Re­gen­eron, Sanofi win a de­layed OK for rheuma­toid arthri­tis IL-6 heavy­weight sar­ilum­ab

It took more than six months and like­ly caused more than a few red faces, but Sanofi has dealt with the FDA’s is­sues with its man­u­fac­tur­ing ops and won a green light to start mar­ket­ing the like­ly block­buster sar­ilum­ab along­side its part­ners at Re­gen­eron.

Con­sen­sus peak sales fore­casts on the drug — to be mar­ket­ed as Kevzara — top the $1 bil­lion block­buster mark, mak­ing it a big ad­di­tion for both com­pa­nies.

George Yan­copou­los, Re­gen­eron (Get­ty/Bloomberg)

The part­ners say they set the WAC at $39,000/year for the 200 mg and 150 mg dos­es, which is ap­prox­i­mate­ly “30 per­cent low­er than the WAC for the two most wide­ly used TNF-al­pha in­hibitors.” Those two are Hu­mi­ra – which earned $16 bil­lion last year – and En­brel.

The IL-6 drug whet­ted an­a­lysts’ ex­pec­ta­tions last March when it beat out Ab­b­Vie’s Hu­mi­ra in a head-to-head show­down for rheuma­toid arthri­tis. The Hu­mi­ra da­ta weren’t in reg­u­la­tors’ pack­age for the ap­proval, but you can be sure that pay­ers will give it a good look over once the sales team hits the streets. On the down­side, sar­ilum­ab was linked to a sig­nif­i­cant­ly high­er rate of neu­trope­nia.

Leerink high­light­ed the price com­pe­ti­tion with a nod to the low­er price mod­el.

As im­por­tant­ly, Kevzara is al­so ap­prox­i­mate­ly 15% be­low the price of Actem­ra at the high­est dose and, with dis­counts, should of­fer a cost ef­fec­tive treat­ment op­tion for pay­ers in this set­ting. In a re­cent In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view (ICER) analy­sis, Kevzara did not reach a typ­i­cal $100,000 per qual­i­ty-ad­just­ed life year (QALY) cost ef­fec­tive­ness thresh­old at this lev­el, but nei­ther did any of the oth­er wide­ly pre­scribed bi­o­log­i­cals for this dis­ease, in­clud­ing En­brel, Hu­mi­ra, Cimzia, Oren­cia, Actem­ra and Xel­janz.

Sar­ilum­ab now be­comes the third an­ti­body to win ap­proval from a Re­gen­eron/Sanofi part­ner­ship. The first was the PC­SK9 drug Pralu­ent, which has trig­gered a bruis­ing le­gal bat­tle with Am­gen and has yet to find any re­al trac­tion in the mar­ket, de­spite its dra­mat­ic im­pact on cho­les­terol. The part­ners are now lin­ing up car­dio out­comes da­ta from a big Phase III, hop­ing to push that out front of the com­pe­ti­tion. Then there was an OK ear­li­er this year for Dupix­ent, which a num­ber of fore­casts have pegged as a po­ten­tial megablock­buster.

Rheuma­toid arthri­tis is a tough dis­ease to beat, es­pe­cial­ly when you have to line up against some big ri­vals that are al­ready well en­trenched in the field. J&J and Glax­o­SmithK­line demon­strat­ed that when they came up with mixed re­sults in their head-to-head with sirukum­ab vs. Hu­mi­ra. But it was Eli Lil­ly that turned in the big nasty sur­prise, with the FDA stun­ning an­a­lysts with their re­jec­tion of baric­i­tinib, a drug li­censed from In­cyte.

“In the clin­i­cal tri­al pro­gram, sar­ilum­ab demon­strat­ed sta­tis­ti­cal­ly sig­nif­i­cant, clin­i­cal­ly-mean­ing­ful im­prove­ments in adult pa­tients with rheuma­toid arthri­tis by re­duc­ing signs and symp­toms and im­prov­ing phys­i­cal func­tion, re­sult­ing in sig­nif­i­cant­ly less ra­di­ograph­ic pro­gres­sion of struc­tur­al dam­age of RA,” said Alan Kivitz, an in­ves­ti­ga­tor in the glob­al SAR­IL-RA clin­i­cal pro­gram for sar­ilum­ab. “This is im­por­tant be­cause not all cur­rent­ly avail­able treat­ments work in all pa­tients, and some pa­tients may spend years cy­cling through dif­fer­ent treat­ments with­out achiev­ing their treat­ment goals. Sar­ilum­ab works dif­fer­ent­ly from the most com­mon­ly used bi­o­log­ics, such as those in the an­ti-TNF class, and is a wel­come new op­tion for pa­tients and their physi­cians.”

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.

H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

Endpoints News

Basic subscription required

Unlock this story instantly and join 55,100+ biopharma pros reading Endpoints daily — and it's free.