Al­ler­gan’s trib­al treaty in Resta­sis patent fight trig­gers a Con­gres­sion­al don­ny­brook

Phar­ma sto­ries have to have a cer­tain col­or­ful qual­i­ty to swell in­to a full pub­lic scan­dal. Mar­tin Shkre­li had his so­cial me­dia tantrums to keep him ra­dioac­tive. My­lan was ac­cused of rip­ping off schools by lever­ag­ing vul­ner­a­ble kids. And now Al­ler­gan has the casi­no-own­ing Saint Reg­is Mo­hawk Tribe as an al­ly to win the spot­light.

And it’s get­ting hot un­der those lights.

To­day four pow­er­ful De­mo­c­ra­t­ic US sen­a­tors signed off on a scathing let­ter to the pow­ers that be in Con­gress, of­fer­ing a scathing de­nun­ci­a­tion of Al­ler­gan CEO Brent Saun­ders’ de­ci­sion to trans­fer the patents it holds on Resta­sis to the tribe and then leas­ing them back on their block­buster med, all af­ter a $13.75 mil­lion pay­day to shift con­trol to a group with sov­er­eign im­mu­ni­ty — which they be­lieve will pro­tect them from an un­fair IPR chal­lenge.

The move was “a bla­tant­ly an­ti-com­pet­i­tive at­tempt to shield its patents from re­view and keep drug prices high,” the sen­a­tors — Mar­garet Wood Has­san (D-NH), Sher­rod Brown (D-OH), Robert Casey (D-PA) and Richard Blu­men­thal (D-CT) — wrote.

The let­ter dis­miss­es one of Al­ler­gan’s key de­fens­es, which is that state uni­ver­si­ties have gained that priv­i­lege, by not­ing that the key case in­volved patents where the orig­i­nal own­ers had sov­er­eign im­mu­ni­ty. This dodge by Al­ler­gan, they said, was us­ing sov­er­eign im­mu­ni­ty at the “ex­pense of pa­tients” who would be sub­ject­ed to those high­er prices.

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Now they want the Sen­ate Ju­di­cia­ry Com­mit­tee to step in and in­ves­ti­gate. With pub­lic hear­ings, pre­sum­ably, in which Saun­ders and oth­er ex­ecs at Al­ler­gan will be asked to take an oath and tes­ti­fy in front of the cam­eras.

Saun­ders adamant­ly told me a cou­ple of weeks ago that he wouldn’t budge, re­gard­less of the back­lash. The deal with the tribe, he said, had been ne­ces­si­tat­ed by an un­fair sys­tem that re­quired Al­ler­gan to fight for patent pro­tec­tion on two fronts.

“Every­thing we have done here,” he added, “is com­plete­ly con­sis­tent with our so­cial con­tract.”

Part of that so­cial con­tract called for some re­straint on drug pric­ing, which the sen­a­tors al­so at­tacked in their let­ter by cit­ing a 9.9% price hike on Resta­sis.

Al­ler­gan quick­ly fired back at the sen­a­tors Wednes­day, say­ing they were fo­cused on the wrong things. Al­ler­gan and the trib­al deal shouldn’t be their con­cern; it’s the IPR process that’s the scan­dal.

As the Sen­a­tors are well aware, ex­perts across the le­gal, bio­phar­ma­ceu­ti­cal and busi­ness com­mu­ni­ties have called on Con­gress to fix the is­sues in­her­ent with­in IPR. Con­gress has failed to act to pro­tect in­no­va­tion, and the mat­ter is now be­fore the Unit­ed States Supreme Court.

As we have with the staffs of Sen­a­tors Mag­gie Has­san and Sher­rod Brown, we wel­come the op­por­tu­ni­ty to dis­cuss these is­sues with Sen­a­tors Richard Blu­men­thal and Robert Casey.  This is an im­por­tant dis­cus­sion that needs to be had to en­sure we are pro­tect­ing in­no­va­tion in the Unit­ed States.

My­lan CEO Heather Bresch has been here be­fore. Iron­i­cal­ly, My­lan has al­so al­ready chal­lenged the deal, look­ing to get its own gener­ic in­to the mar­ket.

See­ing an­oth­er phar­ma ex­ec dragged in­to pub­lic hear­ings to dis­cuss pric­ing and trib­al deals and patent con­trol is prob­a­bly the last thing the in­dus­try lob­by­ists would like to see now, es­pe­cial­ly as the ear­li­er pric­ing scan­dals had been qui­et­ing down.

But these sto­ries have a life of their own, if they are built just so.

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.