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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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One work­er at a Lat­vian man­u­fac­tur­er is dead af­ter a fire breaks out at fa­cil­i­ty

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Fu­ji­film Diosynth dumps an­oth­er $454M in­to its sup­ply chain, this time at a fa­cil­i­ty in the UK

Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the “beating heart” of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.