Slammed by a tri­al hold, Intar­cia ter­mi­nates stud­ies and ax­es staff in wake of an FDA re­jec­tion

Intar­cia’s trou­bled late-stage ef­forts to rev­o­lu­tion­ize the way di­a­betes is treat­ed has run in­to a fresh round of set­backs.

The Boston-based biotech — a pri­vate com­pa­ny once val­ued at $3.5 bil­lion — con­firmed to End­points News late Fri­day night that the com­pa­ny has cut 60 staffers and been hit by a clin­i­cal hold from the FDA.

Kurt Graves

Those set­backs come four months af­ter the FDA re­ject­ed Intar­cia’s im­plant­ed di­a­betes drug/de­vice, which is de­signed to de­liv­er sta­ble dos­es of ex­e­natide with twice-year­ly tune-ups. Intar­cia CEO Kurt Graves has long cham­pi­oned the de­vice as a cer­tain block­buster, earn­ing ku­dos and $600 mil­lion in Se­ries EE in­vest­ment cap­i­tal along the way.

The Boston Busi­ness Jour­nal first re­port­ed the lay­offs and the clin­i­cal hold. A com­pa­ny spokesper­son tells End­points:

As Intar­cia Ther­a­peu­tics, Inc. works to­wards re­sub­mis­sion and the ul­ti­mate goal of ap­proval for IT­CA 650, a holis­tic as­sess­ment of the or­ga­ni­za­tion was con­duct­ed and the de­ci­sion was made to re­struc­ture and re­shape the com­pa­ny to fo­cus on our crit­i­cal pri­or­i­ties. The re­struc­tur­ing and re­shap­ing in­volves rough­ly 60 po­si­tions that were re­duced across var­i­ous func­tions, how­ev­er, it al­so in­volves on­go­ing hir­ing in key ar­eas of the com­pa­ny that sup­port our 2018 pri­or­i­ties.  The net/net head­count changes are ex­pect­ed to be rel­a­tive­ly neu­tral over the course of the year.

Sep­a­rate­ly, the clin­i­cal hold was put in place for on­go­ing mar­ket­ing stud­ies and it is not re­lat­ed to the piv­otal tri­als da­ta in our NDA ap­pli­ca­tion.  The clin­i­cal hold was im­ple­ment­ed to al­low for an in­ves­ti­ga­tion of a 3rd par­ty lab re­sult, not pre­vi­ous­ly ob­served, dur­ing rou­tine long-term mon­i­tor­ing of IT­CA 650 prod­uct batch­es.  The in­ves­ti­ga­tion was re­cent­ly com­plet­ed and we plan to up­date the FDA to ad­dress the clin­i­cal hold around the time of our planned re­sub­mis­sion this year.

Bio­Cen­tu­ry re­port­ed Fri­day night that Intar­cia ter­mi­nat­ed two late-stage stud­ies ear­li­er in the week, not­ing that the ter­mi­na­tions were record­ed on clin­i­cal­tri­ Both those ter­mi­na­tions were record­ed as a “de­ci­sion by spon­sor.” The news ser­vice re­port­ed:

The ter­mi­nat­ed Phase II­Ib tri­al com­pared IT­CA 650 to em­pagliflozin or glimepiri­de as an add-on ther­a­py to met­formin in pa­tients with Type II di­a­betes. The sec­ond tri­al was a Phase III sub-study eval­u­at­ing IT­CA 650 in Type II di­a­bet­ic pa­tients with high base­line HbA1c.

The com­pa­ny spokesper­son had this to add:

For clar­i­ty on Bio­cen­tu­ry, the clin­i­cal hold im­pact­ed the two tri­als not­ed and did not re­late to the piv­otal tri­als in the NDA ap­pli­ca­tion.  The tri­als were be­ing done for com­mer­cial pur­pos­es and are not re­quired for the NDA re­view.

Holds and prod­uct re­jec­tions are not ac­knowl­edged or ex­plained by the FDA, which keeps most of its in­ter­ac­tions with com­pa­nies se­cret.

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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Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

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.

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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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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