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. 

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

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Jeff Dachis, founder and CEO, One Drop

Q&A: One Drop founder Jeff Dachis, from dig­i­tal agency to healthtech en­tre­pre­neur, catch­es the wave again

Jeff Dachis knows how to pick a business wave — although it may be more accurate to say he knows how to create them. The founder and CEO of digital health platform One Drop is working to transform the industry with predictive analytics and sophisticated tools. Alongside partner Bayer, which has now invested enough to own a third of the company, Dachis and One Drop are advancing data-driven personalized self-care for chronic disease management.

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Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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