Idorsia's newest patient ambassador champion skier Lindsey Vonn developed insomnia after major knee surgery. (AP Photo/Alessandro Trovati)

Idor­sia adds Olympic gold medal­ist and in­som­nia pa­tient Lind­sey Vonn to its celebri­ty spokesper­son ros­ter

Af­ter Olympic gold medal­ist Lind­sey Vonn’s first ma­jor knee surgery in 2013, she couldn’t sleep. That was the be­gin­ning of a cy­cle of more in­juries, added anx­i­ety and stress snow­balling in­to an even­tu­al di­ag­no­sis of in­som­nia.

Taye Dig­gs

Now Vonn’s team­ing up with Idor­sia Phar­ma­ceu­ti­cals on its sleep drug Qu­viviq as its newest celebri­ty pa­tient am­bas­sador. Vonn ap­peared in me­dia in­ter­views this week, in­clud­ing on the To­day Show and Peo­ple mag­a­zine, talk­ing about her strug­gles with sleep, along with over­all men­tal health is­sues.

She’s al­so ap­pear­ing in dig­i­tal and so­cial pro­mo­tions, and, along with an­oth­er Qu­viviq celebri­ty pa­tient, ac­tor Taye Dig­gs, will star in up­com­ing di­rect-to-con­sumer TV ads be­ing prepped for the fall.

For Vonn, it was ski­ing in­juries that “re­al­ly set me down a path of in­som­nia for the next, how many? Nine years,” she says in a video on the Qu­viviq web­site.

“It was dif­fi­cult be­cause I knew how im­por­tant sleep was in or­der to re­cov­er from my phys­i­cal in­juries be­cause sleep is not just im­por­tant for your mind, it’s al­so re­al­ly im­por­tant for your body to re­cov­er. When I re­tired, it made my sleep so much worse,” she says.

Vonn re­tired in 2019 af­ter a 19-year ca­reer in down­hill ski­ing, win­ning three Olympic medals, a world-record 20 World Cup crys­tal globes and a women’s record over­all of 82 World Cup wins.

Pa­tri­cia Torr

“Re­al au­then­tic sto­ries re­al­ly con­nect with pa­tients and we’re all about try­ing to em­pow­er pa­tients to talk to their doc­tors about in­som­nia and po­ten­tial so­lu­tions to help im­prove their con­di­tion. Lind­sey fits that to a tee,” said Pa­tri­cia Torr, Idor­sia’s pres­i­dent and gen­er­al man­ag­er.

While Vonn and Dig­gs sim­i­lar­ly suf­fer from in­som­nia, their con­di­tions had dif­fer­ent trig­gers — in Dig­gs’ case, by be­com­ing a par­ent and wak­ing up at night to help take care of his son.

Michael Moye, Idor­sia VP and head of mar­ket­ing said, “Just like those two ex­pe­ri­enced, there are trig­gers out there. Peo­ple think ‘Oh, this will pass — it just has to do with what’s hap­pen­ing in the mo­ment.’ Then lit­er­al­ly years lat­er, they’re still suf­fer­ing from in­som­nia.”

Michael Moye

The Idor­sia team be­lieves that hear­ing Vonn and Dig­gs’ sto­ries about years of sleep­less­ness trig­gered by dif­fer­ent caus­es “will re­al­ly res­onate with a lot of peo­ple,” he added.

Idor­sia is al­so run­ning an un­brand­ed mul­ti-year in­som­nia aware­ness cam­paign in dig­i­tal, so­cial and TV ads fea­tur­ing ac­tress Jen­nifer Anis­ton. The “Seize the Night & Day” ef­fort be­gan in Jan­u­ary with TV ads di­rect­ed by well-known di­rec­tor Tai­ka Wait­i­ti. The TV spots show Anis­ton strug­gling through sleep­less nights and in the newest com­mer­cial, grog­gy morn­ings, as she ap­pears con­cur­rent­ly with a perki­er ver­sion of her­self who tells her ”Good days start with good nights” and ad­vis­es talk­ing to her (their?) doc­tor.

Idor­sia es­ti­mates 25 mil­lion peo­ple in the US suf­fer from in­som­nia, rank­ing it as the most preva­lent sleep dis­or­der in the coun­try.

The FDA ap­proved Qu­viviq, a dual orex­in re­cep­tor an­tag­o­nist (DO­RA), in Jan­u­ary in two dos­es — 25 mg and 50 mg — with both show­ing sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in polysomnog­ra­phy and self-re­port­ed to­tal sleep. Qu­viviq was on par with place­bo in safe­ty, notch­ing it ahead of two pre­vi­ous­ly ap­proved DO­RAs Mer­ck’s Bel­som­ra and Ei­sai’s Dayvi­go which both come with warn­ing la­bels.

Old­er sleep aids such as Am­bi­en, Lunes­ta and Sonata were slapped with FDA black box warn­ings in 2019 af­ter re­ports of pa­tients walk­ing and eat­ing in their sleep with some­times dis­as­trous out­comes in­clud­ing 20 linked deaths from drown­ing, falls, car crash­es and sui­cide.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; 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.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.