Dems, Re­pub­li­cans split on 340B drug pric­ing pro­gram in Sen­ate hear­ing

The di­vid­ing line be­tween Sen­ate De­moc­rats and Re­pub­li­cans on the 340B drug pric­ing pro­gram was set on Thurs­day, with De­moc­rats sid­ing with the hos­pi­tals, say­ing the sav­ings from the pro­gram is des­per­ate­ly need­ed for the poor­est pop­u­la­tions, while Re­pub­li­cans took the side of drug­mak­ers, say­ing the pro­gram is be­ing abused and needs to be re­formed.

But the hear­ing al­so put the spot­light on the lack of trans­paren­cy from both the phar­ma­ceu­ti­cal and hos­pi­tal in­dus­tries, as nei­ther side could agree to some ba­sic sta­tis­tics, such as what per­cent of the to­tal drug spend in the US goes in­to the 340B pro­gram.

Lamar Alexan­der

For in­stance, the Health Re­sources & Ser­vices Ad­min­is­tra­tion, which over­sees the pro­gram, says that some­where be­tween 1% and 2% of the na­tion’s drug spend is at­trib­uted to the 340B pro­gram.

But Sen Lamar Alexan­der (R-TN) on Thurs­day ques­tioned what per­cent of what Amer­i­cans spend on pre­scrip­tion drugs is avail­able to safe­ty net hos­pi­tals and clin­ics for the pur­pos­es of 340B.

“Is it $6 bil­lion or $8 bil­lion or $14 bil­lion? If it’s 1 or 2%, well that’s just a tax on phar­ma­ceu­ti­cal com­pa­nies that we’re spend­ing for a good pur­pose, but if it’s 6% to 8%, then that’s a pret­ty big tax. I’d like to get those fig­ures,” Alexan­der said.

Lori Reil­ly

Lori Reil­ly, ex­ec­u­tive vice pres­i­dent of the lob­by­ing group PhRMA, told law­mak­ers that the to­tal spend on dis­counts by phar­ma­ceu­ti­cal com­pa­nies was $8 bil­lion in 2016, and that the to­tal 2016 spend on phar­ma­ceu­ti­cals in the US was “in the $390 bil­lion range,” though she could not con­firm an ex­act fig­ure to Alexan­der.

Sen Eliz­a­beth War­ren (D-MA), mean­while, said the size of the US drug mar­ket in 2015 was $457 bil­lion, while point­ing out that phar­ma­ceu­ti­cal com­pa­nies’ mar­gins were sig­nif­i­cant­ly high­er (she said six times as high) than hos­pi­tals’ mar­gins.

Eliz­a­beth War­ren

Pew Char­i­ta­ble Trusts, mean­while, re­cent­ly spot­light­ed the var­i­ous es­ti­mates and pro­jec­tions on drug spend­ing in the US, not­ing the dif­fer­ences among dif­fer­ent groups.

And though PhRMA’s Reil­ly said ear­li­er in the hear­ing that phar­ma­ceu­ti­cal com­pa­nies “do not want this pro­gram to dis­ap­pear,” War­ren took is­sue with PhRMA’s ar­gu­ment that the 340B rais­es drug prices.

“If 340B didn’t ex­ist, drug com­pa­nies would have an ex­tra $6 bil­lion in their pock­et, that’s less than 1% of glob­al phar­ma­ceu­ti­cal sales rev­enue,” War­ren said. “The loss that they’re kick­ing and scream­ing about is a tiny frac­tion of the many bil­lions of dol­lars they pull down every year in prof­its.”

Rep­re­sen­ta­tives of health cen­ters and hos­pi­tals, mean­while, not­ed that re­forms to low­er what drug­mak­ers spend on 340B dis­counts would hurt.

How­ev­er, re­form and more over­sight may still come.

study pub­lished in Health Af­fairs in 2014 found that 340B hos­pi­tals are ex­pand­ing their base in­to com­mu­ni­ties that tend to be af­flu­ent and well-in­sured, which runs counter to the ob­jec­tives of the pro­gram. The Al­liance for In­tegri­ty and Re­form of 340B, backed by the bio­phar­ma in­dus­try and oth­er groups, al­so re­leased a re­port that found in 2015, 61% of par­tic­i­pants spent less on char­i­ty care com­pared to both 2014 and 2013 de­spite ad­di­tion­al rev­enue re­ceived.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.

Pharma ads are showing up on cooler screens at retail pharmacies, including Walgreens and CVS, under a new OptimizeRx deal (OptimizeRx)

Phar­ma brands chill in the phar­ma­cy re­tail aisle with new style ads on re­frig­er­a­tion screens

Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.

OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.

The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.

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