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 clin­i­cal­tri­als.gov. 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.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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UP­DAT­ED: Am­gen tops cost watch­dog's price gougers list based on 'un­sup­port­ed' in­creas­es for En­brel with­out mean­ing­ful da­ta

In a top 10 ranking of the most egregious price gougers from 2019, Amgen’s Enbrel topped US cost watchdog ICER’s naughty list with “unsupported” markups that added as much as $403 million to the nation’s drug spend during that time.

Price increases for some of pharma’s most popular drugs have long been a focus of consumer ire, but the industry has argued those increases are routine and meant to cover the cost of R&D innovation. Without meaningful guidance at the state or federal level, ICER looked to connect how much a drug had progressed in the clinic compared with its increase in both wholesale and net price in 2019.

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Eli Lil­ly re-ups di­ver­si­ty pledge, pitch­ing in $30M to ven­ture fund for mi­nor­i­ty-owned health­care firms

The fight against racial injustice spurred by a series of high-profile shootings of Black men by police earlier this year put Big Pharma and healthcare — industries targeted for their lack of diversity — in the hot seat. Eli Lilly made an early pledge to change its ways and put more back into the community, and now it’s continuing to make good on that commitment.

Lilly will infuse $30 million into the Unseen Capital Health Fund, a venture fund looking to invest in early-stage minority-owned healthcare companies that have been historically “unseen” by the investment community, the pharma said Friday.

Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

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CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

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David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

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Nadim Ahmed (Bristol Myers Squibb)

Bris­tol My­er­s' top hema­tol­ogy ex­ec is on his way out — right on the heels of a $6B CVR im­plo­sion

Fourteen days after the $6.3 billion CVR tied to the approval of liso-cel went up in smoke, one of the top execs in charge of the work at Bristol Myers Squibb is preparing to step out of his job.

Mizuho analyst Salim Syed, who’s been following every twist and turn in the CVR saga, told investors on Thursday morning that Nadim Ahmed is on his way out. Syed’s note:

Recall, Ahmed is EVP and President of Hematology at BMY (i.e. JCAR017 and bb2121 are both hematological drugs). He’s still listed on the BMY management page. This is true — he’s still technically there. However, I have confirmed w/ BMY that his last day is tomorrow, Friday 1/15. To my best knowledge, Ahmed does not have another job lined up post his departure tomorrow.

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Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

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