Gilead of­fers rare apol­o­gy to pay­ers over the hep C drug stick­er shock

Gilead CEO John Mil­li­gan

Gilead is known for many things, but apol­o­giz­ing for its ac­tions is not one of them. The big biotech has cul­ti­vat­ed rhi­no thick skin when it comes to pric­ing is­sues, but CEO John Mil­li­gan was will­ing to turn a con­trite cheek at Matthew Her­p­er’s Health­care Sum­mit last week when called on to ex­plain the out­cry that met the com­pa­ny’s roll­out of a $1,000-per-pill rem­e­dy.

“I think our fail­ure, if I have to take a step back­wards, we were un­able to have a good enough con­ver­sa­tion with the pay­ers,” Mil­li­gan said, as quot­ed by John LaMat­ti­na in a Forbes col­umn to­day. “Per­haps we were a lit­tle con­ser­v­a­tive about what we could have or should have said to them to al­low them to pre­pare for the num­ber of pa­tients that came for­ward. Hon­est­ly, it was far more than we thought. We did not think the sys­tem could or would try to han­dle as many pa­tients as it did. We es­sen­tial­ly quadru­pled the num­ber of pa­tients treat­ed in a year. That surge re­al­ly cre­at­ed a lot of pain.”

Mil­li­gan, though, still thinks the cost was jus­ti­fied. “What hap­pened was a fail­ure to un­der­stand ex­act­ly how many peo­ple were dire­ly ill and had to come in­to care.” You can read it all here.

There are dif­fer­ent brands of price con­tro­ver­sies in bio­phar­ma. There’s the old-drug-sud­den­ly-priced-high sto­ry on goug­ing — Tur­ing, My­lan and Valeant, plus — but Gilead was one of the few con­tro­ver­sies where pay­ers led the charge against a break­through ther­a­py, fu­ri­ous that they were go­ing to be stuck with a big bill as the first tsuna­mi of pa­tients head­ed straight for the cure, at their doc­tor’s urg­ing.

As more drug de­vel­op­ers set their sights on one-time cures like Gilead’s hep C ther­a­pies, you can ex­pect this tin­der box to flare again. Gilead, mean­while, has now sub­mit­ted a hep C triplet to the FDA as the overnight block­buster blast of cash in the fran­chise melts away.

The con­di­tions may change, but the is­sue re­mains front and cen­ter.

Pub­lish­er’s Note: Our pan­el of bio­phar­ma CEOs and lead­ers — mod­er­at­ed by End­points News Ed­i­tor John Car­roll — will tack­le this sub­ject anew in our dis­cus­sion on ac­cess and af­ford­abil­i­ty, slat­ed for Jan­u­ary 10 in San Fran­cis­co dur­ing #JPM17.

End­points News #JPM17 Ex­ec­u­tive Break­fast Page

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

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”