Ad­di­tion­al ex­clu­siv­i­ty for a can­cer treat­ment could cost the pub­lic $3 bil­lion, an­a­lyst says

Last week, the FDA grant­ed ad­di­tion­al ex­clu­siv­i­ty to Ea­gle Phar­ma­ceu­ti­cals’ can­cer med­i­cine Tre­an­da (ben­damus­tine hy­drochlo­ride), a de­ci­sion that ef­fec­tive­ly halts the in­tro­duc­tion of gener­ic ver­sions of the in­jec­tion un­til 2022, which one an­a­lyst said could cost the pub­lic $3 bil­lion.

The de­ci­sion by the FDA comes as the com­pa­ny’s oth­er ben­damus­tine hy­drochlo­ride prod­uct, known as Ben­de­ka, won sev­en years of or­phan drug ex­clu­siv­i­ty last sum­mer be­cause of a US dis­trict court win for the com­pa­ny against the FDA.

The FDA said in its con­clu­sion last week that be­cause of the court’s de­ci­sion, “the scope of Ben­de­ka’s ex­clu­siv­i­ty ex­tends to all ap­pli­ca­tions con­tain­ing the same ac­tive moi­ety as Ben­de­ka, ben­damus­tine, and bars the ap­proval of any ap­pli­ca­tion con­tain­ing ben­damus­tine for any ex­clu­siv­i­ty-pro­tect­ed in­di­ca­tion start­ing on the date of Ben­de­ka’s ap­proval for sev­en years, i.e., from De­cem­ber 7, 2015 un­til De­cem­ber 7, 2022, un­less a spon­sor es­tab­lish­es clin­i­cal su­pe­ri­or­i­ty or an ex­cep­tion to ex­clu­siv­i­ty ap­plies.”

Ron­ny Gal

Both Ben­de­ka and Tre­an­da are ap­proved in the US for the treat­ment of pa­tients with chron­ic lym­pho­cyt­ic leukemia and pa­tients with in­do­lent B-cell non-Hodgkin’s lym­phoma that has pro­gressed dur­ing or with­in six months of treat­ment with rit­ux­imab or a rit­ux­imab-con­tain­ing reg­i­men.

Ac­cord­ing to an Ea­gle SEC fil­ing Fri­day, the FDA’s de­ci­sion in fa­vor of the com­pa­ny en­sures that no ben­damus­tine prod­uct (in­clud­ing gener­ic ver­sions of Ben­de­ka and Tre­an­da) may launch in the US un­til that date set by the FDA — 7 De­cem­ber 2022.

In mak­ing its de­ci­sion, the FDA ex­plained how its hands were tied by the court’s de­ci­sion. “If Ben­de­ka had been clin­i­cal­ly su­pe­ri­or to Tre­an­da, its ex­clu­siv­i­ty would not have blocked AN­DAs [ab­bre­vi­at­ed new drug ap­pli­ca­tions] ref­er­enc­ing Tre­an­da. Now that it has ob­tained ex­clu­siv­i­ty pur­suant to a court or­der with­out es­tab­lish­ing clin­i­cal su­pe­ri­or­i­ty to Tre­an­da, even though it is not a dif­fer­ent drug from the pre­vi­ous­ly ap­proved drug, Tre­an­da, its ex­clu­siv­i­ty ex­tends to block any drug for the same ac­tive moi­ety.”

Gener­ic ver­sions of Tre­an­da, mean­while, were poised to en­ter the mar­ket in No­vem­ber 2019, Ea­gle said.

Bern­stein an­a­lyst Ron­ny Gal took is­sue with the FDA’s de­ci­sion, not­ing to in­vestors: “This is poor per­for­mance by FDA which shows that even in the Got­tlieb era, the risk-averse bu­reau­cra­cy can get lost in its own maze of reg­u­la­tions. The il­log­i­cal de­ci­sion will cost the pub­lic some $3B in added costs.”

How­ev­er, one of the gener­ic com­pa­nies seek­ing to bring its own ben­damus­tine prod­uct to mar­ket may sue over the de­ci­sion, Gal not­ed.

Te­va Phar­ma­ceu­ti­cals, Ea­gle’s part­ner, al­so said the FDA has ap­pealed the dis­trict court’s de­ci­sion from last sum­mer. How­ev­er, bar­ring a re­ver­sal by the ap­pel­late court, drug ap­pli­ca­tions ref­er­enc­ing Ben­de­ka al­so will not be ap­proved by the FDA un­til the or­phan drug ex­clu­siv­i­ty ex­pires in De­cem­ber 2022.

Gal said that there are at least five gener­ic com­pa­nies pur­su­ing gener­ic ver­sions of Ben­de­ka and Tre­an­da.

First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

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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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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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.