Sanofi takes its own drug pric­ing pledge, point­ing to a de­cline in their ag­gre­gate net price

Sanofi CEO Sanofi Olivi­er Brandi­court (left), flanked by CFO Jerome Con­t­a­mine, speaks dur­ing the pre­sen­ta­tion of the group’s 2016 re­sults in Paris on Feb­ru­ary 8, 2017. ER­IC PIER­MONT/AFP/Get­ty


What do you do when your in­dus­try is rou­tine­ly pil­lo­ried by the pres­i­dent of the US for be­ing run by a group of white col­lar price gougers, rou­tine­ly rip­ping off the Amer­i­can con­sumer?

Brent Saun­ders speak­ing at an End­points News event on Jan 10, 2017 (End­points News)

In Big Phar­ma’s case, you be­gin to un­der­stand that those opaque drug prices you work with are a big part of the prob­lem, and you start to shed a light on the pric­ing menu, while com­mit­ting to an eth­i­cal ap­proach on pric­ing that might help cool the white-hot rhetoric.

Brent Saun­ders at Al­ler­gan got the ball rolling with a pledge to hold year-over-year price in­creas­es to sin­gle dig­its. Oth­ers drove in, like J&J, of­fer­ing a look at ag­gre­gate prices for their whole port­fo­lio. And to­day Sanofi is join­ing the bunch af­ter ham­mer­ing out its own pric­ing pledge, while stak­ing out a unique role for it­self demon­strat­ing that its prices are ac­tu­al­ly falling in the US.

In a new pol­i­cy an­nounced to­day, the French phar­ma gi­ant has de­cid­ed to bench­mark its drug price in­creas­es to the Na­tion­al Health Ex­pen­di­ture growth rate, which is pro­ject­ed to be 5.4% this year, says Cy­bele Bjork­lund, head of glob­al pol­i­cy at Sanofi. And they’ll re­veal what their ag­gre­gate pric­ing changes are — for the list price as well as the low­er net price af­ter dis­counts — each year.

If one drug price in­crease does break the NHE mod­el, Sanofi will ex­plain why, she adds.

Cy­bele Bjork­lund, Sanofi

There’s no his­tor­i­cal da­ta of­fered with a look at the track record over, say, the last decade. But Sanofi is start­ing off with a look at 2016, in which the ag­gre­gate list price jumped 4% and the av­er­age net price dropped 2.1%.

Sanofi picked a good year to start mak­ing these fig­ures avail­able. Its di­a­betes fran­chise has been ham­mered hard, forc­ing all the big play­ers to step back on pric­ing and putting Sanofi CEO Olivi­er Brandi­court in the role of drug dis­counter, even as he has to ex­plain the rev­enue im­pact to in­vestors.

“We want­ed to re­al­ly look for a ra­tio­nal and in­de­pen­dent mea­sure” that was bet­ter than sin­gle-dig­it price hikes, Bjork­lund tells me. This way the com­pa­ny is com­mit­ted to a pol­i­cy that no one in the com­pa­ny will find hard to de­fend, lim­it­ing their price hikes to health­care in­fla­tion. And they don’t plan to make too much of it, ei­ther.

Says Bjork­lund: “We can do what we can do. We’re not go­ing to be run­ning through the hills say­ing look at us and what we’ve done.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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