To tack­le su­per­bug scourge and re­vive R&D, in­cen­tivize FDA an­tibi­ot­ic ap­provals — drug­mak­ers, health groups urge US law­mak­ers

As su­per­bugs flour­ish, the in­dus­try play­ers con­tribut­ing to the ar­se­nal of an­timi­cro­bials are dwin­dling. Drug­mak­ers are en­ticed by green­er pas­tures, com­pared to the long ar­du­ous path to an­tibi­ot­ic ap­proval that of­fers lit­tle fi­nan­cial gain as treat­ments must be priced cheap­ly, and of­ten lose po­ten­cy over time as mi­crobes grow re­sis­tant to them. For one of the biggest threats to glob­al health, the li­on’s share of an­tibi­ot­ic de­vel­op­ment is tak­ing place in a hand­ful of labs of small bio­phar­ma com­pa­nies as their larg­er coun­ter­parts fo­cus on more lu­cra­tive en­deav­ors. Ex­ist­ing in­cen­tives to en­tice an­tibi­ot­ic R&D are too fee­ble to fix this bro­ken sys­tem, a group of drug­mak­ers, pub­lic health or­ga­ni­za­tions and doc­tors said in a let­ter to US law­mak­ers on Tues­day, urg­ing Sen­a­tors to take a fresh ap­proach to stim­u­late an­timi­cro­bial drug de­vel­op­ment by en­act­ing pol­i­cy mea­sures to in­crease the val­ue of a mar­ket­ed an­tibi­ot­ic.

Be­yond the in­cen­tives al­ready in place to push drug­mak­ers to de­vel­op an­tibi­otics, the group urged the pas­sage of “pull in­cen­tives,” or pol­i­cy mea­sures to in­crease the val­ue of a mar­ket­ed an­tibi­ot­ic by re­ward­ing drug­mak­ers on­ly af­ter their an­tibi­ot­ic is ap­proved by the FDA.

The group rep­re­sent­ed in the let­ter in­clude both big drug­mak­ers (GSK, Mer­ck, Pfiz­er) and small (Achao­gen, Melin­ta, Paratek, Tetraphase) as well as or­ga­ni­za­tions such as the An­timi­cro­bial In­no­va­tion Al­liance An­timi­cro­bials Work­ing Group, In­fec­tious Dis­eases So­ci­ety of Amer­i­ca and The Pew Char­i­ta­ble Trusts.

Oth­er law­mak­ers have voiced sim­i­lar con­cerns and pro­posed al­ter­na­tive ways to rein­vig­o­rate an­tibi­ot­ic R&D. Last month, a UK gov­ern­ment re­port out­lined a plan to de-cou­ple price from de­mand and shift to a more val­ue-based ap­proach that would com­pel in­sti­tu­tions to pay fees based on their need for new an­tibi­otics, akin to a li­cens­ing ap­proach that FDA com­mis­sion­er Scott Got­tlieb sug­gest­ed in re­cent months.

“(The) fu­ture of an­tibi­ot­ic de­vel­op­ment is grim…Few ma­jor phar­ma­ceu­ti­cal com­pa­nies re­main en­gaged in an­tibi­ot­ic dis­cov­ery and de­vel­op­ment, and small biotech firms, even those that have launched or are close to launch­ing prod­ucts, strug­gle to sus­tain a vi­able com­mer­cial en­ter­prise,” the group wrote, not­ing that of the cur­rent drugs in de­vel­op­ment, on­ly 11 have the po­ten­tial to ad­dress the most crit­i­cal Gram-neg­a­tive pathogens on the WHO’s pri­or­i­ty list of an­tibi­ot­ic-re­sis­tant mi­crobes.

Mean­while, there are over 1,000 can­cer drugs in de­vel­op­ment.

Each year in the Unit­ed States at least 2 mil­lion peo­ple con­tract an an­tibi­ot­ic-re­sis­tant in­fec­tion, and at least 23,000 peo­ple die, ac­cord­ing to the CDC.

The mass ex­o­dus of large play­ers, in­clud­ing Al­ler­gan, Sanofi and As­traZeneca is now im­pact­ing small­er drug­mak­ers. His­tor­i­cal­ly, small com­pa­nies would shep­herd an­tibi­otics through the ear­ly stages of de­vel­op­ment, and then seek a part­ner with deep pock­ets to help cross the fin­ish line — but with a pauci­ty of Big Phar­ma in the field, small­er play­ers are strug­gling, they wrote.

Achao­gen and Melin­ta, col­lec­tive­ly re­spon­si­ble for five re­cent­ly-mar­ket­ed an­tibi­otics, have both an­nounced the clos­ing of their an­tibi­ot­ic re­search and clin­i­cal de­vel­op­ment pro­grams. Sev­er­al oth­er small com­pa­nies with re­cent­ly ap­proved prod­ucts are in jeop­ardy of shut­ter­ing their op­er­a­tions en­tire­ly in 2019. Many of these com­pa­nies re­ceived sig­nif­i­cant fund­ing to sup­port their R&D pro­grams from U.S. Gov­ern­ment fun­ders…If they fail, it is like­ly to prompt the de­par­ture of what lit­tle pri­vate in­vest­ment re­mains in the an­timi­cro­bial space, with dis­as­trous con­se­quences for the al­ready in­ad­e­quate pipeline.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.