While gene ther­a­py com­pa­nies re­joice as the sec­tor gains trac­tion with ap­provals and a flur­ry of M&A ac­tiv­i­ty, one play­er is feel­ing the heat.

Back in 2015, Voy­ager Ther­a­peu­tics joined forces with Sanofi Gen­zyme in a deal worth up to $845 mil­lion ($100 mil­lion up­front + a po­ten­tial $745 mil­lion in mile­stones) to co-de­vel­op gene ther­a­pies for se­vere cen­tral ner­vous sys­tem dis­or­ders. But two years lat­er, the French drug­mak­er re­treat­ed, elect­ing to not pick up the op­tion to work on Voy­ager’s Parkin­son’s dis­ease pro­gram. (Last year, the FDA dis­ap­point­ed Voy­ager, telling the com­pa­ny that it was not open to an ac­cel­er­at­ed fil­ing on the Parkin­son’s drug on the ba­sis of Phase II da­ta — in­stead re­quir­ing an ad­di­tion­al piv­otal study.)

Sanofi Gen­zyme’s re­treat now re­sem­bles a de­ser­tion.

On Mon­day, Voy­ager $VY­GR said Sanofi Gen­zyme is walk­ing away from op­tions to ac­quire US co-com­mer­cial­iza­tion rights and ex-US de­vel­op­ment and com­mer­cial­iza­tion rights to ex­per­i­men­tal Hunt­ing­ton’s dis­ease drug VY-HTT01 and to Friedre­ich’s atax­ia pro­gram VY-FXN01; and a fu­ture Voy­ager CNS or­phan pro­gram. In ad­di­tion, Voy­ager and Sanofi Gen­zyme’s al­liance on SMA has al­so been ter­mi­nat­ed —  the in­tel­lec­tu­al prop­er­ty rights of the pro­gram are be­ing re­turned/ex­clu­sive­ly li­censed to Sanofi Gen­zyme.

Con­se­quent­ly, Voy­ager has agreed to give $10 mil­lion up­front to Sanofi Gen­zyme, and an ad­di­tion­al $10 mil­lion mile­stone pay­ment up­on the po­ten­tial fil­ing of an ap­pli­ca­tion to test in hu­mans the Hunt­ing­ton’s dis­ease drug, VY-HTT01 or, cer­tain back­up com­pounds, as well as po­ten­tial roy­al­ties. In ad­di­tion, Voy­ager is al­so of­fer­ing Sanofi Gen­zyme ex­clu­sive dibs to se­lect AAV cap­sids from its ar­se­nal of drugs in de­vel­op­ment in up to two non-CNS in­di­ca­tions.

Re­cent­ly, Voy­ager has been busy shop­ping for oth­er part­ners. It has inked deals with Ab­b­Vie and Neu­ro­crine this year.

On Mon­day, Voy­ager trans­ferred the ex-US rights to the Sanofi-aban­doned Friedre­ich’s atax­ia pro­gram to Neu­ro­crine. The com­pa­ny al­so sig­naled that it plans to part­ner out its ALS gene ther­a­py, VY-SOD102, (and no longer plans to file an IND for it this year), to fo­cus its re­sources on Hunt­ing­ton’s.

“While it is un­clear ex­act­ly who might be look­ing to in-li­cense this pro­gram, Bio­gen might serve as an in­ter­est­ing can­di­date giv­en their ex­ist­ing work on SOD1 with their an­ti­sense oligonu­cleotide (ASO), tofersen, and close prox­im­i­ty giv­en both com­pa­nies are based in Cam­bridge. How­ev­er, if Bio­gen were to do this deal it might al­so be an ear­ly sig­nal to in­vestors that they view gene ther­a­py as strong al­ter­na­tive to their ASO port­fo­lio, po­ten­tial­ly ac­cept­ing that Zol­gens­ma is go­ing to be a strong com­peti­tor in SMA,” Baird’s Bri­an Sko­r­ney wrote in a note.

So­cial im­age: Shut­ter­stock

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

More than two years into the Covid-19 pandemic, we’re not done seeing its disruption of biotech.

That’s according to Caladrius execs, who cited the pandemic as one reason for suspending its Phase IIb trial of a cell therapy as a treatment for coronary microvascular dysfunction (CMD). The company plans to go ahead on an interim analysis before deciding what to do with the program, which was built on a licensing deal with Shire in 2018.

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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.