FDA shoots down pe­ti­tion to stall gener­ic ver­sions of Bris­tol My­er­s' block­buster chemo Abrax­ane

Five years af­ter Bris­tol My­ers Squibb’s Cel­gene filed a pe­ti­tion with the FDA as part of an at­tempt to de­lay the launch of gener­ic ver­sions of its block­buster chemo Abrax­ane, the agency has fi­nal­ly, and al­most com­plete­ly, re­ject­ed the pe­ti­tion.

Al­though Cel­gene in 2018 (pri­or to the Bris­tol My­ers’ ac­qui­si­tion) set­tled with Te­va’s Ac­tavis, al­low­ing at least one Abrax­ane gener­ic to en­ter the mar­ket on March 31, 2022, the com­pa­ny in 2015 sent over a pe­ti­tion to the FDA, seek­ing to add new re­quire­ments for any com­pa­nies look­ing to make copy­cats of its treat­ment for breast can­cer, NSCLC and pan­cre­at­ic can­cer, among oth­er can­cers.

For in­stance, Cel­gene re­quest­ed that, in ad­di­tion to the cur­rent in vit­ro char­ac­ter­i­za­tion tests rec­om­mend­ed in FDA’s pa­cli­tax­el draft guid­ance, the agency in­clude ad­di­tion­al in vit­ro tests and cer­tain func­tion­al at­tribute tests that Cel­gene said are nec­es­sary to en­sure prod­uct qual­i­ty and demon­strate same­ness. The pe­ti­tion al­so as­serts that clin­i­cal im­muno­log­i­cal as­says should be re­quired of any ap­pli­ca­tion ref­er­enc­ing Abrax­ane, which brought in more than $1.2 bil­lion for Bris­tol My­ers last year.

Cel­gene fur­ther called on the FDA to re­vise its pa­cli­tax­el draft guid­ance, but the agency, in its re­sponse from June 30, de­murred. His­tor­i­cal­ly, the agency has lament­ed the fact it must use con­sid­er­able time and ef­fort to re­spond to such pe­ti­tions, when the com­pa­nies is­su­ing them of­ten are on­ly do­ing so as part of a wider at­tempt to block com­pe­ti­tion for their lu­cra­tive prod­ucts.

“Even if the Agency adopt­ed the changes to its Pa­cli­tax­el draft guid­ance urged in the Pe­ti­tion, AN­DA ap­pli­cants would be free to use an al­ter­na­tive ap­proach that sat­is­fies re­quire­ments in ap­plic­a­ble statutes and reg­u­la­tions,” the agency said.

Ac­cord­ing to the pe­ti­tion, all three of the pro­posed gener­ic ver­sions of Abrax­ane test­ed in Cel­gene’s stud­ies — none of which have been ap­proved by FDA — are mar­ket­ed in In­dia. But FDA says the pe­ti­tion “does not in­clude any da­ta from which FDA could con­clude that Cel­gene’s re­sults are ap­plic­a­ble to any prod­uct ap­proved by FDA or sub­mit­ted to FDA for ap­proval in an AN­DA or a 505(b)(2) ap­pli­ca­tion.”

And based on the lim­it­ed da­ta re­port­ed in the pe­ti­tion, FDA says, all three for­eign-sourced pa­cli­tax­el prod­ucts like­ly would not be el­i­gi­ble for ap­proval un­der the FDA’s 505(j) path­way for gener­ics and fol­low-on drugs.

But FDA does agree with one re­quest­ed re­vi­sion to the pa­cli­tax­el draft guid­ance to clar­i­fy the de­f­i­n­i­tion of “free” and “bound” pa­cli­tax­el or al­bu­min. “Specif­i­cal­ly, ‘frac­tion of free and bound pa­cli­tax­el or al­bu­min in re­con­sti­tut­ed sus­pen­sion’ should be re­vised to ‘frac­tion of free (in so­lu­tion) and par­ti­cle-bound pa­cli­tax­el and al­bu­min in re­con­sti­tut­ed sus­pen­sion,'” FDA said.

The agency al­so said it does not agree with the in­clu­sion of Cel­gene’s re­quest­ed tech­niques to char­ac­ter­ize a nano­ma­te­r­i­al.

“Be­cause the field of nan­otech­nol­o­gy and meth­ods to char­ac­ter­ize nano­ma­te­ri­als are rapid­ly evolv­ing, as ex­plained in its guid­ances, FDA gen­er­al­ly rec­om­mends the crit­i­cal qual­i­ty at­trib­ut­es of the prod­uct to be mea­sured and not the an­a­lyt­i­cal meth­ods to mea­sure these at­trib­ut­es,” FDA said.

And the agency said it dis­agrees with re­quir­ing that pa­cli­tax­el for­mu­la­tions aim­ing to be bioe­quiv­a­lent to, or oth­er­wise re­ly­ing on FDA’s find­ings of safe­ty and ef­fec­tive­ness for Abrax­ane, must en­sure the tis­sue dis­tri­b­u­tion and re­sult­ing pa­cli­tax­el con­cen­tra­tions to the tu­mor and healthy tis­sues are bioe­quiv­a­lent to en­sure equiv­a­lent clin­i­cal out­comes.

“In ad­di­tion, we dis­agree with the Pe­ti­tion’s con­tention that clin­i­cal stud­ies must al­ways be per­formed to ad­e­quate­ly as­sess any im­muno­genic­i­ty con­cerns due to the pres­ence of al­bu­min,” FDA said.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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