→ UK-based bio­phar­ma­ceu­ti­cal com­pa­ny Mallinck­rodt $MNK — the mak­er of the con­tro­ver­sial drug Ac­thar — has up­dat­ed its plans for its new spin-off com­pa­ny, first an­nounced last year. The new plan is to di­vide the com­pa­ny in­to two in­de­pen­dent pub­licly trad­ed com­pa­nies: one en­cap­su­lat­ing the spe­cial­ty gener­ics/ac­tive phar­ma­ceu­ti­cal in­gre­di­ents side of the busi­ness, while the oth­er will en­com­pass the spe­cial­ty brand­ed phar­ma­ceu­ti­cals busi­ness.

The spe­cial­ty gener­ics/API busi­ness will re­tain the Mallinck­rodt name, be list­ed on the NYSE and as­sume the MNK tick­er sym­bol, while the spe­cial­ty brands com­pa­ny will con­tin­ue to be list­ed on the NYSE, be re­named Sono­rant Ther­a­peu­tics, and adopt SRTX as its sym­bol.

The com­plet­ed spin-off is pro­ject­ed to oc­cur in the sec­ond half of 2019, and the com­pa­ny ex­pects up to $300 mil­lion in fresh debt to be raised.

→ The FDA has ex­pand­ed the use of Al­ler­gan’s $AGN Vray­lar to treat de­pres­sive episodes of bipo­lar I dis­or­der. Un­til now, Vray­lar is an ap­proved treat­ment in the US for schiz­o­phre­nia in adults and for man­ic or mixed episodes as­so­ci­at­ed with bipo­lar I dis­or­der. The drug gen­er­at­ed more than a 70% year-over-year sales jump in the first quar­ter. It is es­ti­mat­ed that near­ly 11 mil­lion adults in the US live with bipo­lar dis­or­der.

Lau­ra Sepp-Loren­zi­no Linkedin

→ Ju­ve­nes­cence’s new ven­ture Sou­vien Ther­a­peu­tics is cre­at­ing in­no­v­a­tive med­i­cines to ad­dress neu­rode­gen­er­a­tive dis­eases. Sou­vien was found­ed “on the pi­o­neer­ing re­search of pro­fes­sor Li-Huei Tsai, di­rec­tor of The Pi­cow­er In­sti­tute for Learn­ing and Mem­o­ry at MIT, and as­so­ciate pro­fes­sor Stephen Hag­gar­ty, the di­rec­tor of the chem­i­cal neu­ro­bi­ol­o­gy lab­o­ra­to­ry at Har­vard Med­ical School/Mass­a­chu­setts Gen­er­al Hos­pi­tal, on the epi­ge­net­ic un­der­pin­nings of neu­rode­gen­er­a­tion.”

Li-Huei Tsai Pi­cow­er In­sti­tute

“We have col­lect­ed a sub­stan­tial body of da­ta im­pli­cat­ing a crit­i­cal epi­ge­net­ic reg­u­la­tor of cel­lu­lar ag­ing in neu­rode­gen­er­a­tion” said Tsai in a state­ment.

Stephen Hag­gar­ty Hag­gar­ty Lab

CEO of Ju­ve­nes­cence, Greg Bai­ley, com­ment­ed: “De­men­tia and neu­rode­gen­er­a­tive con­di­tions are a tremen­dous bur­den on our health­care sys­tem and econ­o­my, and we are ex­cit­ed by the po­ten­tial for Sou­vien to have an im­pact on this un­met clin­i­cal need.”

→ CRISPR/Cas9 tech­nol­o­gy user In­tel­lia Ther­a­peu­tics $NT­LA wel­comed Lau­ra Sepp-Loren­zi­no as its new ex­ec­u­tive vice pres­i­dent and CSO. Sepp-Loren­zi­no joins the com­pa­ny af­ter a stint at Ver­tex Phar­ma­ceu­ti­cals $VRTX as vice pres­i­dent, head of nu­cle­ic acid ther­a­pies, re­search lead­er­ship and a mem­ber of the ex­ter­nal in­no­va­tion team. Pri­or to Ver­tex, Sepp-Loren­zi­no de­vel­oped and im­ple­ment­ed the he­pat­ic in­fec­tious dis­ease strat­e­gy at Al­ny­lam Phar­ma­ceu­ti­cals $AL­NY. Be­fore that, she spent 14 years at Mer­ck $MRK ad­vanc­ing RNAi as a nov­el ther­a­peu­tic modal­i­ty. 

→ It’s time for Ama­ran­tus Bio­science {$AMBS } to go the strate­gic al­ter­na­tives route. The pen­ny stock biotech has brought in Evo­lu­tion Ven­ture Part­ners to check out po­ten­tial busi­ness op­por­tu­ni­ties and strate­gic al­ter­na­tives in the hemp sec­tor. “The en­gage­ment is for a pe­ri­od of six months, dur­ing which time the com­pa­ny will con­tin­ue to ex­e­cute on its bio­phar­ma­ceu­ti­cal hold­ing com­pa­ny fi­nanc­ing and spin­off mod­el,” the com­pa­ny said.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.