In a first for deuter­at­ed drugs, FDA (fi­nal­ly) OKs Te­va’s would-be Hunt­ing­ton’s block­buster Auste­do

Ten months af­ter the FDA put Te­va’s would-be block­buster deutetra­benazine on hold af­ter rais­ing some sus­pi­cions re­gard­ing cer­tain metabo­lites found in pa­tients, the FDA has giv­en the drug an OK for Hunt­ing­ton’s chorea.

Michael Hay­den, Te­va

This is a first FDA ap­proval in the world of deuter­at­ed drugs, which tweaks ther­a­pies so that they break down more slow­ly in pa­tients. That way you can use a low­er dose to greater ef­fect. In this case the drug is a small mol­e­cule in­hibitor of vesic­u­lar monoamine 2 trans­porter, or VMAT2, which is de­signed to reg­u­late the lev­els of dopamine in the brain.

The drug will be sold as Auste­do. Te­va shares $TE­VA surged 2.2% Mon­day evening.

A star-crossed Te­va paid $3.5 bil­lion to ac­quire Aus­pex for this drug two years ago, sup­pos­ed­ly set­ting up a slap shot at the first reg­u­la­to­ry OK. That ap­proval was very slow com­ing, but the pay­off has fi­nal­ly ar­rived.

The big draw­back in the ap­proval is that it came with a black box warn­ing on de­pres­sion and sui­ci­dal­i­ty. But­Te­va al­so wast­ed no time in tack­ling the mar­ket with an ag­gres­sive price point. Ja­son Ger­ber­ry at Leerink not­ed:

While physi­cians will titrate Auste­do, the av­er­age dosage is ex­pect­ed to be 24mg per day which TE­VA priced at $60,000 for a year of ther­a­py and is be­low the list price of (Valeant’s) brand Xe­nazine ($152K) and gener­ic tetra­benazine ($96K). We view tonight’s up­date as a pos­i­tive, elim­i­nat­ing any lin­ger­ing con­cerns around deep­er is­sues with the CRL (com­plete re­sponse let­ter) that de­layed Auste­do ap­proval. We cur­rent­ly fore­cast $850m in 2023E Auste­do sales.

Sev­er­al new drugs have now been re­leased with dis­count pric­ing, un­der­scor­ing a new, harsh­er en­vi­ron­ment on high drug prices.

Te­va has al­so been push­ing this drug along for tar­dive dysk­i­ne­sia, though its mixed batch of late-stage da­ta spurred some an­a­lysts to sing the prais­es of a com­pet­ing drug from Neu­ro­crine. Eval­u­atePhar­ma has tagged this drug as a po­ten­tial block­buster, with a shot at earn­ing slight­ly more than a bil­lion dol­lars a year — though that kind of cash won’t come eas­i­ly.

Still, the FDA ap­proval marks a big win for Te­va, which has been un­der the gun for years now. Cur­rent­ly be­ing re­struc­tured, the CEO de­part­ed re­cent­ly as Te­va’s gener­ic busi­ness is as­sault­ed by low­er prices and its brand­ed di­vi­sion en­dured a lengthy drought in R&D.

The ap­proval al­so marks a big plus for Con­cert Phar­ma­ceu­ti­cals $CNCE, which has been la­bor­ing at deuter­at­ing drugs with the heavy hy­dro­gen for years now.

Hunt­ing­ton’s, a lethal neu­rode­gen­er­a­tive dis­ease, is char­ac­ter­ized by harsh, repet­i­tive twist­ing and writhing as­so­ci­at­ed with chorea.

“Chorea is a ma­jor symp­tom for many liv­ing with Hunt­ing­ton dis­ease. It im­pacts pa­tients’ func­tion­al­i­ty and ac­tiv­i­ties of dai­ly liv­ing, and there have been lim­it­ed treat­ment op­tions for these pa­tients,” said Michael Hay­den, the CSO at Te­va. “Based on the re­sults demon­strat­ed in the clin­i­cal de­vel­op­ment pro­gram which sup­port­ed the ap­proval of AUSTE­DO and our on­go­ing com­mit­ment to pa­tients, we feel unique­ly po­si­tioned to bring this treat­ment op­tion for­ward.”

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.

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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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

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.

Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

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.

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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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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