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.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Top an­a­lyst of­fers a rare, up­beat in­ter­pre­ta­tion of Ab­b­Vie’s $63B Al­ler­gan deal — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took at 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Suf­fer­ing No­var­tis part­ner Cona­tus grabs the ax and packs it in on NASH af­ter a se­ries of set­backs

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.