Puma's fresh shin­er, what the biotech IPO surge tells us, and the trou­ble with can­cer R&D

End­points as­sess­es the big bio­phar­ma sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.


Puma gets an­oth­er shin­er as BioTwit­ter chews on an­oth­er morsel of in­for­ma­tion

One thing you don’t want to see in the fi­nal few days lead­ing up to an FDA pan­el re­view of your big drug is trou­ble on the reg­u­la­to­ry team. This, af­ter all, is where the rub­ber hits the road for reg­u­la­to­ry as they steer the ap­pli­ca­tion to­ward a group of peo­ple at the FDA and their cho­sen ad­vis­ers who will of­fer their ex­pert opin­ions on what you’ve been hop­ing to sell for bad­ly need­ed rev­enue.

Point­ed ques­tions will be raised. Point­ed an­swers need to be sup­plied. And the reg­u­la­to­ry head is sup­posed to be your guide for what’s ahead, help­ing shore up your ar­gu­ment in the com­pa­ny’s fa­vor. They may not do a lot of talk­ing in pub­lic, or qual­i­fy as a top biotech ex­ec, but strat­e­gy and prep from your reg­u­la­to­ry li­ai­son is key to a good pan­el pre­sen­ta­tion and de­fense.

So when Puma Biotech­nol­o­gy $PBYI briefly not­ed on Thurs­day that their reg­u­la­to­ry head — Se­nior VP Robert Char­nas — had de­cid­ed to leave the com­pa­ny “for health rea­sons” in 11 days, 9 days ahead of their pan­el re­view, BioTwit­ter swung in­to ac­tion and be­gan to of­fer a va­ri­ety of con­spir­a­cy the­o­ries to fill the in­for­ma­tion gap.

Did he, per­haps, know that Puma had al­ready been tor­pe­doed in the FDA’s drug re­view?

It sound­ed bad, and Puma’s stock, which was trad­ing at $200 a share a year ago, took an­oth­er hit, cost­ing it about 10% of its share price. And this af­ter the stock closed at $36.55.

It didn’t help that the rea­son cit­ed in their 8-K for Char­nas’ de­par­ture may have been a lit­tle af­ter-the-fact. Cred­it Su­isse says they talked to CEO Alan Auer­bach, and he told an­a­lysts that there was some fric­tion be­tween the reg­u­la­to­ry chief and the team at Puma. The CEO sug­gest­ed a month and a half ago that Char­nas start con­sid­er­ing what he’d like to do next with his ca­reer, and the health rea­son was cit­ed in the reg­u­la­to­ry chief’s res­ig­na­tion last Fri­day. That all hap­pened be­fore he could have seen the FDA’s docs.

So case closed?

Not a chance. There are oth­er an­a­lysts notes and more con­jec­ture. The de­bate over Puma’s chances at the FDA — with a drug that has been both praised and pum­meled for ef­fi­ca­cy as well as some se­vere side ef­fects — is just reach­ing red-hot tem­per­a­tures as a sure-fire cat­a­lyst ap­proach­es. So it’s a nat­ur­al for Twit­ter, where small in­vestors flock for tips and cues. Mon­ey will be made and lost in a war of words where mo­ti­va­tion and iden­ti­ty are the first ca­su­al­ties in the fog of blog war.

It’s not ide­al, but it is the new re­al­i­ty. For biotech CEOs look­ing to go pub­lic, that’s some­thing you’ll want to keep front of mind.

Biotech IPOs flare again, and the bright light spot­lights a new com­pa­ny-build­ing strat­e­gy

Speak­ing of biotech stocks.

Bio­haven got its pipeline the new fash­ioned way. It found a promis­ing ther­a­py on the shelf at Bris­tol-My­ers Squibb, bagged it for a small amount and put it at the top of the pipeline. Hes­to presto and you have a com­pa­ny ready to go pub­lic, Ax­o­vant style.

That’s a lit­tle flip, to be sure, but not too ex­treme. Any­way, what makes it im­por­tant is that Bio­haven pulled off an up­sized $168 mil­lion IPO over the range at $17 a share this week. That’s not some­thing you see very of­ten in biotech cir­cles, where the biotech boom of 2014 is now some­thing of a dis­tant echo. Add that with an up­sized IPO for Uro­Gen and a sol­id score by Ovid, and we have the mak­ings of a biotech IPO resur­gence — at least for a brief pe­ri­od.

I’m not a stock pick­er and there are plen­ty of peo­ple who are bet­ter at sort­ing out these trends than I am, but a mar­ket that’s ready to em­brace biotech again — even as in­sid­ers shore up the price and prob­lems abound with the ul­tra risk in­volved in drug de­vel­op­ment — would prove help­ful to keep­ing the food chain tuned up.

What you shouldn’t over­look in this is the role big­ger play­ers in bio­phar­ma have in set­ting up this next wave of biotech com­pa­nies. And not just at Bio­haven. Ovid got its lead in a cre­ative 50/50 deal with Take­da, which is wide open to new ideas and re­la­tion­ships. In a re­lat­ed move, Ma­gen­ta, which brought its ven­ture tal­ly to $98.5 mil­lion this week, gained a lead drug from their con­tacts at No­var­tis.

So as the big or­ga­ni­za­tions re­or­ga­nize and reeval­u­ate, new op­por­tu­ni­ties are be­ing made for new com­pa­nies.

These IPO trends can turn on a dime. So let’s say con­grats to the win­ners and keep an eye on this. It’s been a good week. Pick­ing up R&D as­sets like this may tur­bo charge a com­pa­ny’s growth. But not all of these re­dis­cov­ered di­a­monds in the rough will sparkle in Phase III.

Can­cer is the king of all pipeline strate­gies — so be care­ful

Con­grats to As­traZeneca for their ap­proval of dur­val­um­ab this week. Yes, it was ex­pect­ed. Yes, they were fifth to the par­ty with the third OK for blad­der can­cer. No, that’s not go­ing to win any prizes in R&D work, par­tic­u­lar­ly for a phar­ma gi­ant that faces mul­ti­ple pipeline is­sues at a time it’s still strug­gling to mount a turn­around.

As­traZeneca, though, has scored some im­por­tant wins in can­cer un­der CEO Pas­cal So­ri­ot and this tro­phy can be added to the block­buster show­case.

As­traZeneca CEO Pas­cal So­ri­ot

But there are some big­ger trends at work here that de­serve some at­ten­tion.

It’s clear from the lat­est fore­cast from Quin­tiles­IMS that can­cer is go­ing to be the big fo­cus in bio­phar­ma R&D over the next five years. As­traZeneca went af­ter check­points be­cause the bi­ol­o­gy is well un­der­stood and you can make some mon­ey here. But their late ar­rival al­so un­der­scores just how ex­tra­or­di­nar­i­ly com­pet­i­tive this field can be­come al­most overnight. Mon­ey is be­ing poured in­to a whole pipeline of PD-1 and PD-L1 check­points. In the near fu­ture you’ll see ap­provals tar­get­ing par­tic­u­lar coun­tries, like Chi­na. Com­pa­nies with a can­cer vac­cine or a next-gen CT­LA-4, re­lat­ed check­points, etc., will want their own check­point. Like In­cyte.

And why not? We know how to make these ther­a­pies.

The FDA, which has helped ush­er in a rev­o­lu­tion in can­cer R&D by en­cour­ag­ing ac­cel­er­at­ed ap­pli­ca­tions, will have lit­tle prob­lem re­view­ing and ap­prov­ing these new meds.

Pay­ers aren’t blind to this. Com­pe­ti­tion will force prices down with for­mu­la­ries as the weapon of choice. Biotech’s role here is to look be­yond where drugs are now and on to the new cock­tails of the fu­ture, like Cy­tomX is do­ing. And out of all the churn­ing, there will be a few win­ners and many losers.

This is not work for the weak of heart; win­ning isn’t al­ways go­ing to be enough to be suc­cess­ful.

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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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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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.