Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

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.

Breyanzi had a dead­line of Dec. 31, 2020. If any of the three drugs failed to win ap­proval by the set dates, BMS would owe noth­ing in CVR pay­outs. They were just 36 days late on the Breyanzi dead­line, and the CVR be­came worth­less.

Last June, UMB Bank filed suit against BMS, ac­cus­ing the com­pa­ny of pur­pose­ly de­lay­ing Breyanzi’s de­vel­op­ment to avoid the pay­outs. Since then, sev­er­al uniden­ti­fied wit­ness­es have come for­ward to de­tail “a se­ries of de­lib­er­ate or reck­less acts” they say BMS took to stall an ap­proval.

“This un­prece­dent­ed string of de­fi­cien­cies in the liso-cel ap­proval process pushed FDA ap­proval 36 days be­yond the mile­stone date, just long enough to spare Bris­tol a $6.4 bil­lion pay­out to CVR hold­ers, while al­low­ing it to reap the eco­nom­ic ben­e­fits of bring­ing the lu­cra­tive drug to mar­ket af­ter a mod­est de­lay,” a com­plaint states.

Breyanzi is pre­scribed to pa­tients suf­fer­ing an ag­gres­sive and dif­fi­cult-to-treat form of blood can­cer called dif­fuse large B cell lym­phoma. While it was pre­vi­ous­ly ap­proved to treat pa­tients who had al­ready re­ceived two pri­or rounds of ther­a­py, the FDA came through with a la­bel ex­pan­sion on Fri­day in the sec­ond-line set­ting.

“Breyanzi rep­re­sents a re­mark­able ad­vance over a near­ly 30-year stan­dard of care, pro­vid­ing sig­nif­i­cant­ly im­proved ef­fi­ca­cy with a well-es­tab­lished safe­ty pro­file,” lead in­ves­ti­ga­tor Man­ali Kam­dar said in a state­ment.

BMS had vowed to do what­ev­er it could to get the three ap­provals in on time. And Cel­gene re­peat­ed­ly stat­ed — even af­ter an­nounc­ing the merg­er — that Breyanzi was on track for a BLA sub­mis­sion in the sec­ond half of 2019, with an ap­proval ex­pect­ed in mid-2020. The com­pa­ny sub­mit­ted the first com­po­nent of a BLA in Sep­tem­ber 2019, and the FDA found no is­sues with that por­tion, ac­cord­ing to the com­plaint.

How­ev­er, BMS took three months to sub­mit the next por­tion, and the FDA found “sig­nif­i­cant ad­di­tion­al omis­sions” in BMS’ por­tion.

The com­plaint ac­cus­es Bris­tol My­ers of leav­ing out “vol­umes of ba­sic in­for­ma­tion,” in­clud­ing omis­sions that were “glar­ing­ly ob­vi­ous, par­tic­u­lar­ly for a drug com­pa­ny of Bris­tol’s so­phis­ti­ca­tion and ex­pe­ri­ence, and would have need­ed to be ap­proved by Bris­tol se­nior ex­ec­u­tives.”

Reg­u­la­tors al­so found “a litany of ba­sic and eas­i­ly avoid­able de­fi­cien­cies at both of the fa­cil­i­ties where liso-cel was be­ing man­u­fac­tured,” ac­cord­ing to the com­plaint.

Ad­dress­ing the man­u­fac­tur­ing de­fi­cien­cies re­quired sup­ple­men­tal reg­u­la­to­ry sub­mis­sions from BMS, but those sub­mis­sions were al­so de­fi­cient and re­quired fur­ther sup­ple­men­ta­tion, the plain­tiffs al­lege. At one point, the FDA con­clud­ed that new in­for­ma­tion pro­vid­ed by BMS was so sub­stan­tial that it re­quired a ma­jor amend­ment.

BMS end­ed up se­cur­ing an ap­proval last Feb­ru­ary, based on piv­otal da­ta show­ing 54% of pa­tients treat­ed with liso-cel achieve com­plete re­mis­sion. Reg­u­la­tors tacked on a black-box warn­ing for cy­tokine re­lease syn­drome and neu­ro­log­ic tox­i­c­i­ties.

The drug raked in $87 mil­lion last year, ac­cord­ing to BMS’ Q4 re­sults.

BMS sought to dis­miss the law­suit, ar­gu­ing that plain­tiffs failed to “com­ply with cer­tain pre-suit no­tice pro­ce­dures re­quir­ing no­tice of an al­leged breach and a nine­ty-day pe­ri­od to cure the breach be­fore fil­ing suit.”

Judge Jesse Fur­man de­nied the mo­tion on Fri­day. BMS was not avail­able for com­ment as of press time.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.