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.”

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.