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.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,700+ biopharma pros reading Endpoints daily — and it's free.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,700+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,700+ biopharma pros reading Endpoints daily — and it's free.

Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,700+ biopharma pros reading Endpoints daily — and it's free.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

UP­DAT­ED: Bris­tol My­ers Squibb com­mits $300 mil­lion to com­bat racial dis­par­i­ties, but de­clines to re­lease own de­mo­graph­ic da­ta

After the police killing of George Floyd, a flurry of pharma and biotech companies, executives and investors jumped out to make statements, either expressing support for Black Lives Matter and the protests or condemning systemic racism.

Now, a Big Pharma company is publicly putting some teeth behind those statements. This morning, Bristol Myers Squibb announced they would spend $300 million on a broad effort to reduce racial health disparities, and diversify both their clinical trials and their own executive team and workforce.

Martin Shkreli (AP Images)

Mar­tin Shkre­li's in­fa­mous Dara­prim falls off top 20 most ex­pen­sive drugs list

Martin Shkreli incited a national uproar five years ago when he raised the price of Daraprim by a factor of 56 essentially overnight from $13.50 to $750 per pill. Now that the “Pharma Bro’s” high-priced project has received a generic, it no longer places among the most expensive drugs in the world.

GoodRx is back with the latest update of the top 20 most expensive drugs and Daraprim’s exclusion marks the biggest change. The drug had previously ranked seventh on the list’s last iteration, which came in February before the world went into quarantine. Another of Shkreli’s former companies, Retrophin, saw its Chenodal drug place in the top 10 again.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,700+ biopharma pros reading Endpoints daily — and it's free.

Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.