Fac­ing a deep­en­ing po­lit­i­cal cri­sis, PhRMA launch­es a ma­jor coun­ter­at­tack against its le­gion of crit­ics

Un­der the most heat­ed po­lit­i­cal at­tack the drug in­dus­try has ever faced on Capi­tol Hill, the lob­by­ing pow­er­house PhRMA is rolling out its most am­bi­tious pub­lic re­la­tions cam­paign in its his­to­ry.

Just months af­ter rais­ing dues to gen­er­ate an ex­tra $100 mil­lion for its war chest, PhRMA is re­port­ed­ly spend­ing tens of mil­lions of dol­lars on a new cam­paign aimed to win hearts and minds in the grow­ing bat­tle over drug prices. PhRMA’s cam­paign will ini­tial­ly hit hard on the sci­en­tif­ic ad­vances that are be­ing made, spot­light­ing big ad­vances in R&D to the gen­er­al pub­lic. And then they want to spon­sor more dis­cus­sions in pub­lic fo­rums while pur­su­ing their leg­isla­tive agen­da.

The cam­paign has been in the works for months now. But it comes just days af­ter Pres­i­dent Don­ald Trump went on a tirade against the in­dus­try, say­ing that drug mak­ers had been “get­ting away with mur­der” on pric­ing and vow­ing to rein in costs. Lat­er, Trump ex­plained that he planned to al­low Medicare to di­rect­ly ne­go­ti­ate drug prices for the first time, putting Big Phar­ma on no­tice that it would soon lose one of its most prized po­lit­i­cal ac­com­plish­ments.

Hillary Clin­ton had more crit­i­cisms for phar­ma dur­ing the pres­i­den­tial cam­paign, but Trump has made up on any lost ground, adopt­ing what is like­ly to be a wide­ly pop­u­lar stance on drug prices.

The most ex­plo­sive el­e­ment in drug prices, and the most po­tent po­lit­i­cal­ly, has fo­cused on com­pa­nies like Tur­ing, My­lan, Valeant and Mallinck­rodt, which all jacked the price on old meds, un­fet­tered by any laws or reg­u­la­tions that might pro­hib­it price goug­ing. But there has al­so been con­sid­er­able crit­i­cism of the in­dus­try’s wide­spread prac­tice of push­ing an­nu­al price hikes on their port­fo­lio drugs. And the price of many new drugs of­ten reach well in­to six fig­ures, adding to the gen­er­al dis­con­tent that could spawn leg­is­la­tion that would have a wide in­flu­ence on all bio­phar­ma com­pa­nies.

PhRMA CEO Stephen Ubl touched on the up­com­ing cam­paign at a pan­el dis­cus­sion I host­ed at JP Mor­gan a few weeks ago. He said:

At PhRMA and with­in the in­dus­try, we’re fo­cused on two things. First, we’re go­ing to launch a very am­bi­tious, com­pre­hen­sive, na­tion­al com­mu­ni­ca­tions and pub­lic af­fairs ef­fort. One com­po­nent will be ad­ver­tise­ments that are fo­cused on the ex­cit­ing break­throughs in sci­ence that we’ve not been, again, re­port­ing on in my view. But more im­por­tant­ly, it’s not just about ads. The ef­fort is go­ing to be putting the in­dus­try in a lead­er­ship role and con­ven­ing stake­hold­ers to talk about how we move the sys­tem from vol­ume to val­ue and what our role in that is. We need to come to the ta­ble with so­lu­tions, whether they’re FDA re­forms, bar­ri­ers to in­no­v­a­tive con­tract­ing, con­sumer-ori­ent­ed trans­paren­cy.

One of the ma­jor themes in this cam­paign is ex­pect­ed to be the ex­tra­or­di­nary cost in­volved in drug de­vel­op­ment as cheap gener­ics con­tin­ue to lim­it the amount of mon­ey spent on drugs in gen­er­al. Pfiz­er has tak­en that stance al­ready. But even with a high lev­el of bi­par­ti­san sup­port in Con­gress, ev­i­dent in the re­cent pas­sage of the 21st Cen­tu­ry Cures Act, PhRMA and phar­ma face a big and grow­ing deficit of pub­lic trust.

This new cam­paign is like­ly to elic­it com­par­isons to the “Har­ry and Louise” cam­paign that the health in­sur­ance lob­by used to help beat back threat­en­ing leg­is­la­tion. But it will come at many times the cost of that $20 mil­lion ef­fort.

Drug prices may ac­tu­al­ly on­ly ac­count for a frac­tion of the health­care dol­lar, but there’s no ques­tion it’s a high-pro­file item for the pub­lic. A few days ago The Har­ris Poll found that on­ly 9% of Amer­i­cans be­lieve that drug com­pa­nies put pa­tients ahead of prof­its.

That’s a dan­ger­ous­ly weak po­si­tion to be in.

“There are un­de­ni­able rep­u­ta­tion­al risks for phar­ma­ceu­ti­cal and health in­sur­ance com­pa­nies – more so than oth­er parts of the health care ecosys­tem,” said Wendy Sa­lomon, vice pres­i­dent of rep­u­ta­tion man­age­ment and pub­lic af­fairs at Nielsen. “Rep­u­ta­tion mat­ters to pa­tients, care providers, in­vestors, em­ploy­ees, and po­ten­tial hires. Pos­i­tive rep­u­ta­tions can pave the way in times of cri­sis, in times of tran­si­tion – and when it’s crit­i­cal to have a seat at the pol­i­cy-set­ting ta­ble.”


Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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FDA ap­proves the third NMOSD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

Martin Shkreli (Shutterstock)

Mar­tin Shkre­li con­tin­ued to or­ches­trate an­ti-com­pet­i­tive schemes for Dara­prim be­hind bars — FTC

Martin Shkreli didn’t just blog, read up on drug development news and run his biotech business with a contraband cell phone in prison. According to the FTC, he was also coordinating the anticompetitive scheme to shield Daraprim — the drug at the center of a price-gouging controversy that earned him the “Pharma Bro” nickname — from generic rivals.

Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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