Re­pub­li­cans un­veil a drug price bill to ri­val the De­moc­rats — promis­ing low­er prices and more cures

Nan­cy Pelosi un­veiled the De­moc­rats’  drug pric­ing bill back in Sep­tem­ber and brought the fight straight to the in­dus­try with a pro­pos­al to em­pow­er the US gov­ern­ment to ne­go­ti­ate prices for se­lect drugs. Re­pub­li­cans, who de­cried the bill reeks of heavy-hand­ed gov­ern­ment in­ter­ven­tion which will sti­fle in­no­va­tion, now have a coun­ter­pro­pos­al they claim will re­sult in cheap­er drugs and in­cen­tivize R&D — fur­ther cloud­ing the prospects of a bi­par­ti­san com­pro­mise that could land on Don­ald Trump’s desk.

“On­ly one of these bills has the po­ten­tial to be­come law. While Speak­er Pelosi’s par­ti­san plan is dead on ar­rival in the Sen­ate and won’t be signed by Pres­i­dent Trump, H.R. 19 could be on Pres­i­dent Trump’s desk to­day,” said Re­pub­li­can Whip Steve Scalise in a state­ment on Mon­day. And in an ac­knowl­edg­ment that the Re­pub­li­can ef­fort would need Pelosi’s sign-off to reach a vote — a high­ly un­like­ly event — Scalise con­tin­ued, “Speak­er Pelosi must come to her sens­es. I am call­ing on her to bring H.R. 19 to the House floor for a vote this week. Amer­i­cans need a bi­par­ti­san so­lu­tion to pre­scrip­tion drug prices, not an­oth­er doomed pro­pos­al from the De­moc­rats.”

Re­pub­li­cans and De­moc­rats both ar­gue drug prices in the Unit­ed States are too high — the in­dus­try holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self — but so far no­body can agree on just how to make the US health care sys­tem great again.

The 350-page Re­pub­li­can bill, HR19, pro­pos­es cre­at­ing the role of a ‘chief phar­ma­ceu­ti­cal ne­go­tia­tor’ at the Of­fice of the Unit­ed States Trade Rep­re­sen­ta­tive to ad­vo­cate on be­half of Amer­i­can pa­tients in trade agree­ments with re­spect to pre­scrip­tion drug prices.

In ad­di­tion, the bill seeks to lim­it an­nu­al out-of-pock­et costs for Medicare ben­e­fi­cia­ries at $3,100; caps the cost of in­sulin for se­niors in the Medicare Part D pro­gram; re­quires in­sur­ance com­pa­nies to make in­for­ma­tion about drug prices trans­par­ent at doc­tor’s of­fices so pa­tients are ap­prised of the po­ten­tial costs be­fore a pre­scrip­tion is writ­ten; and ‘stream­lines’ the reg­u­la­tion of over-the-counter prod­ucts.

Some of the pro­pos­als in HR19 al­so mir­ror poli­cies ad­vo­cat­ed by bi­par­ti­san leg­is­la­tion cur­rent­ly un­der con­sid­er­a­tion in the Sen­ate, in­clud­ing the CRE­ATES act which is de­signed to en­sure gener­ic drug­mak­ers can ac­cess brand­ed drugs to de­vel­op copy­cats, and pro­hibits “pay-for-de­lay” deals, where man­u­fac­tur­ers of brand­ed drugs main­tain their mo­nop­o­lies by of­fer­ing gener­ic com­pa­nies re­wards for de­lay­ing the launch of knock­off prod­ucts. 

The De­moc­rats’ drug pric­ing bill — HR 3, which is set to face a vote this week — could com­pel man­u­fac­tur­ers to com­ply with the prices set by the HHS, or face grave penal­ties and teth­ers the price of the some of the na­tion’s most ex­pen­sive drugs to an in­ter­na­tion­al price in­dex. Un­sur­pris­ing­ly, the bill — which promis­es to cut fed­er­al spend­ing by $345 bil­lion be­tween 2023 and 2029 — elicit­ed the ire of the in­dus­try that has so far thrived by tak­ing a lais­sez-faire ap­proach to pric­ing. Var­i­ous analy­ses have sug­gest­ed the bill, which is un­like­ly to be signed in­to law, could re­sult in be­tween 8 to 100 few­er drugs from reach­ing the mar­ket over the next decade.

A raft of Re­pub­li­can law­mak­ers is­sued state­ments sup­port­ing HR19 on Mon­day, sug­gest­ing not on­ly is HR19 su­pe­ri­or to HR3, but is far more like­ly to be signed in­to law.

“This (bill) con­tains mea­sures with bi­par­ti­san sup­port in the House and Sen­ate, can be­come law, and de­serves a vote. Mean­while, Speak­er Pelosi’s par­ti­san drug pric­ing scheme is not on­ly bad pol­i­cy, it’s nev­er go­ing to be­come law,” said the ar­chi­tects of HR19, Kevin Brady, the se­nior Re­pub­li­can on the pow­er­ful Ways and Means Com­mit­tee, along with Greg Walden (R-OR) and Vir­ginia Foxx (R-NC).

That may well be the case — the White House last week is­sued a scathing re­view of HR3, ac­cus­ing the Pelosi bill of fa­vor­ing short-term sav­ings over the “long-term cost of Amer­i­can pa­tients los­ing ac­cess to new life­sav­ing treat­ments.” But with De­moc­rats firm­ly in charge of the House of Rep­re­sen­ta­tives, HR19 faces a sim­i­lar­ly quixot­ic road to Trump’s desk, with ar­ti­cles of im­peach­ment threat­en­ing to over­shad­ow the po­lit­i­cal cal­en­dar.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Alex Karnal (Deerfield)

Deer­field vaults to the top of cell and gene ther­a­py CD­MO game with $1.1B fa­cil­i­ty at Philadel­phi­a's newest bio­phar­ma hub

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.