As Trump fin­gers phar­ma on drug prices, ex­ecs step up with the lat­est vows of self dis­ci­pline

Ab­b­Vie’s Richard Gon­za­lez

Just as Don­ald Trump was rip­ping the lid off a can of whup-ass and pour­ing it all over the bio­phar­ma in­dus­try, Ab­b­Vie’s chief was step­ping up to fol­low Al­ler­gan CEO Brent Saun­ders’ lead on cap­ping an­nu­al drug price in­creas­es.

In a talk at the J.P. Mor­gan con­fer­ence, Ab­b­Vie CEO Richard Gon­za­lez pledged to keep the com­pa­ny’s an­nu­al price hikes on its drug port­fo­lio to sin­gle dig­its, in line with Saun­ders promise to keep Al­ler­gan’s in­creas­es to sin­gle dig­its. And No­vo Nordisk has al­ready fol­lowed up with its com­mit­ment to do the same, mark­ing a ma­jor shift in the way the in­dus­try han­dles drug prices af­ter years of swift spikes.

“There’s a strong de­bate go­ing on right now about pric­ing,” Gon­za­lez told in­vestors, ac­cord­ing to a re­port in Reuters. “We need to make sure we are op­er­at­ing in an ap­pro­pri­ate way … and demon­strat­ing the val­ue of the prod­ucts that we have.”

What Gon­za­lez ev­i­dent­ly wasn’t aware of was that Trump veered in­to the drug pric­ing is­sue dur­ing his press con­fer­ence on Wednes­day, vow­ing to ham­mer drug prices down through a fed­er­al bid­ding process af­ter the in­dus­try had been  “get­ting away with mur­der.”

Joaquin Du­a­to (Pho­to: End­points News)

Drug prices, and what the in­dus­try is go­ing to do about the grow­ing pres­sure to con­trol costs, was at the cen­ter of a dis­cus­sion End­points News host­ed Tues­day morn­ing at J.P. Mor­gan in San Fran­cis­co. We start­ed with J&J’s Joaquin Du­a­to, who promised to re­veal an­nu­al price in­creas­es to help demon­strate the com­pa­ny’s dis­ci­pline.

But the glob­al phar­ma gi­ant is not go­ing to break down the price hikes on a drug-by-drug ba­sis, he added in re­sponse to a ques­tion, so they can main­tain a com­pet­i­tive edge.

“It’s go­ing to be done on an ag­gre­gate lev­el,” Du­a­to told the crowd. Spe­cif­ic prices are “some­thing that we do not want to dis­close be­cause of the com­pet­i­tive im­pli­ca­tions. The same way that we are talk­ing about dis­counts and re­bates, we are go­ing to dis­close them at an ag­gre­gate lev­el, be­cause dis­clos­ing dis­counts and re­bates by chan­nel does have a com­pet­i­tive im­pli­ca­tion too.”

Richard Pops, Brent Saun­ders (Pho­to: End­points News)

Whether or not that will be enough to dis­pel a grow­ing na­tion­al con­tro­ver­sy won’t be known for some time. But Trump’s re­marks un­der­scored that it’s a new day in bio­phar­ma when it comes to drug prices. And Richard Pops, the CEO of Alk­er­mes, not­ed that change is com­ing af­ter Big Phar­ma got hooked on the crack co­caine of ex­ten­sive price hikes for years.

For me it’s so in­ter­est­ing be­cause un­bur­dened with any ex­pe­ri­ence of hav­ing run a phar­ma­ceu­ti­cal com­pa­ny I come to it al­most like a Mar­t­ian from Mars com­ing to say, “How does this whole thing work?” It’s so bizarre be­cause, I must ad­mit, I don’t think any of us re­al­ized how fre­quent­ly phar­ma­ceu­ti­cal com­pa­nies were in­deed rais­ing prices over the last decade or so. How ex­ten­sive the price in­creas­es were, and in the set­ting of an in­vestor con­fer­ence, you re­al­ize just what crack co­caine that is when you cou­ple unit growth of a launch­ing med­i­cine with se­mi-an­nu­al price in­creas­es. You just get ex­plo­sive earn­ings growth, which is ex­act­ly what the mar­ket wants.

For Saun­ders, the in­dus­try is head­ed in the right di­rec­tion, but peo­ple should pay more at­ten­tion to net rather than gross price hikes.

Ten days in­to the year, you’re right, a lot of com­pa­nies are fig­ur­ing out that they need to be more thought­ful and cau­tious about price in­creas­es, which is a good thing….The re­al num­ber is the net. I mean, we could talk about the gross all day, and we’re hap­py to de­bate that, but the net…is prob­a­bly some­where be­tween one and 4%, de­pend­ing on what their re­bate and dis­count lev­els are. You know, I think com­pa­nies are act­ing more re­spon­si­bly than ever, and I think that’s a good thing.

We’ll have the full pan­el dis­cus­sion for you next week here at End­points.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

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