Two R&D pros map a PhI­II game plan with $65M round and a castoff from Pfiz­er

Can Corey Fish­man and Michael Dunne come back and re­peat the suc­cess they had with Du­ra­ta?

A lit­tle more than two years af­ter they suc­ceed­ed in win­ning an ap­proval for dal­ba­vancin af­ter spin­ning out of Pfiz­er with a castoff an­tibi­ot­ic and then sell­ing the com­pa­ny to Ac­tavis for $675 mil­lion, they have the mon­ey and an­oth­er shelved Pfiz­er an­tibi­ot­ic to work with.

Michael Dunne

This morn­ing they an­nounced that their biotech Iterum had raised $65 mil­lion for the Se­ries B, adding it to the $40 mil­lion that got things start­ed in ear­ly 2016. Their syn­di­cate of mar­quee ven­ture play­ers are back­ing a Phase III pro­gram for su­lopen­em, an old an­tibi­ot­ic that’s been around for years af­ter show­ing some promise for com­bat­ing Gram-neg­a­tive pathogens. Iterum got the an­tibi­ot­ic from Pfiz­er, which put it on the shelf years ago. And Fish­man and Dunne — the for­mer COO and CMO at Du­ra­ta — think they have a win­ner for a new prod­uct that could prove par­tic­u­lar­ly use­ful for uri­nary tract in­fec­tions and com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions.

The Phase III is ex­pect­ed to get start­ed next year, with an NDA in the works for 2019 if it all works out.

The feds have tried adding in­cen­tives to help en­cour­age more an­tibi­ot­ic de­vel­op­ment work as the threat of drug re­sis­tance con­tin­ues to grow, but it’s still fair­ly un­usu­al to see late-stage pro­grams like this. Old­er an­tibi­otics are cheap, mar­gins are thin and Big Phar­ma, in­clud­ing Pfiz­er, didn’t see a lot to gain by stay­ing in the field.

R&D here isn’t nec­es­sar­i­ly easy, ei­ther, as Cem­pra il­lus­trat­ed with its re­cent woes for a lead an­tibi­ot­ic.

With a proven track record, though, Fra­zier Health­care Part­ners, Canaan Part­ners, Sofinno­va Ven­tures and New Leaf Ven­ture Part­ners fund­ed the A round and came back to help with the B, which was led by Ar­ix Bio­science and al­so in­clud­ed first-timers Piv­otal bioVen­ture Part­ners, Ad­vent Life Sci­ences, Do­main As­so­ci­ates and Bay City Cap­i­tal.

Tak­ing ad­vanced ex­per­i­men­tal drugs off the shelves of Big Phar­ma in ex­change for some eq­ui­ty has be­come a busi­ness mod­el in biotech. Fish­man and Dunne helped pi­o­neer it and now they’re out to prove just how durable a strat­e­gy this can be.

Fangliang Zhang, AP Images

Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom

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.

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.

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.

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.

Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

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.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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.

Michael Gladstone, partner at Atlas Venture

At­las rais­es new $400M fund amid spree of VC rais­es. Here’s what they’ll spend it on

You can add another few hundred million to the now Montana-sized reservoir of cash biotech VCs have raised since the WHO declared Covid-19 a pandemic.

Atlas Venture, the prominent Kendall Square incubator, has raised $400 million for its twelfth biotech fund, their first in 3 years. After a string of mammoth new raises from other major VCs in April and May, the total pot now stands between $5 billion and $6 billion, depending on how you slice it.

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