Te­va sees room for growth with FDA com­mu­ni­ca­tions and com­plex gener­ics, COO says

While em­broiled in le­gal bat­tles, gener­ic drug gi­ant Te­va Phar­ma­ceu­ti­cals is hop­ing to turn a cor­ner with the FDA in im­prov­ing their com­mu­ni­ca­tions and fo­cus on com­plex gener­ics.

“The con­cern we have as an in­dus­try as we move in­to a new era of sci­ence where a lot of the prod­ucts that are com­ing off patent are more com­pli­cat­ed and fall in­to this sort of com­plex gener­ics cat­e­go­ry — we think it’s up to a third of the [gener­ic] prod­ucts al­to­geth­er — we need to fig­ure out how to get those prod­ucts to mar­ket,” Chris­tine Baed­er, SVP and chief op­er­at­ing of­fi­cer at Te­va, told End­points News in a phone in­ter­view.

A re­cent white pa­per au­thored by AEI res­i­dent schol­ar Alex Brill and com­mis­sioned by Te­va es­ti­mat­ed that de­lays in the ap­provals and launch­es of just 7 com­plex gener­ics in the US re­sults in an­nu­al lost sav­ings of about $1.3 bil­lion. “The FDA and oth­er stake­hold­ers have made ef­forts to fa­cil­i­tate a more ro­bust com­plex gener­ic mar­ket­place, but these have thus far re­sult­ed in process im­prove­ments more than out­come gains,” Brill wrote.

Part of the prob­lem is the lev­el of sci­en­tif­ic di­a­logue be­tween the FDA and gener­ic in­dus­try, which has to ramp up be­cause of the way these com­plex gener­ics are man­u­fac­tured and de­vel­oped, Baed­er said. Prod­uct-spe­cif­ic guid­ances from FDA “are help­ful to a point,” she not­ed. “Of­ten the FDA will look at a guid­ance and re­do it, and then when they re­do it, they retroac­tive­ly ap­ply it, so any work you may have done is sort of lost, or the goal post is moved. So that seems like maybe not the best ap­proach.”

Chris­tine Baed­er

Baed­er al­so ex­plained how Eu­ro­pean and Cana­di­an drug reg­u­la­tors of­ten en­gage in dis­cus­sions with the spon­sor when there is a ques­tion or a prob­lem. But in the US, “FDA’s main ve­hi­cle for com­mu­ni­ca­tion is CRLs [com­plete re­sponse let­ters] or oth­er writ­ten doc­u­ments that don’t nec­es­sar­i­ly in­volve that di­a­logue — and you lose months and months of de­vel­op­ment.”

There needs to be a bet­ter process for the im­me­di­ate, trans­par­ent and clear sci­en­tif­ic com­mu­ni­ca­tion, she said.

Te­va is part of on­go­ing in­dus­try-FDA ne­go­ti­a­tions on the next it­er­a­tion of the Gener­ic Drug User Fee Amend­ments (GDU­FA III), which will kick in­to ef­fect in Sep­tem­ber 2022. But the bulk of those ne­go­ti­a­tions are kept con­fi­den­tial so it’s un­clear as to what ex­act­ly in­dus­try is fight­ing to in­clude in the pack­age, which al­so must win con­gres­sion­al ap­proval.

“The un­in­tend­ed con­se­quence of some of the lack of [FDA] trans­paren­cy is that peo­ple with jobs like mine have to make a de­ci­sion with very im­per­fect in­for­ma­tion on when we might get an ap­proval and there­fore when should I in­vest in the cap­i­tal equip­ment to make that prod­uct,” she said.

The FDA in re­cent years has raised con­cerns about the grow­ing num­ber of gener­ic drugs that win ap­proval but nev­er launch, of­ten be­cause the mar­ket is no longer vi­able or the gener­ics com­pa­ny has shift­ed its strat­e­gy or doesn’t have sup­plies on hand.

“One of the ma­jor rea­sons is that you don’t nec­es­sar­i­ly know when you’re go­ing get ap­proval,” Baed­er said. “If I look at the gener­ic ver­sion of the EpiPen, which Te­va launched af­ter 10 years of work­ing on the ap­proval — were we ready? No. We had no idea it was go­ing to come, so it took us a cer­tain amount of time to scale up.”

On the EpiPen ex­am­ple she al­so not­ed that Te­va didn’t build the nec­es­sary in­ven­to­ry to im­me­di­ate­ly launch in­to the US mar­ket be­cause the com­pa­ny had built in­ven­to­ry sev­er­al times, she not­ed, and “had to throw it away.”

“It’s very hard to know where you are in the FDA’s ap­proval process — in a per­fect world, we would want to sit with the FDA as a part­ner and have com­plete clar­i­ty to en­sure we’re bring­ing gener­ics to pa­tients once there’s an ap­proved,” she not­ed.

But as far as Te­va’s on­go­ing le­gal trou­bles — the com­pa­ny has been charged for price fix­ing, de­fraud­ing Medicare and its in­volve­ment in the opi­oid epi­dem­ic — Baed­er de­clined to com­ment.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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