As pub­lic furor mounts, Sanofi makes deep cuts to US in­sulin prices in sav­ings pro­gram

In­sulin, the life-sav­ing hor­mone for the mil­lions of di­a­bet­ics in the Unit­ed States, is be­ing stock­piled, ra­tioned and fore­gone to dis­as­trous con­se­quences, as pa­tients strug­gle to af­ford the soar­ing costs of the drug. Pro­voked and prod­ded with bi­par­ti­san furor, stake­hold­ers in the in­sulin sup­ply chain are tak­ing steps to os­ten­si­bly im­prove ac­cess. On Wednes­day, Sanofi — one of three big glob­al in­sulin mak­ers — pledged that come June, pa­tients will be able to pay $99 to ac­cess up to 10 box­es of pens and/or 10 mL vials per month, a far cry from the cur­rent it­er­a­tion of its sav­ings pro­gram, in which the French drug­mak­er charges $99 for one 10mL vial or $149 per box of pens.

Al­though in­sulin was dis­cov­ered in 1921, ad­vances in ge­net­ic en­gi­neer­ing cat­a­pult­ed hu­man in­sulin for­mu­la­tions to pa­tients with di­a­betes in the 1980s. Rapid-act­ing and long-act­ing hu­man in­sulin analogs were in­tro­duced in the 1990s, and since then oth­er up­grades have been in­tro­duced, how­ev­er, the patents for many for­mu­la­tions in cur­rent clin­i­cal use have ex­pired. To­day, the Unit­ed States is home to more than 30 mil­lion di­a­bet­ics, and the av­er­age price of in­sulin near­ly tripled be­tween 2002 and 2013, ac­cord­ing to Amer­i­can Di­a­betes As­so­ci­a­tion (ADA) es­ti­mates.

This stag­ger­ing and some­what in­ex­plic­a­ble, jump in the price of lega­cy in­sulin prod­ucts gar­nered the at­ten­tion of law­mak­ers. The first Con­gres­sion­al hear­ing fo­cused on drug pric­ing held in Jan­u­ary cen­tered around in­sulin, with par­ents tes­ti­fy­ing that their chil­dren had died af­ter un­suc­cess­ful­ly ra­tioning their in­sulin. In Feb­ru­ary, Sen­a­tors Chuck Grass­ley and Ron Wyden sent let­ters to lead­ing in­sulin man­u­fac­tur­ers: Lil­ly $LLY, No­vo Nordisk $NVO and Sanofi $SNY seek­ing in­for­ma­tion re­gard­ing re­cent price in­creas­es of up to 500% or more for in­sulin. Mean­while, for­mer FDA com­mis­sion­er Scott Got­tlieb has un­der­scored the sig­nif­i­cance of carv­ing out a biosim­i­lar path­way and nur­tur­ing biosim­i­lar com­pe­ti­tion for in­sulin to sub­due high prices.

Sanofi’s move fol­lows Lil­ly’s pledge last month to launch a half-price gener­ic of its most pop­u­lar in­sulin, Hu­ma­log — which gen­er­at­ed near­ly $3 bil­lion in 2018 sales. The US drug­mak­er al­so is­sued a re­port break­ing down what it gets paid, on av­er­age, ver­sus the list price of its in­sulin treat­ments. Be­tween 2014 and 2018, the list price for Hu­ma­log in­creased 51.9% while the av­er­age amount that Lil­ly re­ceived — the net price — de­clined by 8.1%, as the com­pa­ny in­creased (and in some cas­es was forced to hike, it said) the mag­ni­tude of re­bates and dis­counts it of­fers.

The dis­clo­sure is a prime ex­am­ple of the fin­ger point­ing be­tween drug­mak­ers and PBMs. Drug man­u­fac­tur­ers con­tend list prices are ris­ing to com­bat the big­ger re­bates/dis­counts the all-pow­er­ful mid­dle­men ne­go­ti­ate, while PBMs ar­gue that ul­ti­mate­ly the pow­er to set list prices lies with the drug­mak­ers. The losers are the fi­nal end-users — the pa­tients whose out-of-pock­et costs are close­ly in­ter­twined with list prices.

The com­pli­cat­ed in­sulin sup­ply chain has al­so con­found­ed law­mak­ers and re­searchers alike. In a re­cent analy­sis con­duct­ed by an ADA work­ing group — which held dis­cus­sions with more than 20 stake­hold­ers in the in­sulin sup­ply chain — it is un­clear pre­cise­ly how the dol­lars flow and how much each in­ter­me­di­ary prof­its.

Last week, Cigna and Ex­press Scripts $ES­RX said their di­a­bet­ic cus­tomers will not be forced to pay more than $25/month out-of-pock­et for in­sulin, down from the av­er­age $41.50/month last year, al­though pa­tients on high-de­ductible plans were pay­ing much more. The move came ahead of a Con­gres­sion­al hear­ing on Tues­day which put phar­ma­cy ben­e­fit man­agers —in­clud­ing Ex­press Scripts — in the hot seat, as law­mak­ers tried their ut­most to di­gest the job de­scrip­tion of these mid­dle­men, and un­pack the role they play in pre­scrip­tion drug pric­ing.

Since it was launched last April, Sanofi’s sav­ings pro­gram — which caters to pa­tients re­gard­less of in­come and in­sur­ance sta­tus — has re­sult­ed in ap­prox­i­mate­ly $10 mil­lion in pa­tient sav­ings, the com­pa­ny said.

How­ev­er, drug man­u­fac­tur­ers are pro­hib­it­ed from of­fer­ing this type of pro­gram to pa­tients in­sured un­der Medicare, Med­ic­aid, or sim­i­lar fed­er­al or state pro­grams, as per reg­u­la­tions, though Sanofi sup­ports chang­ing these rules, it added.

Last year, about $2.2 bil­lion from the rough­ly $4 bil­lion in Sanofi di­a­betes drug sales came from the Unit­ed States.

Im­age: Shut­ter­stock

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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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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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.

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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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

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Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.