Bio­gen pays $900M to set­tle wide-rang­ing physi­cian kick­back claims

Look­ing to clear the deck ahead of its long-await­ed lecanemab da­ta re­lease, Bio­gen agreed to pay the US gov­ern­ment and states a whop­ping $900 mil­lion to set­tle sev­en-year-old al­le­ga­tions that it sub­mit­ted false claims to Medicare and Med­ic­aid by pay­ing kick­backs to physi­cians to in­duce them to pre­scribe Bio­gen drugs.

Michael Baw­duni­ak

The set­tle­ment, which is on the high­er end of these DOJ-re­lat­ed res­o­lu­tions that have be­come com­mon in the phar­ma in­dus­try, re­solves a law­suit filed by for­mer Bio­gen em­ploy­ee (now a di­rec­tor at Gen­zyme) Michael Baw­duni­ak, who will take home al­most $250 mil­lion as part of the deal.

Baw­duni­ak al­leged that for more than five years from 2009 through March 2014, Bio­gen paid speak­er hon­o­raria, train­ing fees, con­sult­ing fees and meals, to health care pro­fes­sion­als at­tend­ing Bio­gen’s speak­er pro­grams, speak­er train­ing meet­ings or con­sul­tant pro­grams to in­duce them to pre­scribe Avonex, Tysabri and Tec­fidera, which ac­cord­ing to the DOJ is in vi­o­la­tion of the An­ti-Kick­back Statute.

The set­tle­ment comes at a cru­cial cross­roads for a com­pa­ny ready to re­lease da­ta on its next top Alzheimer’s prospect, lecanemab, while look­ing to make nice with a fed­er­al gov­ern­ment that has sev­er­al open in­ves­ti­ga­tions (SEC, FTC, OIG, etc.) in­to its con­duct around the ap­proval of its first Alzheimer’s drug, Aduhelm. Adding to the pres­sure for these types of kick­back cam­paigns is Aduhelm’s com­mer­cial flop and grow­ing gener­ic com­pe­ti­tion for its MS drug fran­chise.

Al­most ex­act­ly one year ago, Bio­gen al­so paid an­oth­er $22 mil­lion to set­tle al­le­ga­tions that it con­coct­ed a scheme to lure pa­tients in­to tak­ing these MS drugs by spon­sor­ing their Medicare co­pays.

And to the ques­tion of whether or not these kick­back schemes and the sub­se­quent set­tle­ments are just part of the cost of do­ing busi­ness at this point, Bio­gen’s $900 mil­lion set­tle­ment with DOJ com­pares with a $678 mil­lion set­tle­ment with No­var­tis in 2020, $122 mil­lion for Jazz Phar­ma, Lund­beck and Alex­ion in 2019, $40 mil­lion set­tle­ment for Bay­er this year, and Pur­due Phar­ma’s $2.8 bil­lion set­tle­ment in 2021.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.