‘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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Jay Lichter, Arialys Therapeutics CEO (Avalon Ventures)

Scoop: Aval­on, MPM back new CNS biotech with sci­en­tif­ic chops from Astel­las

A preclinical central nervous system biotech is in the works in La Jolla, CA, and the drug developer has reeled in capital from a syndicate of investors, Endpoints News has learned.

Arialys Therapeutics filed incorporation documents in the Golden State last December and applied its name for trademark protection with the US Patent and Trademark Office the week prior to that. Paperwork with the SEC also outlines plans to offer up equity in exchange for $55 million.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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