Us­ing mon­ey hon­ey in­stead of threats, Sanofi wins a seat at the bar­gain­ing ta­ble for Medi­va­tion buy­out

It took a sweet­er bid and a CVR for its ex­per­i­men­tal ther­a­py ta­la­zoparib, but Sanofi $SNY can now take a seat at the bar­gain­ing ta­ble with Medi­va­tion $MD­VN in pur­suit of one of this year’s biggest biotech buy­outs.

Sanofi an­nounced this af­ter­noon that it pushed its bid to $58.00 a share – up from $52.50 – and added a $3.00 CVR for sales per­for­mance on ta­la­zoparib, Medi­va­tion’s block­buster bid for PARP in­hibitor glo­ry. That’s a po­ten­tial $11 bil­lion pay­out, up from the ini­tial $9.3 bil­lion of­fer.

Medi­va­tion care­ful­ly not­ed that it re­ject­ed the of­fer. And it’s un­like­ly to ac­cept one that isn’t sub­stan­tial­ly larg­er.

Sanofi, which has threat­ened a va­ri­ety of sanc­tions against Medi­va­tion in its push for a deal, ex­pressed con­fi­dence that it could wrap up a deal. That may be eas­i­er said than done, though, as Reuters re­port­ed this af­ter­noon that Pfiz­er and Cel­gene are al­so stand­ing in the wings now, look­ing to see what they may do to step in now. Oth­ers may fol­low.

Sanofi is the first to the ta­ble. And it clear­ly sees the ac­qui­si­tion, bag­ging Xtan­di and a promis­ing late-stage PARP in­hibitor, as a big piece in new CEO Olivi­er Brandi­court’s at­tempt to make over Sanofi.

“We view this mov­ing on past the ini­tial and painful step in the process where both par­ties have to act their very tough­est but one of them has to even­tu­al­ly flinch and move on to the next step, as a very cru­cial and sig­nif­i­cant win for MD­VN share­hold­ers; and as the first step in the process which we see cul­mi­nat­ing in the even­tu­al sale of the com­pa­ny, like­ly with­in the next six months and with a price tag that we ex­pect to be in the $70/share range, in­clud­ing the CVR,” notes RBC’s Simos Sime­oni­dis.

Medi­va­tion has kicked back hard against Sanofi, par­tic­u­lar­ly rais­ing the prospect of a first-line win­ner in ta­la­zoparib. As­traZeneca was the first to the PARP mar­ket with ola­parib, but plen­ty of com­pe­ti­tion has been in hot pur­suit of leapfrog­ging the big phar­ma’s pi­o­neer­ing ef­fort. Tesaro just post­ed promis­ing da­ta for its PARP drug as well, and J&J stepped in to bag prostate can­cer rights for its port­fo­lio.

The deal will like­ly seal Medi­va­tion CEO David Hung’s rep as a top deal­mark­er in the in­dus­try. He’s struck ma­jor col­lab­o­ra­tions and wasn’t afraid to pay Bio­Marin top mon­ey for the rights to ta­la­zoparib. And de­spite Medi­va­tion’s re­cent protests about Sanofi’s lack­lus­ter rep in on­col­o­gy R&D, this sto­ry is all about the mon­ey.

“We are pleased to have the op­por­tu­ni­ty to en­gage with Medi­va­tion,” said Olivi­er Brandi­court, Chief Ex­ec­u­tive Of­fi­cer, Sanofi. “Our will­ing­ness to in­crease our of­fer is dri­ven by our in-depth analy­sis of the ben­e­fits and val­ue cre­ation po­ten­tial of a com­bi­na­tion.  We look for­ward to dis­cus­sions with Medi­va­tion on a com­bi­na­tion which we be­lieve is the most val­ue cre­at­ing trans­ac­tion for both com­pa­nies’ share­hold­ers, and would pro­vide Medi­va­tion and its em­ploy­ees with an out­stand­ing plat­form to fur­ther grow its on­col­o­gy fran­chise.”

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.

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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.

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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.

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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.

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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.

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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.

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.

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.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepreneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film “Fantastic Voyage,” the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his and his co-founders’ own accounts, along with some seed cash from friends and family.