Bil­lion­aire-backed Chi-Med de­clares PhI­II suc­cess for pi­o­neer­ing can­cer drug in Chi­na, seek­ing quick OK

Chris­t­ian Hogg

Hutchi­son Chi­na MediTech has turned an im­por­tant cor­ner, scor­ing pos­i­tive over­all sur­vival and pro­gres­sion-free sur­vival in a Phase III study of fruquin­tinib, its lead on­col­o­gy drug, in colon can­cer. The top-line suc­cess — da­ta will come out this sum­mer at AS­CO — puts Chi-Med on a di­rect path with its part­ners at Eli Lil­ly to an NDA fil­ing with Chi­nese reg­u­la­tors in a few months.

In­ves­ti­ga­tors re­cruit­ed 416 pa­tients with lo­cal­ly ad­vanced or metasta­t­ic colon can­cer who had failed at least two chemother­a­pies for this study. The pa­tients were then divvied be­tween the drug arm and a group treat­ed with place­bo plus best stan­dard of care.

“It’s a re­mark­ably se­lec­tive VEG­FR in­hibitor,” Chi-Med CEO Chris­t­ian Hogg tells me. “We’ve al­ways had con­fi­dence in shut­ting down that tar­get…We have al­ways been su­per con­fi­dent that fruquin­tinib is as clean as you’re go­ing to get.”

Chi-Med’s stock $HCM surged 11% on the news.

Hogg start­ed out as CEO of the com­pa­ny when it launched 17 years ago. He was the first staffer and fruquin­tinib came out of its labs with the back­ing of bil­lion­aire Li Ka-shing. Now Chi-Med, domi­ciled in Hong Kong for tax rea­sons, list­ed in Lon­don and on Nas­daq (with a $1.55 bil­lion mar­ket cap}, has 330 sci­en­tists and staff in Shang­hai. And, if the da­ta hold up, Hogg ex­pects Chi­nese reg­u­la­tors could well come through with an ac­cel­er­at­ed ap­proval.

“There has nev­er been a main­stream on­col­o­gy drug — I’m talk­ing syn­thet­ic med­i­cine, small mol­e­cules or an­ti­bod­ies — but nev­er a main­stream on­col­o­gy drug cre­at­ed in Chi­na by a Chi­nese com­pa­ny tak­en to a pos­i­tive read­out,” he tells me in a phone in­ter­view from his of­fice in Shang­hai.

And he doesn’t plan for it to be the last. While Chi-Med is set­ting up a bridg­ing study in the US for fruquin­tinib, re­searchers are ad­vanc­ing a late-stage pro­gram for non-small cell lung can­cer. Out­side of Chi­na, Hogg ex­pects to fo­cus con­sid­er­ably on com­bi­na­tion stud­ies for his lead drug.

Chi-Med has eight drugs in 30 clin­i­cal stud­ies around the world, says the CEO, with a fol­low-up pro­gram that could pro­vide piv­otal da­ta fair­ly soon for savoli­tinib, part­nered with As­traZeneca. That in­cludes four Phase III stud­ies now un­der­way and 4 more get­ting ready to launch.

Eli Lil­ly has played a key role, ink­ing an $86.5 mil­lion deal in 2013 for fruquin­tinib and pay­ing 70% of the clin­i­cal tri­al costs. Lil­ly has com­mer­cial­iza­tion rights in Chi­na, and has win­dows com­ing up that could al­low it to grab an op­tion on glob­al rights.

Chi­na, says Hogg, has 30% of the world’s can­cer pa­tients and is set to be­come the world’s sec­ond largest phar­ma­ceu­ti­cals mar­ket. And reg­u­la­tors, he says, are keen to ad­vance new drugs in­to the mar­ket.

“We were in the right place at the right time,” says Hogg. “It will on­ly get big­ger and bet­ter.”

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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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

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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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.