel­op­ing Botox, will re­ceive roy­al­ties and fu­ture mile­stones for US sales of Jeu­veau, Botox’s pri­ma­ry ri­val, and glob­al sales of Evo­lus’ frown-line in­jec­tion, Nu­cei­va.

In re­turn, Ab­b­Vie will drop its Cal­i­for­nia trade se­crets suit, and Evo­lus will hold li­cens­es to keep sell­ing both drugs on Ab­b­Vie’s turf. Evo­lus will al­so hand over an undis­closed amount of com­mon stock to Me­dy­tox.

The deal comes three months af­ter the ITC found Evo­lus and South Ko­rea’s Dae­woong Phar­ma­ceu­ti­cals in­fringed Al­ler­gan and Me­dy­tox’s IP in de­vel­op­ing their aes­thet­ics plat­form based on the bot­u­linum neu­ro­tox­in. Evo­lus was is­sued a 21-month ban on the im­por­ta­tion or sale of the wrin­kle treat­ment fol­low­ing the rul­ing — a re­duc­tion from the ini­tial 10-year ban pro­posed by a judge, Bloomberg re­port­ed.

The Fri­day deal set­tle­ment didn’t in­clude on­go­ing lit­i­ga­tion against Dae­woong.

When Ab­b­Vie picked up Al­ler­gan as part of a $63 bil­lion merg­er com­plet­ed in 2020, it ac­quired block­buster Botox as well as a par­tic­u­lar­ly nasty dis­pute with Evo­lus, which has pitched it­self as a ma­jor com­peti­tor. But any po­ten­tial threat Evo­lus may have posed was ef­fec­tive­ly nixed af­ter the rul­ing and would have tak­en a long time to come to fruition any­way giv­en Botox’s big mar­ket lead.

Ear­li­er this month, the FDA ap­proved Botox to treat de­tru­sor (blad­der mus­cle) over­ac­tiv­i­ty as­so­ci­at­ed with neu­ro­log­i­cal con­di­tions in chil­dren 5 and old­er who were in­tol­er­ant to or didn’t im­prove on an­ti­cholin­er­gic meds. It was the 12th in­di­ca­tion across Botox’s aes­thet­ics and ther­a­peu­tic port­fo­lio, Ab­b­Vie said.

With Evo­lus laid low, there are still Botox com­peti­tors out there with some promise. First, there’s Re­vance, which read out pos­i­tive Phase III re­sults for its Dax­i­bot­u­linum­tox­i­nA in Oc­to­ber. The FDA de­ferred its de­ci­sion on Re­vance’s BLA in No­vem­ber due to Covid-re­lat­ed trav­el re­stric­tions that kept the agency from per­form­ing an in­spec­tion of the com­pa­ny’s man­u­fac­tur­ing fa­cil­i­ty.

In June, Re­vance and My­lan an­nounced plans to move for­ward with a sep­a­rate pro­gram for a Botox biosim­i­lar.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to cor­rect an er­ror. Me­dy­tox was a de­vel­op­ment part­ner on Botox for Al­ler­gan. 

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, 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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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CMO Levi Garraway (Genentech)

Fo­cus­ing on the bright side, FDA OKs Roche's Actem­ra for rare lung dis­ease de­spite PhI­II flop

Actemra’s failure to hit the primary endpoint in a Phase III study didn’t stop the FDA from granting Roche priority review. And it’s certainly not standing in the way of a sixth approval for Roche’s IL-6 drug.

Regulators have cleared Actemra, or tocilizumab, for systemic sclerosis-associated interstitial lung disease in adult patients. Roche’s big Genentech subsidiary notes that it is the first biologic approved for this rare disease.

Af­ter three years of courtship (and turn­downs), Mer­ck pounced on the first glance of clin­i­cal da­ta in $1.85B Pan­dion takeover

It’s almost become cliché for biotech executives to talk about the importance of keeping your options open and being prepared to go all the way. But when it comes to negotiating with a giant like Merck, a little patience can indeed go a long way.

Just ask Pandion Therapeutics.

Days ago we already learned that Merck is shelling out $1.85 billion to pick up the biotech and its slate of autoimmune hopefuls. What we didn’t know until the SEC disclosure dropped Thursday is that the deal comes after Pandion turned down two other proposals from Merck over the past three years and held out until the last minute for a sweetened deal.

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