Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

Ab­b­Vie has re­solved a Cal­i­for­nia law­suit al­leg­ing in­sur­ance fraud in the pro­mo­tion of its cash cow Hu­mi­ra, pay­ing $24 mil­lion to set­tle things with the state’s in­sur­ance reg­u­la­tor.

The set­tle­ment comes al­most four years af­ter a whistle­blow­er first re­port­ed Ab­b­Vie’s prac­tice of de­ploy­ing reg­is­tered nurs­es to vis­it pa­tients at home or call them by phone to en­sure that Hu­mi­ra pre­scrip­tions are filled. Ab­b­Vie was al­so charged with pro­vid­ing il­le­gal kick­backs to doc­tors in an at­tempt to en­cour­age them to pre­scribe Hu­mi­ra for a range of an­ti-in­flam­ma­to­ry dis­eases.

The com­pa­ny de­nied any wrong­do­ing, and told Reuters that the nurse am­bas­sador pro­gram will con­tin­ue with no sig­nif­i­cant changes. Its ar­gu­ment has long been that they are sim­ply pro­div­ing ed­u­ca­tion and sup­port ser­vices for pa­tients.

It did, how­ev­er, agree to re­view some of its mar­ket­ing prac­tices. Among oth­er things, the am­bas­sadors will now dis­close to pa­tients that they work with Ab­b­Vie and won’t be al­lowed to dis­cuss spe­cif­ic pa­tients with doc­tors or in­sur­ance com­pa­nies. Hu­mi­ra sales reps will al­so be pro­hib­it­ed from invit­ing pre­scrib­ing health care providers to off­site busi­ness meals.

“Ab­b­Vie’s pri­or prac­tices in mar­ket­ing Hu­mi­ra egre­gious­ly put prof­its ahead of trans­paren­cy in pa­tient care and vi­o­lat­ed Cal­i­for­nia law,” said Cal­i­for­nia in­sur­ance com­mis­sion­er Ri­car­do Lara in a state­ment. “This set­tle­ment de­liv­ers im­por­tant re­forms to Ab­b­Vie’s busi­ness prac­tices and a sub­stan­tial mon­e­tary re­cov­ery that will be used to con­tin­ue to com­bat in­sur­ance fraud.” — Am­ber Tong

Eye­ing lu­cra­tive NSCLC mar­ket, CStone re­ports pos­i­tive PhI­II da­ta

CStone is on its way to­ward break­ing in­to the big non-small cell lung can­cer mar­ket.

The Chi­nese biotech re­leased in­ter­im da­ta from a Phase III tri­al Fri­day morn­ing show­ing that its an­ti-PD-L1 can­di­date CS1001, com­bined with plat­inum-based chemother­a­py, met its pri­ma­ry end­point for the first-line treat­ment of stage IV squa­mous and non-squa­mous NSCLC. The av­er­age pro­gres­sion-free sur­vival was 7.8 months for pa­tients us­ing the com­bo ver­sus 4.9 months with on­ly chemother­a­py.

Oth­er key da­ta high­lights in­clud­ed a well-tol­er­at­ed pro­file with no new safe­ty sig­nal de­tect­ed.

Check­point in­hibitors for lung can­cer have al­ready hit the mar­ket in Chi­na, with As­traZeneca’s PD-L1 Imfinzi join­ing the PD-1s made by Mer­ck and Bris­tol My­ers Squibb late last year. Weeks lat­er, Roche scored a PD-L1 green­light for Tecen­triq for the treat­ment of small cell lung can­cer.

But as In­novent, Jun­shi and Hen­grui have shown, do­mes­tic drug de­vel­op­ers are more than will­ing to com­pete on price. Should CStone’s can­di­date gain ap­proval, it could still shift the land­scape con­sid­er­ably. — Max Gel­man

FDA ap­proves Bay­er’s new for­mu­la­tion of old Cha­gas dis­ease drug

Bay­er’s new for­mu­la­tion of ni­fur­timox, an old­er drug used to treat Cha­gas dis­ease, has been ap­proved by US reg­u­la­tors.

The FDA green-lit Lampit on Fri­day morn­ing for use in new­borns and chil­dren un­der 18. Lampit, an an­tipro­to­zoal med­ica­tion, will be avail­able in a new, di­vid­able tablet that can be split by hand and is de­signed to dis­perse in wa­ter for those too young to swal­low. Pa­tients on Lampit will take a treat­ment reg­i­men for 60 days.

Spread by in­sect bites and caused by the par­a­site Try­panoso­ma cruzi, Cha­gas dis­ease can cause con­ges­tive heart fail­ure if left un­treat­ed. The drug re­ceived ac­cel­er­at­ed ap­proval based on the num­ber of pa­tients who be­came IgG neg­a­tive or who showed an at least 20% de­crease in op­ti­cal den­si­ty on two dif­fer­ent an­ti­body tests.

Bay­er is ex­pect­ed to con­tin­ue Phase III tri­als over the next three years to con­firm ef­fi­ca­cy and safe­ty. — Max Gel­man

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Jim Green­wood opens new pol­i­cy shop, with an eye on drug price con­trols; Mod­er­na, CRISPR, Mus­tang re­ceive tax breaks in Mass­a­chu­setts

Capitol Hill heavyweight Jim Greenwood is taking his decades of experience in the intertwining worlds of biopharma and Congress to the law firm DLA Piper, where he’s opening up a new policy and regulatory practice alongside former Pfizer lawyer Geoffrey Levitt.

As Congress wrangles over how to bring down drug prices, the former BIO CEO told Endpoints News in an interview that his top three priorities will be, “Price controls, price controls and price controls.”

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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