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: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.