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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Robert Spurr, President Salix Pharmaceuticals

Bausch Health’s Sal­ix pi­lots study to shine light on chron­ic liv­er dis­ease and push back on stereo­types

October is both breast cancer awareness and liver disease awareness month. While there’s no doubt which condition draws more attention during the month, Salix wants to change that.

Salix, Bausch Health’s gastroenterology arm, piloted its first chronic liver disease report and physician survey with results out this week aimed at raising awareness and dispelling stereotypes.

While 4.5 million people have chronic liver disease or cirrhosis – which is even more than 3.8 million women diagnosed with breast cancer – the research found chronic liver disease “has not received the attention or level of effort needed for adequate prevention, diagnosis, and standardization of its management.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Katie Fanning, Mozart Therapeutics CEO

Mozart Ther­a­peu­tics makes its of­fi­cial de­but, jump­ing in­to the hot Treg R&D field with some big-name in­vestors back­ing it

Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.

Now, there’s a new Treg player jumping in that wants to distinguish itself in the market: Mozart Therapeutics. Today, the biotech is emerging from stealth in its official debut with a $55 million Series A — with a bunch of A-list Big Pharma names on board a syndicate led by ARCH.