Mallinck­rodt up­dates spin-off plans; FDA ex­pands Vray­lar ap­proval for Al­ler­gan; Ju­ve­nes­cence spawns Sou­vien Ther­a­peu­tics

→ 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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.