In the wake of a dis­as­ter, Cem­pra shares shoot up on a promis­ing PhI­II an­tibi­ot­ic matchup

Just two months af­ter tak­ing a beat­ing on the FDA’s de­ci­sive re­jec­tion of Cem­pra’s an­tibi­ot­ic solithromycin, the biotech has been re­deemed by the suc­cess of a head-to-head Phase III matchup of its oral an­tibi­ot­ic fu­sidic acid against an old stand­by. Cem­pra’s shares $CEMP rock­et­ed up 40% on the turn­around.

Over­all, fu­sidic acid matched up fa­vor­ably to line­zol­id among the 716 pa­tients with acute bac­te­r­i­al skin and skin struc­ture in­fec­tions in the study, hit­ting its marks for non-in­fe­ri­or­i­ty and achiev­ing the pri­ma­ry as well a sec­ondary goals. Fu­sidic acid edged out line­zol­id among men and women, and matched up nice­ly for a range of in­fec­tion types.

The safe­ty pro­file al­so matched up well.

The re­sults leave Chapel Hill, NC-based Cem­pra with a much bet­ter chance of suc­cess for this new an­tibi­ot­ic com­pared to solithromycin. Caught on the horns of a dilem­ma posed by clear ev­i­dence of liv­er tox­i­c­i­ty and a grow­ing de­mand for new an­tibi­otics, the FDA de­cid­ed to re­ject Cem­pra’s lead an­tibi­ot­ic late in De­cem­ber, de­mand­ing a large new safe­ty study be­fore re­con­sid­er­ing its po­si­tion. And the agency flagged a warn­ing that any fu­ture la­bel will care­ful­ly re­strict its use, which will dam­age its mar­ket po­ten­tial.

Cem­pra’s spike to­day still leaves its stock trad­ing at just a frac­tion of the peak in mid-2015.

Cem­pra is one of a hand­ful of biotechs de­vel­op­ing new an­tibi­otics, de­spite a grow­ing need for new weapons to dis­arm drug re­sis­tant in­fec­tions.

“Con­sid­er­ing com­pli­cat­ed skin in­fec­tions are one of the most rapid­ly grow­ing rea­sons for hos­pi­tal­iza­tions and emer­gency de­part­ment vis­its each year, the re­sults with fu­sidic acid in this study are promis­ing, es­pe­cial­ly for an out­pa­tient pop­u­la­tion where there is a need for new oral drugs that are ef­fec­tive against MR­SA,” said William O’Ri­or­dan, M.D., chief med­ical of­fi­cer of eS­tudySite.

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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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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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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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.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

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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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.