Phase­Bio de­tails dol­lars in As­traZeneca deal as it rolls out a plan for $86M-plus IPO

It turns out the $34 mil­lion Se­ries D Phase­Bio an­nounced just days ago was a pre­lude to a big­ger sto­ry: With its new­ly honed or­phan dis­ease-fo­cused strat­e­gy, the biotech is an­gling for an IPO worth at least $86 mil­lion.

Jonathan Mow

The main draw re­mains PB2452, a re­ver­sal agent for the blood thin­ner Bril­in­ta (tica­grelor) for use in acute sit­u­a­tions where pa­tients are ex­pe­ri­enc­ing ac­tive bleed­ing or re­quire ur­gent surgery. Phase­Bio li­censed the drug — al­so known as an an­ti-an­ti-co­ag­u­lant — late last year from Med­Im­mune with­out dis­clos­ing the terms; we now know the deal is heav­i­ly back-end­ed with an up­front fee of on­ly $100,000 and $68 mil­lion in to­tal po­ten­tial mile­stones.

Med­Im­mune, the bi­o­log­ics arm of As­traZeneca (which mar­kets Bril­in­ta), al­so owns 5% of the stock, sec­ond on­ly to New En­ter­prise As­so­ci­ates. Oth­er ma­jor share­hold­ers in­clude Hat­teras Ven­ture Part­ners, John­son & John­son In­no­va­tion – JJDC, Fletch­er Spaght Ven­tures, and board chair­man Clay Thorp.

Though the drug has on­ly just gone through Phase I, Phase­Bio in­tends to hus­tle through a dose-find­ing Phase IIa and be­gin a larg­er Phase II tri­al in the sec­ond half of 2019 with mon­ey from the pub­lic raise.

“PB2452 can be de­vel­oped in a much short­er time pe­ri­od, and it will pay for us to de­vel­op PB1046,” their in-house as­set for pul­monary ar­te­r­i­al hy­per­ten­sion, CEO Jonathan Mow told me in a re­cent in­ter­view. “So even though it’s on­ly in Phase I, we will get to the lat­er stages of de­vel­op­ment much more quick­ly than we will with PB1046.”

Com­pared to PB2452, PB1046 strikes clos­er to Phase­Bio’s roots — it’s been in the pipeline for some time, and is based on the “elastin-like polypep­tides” plat­form tech that the com­pa­ny was found­ed on. The ther­a­peu­tic fu­sion pro­teins cre­at­ed on this plat­form un­der­go a ful­ly re­versible phase tran­si­tion — there­by sig­nif­i­cant­ly ex­tend­ing their half lives. That al­lows for PB1046 to be dosed once-week­ly, an ex­tra ad­van­tage com­bined with its nov­el mech­a­nism of ac­tion that Mow be­lieves would give it a shot in the com­pet­i­tive PAH mar­ket.

Pro­ceeds from the IPO would al­so pay for Phase­Bio to ex­plore ad­di­tion­al in­di­ca­tions for PB1046, which is cur­rent­ly in Phase II, as well as “de­vel­op­ment of our ELP tech­nol­o­gy and pre­clin­i­cal pro­grams.”

It would be a siz­able in­fu­sion of cash for the com­pa­ny, which un­til three months ago had on­ly $8.7 mil­lion in the bank.

The Malvern, PA-based biotech plans to list un­der the sym­bol $PHAS.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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