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

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

The EU is reportedly working toward a centralized procurement deal for smallpox vaccines to tackle the rising number of cases of monkeypox, according to sources who spoke to the Financial Times.

Andrea Ammon, director of Europe’s CDC, told the FT that the European Commission is “definitely looking at what can be done centrally” and central procurement is “one of the options that are looked at but of course countries are also” looking into bilateral avenues.

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.