New year, new (high­er) drug prices

Surg­ing drug prices in the Unit­ed States are a thorny yet key bi­par­ti­san is­sue as an­oth­er pres­i­den­tial elec­tion beck­ons. While US Pres­i­dent Trump strug­gles to make good on his promise to low­er drug prices, the in­dus­try, which has long thrived in its lais­sez-faire ecosys­tem, has per­sis­tent­ly ar­gued that gov­ern­ment in­ter­ven­tion will sti­fle in­no­va­tion. And now, as the new year kicks off, a cadre of drug­mak­ers has qui­et­ly in­flat­ed prices on more than 250 drugs, ac­cord­ing to a Reuters re­port.

From Gilead to Pfiz­er, big phar­ma has clicked up­grade on their stick­er prices — large­ly by the mid-sin­gle-dig­it per­cent­age in­creas­es. As the spot­light on drug pric­ing in­ten­si­fied, with pa­tients, pol­i­cy­mak­ers, and politi­cians de­cry­ing the mag­ni­tude and fre­quen­cy of hikes, a raft of drug­mak­ers pre­vi­ous­ly pledged to not raise their prices by more than 10% an­nu­al­ly.

British drug­mak­er GSK is set to raise US prices on more than 30 drugs in the range of 1% and 5%, Reuters re­port­ed, cit­ing da­ta from health­care re­search firm 3 Ax­is Ad­vi­sors.

Among the Pfiz­er hikes, there are no­table in­creas­es on a trio of block­busters — the can­cer drug Ibrance, the blood-thin­ner Eliquis and the vac­cine Pre­vnar. The US drug­mak­er has lift­ed its prices by 5%, 6%, and 7.3% re­spec­tive­ly in the Unit­ed States. The com­pa­ny in­tends to boost US prices on around 27% of its port­fo­lio by an av­er­age of 5.6%, the wire ser­vice re­port­ed.

Ever­core ISI’s Umer Raf­fat of­fered a snap­shot of Pfiz­er’s hikes, among oth­er key drug­mak­ers, in re­cent years in a note pub­lished on Wednes­day.

Source: Ever­core ISI, 2020

Click on the im­age to see the full-sized ver­sion

Bris­tol-My­ers, which swal­lowed Cel­gene in a $74 bil­lion deal last year, al­so in­creased the prices of 10 drugs on Wednes­day, in­clud­ing a 1.5% hike on its im­munother­a­pies Op­di­vo and Yer­voy. Cel­gene’s cash cow Revlim­id was giv­en a 6% raise, Reuters re­port­ed, adding that the com­pa­ny has promised not to is­sue hikes high­er than 6% this year.

Source: Ever­core ISI, 2020

Click on the im­age to see the full-sized ver­sion

Gilead, Bio­gen, Lil­ly, and Te­va al­so took a range of hikes on some key drugs — all up to and equal to 6%.

Source: Ever­core ISI, 2020

Click on the im­age to see the full-sized ver­sion

Source: Ever­core ISI, 2020

Click on the im­age to see the full-sized ver­sion

Source: Ever­core ISI, 2020

Click on the im­age to see the full-sized ver­sion

Source: Ever­core ISI, 2020

Click on the im­age to see the full-sized ver­sion

Am­gen, Mer­ck and the prices of some oth­er key drugs from drug­mak­ers al­ready fea­tured above are ex­pect­ed in the com­ing days and months, Raf­fat not­ed.

Law­mak­ers left, right and cen­ter all ar­gue drug prices in the Unit­ed States are too high — and 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. Last month, the HHS opened the door to a pol­i­cy that al­lows for the im­por­ta­tion of drugs from Cana­da.

The De­moc­rats’ drug pric­ing bill — HR 3, un­veiled by Speak­er Nan­cy Pelosi in Sep­tem­ber — was re­cent­ly passed by the House and could com­pel man­u­fac­tur­ers to com­ply with the prices set by the HHS, or face an ex­cise tax of up to 95% of sales, which in turn could trig­ger fi­nan­cial loss­es due to drug sales. The Sen­ate, with a Re­pub­li­can ma­jor­i­ty, is un­like­ly to en­dorse it.

The GOP has cooked up its own leg­is­la­tion. The 350-page bill, HR19, pro­pos­es cre­at­ing the role of a ‘chief phar­ma­ceu­ti­cal ne­go­tia­tor’ to ad­vo­cate on be­half of Amer­i­can pa­tients in trade agree­ments with re­spect to pre­scrip­tion drug prices. In ad­di­tion, the bill al­so seeks to lim­it an­nu­al out-of-pock­et costs for Medicare ben­e­fi­cia­ries; re­quires in­sur­ance com­pa­nies to make in­for­ma­tion about drug prices trans­par­ent at doc­tor’s of­fices; and ‘stream­lines’ the reg­u­la­tion of over-the-counter prod­ucts.

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.

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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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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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Mer­ck KGaA spin­out gets first fund­ing to bring dual-act­ing can­cer mol­e­cules in­to the clin­ic

Two and a half years after launch, Merck KGaA spinout iOnctura is getting its first major round of funding.

The oncology startup raised €15 million ($16.6 million) to put its lead drug into the clinic and get its second drug past IND-enabling tests. INKEF Capital and VI Partners co-led the round and were joined by the biotech’s longtime backer M Ventures, an arm of Merck KGaA, and Schroder Adveq.

Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.