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.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.