That turn­around on new FDA drug ap­provals? We’re right on sched­ule

We were due for a pret­ty good year on new drug ap­provals from the FDA, and so far the agency and the in­dus­try have been per­form­ing on sched­ule.

Last year at this time the FDA had record­ed just 7 new drug OKs on the way to a mis­er­able 22 new drug ap­provals for 2016. In a num­ber of cas­es the ane­mic rate of ap­provals was fed by tem­po­rary re­ver­sals based on man­u­fac­tur­ing sna­fus, a con­di­tion still acute­ly felt at As­traZeneca, which just had its sec­ond re­jec­tion on ZS-9.

This year, a lit­tle more than a quar­ter in­to the year, we have 14 new drug ap­provals, in­clud­ing the re­cent green light for Neu­ro­crine’s In­grez­za. The full list in­cludes the ques­tion­able and con­tro­ver­sial or­phan drug ap­proval of the steroid de­flaza­cort for Duchenne mus­cu­lar dy­s­tro­phy, now owned by PTC Ther­a­peu­tics. But it al­so in­cludes some like­ly block­busters, most no­tably Ocre­vus from Roche and Dupix­ent from the cross-com­pa­ny team at Re­gen­eron and Sanofi.

Most an­a­lysts were ex­pect­ing a sig­nif­i­cant­ly bet­ter year in 2017 com­pared to 2016. New drug ap­provals rose at a fast clip in the pre­vi­ous few years, jump­ing to 45 in 2015 and trig­ger­ing some buoy­ant ex­pec­ta­tions that the in­dus­try had turned the cor­ner on a bleak pe­ri­od of scant prod­uct re­leas­es.

The ques­tion now is whether new ap­provals can get close to that 2015 num­ber. RAPS count­ed the sched­uled PDU­FA dead­lines and came up with 20, af­ter you deduct the new­ly spurned baric­i­tinib, which may hold back the ex­pect­ed bot­tom line. They all won’t make it to the mar­ket.

The ju­ry is still out on that, but this year’s ear­ly crop of new prod­ucts bodes well for the rest of 2017.

1 tru­lance ple­ca­natide Syn­er­gy
2 parsabiv etel­cal­ce­tide Kai Phar­ma
3 em­flaza de­flaza­cort Marathon*
4 siliq bro­dalum­ab Valeant
5 xer­me­lo telotri­s­tat eth­yl Lex­i­con
6 kisqali ri­bo­ci­clib No­var­tis
7 xada­go sa­fi­namide Newron
8 baven­cio avelum­ab EMD Serono
9 sym­proic naldeme­dine Sh­iono­gi
10 ze­ju­la ni­ra­parib Tesaro
11 dupix­ent dupilum­ab Re­gen­eron/Sanofi
12 ocre­vus ocre­lizum­ab Genen­tech
13 auste­do deutetra­benazine Te­va
14 in­grez­za val­be­nazine Neu­ro­crine

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

Alexis Borisy (file photo)

EQRx and Ex­sci­en­tia, a pair of self-styled dis­rup­tors, team up to over­turn the drug pric­ing ap­ple cart

The biotech industry has seen no shortage of innovation in recent years, but in one area — drug pricing — the field has been anything but innovative. Now, two brash startups taking different roads to upset the drug pricing model will partner up to create a sort of “super-disruptor.”

EQRx and UK-based AI specialist Exscientia will team up on a discovery-through-commercialization collaboration the partners hope will work better than the sum of its parts to bring cheaper medicines to patients faster, the companies said Thursday.