Fifth Cir­cuit sides with FTC in ma­jor pay-for-de­lay set­tle­ment case

The US Court of Ap­peals for the Fifth Cir­cuit on Tues­day up­held the Fed­er­al Trade Com­mis­sion’s rul­ing that gener­ic drug­mak­er Im­pax Lab­o­ra­to­ries should be charged with an­titrust vi­o­la­tions for ac­cept­ing pay­ments worth about $100 mil­lion to de­lay the en­try of a gener­ic opi­oid for more than two years.

The court’s opin­ion up­held the FTC’s an­ti­com­pet­i­tive find­ings on the deal be­tween Im­pax (now owned by Am­neal Phar­ma­ceu­ti­cals) and En­do Phar­ma­ceu­ti­cals, un­der which En­do com­mit­ted to not mar­ket an au­tho­rized gener­ic, which in­creased Im­pax’s pro­ject­ed prof­its by $24.5 mil­lion. En­do agreed to pay Im­pax cred­its for the shrunk­en mar­ket that Im­pax would in­her­it if, as ex­pect­ed, En­do made a suc­cess­ful hop to a re­for­mu­lat­ed Opana ER.

“The $102 mil­lion En­do ul­ti­mate­ly paid is like­ly a good ap­prox­i­ma­tion of the par­ties’ ex­pect­ed val­ue for these cred­its,” the Fifth Cir­cuit said.

The wider ram­i­fi­ca­tions of the rul­ing may mean less brand name drug­mak­ers will pay gener­ic firms to keep the brand­ed prod­ucts on the mar­ket longer.

“The num­ber of pay-for-de­lay set­tle­ments has been falling since Ac­tavis, and this rul­ing from one of the most con­ser­v­a­tive courts in the coun­try will on­ly ac­cel­er­ate that trend,” Michael Car­ri­er, dis­tin­guished pro­fes­sor at Rut­gers Law School, told End­points News via email.

The Fifth Cir­cuit al­so not­ed that “a large re­verse pay­ment might be jus­ti­fied if it rep­re­sents ‘avoid­ed lit­i­ga­tion costs or fair val­ue for ser­vices.’ That is not the case here.” Nei­ther the saved costs of for­go­ing a tri­al nor any ser­vices En­do re­ceived jus­ti­fied these pay­ments to Im­pax, the court said. “Sub­stan­tial ev­i­dence sup­ports the Com­mis­sions’ find­ing that the re­verse pay­ment set­tle­ment threat­ened com­pe­ti­tion.”

Car­ri­er called the opin­ion a “HUGE win for con­sumers and FTC.” He al­so not­ed that in re­sponse to Im­pax’s claim that this rul­ing means the end of all set­tle­ments, the court took the cal­cu­la­tion from his brief on be­half of 82 pro­fes­sors that the FTC chal­lenged on­ly 6 of the 1336 brand/gener­ic set­tle­ments be­tween 2000 and 2015.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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