Por­to­la gets EU clear­ance to mar­ket An­dexxa un­der new name; Four biotechs set terms for Nas­daq de­but

Por­to­la $PT­LA has made in­roads for its an­ti­co­ag­u­lant an­ti­dote in Eu­rope, win­ning a con­di­tion­al OK to mar­ket an­dex­anet al­fa as On­dexxya. Sold in the US as An­dexxa, the drug is de­signed to re­verse the blood thin­ning ef­fects of Fac­tor Xa in­hibitors like apix­a­ban and ri­varox­a­ban in acute sit­u­a­tions. Por­to­la’s fourth quar­ter rev­enue for 2018 was $15.3 mil­lion, $14 mil­lion of which was net prod­uct rev­enue from An­dexxa sales.

→ French-based Cal­ixar an­nounced to­day that it has en­tered in­to an ex­clu­sive li­cens­ing agree­ment with Re­gen­eron $REGN. Un­der the agree­ment, Re­gen­eron has ex­clu­sive rights to ac­cess its tech­nol­o­gy and ex­per­tise to con­duct re­search and dis­cov­ery of an­ti­bod­ies against an undis­closed tar­get in var­i­ous ther­a­peu­tic fields. This agree­ment in­cludes up­front mile­stone pay­ments to Cal­ixar; how­ev­er, fi­nan­cial terms were not dis­closed.

Cor­texyme has set terms for its IPO, which is down­sized from its orig­i­nal plan of $86 mil­lion. The South San Fran­cis­co-based com­pa­ny is now plan­ning to raise $75 mil­lion by sell­ing 4.4 mil­lion shares be­tween $16 and $18, based on a pitch around its the­o­ry that a bac­te­r­i­al pathogen plays a ma­jor role in Alzheimer’s. At the mid­point range, mar­ket val­ue would hit $476 mil­lion. Re­nais­sance Cap­i­tal says that “in­sid­ers in­tend to pur­chase $35 mil­lion worth of shares in the of­fer­ing.” The com­pa­ny will list un­der the tick­er CRTX.

Mile­stone Phar­ma­ceu­ti­cals, a Mon­tre­al, Cana­da-based biotech de­vel­op­ing ther­a­pies for heart con­di­tions, laid plans to raise $75 mil­lion in an IPO. The com­pa­ny, which in­tends to list un­der the tick­er $MIST, is of­fer­ing 5 mil­lion shares priced be­tween $14 to $16. At the mid­point of that range, its mar­ket val­ue would hit $378 mil­lion. The an­nounce­ment comes less than a year af­ter the com­pa­ny raised $80 mil­lion in a round of fi­nanc­ing to de­vel­op its lead drug, etri­pamil, a cal­ci­um chan­nel block­er that Mile­stone has for­mu­lat­ed in­to a nasal spray to treat tachy­car­dia.

→ Weeks af­ter blue­print­ing the sci­en­tif­ic foun­da­tion for the im­muno-on­col­o­gy com­pa­ny in a pre­clin­i­cal study pub­lished in Na­ture Med­i­cine, Lil­ly-part­nered NextCure set terms to raise $75 mil­lion in an IPO on Mon­day. The Beltsville, Mary­land-based com­pa­ny, which has al­ready raised $180 mil­lion in ven­ture cap­i­tal to go af­ter PD-L1 neg­a­tive tu­mors where ex­ist­ing check­point in­hibitors are im­po­tent, counts Lieping Chen — a not­ed I/O re­searcher who was be­hind Am­plim­mune, which was swal­lowed by As­traZeneca $AZN — as its sci­en­tif­ic founder. NextCure plans to list un­der the sym­bol $NXTC and is of­fer­ing 5 mil­lion shares at a price range of $14 to $16 — at the mid­point of that range it will car­ry a mar­ket val­ue of $350 mil­lion.

→ New York, NY-based Ap­plied Ther­a­peu­tics, de­vel­op­ing ther­a­pies for di­a­bet­ic car­diomy­opa­thy, an­nounced terms for its IPO to raise $60 mil­lion by of­fer­ing 4 mil­lion shares at a price range of $14 to $16. At the mid­point range, mar­ket val­ue would hit $292 mil­lion. The com­pa­ny will list un­der the tick­er $APLT.

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.