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

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.