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 fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

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It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

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We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

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Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.