‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New re­search shows how gener­ic drug com­pa­nies can suc­cess­ful­ly mar­ket a lim­it­ed num­ber of ap­proved in­di­ca­tions for a brand name drug, pri­or to com­ing to mar­ket for all of the in­di­ca­tions. But sev­er­al re­cent court de­ci­sions have cre­at­ed a lay­er of un­cer­tain­ty around these so-called “skin­ny” la­bels.

Aaron Kessel­heim

While courts have gen­er­al­ly al­lowed gener­ic man­u­fac­tur­ers to use their statu­to­ri­ly per­mit­ted skin­ny-la­bel ap­provals, last sum­mer, a fed­er­al cir­cuit court found that Te­va Phar­ma­ceu­ti­cals was li­able for in­duc­ing pre­scribers and pa­tients to in­fringe Glax­o­SmithK­line’s patents through ad­ver­tis­ing and mar­ket­ing prac­tices that sug­gest­ed Te­va’s gener­ic, with its skin­ny la­bel, could be em­ployed for the patent­ed us­es.

“Te­va was a prob­lem­at­ic de­ci­sion be­cause it made it hard­er for gener­ic com­pa­nies to do what they’re legal­ly al­lowed to do,” Har­vard med­ical pro­fes­sor Aaron Kessel­heim told End­points News.

Kessel­heim and col­leagues at Har­vard’s Pro­gram On Reg­u­la­tion, Ther­a­peu­tics, And Law pub­lished a pa­per on Tues­day in the Jour­nal of Clin­i­cal On­col­o­gy that looks in­to how the skin­ny la­bel for gener­ic ver­sions of the can­cer drug Gleevec worked.

What they found was that gener­ic ver­sions of Gleevec were dis­pensed fre­quent­ly for in­di­ca­tions that were both in­clud­ed and ex­clud­ed from the skin­ny la­bel­ing, al­though pa­tients with one of the ex­clud­ed in­di­ca­tions were “slight­ly less like­ly to re­ceive a gener­ic ver­sion.”

Those on the gener­ic saved mon­ey.

“We found that out-of-pock­et costs for brand-name ima­tinib far ex­ceed­ed such costs for gener­ics for pa­tients with cer­tain types of in­sur­ance, al­though we were un­able to ac­count for coupons or pa­tient as­sis­tance pro­grams that might off­set these out-of-pock­et costs for some pa­tients,” the re­searchers wrote.

They al­so called on Con­gress to cre­ate an ex­emp­tion to shield physi­cians and phar­ma­cists from le­gal li­a­bil­i­ty for writ­ing pre­scrip­tions for gener­ics or sub­sti­tut­ing gener­ics in place of brand-name drugs in cas­es when one or more in­di­ca­tions are carved out of the gener­ic la­bel­ing.

Bryan Walsh

“Con­gress has cre­at­ed a sim­i­lar ex­cep­tion for med­ical or sur­gi­cal pro­ce­dure patents that al­lowed the is­suance of patents for such pro­ce­dures or tech­niques, but shield­ed physi­cians and re­lat­ed health care en­ti­ties from li­a­bil­i­ty for patent in­fringe­ment,” they wrote.

Co-au­thor of the pa­per Bryan Walsh al­so told End­points that there is added un­cer­tain­ty from the re­cent Amarin v. Hik­ma opin­ion, where a court threw out a chal­lenge to the skin­ny la­bel on a fish oil drug.

“The court, in this case, sided with the gener­ic com­pa­ny in dis­miss­ing Amarin’s law­suit – yet the facts were ex­treme­ly sim­i­lar to those pre­sent­ed in the GSK v. Te­va case. Ul­ti­mate­ly it will be up to the low­er courts to de­ter­mine how (or if) the GSK v. Te­va should be fac­tored in­to fu­ture law­suits, cre­at­ing more un­cer­tain­ty for gener­ics look­ing to de­vel­op skin­ny la­bel gener­ic ver­sions of brand-name drugs,” Walsh said.

And while the Fed­er­al Cir­cuit’s ma­jor­i­ty said in its opin­ion that its “nar­row, case-spe­cif­ic re­view of sub­stan­tial ev­i­dence does not up­set the care­ful bal­ance struck by the Hatch-Wax­man Act” re­gard­ing la­bel carve-outs, con­cerns re­main around the un­cer­tain­ty of these skin­ny la­bels.

“Skin­ny-la­beled gener­ics can pro­vide sub­stan­tial sav­ings for pa­tients and the health care sys­tem by help­ing cir­cum­vent a com­mon gener­ic-de­lay­ing prac­tice used by brand-name man­u­fac­tur­ers,” the au­thors con­clud­ed.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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