Clin­ton cam­paign staff: "We have start­ed the war with phar­ma!!"

Just one Tweet from Hillary Clin­ton drove biotech stocks down sharply last fall, the open­ing round in what would be a sav­age bear mar­ket for the in­dus­try. And her se­nior staffers in the cam­paign were deliri­ous.

Clin­ton had jabbed Mar­tin Shkre­li hard for his de­ci­sion to jack up the price of Dara­prim by more than 5,000%, and the sharp, swift re­ac­tion on Wall Street to the mes­sage on drug prices was cheered by her se­nior pol­i­cy ad­vis­ers, ac­cord­ing to one of sev­er­al email ex­changes in­clud­ed in Wik­iLeaks hacked John Podes­ta files.

FYI – We have start­ed the war with Phar­ma!!,” ex­claimed Ann O’Leary re­gard­ing the press that fol­lowed. “Great!,” replied out­side ad­vis­er Mandy Grun­wald.

A few weeks lat­er, though, Clin­ton strate­gist Jim Mar­go­lis was be­gin­ning to fret that Shkre­li hadn’t caved on the price.

I’m a lit­tle ner­vous that we ran the spot and this dude is still stick­ing it to pa­tients. Has there been any fur­ther dis­cus­sion about this?

That wouldn’t be the on­ly ex­change re­gard­ing Hillary Clin­ton’s ad­ver­sar­i­al re­la­tion­ship with Big Phar­ma, which was care­ful­ly con­sid­ered in­side her cam­paign.

Last fall, as Hillary Clin­ton’s cam­paign team was sound­ing out var­i­ous po­si­tions that would help high­light her stance on the phar­ma in­dus­try, the nom­i­na­tion of Robert Califf as FDA com­mis­sion­er pre­sent­ed a tempt­ing tar­get to at least one of her top ad­vis­ers.

A New York Times ar­ti­cle had raised the is­sue of Califf’s ties to the in­dus­try, and O’Leary – a se­nior pol­i­cy ad­vis­er – saw it as a po­ten­tial open­ing for a po­lit­i­cal jab that would high­light Hillary Clin­ton’s ea­ger­ness to stand up to Big Phar­ma, ac­cord­ing to one of the hacked emails that emerged in the John Podes­ta files re­leased by Wik­iLeaks.

O’Leary wrote:

Califf the Oba­ma nom­i­nee does have re­al ties to the drug in­dus­try – Chris Jen­nings is call­ing a few peo­ple for me to learn more so we don’t tip our hand di­rect­ly. We are clean on Clin­ton Ad­min FDA Com­mis­sion­er – it was David Kessler, an aca­d­e­m­ic who had run a teach­ing hos­pi­tal – and best known for tak­ing on big to­bac­co.  We could cer­tain­ly sig­nal that we want some­one will­ing to stand up to Phar­ma (in the same way Kessler stood up to To­bac­co).

BUT – I want to do a lit­tle more dig­ging and due dili­gence be­fore we hit this guy.  Hav­ing been through a nom­i­na­tion fight with my hus­band (in which he lost), this is per­son­al and messy and hor­ri­ble on the per­son nom­i­nat­ed and their fam­i­lies – so I don’t take at­tack­ing this guy light­ly.

Clin­ton spokesman Bri­an Fal­lon not­ed that he liked the idea, not­ing that Joe Biden – a po­ten­tial con­tender for the nom­i­na­tion – would be re­quired to be in Califf’s cor­ner.

Any up­date on this? As we con­sid­er fights that fit in­to the larg­er themes we are try­ing to pro­mote, this seems like a good fight to have.

Plus, the VP would be in a box of hav­ing to sup­port this nom­i­nee.

The email ex­change even­tu­al­ly pe­ters out, but it does un­der­score that Clin­ton all along in­tend­ed to help dis­tin­guish her can­di­da­cy by crit­i­ciz­ing the phar­ma in­dus­try, a po­si­tion that fell more nat­u­ral­ly in­to her lap when Mar­tin Shkre­li was be­ing pil­lo­ried for rais­ing the price of an old gener­ic drug more than 5,000%.

(Shehla Shakoor con­tributed to this sto­ry.)

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Af­ter 4 years of furor, the FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. And this time they plan to squash it

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition.

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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UP­DAT­ED: Ac­celeron of­fers thumbs up on a PhII suc­cess for would-be block­buster drug — and shares rock­et up

There’s no public data yet, but Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

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Civi­ca and Blue Cross Blue Shield launch new ven­ture to low­er gener­ic prices

Five years after Martin Shkreli put a smug face to the volatile prices companies can charge even for generic drugs, payers and governments are coming up with outside-the-box solutions.

The latest fix is a new venture from the Blue Cross Blue Shield Association, 18 of its members and Civica, the generics company founded in 2018 by hospitals fed up with high prices for drugs that had long-since lost patent protection. While Civica focused on drugs that hospitals purchased, the new company will aim to lower prices on drugs that, like Shkreli’s Daraprim, are purchased by individuals.

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Merck Invests in State-Of-The-Art Biotech Development Facility in Switzerland

Mer­ck KGaA match­es lofty R&D goals with €250M in­vest­ment in­to a new clin­i­cal man­u­fac­tur­ing site in Switzer­land

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

Breast can­cer ap­proval in tow, As­traZeneca, Dai­ichi armed an­ti­body scores in key gas­tric can­cer study

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.

Sor­ren­to shrugs off an anony­mous pri­vate eq­ui­ty group’s $1B of­fer to buy the com­pa­ny

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.