As Bris­tol-My­ers, Pfiz­er bat­tle copy­cat chal­lengers in court, FDA ap­proves gener­ics for block­buster Eliquis

Eliquis, the block­buster blood thin­ner that has been a lead­ing fix­ture in Bris­tol-My­ers’ top line for years, now has FDA ap­proved copy­cats.

Sold by an al­liance be­tween Bris­tol and Pfiz­er, the drug has gen­er­at­ed at least a bil­lion dol­lars in an­nu­al sales since 2014 and has kept grow­ing: In the first nine months of 2019, it raked in near­ly $5.9 bil­lion in sales, sur­pass­ing the $5.4 bil­lion gen­er­at­ed by Bris­tol’s pi­o­neer­ing check­point in­hibitor Op­di­vo.

The part­ners, akin to ri­vals J&J and Bay­er and their an­ti­co­ag­u­lant Xarel­to, have been work­ing on ex­pand­ing Eliquis’ reach. At ASH, da­ta from a re­al-world study showed Eliquis was as­so­ci­at­ed with low­er rates of ma­jor bleed­ing, clin­i­cal­ly-rel­e­vant non-ma­jor bleed­ing and re­cur­rent ve­nous throm­boem­bolism (VTE) in pa­tients with ac­tive can­cer (can­cer pa­tients car­ry a high risk for de­vel­op­ing blood clots).

The copy­cat ap­provals were grant­ed to Mi­cro Labs and My­lan Phar­ma­ceu­ti­cals — but when they will hit the mar­ket is un­clear.

The man­u­fac­tur­ers of the brand­ed ver­sion are cur­rent­ly bat­tling patent chal­lenges by a pletho­ra of gener­ic drug­mak­ers in court. Eliquis is pro­tect­ed by three patents. One ran out on De­cem­ber 22 of this year — the oth­er two are years away: No­vem­ber 21, 2026 and Feb­ru­ary 24, 2031. Last year, Au­robindo Phar­ma was grant­ed ten­ta­tive ap­proval for its Eliquis gener­ic.

Eliquis, known chem­i­cal­ly as apix­a­ban, is cur­rent­ly ap­proved to dimish the risk of stroke and sys­temic em­bolism in pa­tients with non­va­lvu­lar atri­al fib­ril­la­tion, as well as pro­phy­lax­is of deep vein throm­bo­sis, which may lead to pul­monary em­bolism, in pa­tients who have un­der­gone hip or knee re­place­ment surgery; in ad­di­tion, to treat DVT and PE and for the re­duc­tion in the risk of re­cur­rent DVT and PE fol­low­ing ini­tial ther­a­py.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.