US sells Wu-Tang Clan al­bum to cov­er Shkre­li debt; Or­biMed backs GSK vet­s' Chi­nese start­up

Mar­tin Shkre­li be­came a top tar­get for ridicule and anger in the mid-2010s when he and his biotech Tur­ing Phar­ma­ceu­ti­cals raised the price of a life-sav­ing med­i­cine from $13.50 to $750 per pill. But he al­so gained no­to­ri­ety around that time for pur­chas­ing a one-of-a-kind al­bum from rap group the Wu-Tang Clan at auc­tion for about $2 mil­lion.

Now, the al­bum is on the move again.

The De­part­ment of Jus­tice an­nounced Tues­day it has sold the al­bum, “Once Up­on a Time in Shaolin,” to an undis­closed buy­er to help cov­er Shkre­li’s $7.36 mil­lion debt when he was con­vict­ed for de­fraud­ing in­vestors in 2017. The sale of the al­bum ac­count­ed for the re­main­der of Shkre­li’s bal­ance, the de­part­ment said in a news re­lease.

Pros­e­cu­tors had seized the al­bum back in 2018 and the new buy­er is a group of peo­ple, rather than an in­di­vid­ual, per a New York Times re­port. The iden­ti­ties of the pur­chasers re­main undis­closed, as does the sale price.

The al­bum was per­ceived as akin to a fine art piece as the pur­chas­ing agree­ment from the orig­i­nal auc­tion con­tained sev­er­al re­stric­tions, in­clud­ing bar­ring the own­er from re­leas­ing any of the songs com­mer­cial­ly for 88 years. On­ly one copy of the al­bum was made, and the new own­ers are bound to the same re­stric­tions.

A lawyer for the group, Pe­ter Scoolidge, lis­tened to the al­bum as part of the sale arrange­ment, per the NYT, say­ing, “It’s a banger, man. It’s a banger.”

The move to sell the al­bum came the same day that DoJ seized a tablet bear­ing part of the epic of Gil­gamesh, one of the world’s old­est sur­viv­ing pieces of lit­er­a­ture. Known as the Gil­gamesh Dream Tablet, it was for­feit­ed by the own­ers of re­tail chain Hob­by Lob­by, who were ac­cused of smug­gling more than 5,500 ar­ti­facts out of Iraq to dis­play at their Mu­se­um of the Bible. Hob­by Lob­by paid a $3 mil­lion fine in 2018 in the scan­dal. — Max Gel­man

Or­biMed backs GSK vets’ take on brain-pen­e­trant breast can­cer drugs

Three years af­ter launch­ing Zion Phar­ma with a unique take on small mol­e­cule can­cer drugs, a pair of Glax­o­SmithK­line vets have bagged their sec­ond round.

Jack Cheng and Ding Zhou, who had both worked at GSK’s Shang­hai hub, had cen­tered the pitch around their deep grasp of drug me­tab­o­lism and phar­ma­co­ki­net­ics, or DMPK. Where­as Zhou spent close to two decades as a chem­istry lead at the British phar­ma, Cheng held a stint as head of DMPK at As­traZeneca be­fore re­unit­ing with his for­mer col­league.

Or­biMed led the $40 mil­lion Se­ries B, which is de­signed to fu­el a hir­ing dri­ve on top of R&D.

Stay­ing on a straight and nar­row path, Zion’s lead can­di­date is a breast can­cer drug that can get in­to the brain, in hopes of treat­ing the metas­tases that af­fect be­tween 30% to 50% of new­ly di­ag­nosed pa­tients. Cur­rent treat­ments like surgery or ra­di­a­tion have too many side ef­fects and don’t help pa­tients live too much longer, ac­cord­ing to the com­pa­ny.

“De­sign­ing chem­i­cal en­ti­ties that can pass through the blood-brain bar­ri­er and the abil­i­ty to pre­dict and as­sess the en­ti­ties’ DMPK at­trib­ut­es are core to the Zion team’s com­pet­i­tive­ness,” Or­biMed part­ner Da­song Wang said in a state­ment. “Zion’s breast can­cer pro­gram for brain metas­tases showed PK, tox­i­col­o­gy and ef­fi­ca­cy re­sults in Phase I that aligned very well with pre­clin­i­cal pre­dic­tions.”

Ex­ist­ing in­vestors at Qim­ing, Sher­pa Ven­ture Cap­i­tal, Ming Bioven­tures and Med-Fine Cap­i­tal al­so joined the fi­nanc­ing. — Am­ber Tong

My­covia wins pri­or­i­ty re­view in quest to shake up yeast in­fec­tion mar­ket

Pulling up be­hind Scynex­is in the race to de­vel­op oral an­ti­fun­gals against yeast in­fec­tions, My­covia is speed­ing to­ward a pri­or­i­ty re­view.

The Durham, NC-based biotech an­nounced Wednes­day the FDA has ac­cept­ed its NDA for otesec­ona­zole and grant­ed the com­pound a speedy look-see. Reg­u­la­tors have set the PDU­FA date for Jan. 27, 2022.

My­covia is aim­ing to win an OK in an area that Scynex­is hasn’t won ap­proval yet: re­cur­rent vul­vo­vagi­nal can­didi­a­sis, or chron­ic yeast in­fec­tion de­fined as at least three episodes per year. Scynex­is gained ap­proval in vul­vo­vagi­nal can­didi­a­sis for its Brex­afemme pill last month.

My­covia says da­ta from three Phase III stud­ies are back­ing the NDA, in­clud­ing two glob­al tri­als and one US-based tri­al. The drug­mak­er says otesec­ona­zole showed su­pe­ri­or ef­fi­ca­cy to Pfiz­er’s flu­cona­zole, cur­rent­ly the mar­ket’s stan­dard-bear­er.

“RVVC is a dif­fer­ent con­di­tion from yeast in­fec­tions, sim­ply known as VVC, so it re­quires a dif­fer­ent treat­ment. Re­search shows that flu­cona­zole, the stan­dard of care for VVC, is more than 90% ef­fec­tive in treat­ing an ini­tial episode of VVC, but in stud­ies of pa­tients with RVVC, greater than 50% of women ex­pe­ri­ence a re­cur­rence fol­low­ing main­te­nance ther­a­py dis­con­tin­u­a­tion,” My­covia CEO Patrick Jor­dan said in a state­ment. — Max Gel­man

On the heels of a $363M Parkin­son’s deal, Ipsen places a big bet on a new can­cer tar­get

It’s been a cou­ple of weeks since Ipsen bet $363 mil­lion on IR­LAB’s lev­odopa-in­duced dysk­i­ne­sia (LID) can­di­date — but the Paris-based com­pa­ny isn’t quite done mak­ing deals.

Ipsen has promised up to $852 mil­lion to col­lab­o­rate on BAKX Ther­a­peu­tics’ pre­clin­i­cal BAX ac­ti­va­tor in leukemia, lym­phoma and sol­id tu­mors, the com­pa­nies said on Tues­day.  Ipsen will shell out $14.5 mil­lion of that up­on clos­ing, and the part­ners will split the costs and prof­its.

“This part­ner­ship brings to­geth­er Ipsen’s ex­cel­lent clin­i­cal de­vel­op­ment and com­mer­cial ca­pa­bil­i­ties with our in­dus­try-lead­ing knowl­edge of the BAX pro­tein and our unique com­pu­ta­tion­al plat­form,” BAKX CEO Sree Kant said in a state­ment.

The pro­gram, dubbed BKX-001, is the re­sult of pi­o­neer­ing work around apop­to­sis by BAKX’s sci­en­tif­ic co-founders Loren Walen­sky and Evri­pidis Ga­vathi­o­tis. When dereg­u­lat­ed, apop­to­sis — the nat­u­ral­ly oc­cur­ring process of pro­grammed cell death — can lead to un­con­trolled cell di­vi­sion and tu­mor de­vel­op­ment. BAX is a new tar­get in the apop­to­sis cell-sig­nal­ing path­way, down­stream of oth­er an­ti-apop­tot­ic pro­teins like  BCL-2, BCL-XL, and MCL-1, the com­pa­ny said.

BAKX has an­oth­er two undis­closed can­di­dates in the dis­cov­ery stage, ac­cord­ing to its web­site. — Nicole De­Feud­is 

A pre­vi­ous ver­sion of this ar­ti­cle in­cor­rect­ly stat­ed that BAKX’s can­di­date is a BAX in­hibitor. A cor­rec­tion has been made.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.