Pfiz­er, Mer­ck KGaA throw in the tow­el on an­oth­er Baven­cio PhI­II as once bright hopes shriv­el fast

Pfiz­er and Mer­ck KGaA have hit the tri­fec­ta for PD-L1 fail­ure in ovar­i­an can­cer.

The two part­ners said late to­day that they are shut­ter­ing the Phase III JAVELIN Ovar­i­an PARP 100 study, their third straight fail in the ovar­i­an can­cer sec­tor in re­cent months. The de­ci­sion to close the tri­al, they added, was due to its ear­li­er set­backs as well as the ap­proval of As­traZeneca’s dom­i­nant PARP Lyn­parza in front­line cas­es.

David Hung

Re­searchers had hoped to find promis­ing da­ta for their com­bi­na­tion of Baven­cio with ta­la­zoparib, the PARP Pfiz­er $PFE ob­tained in the Medi­va­tion buy­out, which had been bru­tal­ly hyped by the biotech’s CEO David Hung as he sought to round up the sales price for the com­pa­ny. 

Re­searchers had hoped to make a case that the im­muno-on­col­o­gy drug plus chemo, fol­lowed by a main­te­nance round of Baven­cio plus ta­la­zoparib, would prove a big help to front­line pa­tients.

The lat­est set­back, which fol­lows a long line­up of fail­ures for the part­ners, will on­ly un­der­score the grow­ing sense of dread about Baven­cio’s fu­ture. Pfiz­er paid $850 mil­lion in a cash up­front for rights to this drug, which Re­gen­eron R&D chief George Yan­copou­los — who’s been pump­ing the fu­ture of their PD-1 ri­val — re­cent­ly told me was the worst of a bad lot.

There’s been a lot of buzz about Baven­cio in the in­dus­try, and none of it is par­tic­u­lar­ly good.

Mer­ck’s $MRK Keytru­da and Bris­tol-My­ers’ $BMY Op­di­vo were the first two PD-1/L1 drugs to be ap­proved, and they are by far way ahead in mar­ket share, with bil­lions in added rev­enue from each every year. As Re­gen­eron $REGN, Chi­na-based drug mak­ers and many oth­ers fol­low up with their own check­points in the field, and while PARPs duke it out against Lyn­parza, it will get tougher and tougher for new ther­a­pies to make a mark. And the in­dus­try is rife with new clin­i­cal pro­grams around the world.

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)

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

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 writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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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.

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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.

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.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Roche pulls a tu­mor mi­cro-en­vi­ron­ment drug out of the freez­er, hands it to a UK up­start

Two years after pulling it from clinical development, Roche has handed control of a solid tumor cancer drug to a tiny Oxford University spinout.

For an undisclosed fee, Celleron Therapeutics acquired the drug, an anti-CSF1R antibody that’s designed to modulate the tumor micro-environment — an increasingly popular approach among cancer drug developers. Celleron says it will now put the drug into trials for patients with tenosynovial giant cell tumors, a rare disease where series of benign tumors begin to grow around the joints and tendons. It’s caused by cells over-producing CSF1R.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Ko­dak board mem­ber's gift comes un­der scruti­ny; Red­hill be­gins Phase II/III tri­al for Covid-19 treat­ment in Mex­i­co

Eastman Kodak’s $765 million government loan to boost pharmaceutical manufacturing capacities was put on hold just last week, and now reports of a well-timed charitable donation have come to light.

Kodak board member George Karfunkel and his wife Renee Karfunkel reported in a securities filing a donation valued at $116.3 million to a Jewish synagogue in Brooklyn, NY, according to the Wall Street Journal. Per the filing, the donation took place on July 29, the day that Kodak’s stock hit its highest peak since 2014.

Ian Nicholson (F2G)

No­vo backs 'break­through' an­ti­fun­gal play­er's $60M round — with a fo­cus on rare mold in­fec­tions

The plight of antibiotics developers has been well documented: chronically underfunded research, daunting scientific challenges, and little commercial upside even for the ones that make it to the market. But in an adjacent corner of the antimicrobial space, an antifungal player is out to paint a very different picture.

F2G, a UK-Austria hybrid, has raised $60.8 million for its final push toward the clinic. Clearing the test could pave the way for its drug to be the first new antifungal agent in 20 years.