Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metasta­t­ic pan­cre­at­ic can­cer pa­tient, showed up for her in­fu­sion at Yale’s Smilow Can­cer Hos­pi­tal in New Haven, CT on Oct. 11, she said she was in­formed that day that she would not be re­ceiv­ing Bris­tol My­ers Squibb’s Abrax­ane, part of her com­bo treat­ment, be­cause of a short­age.

“I was told we don’t know when you can have it,” she told End­points News via email, adding that she doesn’t ex­pect to re­ceive any Abrax­ane this com­ing Mon­day at her treat­ment ap­point­ment ei­ther, and she doesn’t know when things will change.

Since Feb­ru­ary, Hogan has been in­fused with a com­bo of Abrax­ane and Gemzar, she said, which “has been a mir­a­cle for me,” not­ing two suc­ces­sive scans with no can­cer pro­gres­sion. “There has been no dis­cus­sion of an al­ter­na­tive. I think they are wait­ing to see if it re­solves it­self. But I was told that some­thing needs to hap­pen — that they don’t want to go be­yond a month with­out it,” she added.

Sev­er­al oth­er can­cer pa­tients reached out to End­points ask­ing about why they haven’t been able to get their Abrax­ane in­fu­sions. The FDA’s web­site lists man­u­fac­tur­ing de­lays but says lit­tle on when more is com­ing. Two can­cer doc­tors al­so con­firmed that Abrax­ane is re­place­able with the gener­ic form of pa­cli­tax­el, al­though one not­ed that Abrax­ane’s for­mu­la­tion is bet­ter tol­er­at­ed, but it’s “not a life or death dif­fer­ence.”

Bris­tol My­ers said it would pro­vide a fuller up­date in mid-No­vem­ber, and con­firmed that it’s pri­or­i­tiz­ing al­lo­ca­tions of the drug glob­al­ly to min­i­mize dis­rup­tions.

Abrax­ane brought in $1.2 bil­lion in sales for BMS in 2020, and $610 mil­lion in the first six months of 2021.

“A BMS fa­cil­i­ty that man­u­fac­tures Abrax­ane must com­plete ad­di­tion­al test­ing be­fore man­u­fac­ture and re­lease of ad­di­tion­al sup­ply, to en­sure prod­uct qual­i­ty and safe­ty. We have pri­or­i­tized re­sources to mon­i­tor and rem­e­dy this sit­u­a­tion,” a BMS spokesper­son said in an emailed state­ment. “There is no im­pact to the qual­i­ty of Abrax­ane cur­rent­ly on the mar­ket.”

But those man­u­fac­tur­ing is­sues have been lin­ger­ing for more than a year and a half af­ter Chi­nese of­fi­cials or­dered BeiGene to stop sell­ing Abrax­ane in the wake of an alarm­ing in­spec­tion, though the man­u­fac­tur­ing is­sues at the root of Chi­na’s im­port sus­pen­sion re­main un­re­solved. BeiGene dis­closed in an SEC fil­ing ear­li­er this month that BMS-Cel­gene is try­ing to end its agree­ment with the com­pa­ny as it can­not man­u­fac­ture the drug in Chi­na or the US.

While BeiGene looks to mend its re­la­tion­ship with BMS, Chi­na’s drug reg­u­la­tors at the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion no longer al­low cer­tain man­u­fac­tur­ing of Abrax­ane from a site in Mel­rose Park, IL, which was hit with an FDA warn­ing let­ter more than a decade ago. An­oth­er man­u­fac­tur­ing fa­cil­i­ty in Phoenix be­came the pri­ma­ry fa­cil­i­ty for Abrax­ane, ac­cord­ing to BeiGene’s fil­ing. BMS’ Cel­gene ini­tial­ly ac­quired those sites as part of its $2.9 bil­lion buy­out of Abrax­is.

“In Ju­ly 2021, me­dia fill test­ing at that [Phoenix] fa­cil­i­ty re­vealed a fail­ure. Fol­low­ing a root cause in­ves­ti­ga­tion, cor­rec­tive and pre­ven­ta­tive ac­tions were im­ple­ment­ed, but test­ing re­sult­ed in the re­jec­tion of ad­di­tion­al vials. Cel­gene is con­tin­u­ing to cor­rect the un­der­ly­ing is­sue, but all man­u­fac­tur­ing pro­duc­tion ac­tiv­i­ties with re­spect to Abrax­ane have ceased at the Phoenix fa­cil­i­ty for the time be­ing and the U.S. Food and Drug Ad­min­is­tra­tion has been no­ti­fied,” ac­cord­ing to a no­tice from BMS to BeiGene.

The an­nounce­ment of the short­age comes on the heels of the FDA deny­ing a pe­ti­tion by Bris­tol My­ers to stall gener­ic ver­sions of Abrax­ane. BMS set­tled with Te­va’s Ac­tavis, al­low­ing at least one Abrax­ane gener­ic to en­ter the mar­ket on March 31, 2022.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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