Pfiz­er takes its op­tion in An­Tol­Rx deal; Se­cu­ra Bio scores ac­cess to $145M for can­cer drug launch­es

→ Two-and-a-half years af­ter Pfiz­er stepped up to seed the biotech start­up An­Tol­Rx, the phar­ma gi­ant has stepped in to take their op­tion on an im­mune tol­er­ance ther­a­py for Type 1 di­a­betes. Based on the lab work of Fran­cis­co Quin­tana, a pro­fes­sor of neu­rol­o­gy at Brigham and Women’s Hos­pi­tal in Boston — who’s spe­cial­ized in anti­gen-spe­cif­ic tol­er­ance — An­Tol­Rx has been work­ing on a pipeline of im­mune tol­er­ance ther­a­pies for au­toim­mune and in­flam­ma­to­ry ail­ments. The biotech is pick­ing up an un­spec­i­fied up­front pay­ment in the deal.

→ As a group of in­dus­try vets gath­er at Se­cu­ra Bio to com­mer­cial­ize can­cer ther­a­pies around the world, Athyri­um Cap­i­tal Man­age­ment has jumped in to pro­vide the funds they need to iden­ti­fy and bag new as­sets. The ex­ec­u­tive team — com­pris­ing Joseph Lim­ber, Mark Spring, Brett Lund, William Davis and Juan Es­truch — chipped in for the $55 mil­lion in eq­ui­ty fi­nanc­ing, and in ad­di­tion to that Athyri­um is al­so com­mit­ting to $90 mil­lion in the form of debt, $50 mil­lion of which is payable im­me­di­ate­ly. Head­quar­tered in Hen­der­son, Neva­da with a San Diego of­fice, Se­cu­ra Bio’s first prod­uct will be No­var­tis’ Fary­dak.

→ Long strug­gling to get the FDA on its side re­gard­ing an over­due BLA, lit­tle Am­pio Phar­ma $AMPE now says it has reached a key agree­ment with reg­u­la­tors, mark­ing an­oth­er step in start­ing a con­fir­ma­to­ry tri­al. It has to do with the forms of con­cur­rent con­trol to be used in the os­teoarthri­tis of the knee tri­al — a ma­jor fac­tor in the FDA’s de­ci­sion to slap down its ap­pli­ca­tion for Am­pi­on last Au­gust in the first place. “The com­pa­ny will quick­ly de­ter­mine which con­trol to in­clude in our tri­al de­sign and then up­date and re­sub­mit our SPA,” CEO Michael Macalu­so said. “We will be ready to be­gin the con­fir­ma­to­ry clin­i­cal tri­al as soon as the SPA is award­ed.”

→ A re­struc­tured Intar­cia is go­ing ahead and li­cens­ing the au­toim­mune drug Switzer­land’s Num­ab has dis­cov­ered for them un­der a re­search and op­tion agree­ment. A tri-spe­cif­ic an­ti­body frag­ment, ND016 si­mul­ta­ne­ous­ly tar­gets in­ter­leukin-17A, tu­mor necro­sis fac­tor-al­pha and serum al­bu­min, with po­ten­tial in rheuma­toid arthri­tis and pso­ri­at­ic arthri­tis. Per the deal, Boston-based Intar­cia will pay up to $69 mil­lion in li­cense fees as it con­tin­ues to de­vel­op the drug.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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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.