Trump tweets a new vow to spur com­pe­ti­tion in the phar­ma biz, slash­ing prices

Pres­i­dent Trump has a re­minder for the bio­phar­ma in­dus­try to­day: He hasn’t for­got­ten you or the con­tro­ver­sy over drug prices.

This lat­est tweet from the pres­i­dent of the Unit­ed States un­der­scores Trump’s re­peat­ed in­sis­tence that the fed­er­al gov­ern­ment can ratch­et down health­care prices by fos­ter­ing com­pe­ti­tion.

Trump proved that he can still send a jolt through in­dus­try shares. Both the IBB and XBI dropped more than a point on the tweet, then start­ed re­cov­er­ing some­what. The pres­i­dent’s so­cial me­dia pro­nounce­ments don’t have the same bite as we saw in the days af­ter his in­au­gu­ra­tion.

This lat­est tweet is al­so long on promise and short on de­tails. And it’s the de­tails — like Trump’s pick for FDA com­mis­sion­er — which peo­ple in the in­dus­try want to see now.

Trump’s brand of change may come through a re­formed FDA, where he’s in­sist­ed that dereg­u­la­tion can make a big dif­fer­ence in re­duc­ing the amount of time and mon­ey spent on drug de­vel­op­ment. Or Medicare could be re­jigged to al­low for price ne­go­ti­a­tions which have been barred by law.

Or all that and more could be in­clud­ed.

I’ve found many ex­ecs in bio­phar­ma be­lieve that the drug in­dus­try is plen­ty com­pet­i­tive as it stands. Al­so, there’s been lit­tle ev­i­dence that faster de­vel­op­ment will re­duce the cost of new drugs.

Umer Raf­fat at Ever­core ISI had this to say:

Ques­tion re­al­ly is:  what does that mean?  Re­call that Pres­i­dent Trump has pre­vi­ous­ly made ref­er­ences to “bid­ding”.

There are 2 types of com­pe­ti­tion:

1.   Brand vs gener­ic – this al­ready ex­ists (and in fact, mar­ket forces dri­ve gener­ics to have very fierce pric­ing wars)

2.   Brand vs brand – for this to hap­pen, you need in­ter­change­able brand­ed prod­ucts … e.g., just be­cause 2 drugs are ap­proved for same in­di­ca­tion doesn’t make them di­rect “com­pe­ti­tion”

o   For true “com­pe­ti­tion” among brands, you need:

§  Mul­ti­ple drugs in same class

§  Same in­di­ca­tion

§  Same route of ad­min­is­tra­tion

§  Sim­i­lar ef­fi­ca­cy

§  Sim­i­lar safe­ty

o   Some ther­a­peu­tic ar­eas have this … but not all

Most im­por­tant­ly, many ther­a­peu­tic ar­eas with gen­er­al­ly in­ter­change­able brand­ed prod­ucts are al­ready un­der Part D … and have for­mu­la­ry tiers etc. 

And that’s the ul­ti­mate ques­tion:  is the Pres­i­dent re­fer­ring more to Part B (where no for­mu­la­ries ex­ist cur­rent­ly)?  Re­al­i­ty is, we just don’t know un­til some­thing de­fin­i­tive is put out

Mean­while, phar­ma may have some ne­go­ti­at­ing lever­age with the Trump ad­min­is­tra­tion be­cause of the abil­i­ty to pitch a job-cre­ation plan … e.g., look at this tweet (al­so from to­day):

One sug­ges­tion from Jim O’Neill, a for­mer HHS of­fi­cial un­der Bush who is ev­i­dent­ly un­der con­sid­er­a­tion as the new head of the FDA, could have an im­pact on pric­ing. He has said in the past that drugs proven to be “safe” should be put on the mar­ket so that peo­ple can find out for them­selves how ef­fec­tive it may be.

A slew of new drugs hur­ried out un­der those stan­dards could start com­pet­ing with es­tab­lished drugs — we just won’t know if they’re worth any­thing at all.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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