Donald Trump holds up a signed executive order in the South Court Auditorium in the White House complex on Friday, July 24, 2020 (AP Photo/Alex Brandon)

Trump looks to ham­mer down drug prices with 4 ex­ec­u­tive or­ders

Pres­i­dent Don­ald Trump signed 4 ex­ec­u­tive or­ders tar­get­ing the phar­ma­ceu­ti­cal in­dus­try Fri­day af­ter­noon, four months be­fore vot­ers head to the polls.

The pres­i­den­tial di­rec­tives are part of Trump’s long-stand­ing goal to re­duce pre­scrip­tion drug prices in the US. As the cal­en­dar turns to­ward No­vem­ber, the pres­i­dent has shift­ed to ex­ec­u­tive ac­tion over work­ing with Con­gress to reach this ob­jec­tive.

Whether or not such ac­tion will re­sult in any mean­ing­ful changes be­fore the elec­tion re­mains to be seen, as the phar­ma in­dus­try con­tin­ues to be a lob­by­ing force on Capi­tol Hill. The ex­ec­u­tive or­ders are al­so like­ly to be chal­lenged in court.

The most con­tro­ver­sial or­der re­port­ed­ly at­tempts to cap some prices Medicare pays to the price in for­eign coun­tries, which are usu­al­ly sig­nif­i­cant­ly low­er. The text wasn’t im­me­di­ate­ly avail­able.

These “most-fa­vored na­tions” claus­es are akin to price con­trols in phar­ma cir­cles, and Trump threat­ened drug com­pa­nies by im­pos­ing this or­der with­in a month if the com­pa­nies didn’t low­er prices on their own. How Trump can en­act the clause with­out Con­gress re­mains un­clear.

One of phar­ma’s most in­flu­en­tial lob­by­ist groups, PhRMA, un­sur­pris­ing­ly re­act­ed neg­a­tive­ly to the de­vel­op­ments. Here’s PhRMA pres­i­dent Stephen Ubl:

In his 2020 State of the Union Ad­dress, Pres­i­dent Trump de­clared that ‘we will nev­er let so­cial­ism de­stroy Amer­i­can health care.’

Yet, in the mid­dle of a glob­al pan­dem­ic, when near­ly 145,000 Amer­i­cans have lost their lives and mil­lions of oth­ers have suf­fered un­told eco­nom­ic hard­ships, this ad­min­is­tra­tion has de­cid­ed to pur­sue a rad­i­cal and dan­ger­ous pol­i­cy to set prices based on rates paid in coun­tries that he has la­beled as so­cial­ist, which will harm pa­tients to­day and in­to the fu­ture.

The re­search-based bio­phar­ma­ceu­ti­cal in­dus­try has been work­ing around the clock to de­vel­op ther­a­peu­tics and vac­cines to treat and pre­vent COVID-19. The ad­min­is­tra­tion’s pro­pos­al to­day is a reck­less dis­trac­tion that im­pedes our abil­i­ty to re­spond to the cur­rent pan­dem­ic – and those we could face in the fu­ture. It jeop­ar­dizes Amer­i­can lead­er­ship that re­wards risk-tak­ing and in­no­va­tion and threat­ens the hope of pa­tients who need bet­ter treat­ments and cures.

The pres­i­dent’s at­tempt to open our coun­try up to so­cial­ized health care sets Amer­i­ca, our eco­nom­ic re­cov­ery and sci­en­tif­ic progress back at a time when we need them most.

BIO’s chief Michelle Mc­Mur­ry-Heath al­so slammed the move, say­ing she was “dumb­found­ed that the Trump ad­min­is­tra­tion would seek to crip­ple the in­dus­try try­ing to end the COVID-19 pan­dem­ic.”

Dur­ing the press con­fer­ence Trump said top phar­ma ex­ec­u­tives will meet with ad­min­is­tra­tion of­fi­cials next week.

A sec­ond or­der is an ex­ten­sion of a plan in­tro­duced late last year that would al­low states, drug whole­salers and phar­ma­cies to re-im­port drugs from Cana­da at a low­er cost. Phar­ma lob­by­ists claim that such plans would not be able to guar­an­tee the safe­ty of the US drug sup­ply chain, a stance that has been met with skep­ti­cism, while Cana­da isn’t par­tic­u­lar­ly in­ter­est­ed in act­ing as a proxy be­tween drug com­pa­nies and states.

The oth­er two or­ders tar­get in­sulin pric­ing and the re­bates drug whole­salers and phar­ma­ceu­ti­cal ben­e­fit man­agers re­ceive when sell­ing to in­sur­ers.

The lob­by­ist group PC­MA has al­ready come out in op­po­si­tion to the lat­ter mea­sure, with pres­i­dent JC Scott say­ing in a state­ment, “This pol­i­cy does noth­ing to ad­dress drug prices, it on­ly serves to cre­ate un­cer­tain­ty and raise pre­mi­ums for se­niors while im­pos­ing near­ly $400 bil­lion in ad­di­tion­al tax­pay­er costs, all at a time when tax­pay­ers are al­ready foot­ing ad­di­tion­al costs to counter the pan­dem­ic and the na­tion­al debt is at record lev­els.”

Drug prices have been a pet is­sue for Trump, and the pres­i­dent re­port­ed­ly ex­pressed his frus­tra­tion with HHS sec­re­tary Alex Azar in Jan­u­ary say­ing the De­mo­c­ra­t­ic Par­ty will “kill us” on the is­sue. The COVID-19 pan­dem­ic has fur­ther com­pli­cat­ed the is­sue, as Trump’s ap­proval re­gard­ing how he’s han­dling the coro­n­avirus is deep in the red, and the White House has been fun­nel­ing cash in­to the in­dus­try to fu­el the re­search and de­vel­op­ment of po­ten­tial vac­cines.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.