No­var­tis to spin off Al­con eye care unit, buy back $5B in stock; Ri­val CAR-Ts from No­var­tis and Gilead get thumbs up in Eu­rope

→ Hav­ing mulled over it for more than a year, No­var­tis $NVS is fi­nal­ly spin­ning off Al­con, the eye care unit that for­mer CEO Daniel Vasel­la pur­chased for a to­tal of $51.6 bil­lion. His tenure marked an era when phar­ma­ceu­ti­cal com­pa­nies were try­ing to di­ver­si­fy their busi­ness in face of gener­ic com­pe­ti­tion to brand­ed drugs. But No­var­tis is a dif­fer­ent com­pa­ny now, led by for­mer R&D chief Vas Narasimhan, who told Bloomberg of the de­ci­sion: “We want to be able to fo­cus our cap­i­tal al­lo­ca­tion to our core, and we be­lieve our core is go­ing to be nov­el plat­forms to de­vel­op in­no­v­a­tive med­i­cines and to in­vest in da­ta and dig­i­tal tech­nolo­gies.” The move, which fol­lows Narasimhan’s de­ci­sion to sell No­var­tis’ stake in a con­sumer health­care joint ven­ture to part­ner GSK for $13 bil­lion, comes at a time Al­con — long con­sid­ered an un­der­per­former — is bounc­ing back on rev­enue. That might help with the val­u­a­tion, which ex-CEO Joe Jimenez said could range from $25 bil­lion to $35 bil­lion. Cur­rent Al­con CEO Mike Ball will be­come chair­man af­ter the spin­off, with COO David En­di­cott slat­ed to be­come the new chief — as­sum­ing the mo­tion goes through at No­var­tis’ an­nu­al gen­er­al meet­ing next year. Af­ter the spin-off wraps up in the first half of 2019, No­var­tis is plan­ning to buy back up to $5 bil­lion in stock.

→ Two ri­val CAR-T drugs both got nods from the Eu­ro­pean Med­i­cines Agency pan­el, a sign that their paths to the Eu­ro­pean mar­ket is clear. The Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) rec­om­mend­ed No­var­tis$NVS Kym­ri­ah for the treat­ment of B cell acute lym­phoblas­tic leukemia and dif­fuse large B cell lym­phoma (DL­B­CL). At the same time, the CHMP rec­om­mend­ed Gilead’s $GILD Yescar­ta for DL­B­CL and pri­ma­ry me­di­asti­nal B cell lym­phoma and trans­formed fol­lic­u­lar lym­phoma. Eu­rope’ reg­u­la­to­ry agency usu­al­ly fol­lows the com­mit­tee’s ad­vice, which means both CAR-Ts could soon go head-to-head in DL­B­CL in Eu­rope.

→ Ul­tragenyx $RARE al­so scored CHMP’s pos­i­tive opin­ion, rec­om­mend­ing the com­pa­ny’s drug Mep­se­vii to treat non-neu­ro­log­i­cal man­i­fes­ta­tions of Mu­copolysac­cari­do­sis VII in Eu­rope. Mep­se­vii is an en­zyme re­place­ment ther­a­py de­signed to re­place the de­fi­cient lyso­so­mal en­zyme be­ta-glu­curonidase in pa­tients with MPS VII, a pro­gres­sive and de­bil­i­tat­ing rare ge­net­ic dis­ease.

→ Pre­ci­sion Ther­a­peu­tics, an Ea­gan, Min­neso­ta-based com­pa­ny ap­ply­ing AI to per­son­al­ized med­i­cine and drug dis­cov­ery, is merg­ing with Pitts­burgh di­ag­nos­tics com­pa­ny Helomics. The merg­er ups Pre­ci­sion’s stake in Helomics from 25% to 100%, and gets Pre­ci­sion ac­cess to Helomics’ suite of AI, pre­ci­sion di­ag­nos­tic, and in­te­grat­ed CRO ca­pa­bil­i­ties, the com­pa­nies said in a state­ment. Carl Schwartz, Pre­ci­sion’s CEO, com­ment­ed, “Up­on com­ple­tion of the merg­er, we will have com­plete own­er­ship of Helomics’ one of a kind tu­mor data­base, which has been de­vel­oped over 15 years of clin­i­cal test­ing and con­tains drug re­sponse pro­files of over 149,000 pa­tient can­cer tu­mors, and its D-CHIP bioin­for­mat­ics en­gine that pro­vides ac­tion­able in­sights in­to this da­ta.”

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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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.

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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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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RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.