An­gry Pfiz­er ac­cus­es J&J of vi­o­lat­ing an­titrust laws in safe­guard­ing a megablock­buster fran­chise

John Young

By most ac­counts, Pfiz­er was on the verge of in­flict­ing some se­ri­ous pain on J&J’s fran­chise drug Rem­i­cade when it rolled out a biosim­i­lar of the megablock­buster drug in the US last year. But the com­pe­ti­tion from knock­offs bare­ly dent­ed sales, and now Pfiz­er is claim­ing in a fed­er­al law­suit that its Big Phar­ma ri­val owes its suc­cess to mo­nop­o­lis­tic sales prac­tices.

Pfiz­er is tack­ling J&J in the US Dis­trict Court for the East­ern Dis­trict of Penn­syl­va­nia, where it al­leges that its phar­ma ri­val em­ployed “ex­clu­sion­ary con­tracts and oth­er an­ti­com­pet­i­tive prac­tices (which) have de­nied U.S. pa­tients ac­cess to ther­a­peu­tic op­tions and un­der­mined the ben­e­fits of ro­bust price com­pe­ti­tion in the in­no­v­a­tive and grow­ing bi­o­log­ics mar­ket­place for pa­tients,” ac­cord­ing to a state­ment from the com­pa­ny.

Pfiz­er is claim­ing that J&J vi­o­lat­ed fed­er­al laws along the way, in­clud­ing an­titrust pro­vi­sions. The law­suit states:

The threat from In­flec­tra did not go un­no­ticed by J&J. With­in weeks of In­flec­tra’s launch, J&J be­gan to de­ploy what it pub­licly terms its “Biosim­i­lar Readi­ness Plan.” The core fea­tures of the plan are ex­clu­sion­ary con­tracts that fore­close Pfiz­er’s ac­cess to an over­whelm­ing share of con­sumers, cou­pled with an­ti­com­pet­i­tive bundling and co­er­cive re­bate poli­cies de­signed to block both in­sur­ers from re­im­burs­ing, and hos­pi­tals and clin­ics from pur­chas­ing, In­flec­tra and oth­er biosim­i­lars of Rem­i­cade de­spite their low­er pric­ing.

J&J, though, has al­ready shrugged off any near-term hit from biosim­i­lar com­pe­ti­tion, and ex­ecs say they have some big ad­van­tages in main­tain­ing their fran­chise rev­enue.

J&J CFO Do­minic Caru­so re­cent­ly told at­ten­dees at a con­fer­ence that the small dis­count of­fered by Pfiz­er as well as the lack of in­ter­change­abil­i­ty with the main­stay is blunt­ing the ri­val’s abil­i­ty to carve away mar­ket share.

Pfiz­er, though, begs to dif­fer on that score. And the case will be close­ly fol­lowed by all the big play­ers in the in­dus­try — from those de­vel­op­ing biosim­i­lars of some of the biggest block­busters now on the mar­ket to the com­pa­nies that are afraid of the gener­ic com­pe­ti­tion that is loom­ing.

“By of­fer­ing high­ly sim­i­lar ther­a­peu­tic op­tions for pa­tients, doc­tors and health plans, biosim­i­lars fos­ter ther­a­peu­tic choice and in­creased ac­cess to bi­o­log­ic med­i­cines around the world,” said John Young, Pfiz­er’s group pres­i­dent of its Es­sen­tial Health di­vi­sion. “For U.S. pa­tients and providers to re­al­ize the ben­e­fits of biosim­i­lars, new and ex­ist­ing biosim­i­lar en­trants should have a fair chance to com­pete with orig­i­na­tor prod­ucts – now and in the fu­ture – based on law­ful pric­ing and ac­cess prac­tices. By sup­port­ing the avail­abil­i­ty of biosim­i­lar ther­a­pies, we can help en­sure that pa­tients have bet­ter ac­cess to a wide range of low­er cost ther­a­peu­tic op­tions.”

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.