With the FDA run­ning out of funds, health­care groups warn that the drug ap­proval process will soon be de­railed

The longest ever US gov­ern­ment shut­down has forced the FDA to fur­lough work­ers and hun­ker down around key tasks. But with cash run­ning out and their hands tied on gath­er­ing new fees, the agency is on the verge of see­ing its work on new drug ap­provals be­gin to grind to a halt. And a host of promi­nent health­care groups — in­clud­ing some well known sci­en­tif­ic or­ga­ni­za­tions — are warn­ing that the shut­down now threat­ens the na­tion’s ac­cess to cru­cial new ther­a­pies.

In a let­ter to Pres­i­dent Trump, Speak­er Nan­cy Pelosi and oth­er law­mak­ers on Tues­day, 46 ad­vo­ca­cy or­ga­ni­za­tions and pro­fes­sion­al so­ci­eties called for an end to the shut­down and asked that the FDA re­turn to full ca­pac­i­ty be­cause the health of Amer­i­cans is at stake.

“(W)e fear that this con­tin­ued shut­down not on­ly puts the cur­rent health and safe­ty of Amer­i­cans at risk, but has be­gun to put fu­ture sci­en­tif­ic dis­cov­ery and in­no­va­tion in jeop­ardy,” they wrote. “The on­go­ing gov­ern­ment shut­down forces the FDA to make dif­fi­cult choic­es re­gard­ing to which es­sen­tial func­tions its great­ly re­duced re­sources are di­rect­ed. These are de­ci­sions that nev­er should have to be made — the health and safe­ty of Amer­i­cans to­day should nev­er be weighed against the prospect of new life-sav­ing ther­a­pies for pa­tients…”

“While we ap­plaud Com­mis­sion­er Got­tlieb, FDA lead­er­ship, and ‘es­sen­tial staff’ for tru­ly hero­ic work to keep many as­pects of its mis­sion func­tion­ing, we fear that this con­tin­ued shut­down not on­ly puts the cur­rent health and safe­ty of Amer­i­cans at risk, but has be­gun to put fu­ture sci­en­tif­ic dis­cov­ery and in­no­va­tion in jeop­ardy.”

The group in­cludes AS­CO and the Na­tion­al Or­ga­ni­za­tion for Rare Dis­eases, which play a role in fo­cus­ing at­ten­tion on im­por­tant new sci­en­tif­ic de­vel­op­ments in their re­spec­tive fields.

Ex­perts sug­gest the FDA has rough­ly 2 to 3 months of fund­ing on the de­vice side. The drug side is less flush, with about a month of fund­ing left. Sub­mis­sions made pri­or to the shut­down on De­cem­ber 22 will be dealt with as usu­al, while sub­mis­sions made af­ter that date are placed in queue and will like­ly not be worked on un­til the shut­down is re­solved, ac­cord­ing to Jef­feries an­a­lysts, who added that if the shut­down con­tin­ues be­yond a month from now, the FDA will on­ly be able to fo­cus on es­sen­tial mat­ters such as food/prod­uct/man­u­fac­tur­ing safe­ty and pri­or­i­ty re­view.

Over the past few years, the FDA has grown in­creas­ing­ly pop­u­lar with bio­phar­ma com­pa­nies, which have en­joyed the most re­spon­sive agency they’ve ever known. The fo­cus un­der Scott Got­tlieb has been on ac­cel­er­at­ed ap­provals and rapid re­sponse to hur­ry along new drugs from es­tab­lished com­pa­nies. And all of that is be­ing jeop­ar­dized by the shut­down af­ter a pe­ri­od of climb­ing pro­duc­tiv­i­ty and record drug ap­provals.

If the shut­down con­tin­ues for the fore­see­able fu­ture, “the agency will have some al­go­rithm of how they go through the queue with drugs/agents with pri­or­i­ty re­view and/or oth­er high need tak­ing pri­or­i­ty…our es­ti­mate is a PDU­FA could get de­layed by per­haps the length of time from when funds dry up (next month) to when the gov­ern­ment is back open,” Jef­feries an­a­lysts said.

A sep­a­rate let­ter from more than 280 or­ga­ni­za­tions rep­re­sent­ing health, the en­vi­ron­ment, doc­tors and pa­tients al­so urged Pres­i­dent Trump last week to re­open the gov­ern­ment.

“Sev­er­al agen­cies’ abil­i­ty to pro­vide crit­i­cal ser­vices, rang­ing from food and en­vi­ron­men­tal risk in­spec­tions to health ser­vices, have al­ready been dras­ti­cal­ly re­duced or are threat­ened if the shut­down con­tin­ues. We fear a pro­longed shut­down will cause need­less suf­fer­ing and have long-last­ing health con­se­quences,” they wrote.

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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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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UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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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.

SQZ, Ery­tech kick off $57M cell ther­a­py part­ner­ship; Jean-Paul Kress lands new CEO gig at Mor­phoSys

→ In a mar­riage of two tech­nolo­gies meant to make cell ther­a­pies more pow­er­ful, SQZ Biotech is team­ing up with France’s Ery­tech Phar­ma for a col­lab­o­ra­tion, with $57 mil­lion re­served for the first project and $50 mil­lion for each sub­se­quent ap­proval (prod­uct or in­di­ca­tion). Hav­ing ac­cess to Ery­tech’s method of fash­ion­ing ther­a­peu­tics from red blood cells, the Cam­bridge, MA-based com­pa­ny said, will am­pli­fy SQZ’s cell en­gi­neer­ing ca­pa­bil­i­ties and al­low them to de­vleop a new class of im­munomod­u­la­to­ry ther­a­pies. Its own tech — so far ap­plied in can­cer but al­so has po­ten­tial in di­a­betes — tem­po­rary dis­rupts the cell mem­brane by squeez­ing the cell, thus cre­at­ing a brief win­dow for tar­get ma­te­ri­als such as anti­gens to en­ter.

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.

Tasly Bio­phar­ma pitch­es long-await­ed IPO — will it trig­ger an­oth­er $1B gold rush on HKEX?

In the run up to the Hong Kong stock ex­change’s an­tic­i­pat­ed rule change — open­ing the door for Chi­nese pre-rev­enue biotechs to go pub­lic clos­er to home — more than a year ago, Tasly Bio­phar­ma was one of the big play­ers whose ru­mored in­ter­est helped stoke en­thu­si­asm for the new list­ing venue. The com­pa­ny has since kept the drum­roll rum­bling in the back­ground, rais­ing a pre-IPO round and con­vinc­ing part­ner Trans­gene to swap own­er­ship in a joint ven­ture for eq­ui­ty. Now the oth­er shoe has fi­nal­ly dropped as ex­ecs out­line plans for a pipeline dom­i­nat­ed by car­dio­vas­cu­lar drugs.

With 4 more biotech IPOs due to wrap up Q2, how is the class of 2019 far­ing?

With 22 biotech IPOs on the books and four more set to price in the last week of June, in­vest­ment ad­vis­er Re­nais­sance Cap­i­tal has tak­en the pulse of the re­cent rush.

By the IPO ex­perts’ count, 25 out of 32 health­care of­fer­ings this year have been from biotechs — dif­fer­ing slight­ly from Brad Lon­car’s tal­ly — and the over­all pic­ture is one of un­der­per­for­mance. While they av­er­aged a first-day re­turn of 9.0%, col­lec­tive­ly they have trad­ed down to a 5.9% re­turn. Turn­ing Point $TP­TX and Cor­texyme $CRTX emerged on top at the half-year mark, ris­ing 135% and 109% re­spec­tive­ly.

Eye­ing a $500M peak sales pot, Almi­rall dou­bles down on le­brik­izum­ab as Der­mi­ra lines up PhI­II

With eyes on what it be­lieves is a $500 mil­lion peak rev­enue op­por­tu­ni­ty in Eu­rope, Barcelona-based Almi­rall has stepped up with $50 mil­lion in cash to take up the op­tion on Der­mi­ra’s IL-13 an­ti-in­flam­ma­to­ry drug le­brik­izum­ab just ahead of the start of Phase III. And there’s an­oth­er $30 mil­lion due as the late-stage pro­gram gets geared up.

That shouldn’t be long from now, as Der­mi­ra ex­pects to be­gin the late-stage tri­al work for atopic der­mati­tis be­fore the end of this year as it fol­lows a trail that ex­ecs in­sist leads to block­buster re­turns. Along the way, they’ll need to take on the 600-pound go­ril­la in atopic der­mati­tis: the IL-13/IL-4 drug Dupix­ent, from Re­gen­eron and Sanofi. Ri­vals al­so in­clude Leo Phar­ma, in its piv­otal with tralok­izum­ab, and Anap­tys­Bio in the hunt with a mid-stage pro­gram for etokimab, pre­vi­ous­ly re­ferred to as ANB020.