Sen­a­tors heap abuse on Al­ler­gan's at­tempt at an end run around patent re­views, of­fer bill to stop 'sham'

Brent Saun­ders

Al­ler­gan CEO Brent Saun­ders $AGN ve­he­ment­ly de­fend­ed his move to try and shield the com­pa­ny’s Resta­sis fran­chise by hand­ing its patents over to a Mo­hawk In­di­an tribe as a strike against the in­ter partes re­view process, which the com­pa­ny felt was an in­her­ent­ly un­fair threat to its block­buster drug.

What the com­pa­ny ac­com­plished, though, was to stir up a hor­net’s nest of an­gry law­mak­ers who con­demned the move as a sham. And a bi­par­ti­san group of law­mak­ers heav­i­ly rep­re­sent­ed by Re­pub­li­cans re­tal­i­at­ed this week with a new bill that would pre­vent any­one from try­ing this again.

The patent moves re­ly on the tribe’s claim of sov­er­eign im­mu­ni­ty. If they held the patents, then the IPR process could not be used to wres­tle away their pro­tec­tions. The fact that Al­ler­gan paid them for the patent deal, then leased back the patents, didn’t sit well with crit­ics.

The Pre­serv­ing Ac­cess to Cost Ef­fec­tive Drugs (PACED) Act, a ti­tle that un­der­scores the law­mak­ers’ be­lief that the on­ly thing Al­ler­gan had in mind was pro­tect­ing its sec­ond biggest drug fran­chise, would kill that ma­neu­ver.

Claire Mc­Caskill

“We watched a com­pa­ny brazen­ly try to ex­ploit a po­ten­tial le­gal loop­hole to game the sys­tem in an ef­fort to pro­tect their bot­tom line-and keep Mis­souri­ans from ac­cess to cheap­er gener­ic drug op­tions in the process. That should be il­le­gal, and our bi­par­ti­san bill would make it so by end­ing this as­tound­ing as­ser­tion of sov­er­eign im­mu­ni­ty to avoid patent re­view, be­fore any oth­er com­pa­nies fol­low suit,” said Sen­a­tor Claire Mc­Caskill, a De­mo­c­rat from Mis­souri.

The Re­pub­li­cans were just as harsh in con­demn­ing it.

Pat Toomey

Sen­a­tor Pat Toomey, a Re­pub­li­can from Penn­syl­va­nia: “Sham trans­ac­tions in­volv­ing the trans­fer of patent own­er­ship from a phar­ma­ceu­ti­cal com­pa­ny to a tribe for the sole pur­pose of shield­ing the patent from chal­lenges are a clear abuse of our patent sys­tem and set a dan­ger­ous prece­dent for oth­er con­sumer prod­ucts.”

David Per­due

Sen­a­tor David Per­due, Re­pub­li­can from Geor­gia: ”Gam­ing the patent sys­tem is not good for con­sumers or busi­ness­es. I’m dis­ap­point­ed this leg­is­la­tion even has to be of­fered due to a few bad ac­tors try­ing to do an end run around the U.S. Patent and Trade­mark Of­fice.”

Joni Ernst

Sen­a­tor Joni Ernst, Re­pub­li­can from Iowa: “Con­gress can­not look the oth­er way as some phar­ma­ceu­ti­cal com­pa­nies at­tempt to sti­fle com­pe­ti­tion and pre­vent Amer­i­cans from ac­cess­ing af­ford­able gener­ic drugs.”

Al­ler­gan’s de­ci­sion to try the Mo­hawk so­lu­tion to their trou­bles has al­ready been dissed by the courts as well as the Patent Tri­al and Ap­peal Board. The sen­a­tors’ state­ment al­so list­ed their sup­port­ers, in­clud­ing some promi­nent play­ers in the health in­sur­ance field. This is all lean­ing heav­i­ly in one di­rec­tion.

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.