Eli Lil­ly dish­es out first mile­stone pay­ment for Alzheimer's deal; ADC Ther­a­peu­tics, Viela Bio set terms for IPO

→ With oth­ers shy­ing away from the Alzheimer’s field af­ter the many clin­i­cal im­plo­sions and dis­as­ters, Eli Lil­ly is still chug­ging along with its $2 bil­lion deal with AC Im­mune — de­spite its share of BACE woes. AC Im­mune is set to re­ceive its first mile­stone pay­ment of CHF30 mil­lion, al­most a year af­ter the deal was inked. The com­pa­ny said that the pay­ment “is a recog­ni­tion of progress in the col­lab­o­ra­tion be­tween the two com­pa­nies and fol­lows ini­ti­a­tion in Ju­ly 2019 of the Phase 1 study of ACI-3024, a first-in-class in­ves­ti­ga­tion­al oral small mol­e­cule Tau Mor­phomer in de­vel­op­ment for treat­ment of Alzheimer’s dis­ease (AD) and oth­er neu­rode­gen­er­a­tive dis­or­ders.” A sec­ond mile­stone pay­ment of the same amount is sched­uled for Q1 of 2020.

→ Af­ter sign­ing a pact with Freenome and clos­ing a mon­ster $303 mil­lion E round in the last few months, ADC Ther­a­peu­tics set terms for its IPO on Mon­day. The Swiss com­pa­ny plans to of­fer 8.2 mil­lion shares at a price range of $23 to $26 to raise $200 mil­lion. In­sid­ers in­tend to pur­chase $115 mil­lion worth of shares in the of­fer­ing. At the mid­point of the pro­posed range, ADC would com­mand a mar­ket val­ue of $1.8 bil­lion.

As­traZeneca spin­out Viela Bio has closed in on the price range of its IPO, dis­clos­ing that it plans to of­fer 7.5 mil­lion shares be­tween $19 and $21 each. At the top of the range, the biotech will bring in $157.5 mil­lion to bankroll the de­vel­op­ment and com­mer­cial­iza­tion of its lead au­toim­mune drug, inebi­lizum­ab. The ful­ly di­lut­ed mar­ket val­ue (at the mid­point) could reach $1 bil­lion.

→ Is­raeli-based En­tera Bio has re­leased pos­i­tive da­ta for its oral parathy­roid hor­mone (PTH) drug Oral hPTH(1-34) from its Phase II study in pa­tients with hy­poparathy­roidism. Hav­ing test­ed four times dai­ly (QID) dos­ing in a pre­vi­ous study, the com­pa­ny want­ed to al­so com­pare twice dai­ly (BID) and three times dai­ly (TID) reg­i­mens and dose strengths.

“The re­sults showed that the largest changes in PD end­points were found with QID dos­ing, with mod­er­ate changes in PD end­points gen­er­al­ly found with BID and TID dos­ing,” stat­ed Pro­fes­sor Sofia Ish-Shalom, a prin­ci­pal in­ves­ti­ga­tor at the En­docrine Re­search Cen­ter at Lin Med­ical Cen­ter in Haifa, Is­rael. “In ad­di­tion, the QID dos­ing de­creased urine cal­ci­um over 24-hours, which in­di­cates that it may be able to re­duce uri­nary cal­ci­um in hy­poparathy­roid pa­tients with hy­per­cal­ci­uria dur­ing long-term treat­ment.”

→ In June, teplizum­ab (PRV-031) — which was re­ject­ed by Eli Lil­ly 9 years ago, but picked up by Proven­tion Bio — was shown to de­lay type 1 di­a­betes. Now, Proven­tion an­nounced that “based on writ­ten com­mu­ni­ca­tions from the FDA and the FDA’s des­ig­na­tion of PRV-031 as a break­through ther­a­py, the Com­pa­ny be­lieves that ex­ist­ing clin­i­cal and non-clin­i­cal da­ta for PRV-031 will be suf­fi­cient to sup­port a Bi­o­log­ics Li­cense Ap­pli­ca­tion (BLA) sub­mis­sion for PRV-031 in the fourth quar­ter of 2020 for the at-risk in­di­ca­tion.” The New Jer­sey-based com­pa­ny ex­pects to meet with the FDA in the fourth quar­ter of 2019 to dis­cuss this ex­pe­dit­ed plan.

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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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.

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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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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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.