No­var­tis CEO Vas Narasimhan: We can do bet­ter at R&D, but we need FDA’s help; J&J gets $2.1B bid for LifeS­can

→ Why has med­ical in­no­va­tion in car­dio­vas­cu­lar dis­eases stag­nat­ed even as oth­er ther­a­peu­tic ar­eas have thrived? No­var­tis CEO Vas Narasimhan thinks a shift from broad-based de­vel­op­ment strate­gies to a more fo­cused med­i­cines ap­proach is need­ed, and drug mak­ers, reg­u­la­tors and pay­ers all have a role to play.

Vas Narasimhan

In a col­umn pub­lished in For­tune this week, Narasimhan ar­gues that phar­ma com­pa­nies need to be bet­ter at pre­ci­sion med­i­cine in this field: cat­e­go­riz­ing pa­tients, track­ing bio­mark­ers, and us­ing more re­al world da­ta. They can’t, how­ev­er, do it alone; reg­u­la­tors must adopt their poli­cies to rec­og­nize “sci­en­tif­i­cal­ly ro­bust sub­group da­ta” for that to work. Last­ly, he wrote, pay­ers could make it eas­i­er for pa­tients by im­ple­ment­ing val­ue-based re­im­burse­ment strate­gies. Giv­en the case No­var­tis has been pitch­ing for canakinum­ab, Narasimhan has a stake in push­ing for all this: “There’s been much dis­cus­sion on this top­ic, but the time to act is now.”

J&J $JNJ has re­ceived a $2.1 bil­lion bid from se­r­i­al buy­out in­vestor Plat­inum Eq­ui­ty, which wants to snatch up the phar­ma gi­ant’s di­a­betes care com­pa­ny LifeS­can. A ma­jor mak­er of blood glu­cose mon­i­tor­ing prod­ucts, LifeS­can brought in $1.5 bil­lion in rev­enue for J&J in 2017. If Plat­inum takes over the op­er­a­tions, the com­pa­ny’s pres­i­dent Va­lerie As­bury would con­tin­ue lead­ing the busi­ness un­der new own­er­ship, Plat­inum said in a state­ment. Last year, J&J said it was eval­u­at­ing op­tions for its di­a­betes care com­pa­nies — specif­i­cal­ly LifeS­can, An­i­mas Corp, and Cal­i­bra Med­ical — as sales have been falling since 2012. J&J has un­til June to ac­cept Plat­inum’s of­fer.

→ Bavar­i­an Nordic signed a $36 mil­lion al­liance with the US De­part­ment of De­fense to de­vel­op a pro­phy­lac­tic vac­cine against the equine en­cephali­tis virus — a rare mos­qui­to-borne ill­ness. With fund­ing from the DoD, Bavar­i­an Nordic will use its MVA-BN plat­form to de­vel­op a vac­cine against var­i­ous strains of the virus.

With con­tri­bu­tion by John Car­roll.

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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Fangliang Zhang, AP Images

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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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.

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.

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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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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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.