Scoop: Tur­ing is con­sid­er­ing a $100M cash of­fer for the drug that trig­gered a na­tion­al scan­dal over drug pric­ing

Tur­ing Phar­ma­ceu­ti­cals has re­ceived a $100 mil­lion of­fer for the drug that trig­gered a na­tion­al up­roar over drug price goug­ing, End­points News has learned.

Eliseo Sali­nas

The com­pa­ny, launched by Mar­tin Shkre­li be­fore he be­came a light­ning rod in the con­tro­ver­sy over ex­treme drug pric­ing, was sup­posed to gath­er votes to­day on pro­posed mem­bers of the board at Tur­ing. That vote was sched­uled af­ter re­search chief Eliseo Sali­nas took over re­cent­ly as in­ter­im CEO as var­i­ous fac­tions fought for con­trol of the com­pa­ny.

In­stead of a board vote, though, Sali­nas dis­trib­uted a let­ter to share­hold­ers to­day say­ing that the vote would be post­poned as the com­pa­ny con­sid­ers an of­fer of $100 mil­lion in cash for Dara­prim from an un­named third par­ty.

One of the in­di­vid­u­als in­volved in the vote sent a copy of the let­ter to End­points News, which has been cov­er­ing this sto­ry from the be­gin­ning.

The bid­der “has con­duct­ed sig­nif­i­cant due dili­gence on Dara­prim un­der a Con­fi­den­tial­i­ty Agree­ment, and is com­mit­ted to clos­ing the trans­ac­tion with­in 30 days of ac­cep­tance of the of­fer, sub­ject to a pos­si­ble de­lay for Hart-Scott-Rodi­no fil­ing or oth­er le­gal or reg­u­la­to­ry re­views,” the let­ter states.

The let­ter goes on to say that the of­fer ar­rived last Fri­day and is be­ing re­viewed for fair­ness. That re­view is ex­pect­ed by the end of May. It goes on to add that the com­pa­ny has been con­sid­er­ing a sale, merg­er or new cap­i­tal in­fu­sion for the past year, af­ter the con­tro­ver­sy over Shkre­li’s de­ci­sion to jack up the price of Dara­prim by more than 5000% erupt­ed in­to con­tro­ver­sy.

Tur­ing is a pri­vate com­pa­ny and has nev­er re­vealed ex­act­ly what it’s been mak­ing on Dara­prim af­ter buy­ing it from Im­pax for $55 mil­lion, hik­ing the price of the old drug from $13.50 to $750 a tablet.

The com­pa­ny con­firmed the talks late Tues­day and is­sued this state­ment:

“In keep­ing with stan­dard cor­po­rate prac­tice, Tur­ing’s Board is ful­fill­ing its fidu­cia­ry oblig­a­tion to eval­u­ate a cred­i­ble of­fer for DARA­PRIM that was re­cent­ly re­ceived from a rep­utable phar­ma­ceu­ti­cal en­ti­ty. Due to con­fi­den­tial­i­ty re­stric­tions, we can­not dis­close in­for­ma­tion about the of­fer­or. Tur­ing con­tin­ues to fo­cus on de­vel­op­ment and com­mer­cial­iza­tion of in­no­v­a­tive treat­ments for se­ri­ous dis­eases and con­di­tions across a broad range of ther­a­peu­tic ar­eas.”

Shkre­li, who first of­fered to re­duce the price, in­stead scam­pered away, taunt­ing crit­ics and claim­ing that his move was just small time when com­pared to Big Phar­ma’s an­nu­al price hikes. He is now fac­ing a tri­al on un­re­lat­ed fed­er­al fraud charges next month in a Man­hat­tan court­room.

Mar­tin Shkre­li, for­mer chief ex­ec­u­tive of­fi­cer for Tur­ing Phar­ma­ceu­ti­cals AG, left, ar­rives at Fed­er­al Court with his at­tor­ney Ben­jamin Braf­man on Ju­ly 14, 2016 Bloomberg/Get­ty

Shkre­li’s tri­al is slat­ed to be­gin June 26, 5 days af­ter the CEO sched­uled a new board vote.

If the sale goes through, the let­ter con­tin­ues, in­vestors will be in line for $11 to $13 a share, once enough cash is set aside for le­gal and oth­er con­tin­gen­cies. The com­pa­ny will con­tin­ue to work in R&D, ac­cord­ing to the CEO.

Sali­nas took over the com­pa­ny re­cent­ly af­ter serv­ing as re­search chief. He re­placed long­time Shkre­li as­so­ciate Ron Tilles, who was left in charge af­ter Shkre­li re­signed short­ly af­ter his ar­rest. That switchup re­cent­ly trig­gered a fight over the board seats and con­trol of Tur­ing, start­ing a fight that has yet to be re­solved.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,400+ biopharma pros reading Endpoints daily — and it's free.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.