President Donald Trump speaks at a Nov. 20 news conference in the briefing room at the White House (Susan Walsh/AP)

With on­ly weeks left in his pres­i­den­cy, Trump makes a fi­nal, long-shot bid to re­make US drug pric­ing

As the cur­tain clos­es on his ad­min­is­tra­tion, Pres­i­dent Don­ald Trump is us­ing his fi­nal weeks in of­fice to push one of his longest-run­ning cam­paign promis­es of low­er­ing pre­scrip­tion drug prices.

Trump an­nounced in a brief Fri­day news con­fer­ence that he would be in­sti­tut­ing the “most fa­vored na­tions” rule ty­ing prices in the US to those in oth­er de­vel­oped coun­tries, as well as end­ing cer­tain re­bates paid to mid­dle­men, al­so known as phar­ma­cy ben­e­fit man­agers, in Medicare. The two rules were part of a se­ries of four ex­ec­u­tive or­ders Trump un­veiled in Ju­ly aimed at tack­ling high pre­scrip­tion costs.

The rule will be­gin to take ef­fect on Jan. 1, Trump said, and is slat­ed to run for the next sev­en years. In the mean­time, Trump said he would al­low state gov­er­nors to pur­chase drugs from Cana­da at low­er prices, though he of­fered no de­tails about how this would take place.

It’s not im­me­di­ate­ly clear how Pres­i­dent-elect Joe Biden’s in­com­ing ad­min­is­tra­tion would han­dle the rule. Biden has said pre­vi­ous­ly that he would con­sid­er es­tab­lish­ing an in­de­pen­dent re­view board to as­sess the val­ues of med­i­cines, ac­cord­ing to Politi­co. Law­suits chal­leng­ing the new rules are like­ly forth­com­ing, fur­ther com­pli­cat­ing their im­ple­men­ta­tion. Trump is al­so con­test­ing the elec­tion re­sults, though in­de­pen­dent ob­servers don’t give him any kind of a re­al chance at suc­ceed­ing.

PhRMA, one of the in­dus­try’s top lob­by­ist groups, ex­pressed its dis­plea­sure with the moves in a state­ment Fri­day af­ter­noon. Pres­i­dent Stephen Ubl said, in part:

It de­fies log­ic that the ad­min­is­tra­tion is blind­ly pro­ceed­ing with a “most fa­vored na­tion” pol­i­cy that gives for­eign gov­ern­ments the up­per hand in de­cid­ing the val­ue of med­i­cines in the Unit­ed States. His­to­ry proves that when gov­ern­ments take uni­lat­er­al ac­tion to set prices, it dis­rupts pa­tient ac­cess to treat­ments, dis­cour­ages in­vest­ment in new med­i­cines and threat­ens jobs and eco­nom­ic growth.

In its cur­rent form, the most fa­vored na­tions rule would ap­ply to 50 cost­ly Medicare Part B med­i­cines, which are ad­min­is­tered in doc­tors’ of­fices, such as ex­pen­sive can­cer and rheuma­toid arthri­tis ther­a­pies. The ad­min­is­tra­tion plans to phase in the low­est price in oth­er coun­tries and “blend” it with the av­er­age sales price, and then add a flat amount per dose for each ap­plic­a­ble drug.

Phar­ma com­pa­nies have staunch­ly op­posed en­act­ing the most fa­vored na­tions clause, and it was a source of much con­tention when Trump ini­tial­ly un­veiled the pro­pos­al four months ago. There were scant de­tails at the time and PhRMA sub­mit­ted a coun­ter­pro­pos­al in Au­gust that would have cut Part B prices by 10%, com­pared to the 30% the White House sought.

The White House re­leased the full text of the ex­ec­u­tive or­der in Sep­tem­ber, di­rect­ing HHS Sec­re­tary Alex Azar to es­tab­lish the clause for both Medicare Part B and Part D, which cov­ers pre­scrip­tion drugs. Ul­ti­mate­ly, a pric­ing deal re­port­ed­ly fell through be­tween the gov­ern­ment and the in­dus­try af­ter White House Chief of Staff Mark Mead­ows asked the com­pa­nies to send a $100 “cash card” to se­niors be­fore No­vem­ber and pin the blame for failed ne­go­ti­a­tions on phar­ma com­pa­nies.

Trump al­so an­nounced Fri­day that he would be end­ing the un­ap­proved drugs ini­tia­tive, in which the FDA re­moves un­ap­proved drugs from the mar­ket for safe­ty rea­sons, al­leg­ing they cre­at­ed sev­er­al price goug­ing op­por­tu­ni­ties for com­pa­nies look­ing to ex­tend their mar­ket ex­clu­siv­i­ty win­dows. Since 2006, the FDA has re­port­ed­ly shelved rough­ly 3,400 med­i­cines and has on­ly 11 left to re­view as part of the pro­gram, per Politi­co.

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.