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.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.