My­lan claims win in Lan­tus patent bat­tle, but le­gal war with Sanofi is far from over

Ear­li­er this week, the FDA took aim at es­ca­lat­ing in­sulin prices that have forced di­a­bet­ics to ra­tion out the drug as out-of-pock­et costs soar. Now, the US Patent and Trade­mark Of­fice has de­nied Sanofi’s claim on two patents for its top-sell­ing Lan­tus, in re­sponse to a pe­ti­tion from My­lan, al­though on­go­ing lit­i­ga­tion be­tween the two com­pa­nies in US courts could still sub­vert a po­ten­tial launch of the gener­ic drug­mak­er’s copy­cat ver­sion.

Sanofi $SNY, No­vo Nordisk $NVO and Eli Lil­ly $LLY — the tri­fec­ta that pro­duce the li­on’s share of in­sulin — have come un­der pres­sure in re­cent years in re­sponse to surg­ing prices (the av­er­age price of in­sulin near­ly tripled be­tween 2002 and 2013).  Rev­enue from Sanofi’s di­a­betes fran­chise, which is down down near­ly 30% since 2015, is large­ly de­pen­dent on the in­sulin glargine in­jec­tion Lan­tus. Sales from the long-act­ing ver­sion of hu­man in­sulin shrank to rough­ly €1.8 bil­lion (about $2 bil­lion) in the first half of this year.

On Thurs­day, My­lan $MYL said that the US patent and re­view board (PT­AB) had ruled in its fa­vor, con­clud­ing two of Sanofi’s for­mu­la­tion patents were ‘un­patentable’. But last year, the French drug­mak­er ini­ti­at­ed patent in­fringe­ment lit­i­ga­tion against My­lan’s (and Bio­con’s) NDA that in­cludes these two for­mu­la­tion patents cov­er­ing Lan­tus, as well as oth­er patents cov­er­ing the Lan­tus SoloSTAR in­jec­tion pen.

No date for the rul­ing has been set yet, al­though lit­i­ga­tion pro­ceed­ings have en­sured that the ap­proval of My­lan and Bio­con’s Lan­tus copy­cat is sub­ject to a 30-month stay which ex­tends to ear­ly 2020.

“We be­lieve that it is un­like­ly that the PT­AB rul­ing on the for­mu­la­tion patents will have an im­pact on My­lan’s tim­ing for a launch of its glargine prod­ucts.  The PT­AB de­ci­sion alone does not af­fect the ex­ist­ing 30-month stay and My­lan does not have ten­ta­tive FDA ap­proval for its prod­ucts at this time,” a Sanofi spokes­woman told End­points News in an emailed state­ment.

Aside from pric­ing pres­sure, Lan­tus is al­ready suf­fer­ing from com­pe­ti­tion from Lil­ly’s Basaglar, which was launched in late 2016, af­ter the set­tle­ment of a sim­i­lar case with Lil­ly the pre­ced­ing year. CVS and Unit­ed Health have re­placed Lan­tus in fa­vor of Basaglar in their for­mu­la­ries.

The sit­u­a­tion with in­sulin — as point­ed out by Scott Got­tlieb ear­li­er this week — is in­fi­nite­ly com­plex. Al­though they are tech­ni­cal­ly bi­o­log­i­cal prod­ucts – that hit the mar­ket decades ago – they are clas­si­fied as drugs and ap­proved via NDAs, thwart­ing the de­vel­op­ment of biosim­i­lars. In­stead, com­pa­nies like Lil­ly and My­lan have de­vel­oped or are de­vel­op­ing what are called fol­low-on bi­o­log­ics, which are es­sen­tial­ly copy­cat ver­sions of the prod­uct, but are not sub­sti­tutable with the brand­ed prod­uct.

Mer­ck and part­ner Sam­sung Bioepis, mean­while, elect­ed to halt the de­vel­op­ment of their Lan­tus fol­low-on bi­o­log­ic ear­li­er this year.

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.