As­traZeneca hands off epilep­sy pro­grams to Ovid; Amy­lyx scores pri­or­i­ty re­view for ALS drug 

Still re­cov­er­ing from a set­back in its lead pro­gram, Ovid Ther­a­peu­tics has turned to As­traZeneca for a suite of ex­per­i­men­tal epilep­sy drugs.

Ovid is pay­ing the Big Phar­ma part­ner $5 mil­lion in cash and $7.5 mil­lion in stock to ac­cess a li­brary of ear­ly-stage small mol­e­cules tar­get­ing the KCC2 trans­porter, in­clud­ing lead can­di­date OV350. As­traZeneca stands to re­ceive mile­stones adding up to more than $200 mil­lion and re­tains an op­tion for a strate­gic col­lab­o­ra­tion.

The epilep­sy fran­chise did rel­a­tive­ly well in a year full of bad news for Ovid, as Take­da bought back rights to soti­cle­stat, a cho­les­terol 24-hy­drox­y­lase in­hibitor in Phase III tri­als for Dravet and Lennox Gas­taut syn­dromes.

Oth­er than OV350, Ovid al­so got its hands on OV329, a new ver­sion of pre­ga­balin for tuber­ous scle­ro­sis and in­fan­tile spasms, which is ex­pect­ed to en­ter the clin­ic in 2022.

“The KCC2 trans­porter is an ex­cit­ing and nov­el tar­get that we be­lieve holds great promise in treat­ing epilep­sies,” CEO Je­re­my Levin said in a state­ment. “The com­pounds are a nat­ur­al fit for our fran­chise ded­i­cat­ed to small mol­e­cule epilep­sy med­i­cines, and they fol­low our track record of suc­cess­ful part­ner­ing with large phar­ma­ceu­ti­cal com­pa­nies.”

As­traZeneca had worked with Stephen Moss and Jamie Maguire at the Tufts Lab­o­ra­to­ry for Ba­sic and Trans­la­tion­al Neu­ro­science Re­search to de­vel­op these com­pounds. Ovid said it will con­tin­ue col­lab­o­rat­ing with them. — Am­ber Tong

Amy­lyx scores pri­or­i­ty re­view for ALS drug 

Af­ter years of fu­tile ef­forts, the FDA is ready to make a de­ci­sion on a po­ten­tial new amy­otroph­ic lat­er­al scle­ro­sis drug in six months — but not be­fore con­ven­ing an ad­vi­so­ry com­mit­tee.

Amy­lyx an­nounced over the hol­i­day that its on­ly drug, AMX0035, has been grant­ed pri­or­i­ty re­view and as­signed a PDU­FA date of June 29, 2022. But the FDA not­ed it’s plan­ning to hold an ad­comm to dis­cuss the NDA.

Ex­perts will like­ly be dis­sect­ing da­ta from the Phase II CEN­TAUR tri­al, where ALS pa­tients demon­strat­ed sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in clin­i­cal de­cline.

While reg­u­la­tors had asked last year for a Phase III study to con­firm those ben­e­fits, they lat­er re­versed course, flash­ing the green light for Amy­lyx to file di­rect­ly for ap­proval amid an up­roar in the ALS com­mu­ni­ty over what they saw as dou­ble stan­dards in the wake of the con­tro­ver­sial Aduhelm ap­proval. — Am­ber Tong

Eli Cas­din-backed DNA se­quenc­ing play­er tacks $35M more on­to Se­ries C

DNA Script has tacked on an­oth­er bun­dle of cash, of­fi­cial­ly clos­ing its Se­ries C.

The South San Fran­cis­co-based com­pa­ny com­plet­ed the round’s sec­ond tranche of $35 mil­lion, it an­nounced Tues­day, adding to the $165 mil­lion raised in the Se­ries C last Oc­to­ber. New funds come from T. Rowe Price As­so­ci­ates, Bail­lie Gif­ford, Health­cor Man­age­ment, eu­reKARE and Irv­ing In­vestors.

Al­so backed by Eli Cas­din, DNA Script is look­ing to make a mark on the DNA se­quenc­ing field by cut­ting down on ex­pen­sive and messy byprod­ucts as­so­ci­at­ed with ear­li­er ver­sions of se­quenc­ing tech­nol­o­gy. The com­pa­ny, found­ed in 2014, is gear­ing up for its first prod­uct launch this year, a bench­top DNA print­er us­ing a plat­form known as SYN­TAX.

The com­pa­ny hopes to even­tu­al­ly de­liv­er ther­a­peu­tics for per­son­al­ized and pre­ci­sion med­i­cine.

“SYN­TAX is the first step to­ward cre­at­ing a new par­a­digm for DNA and RNA syn­the­sis,” CEO Thomas Ybert said in a state­ment. “With the sup­port of our in­vestors, we look for­ward to con­tin­u­ing to ad­vance this new par­a­digm to solve some of our largest chal­lenges and ad­vance hu­man health.” — Max Gel­man

Af­ter al­most a year, the FDA lifts clin­i­cal tri­al hold on Spero’s lung dis­ease can­di­date

Spero Ther­a­peu­tics got a breath of fresh air from the FDA — the agency lift­ed its hold on Spero’s planned Phase II tri­al for SPR720, a drug can­di­date for non­tu­ber­cu­lous my­cobac­te­r­i­al dis­ease, a bac­te­r­i­al in­fec­tion in the lungs.

The Phase IIa tri­al was of­fi­cial­ly put on hold back in Feb­ru­ary last year af­ter Spero no­ti­fied reg­u­la­tors of its de­ci­sion to pause dos­ing.

Sci­en­tists had un­cov­ered “mor­tal­i­ties with in­con­clu­sive causal­i­ty” in a tox­i­col­o­gy study in­volv­ing non-hu­man pri­mates, and a Safe­ty Re­view Board rec­om­mend­ed that Spero hit the brakes on the drug, which it had ac­quired from Ver­tex. Spero’s stock $SPRO went down more than 20% to $4.04 af­ter the news broke.

Spero said ear­li­er to­day that it plans to meet with the FDA by the end of the quar­ter to dis­cuss restart­ing the tri­al, and hope to have it run­ning by next quar­ter.

CEO Ankit Ma­hade­via ex­pressed op­ti­mism, say­ing in a pre­pared state­ment “We are very pleased with the FDA’s de­ci­sion and ea­ger to bring SPR720 back in­to the clin­ic.” — Paul Schloess­er 

Boast­ing ‘com­pre­hen­sive cov­er­age of breast can­cer,’ Chi­na’s Xu­anzhu nabs $96M

As the tune of the in­no­v­a­tive drug busi­ness gets loud­er in Chi­na’s phar­ma in­dus­try, a biotech spun out of a 20-year-old play­er has bagged $96 mil­lion in Se­ries B cash.

Xu­anzhu Bio­pharm plans to de­ploy the cash on de­vel­op­ing its sprawl­ing pipeline, which has more than 25 pro­grams, in­clud­ing two in the NDA stage: anapra­zole sodi­um for duo­de­nal ul­cer, and an SGLT-2 in­hibitor for di­a­betes.

Re­tain­ing close ties to its par­ent com­pa­ny Si­huan Phar­ma­ceu­ti­cal Hold­ings Group, Xu­anzhu says it’s fo­cus­ing on the R&D of “new fron­tier drugs” in ar­eas like on­col­o­gy, di­a­betes, NASH, an­ti-in­fec­tion and di­ges­tion dis­or­ders.

Specif­i­cal­ly, Xu­anzhu said its 400 staffers main­ly tar­get breast can­cer, lung can­cer and oth­er sol­id tu­mors — mak­ing it “one of the com­pa­nies with the most com­pre­hen­sive cov­er­age of breast can­cer do­mes­ti­cal­ly.”

Oth­er on­col­o­gy drugs in de­vel­op­ment in­clude a next-gen­er­a­tion CDK4/6 in­hibitor and an ALK/ROS1 dual-tar­get in­hibitor.

“(W)e will grad­u­al­ly ex­pand the com­pre­hen­sive strength en­com­pass­ing over­seas col­lab­o­ra­tion, in­dus­tri­al­iza­tion and com­mer­cial­iza­tion, and cre­ate a nov­el, in­no­v­a­tive pipeline and port­fo­lio that is dif­fer­en­ti­at­ed and sus­tain­able,” CEO Yan­jun Xu said in a state­ment. — Am­ber Tong

No­var­tis keeps gener­ic chal­lenger out of Gilenya’s way 

Thanks to a new court rul­ing, No­var­tis can now guar­an­tee that it can con­tin­ue sell­ing its mul­ti­ple scle­ro­sis drug Gilenya with­out any gener­ic com­pe­ti­tion in the US at least for the next two years.

The Swiss phar­ma gi­ant an­nounced that the US Court of Ap­peals has up­held a patent cov­er­ing a dos­ing reg­i­men of Gilenya, mean­ing a per­ma­nent in­junc­tion against the gener­ic mak­er HEC Phar­ma will re­main in place un­til that patent ex­pires in De­cem­ber 2027.

Hav­ing reached set­tle­ment agree­ments with a num­ber of ab­bre­vi­at­ed new drug ap­pli­ca­tion fil­ers, pre­clud­ing them from launch­ing copy­cat ver­sions of Gilenya, No­var­tis said HEC Phar­ma was the on­ly re­main­ing AN­DA fil­er chal­leng­ing the patent.

The po­ten­tial gener­ic en­try date and oth­er terms, it added, are con­fi­den­tial. — Am­ber Tong

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

Sanofi re­news so­cial cam­paign to re­mind that vac­cines let peo­ple ‘Dream Big’

Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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