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.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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