With an FDA de­ci­sion loom­ing, Flex­ion touts new da­ta spot­light­ing a safe­ty edge for os­teoarthri­tis drug

Now that Flex­ion $FLXN is less than four months away from an FDA de­ci­sion on its new os­teoarthri­tis drug Zil­ret­ta (FX006), the biotech has float­ed some new da­ta from a tiny mid-stage study that it’s hop­ing will find its way in­to the la­bel.

The Burling­ton, MA-based group turned up at the ADA meet­ing in San Diego over the week­end to say that it now has da­ta to prove that its drug is not as­so­ci­at­ed with the same spikes in blood glu­cose that di­a­bet­ics com­mon­ly ex­pe­ri­ence when they get a steroid shot in an aching joint. And they’re look­ing to use it to gain a leg up in a siz­able mar­ket.

Steroid shots are well known for push­ing up blood glu­cose in­to the dan­ger zone, how­ev­er briefly, so it was to be ex­pect­ed that re­searchers could chart a dis­tinc­tive break be­tween Flex­ion’s drug and the in­jec­tions known to de­liv­er fast and cheap re­lief to pa­tients who suf­fer from os­teoarthri­tis.

Re­searchers on­ly re­cruit­ed 33 pa­tients for this, find­ing that Zil­ret­ta had sig­nif­i­cant­ly less im­pact on blood glu­cose lev­els (14.7 mg/dL) com­pared with steroids (33.9 mg/dL).

Mike Clay­man

“You don’t have to be a sci­en­tist to see there is a dif­fer­ence,” says Flex­ion CEO Michael Clay­man, point­ing to their chart track­ing the im­pact of steroid shots vers­es their late-stage ther­a­py. “The full study re­port was filed with the NDA. We pro­pose ref­er­ence to these da­ta in Zil­ret­ta not be­ing as­so­ci­at­ed with a spike in glu­cose.”

The pa­tient groups are tiny in this study, but the mar­ket num­bers Clay­man has in mind are huge. More than 4 mil­lion peo­ple suf­fer­ing from os­teoarthri­tis get these steroid shots, he adds, and 20% of them have di­a­betes — about 800,000 pa­tients. Hav­ing some da­ta that il­lus­trates the dif­fer­en­ti­a­tion in the blood glu­cose pro­file, — where hy­per­glycemia, even quick­ly flushed away as it is with steroids, is to be avoid­ed wher­ev­er pos­si­ble —could help per­suade vig­i­lant pay­ers to opt for a much more ex­pen­sive brand­ed ther­a­py.

Flex­ion has been fo­cused more and more on their Oc­to­ber PDU­FA date for Zil­ret­ta. The biotech’s been steadi­ly build­ing out a com­mer­cial op­er­a­tion, Clay­man tells me, lin­ing up job of­fers for 80 to 100 sales reps as they keep their fin­gers crossed that the FDA will come through with an ap­proval.

Close to three months ago, Fier­cePhar­ma re­port­ed that Sanofi was an­gling for a Flex­ion buy­out, look­ing to bag a drug now un­der re­view. The con­nec­tion made sense, con­sid­er­ing Sanofi’s work in di­a­betes and a big need to beef up the port­fo­lio of drugs. But so far, noth­ing has hap­pened on that front and Flex­ion raised more cash re­cent­ly, sell­ing shares in a move that cast doubt on the prospects of a deal.

I asked Clay­man about the re­port, which I fol­lowed up on, but he on­ly told me the same thing he’s told every­one else who has asked: The com­pa­ny doesn’t com­ment on mar­ket ru­mors.

Com­pa­ny ex­ecs, though, are hap­py to dis­cuss its prospects for crack­ing a big mar­ket, with its stock trad­ing be­low where it was ahead of the buy­out buzz. And that’s where we will leave it — for to­day.

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.