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.”

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.