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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Xen­cor, UCLA to part­ner for new ther­a­peu­tic an­ti­bod­ies; Schrödinger ex­pands part­ner­ship with Google Cloud

Seeking to build on the 20 clinical-stage drug candidates already in its pipeline, California oncology and autoimmune disease-focused biotech Xencor announced on Thursday a partnership with nearby UCLA and the university’s Technology Development Group.

The two will collaborate to develop novel therapeutic antibodies, pairing novel targets proposed by scientists at UCLA with Xencor’s XmAb technology platforms that engineer monoclonal antibodies to create new protein structures. No financial terms of the agreement were disclosed, but any selected drug candidates resulting from the partnership will use a framework of “predefined terms to enter sponsored research agreements and potential license agreements,” the organizations said.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.