J&J takes Au­robindo to court over po­ten­tial Er­lea­da gener­ic

Since snag­ging a first ap­proval in prostate can­cer back in 2018, John­son & John­son has been work­ing to make Er­lea­da a block­buster fran­chise. Now that means fight­ing off a po­ten­tial gener­ic from Au­robindo.

A group of plain­tiffs, in­clud­ing J&J’s Janssen unit and the Sloan Ket­ter­ing In­sti­tute for Can­cer Re­search, filed a law­suit against Au­robindo on Thurs­day ac­cus­ing it of ap­ply­ing to mar­ket an Er­lea­da copy­cat be­fore five patents are up.

In the com­plaint, the plain­tiffs said Au­robindo sent a let­ter back in April in­form­ing them that the com­pa­ny had sub­mit­ted an ab­bre­vi­at­ed new drug ap­pli­ca­tion (AN­DA) for a gener­ic ver­sion of Er­lea­da. Ac­cord­ing to the de­fen­dants — Au­robindo and its units Eu­gia Phar­ma and Au­roMedics — the gener­ic doesn’t in­fringe on J&J’s patents be­cause it doesn’t con­tain crys­talline Form B of apa­lu­tamide, the ac­tive in­gre­di­ent in Er­lea­da.

The plain­tiffs claimed that they re­quest­ed more in­for­ma­tion re­gard­ing the AN­DA, but the de­fen­dants didn’t re­spond.

“By fail­ing to pro­vide in­for­ma­tion, De­fen­dants im­ped­ed Plain­tiffs’ abil­i­ty to eval­u­ate in­fringe­ment of the 663 Patent,” the com­plaint states.

How­ev­er, on in­for­ma­tion and be­lief, the plain­tiffs al­leged that Au­robindo’s gener­ic con­tains some amount of crys­talline Form B of apa­lu­tamide.

The plain­tiffs are look­ing for a rul­ing that Au­robindo has in­fringed on Er­lea­da’s patents through its AN­DA sub­mis­sion and that the man­u­fac­tur­ing or com­mer­cial­iza­tion of a gener­ic would al­so in­fringe up­on those patents.

Nei­ther J&J nor Au­rbindo re­spond­ed to a re­quest for com­ment.

Er­lea­da was first ap­proved for non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer back in 2018, months ahead of its PDU­FA date. At the time, Eval­u­ate Phar­ma pegged 2022 sales at $1.6 bil­lion, which is pos­si­ble con­sid­er­ing the drug raked in near­ly $1.3 bil­lion last year, up from $760 mil­lion the year be­fore. J&J lined Er­lea­da up as a suc­ces­sor to the best­selling Zyti­ga as gener­ic com­pe­ti­tion clos­es in.

In 2019, J&J ex­pand­ed Er­lea­da’s la­bel to in­clude pa­tients with metasta­t­ic cas­tra­tion-sen­si­tive prostate can­cer.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Kenji Yasukawa, Astellas Pharma CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.

Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

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