Pfiz­er’s lat­est copy­cat could put the squeeze on Roche — again

Pfiz­er $PFE is bar­rel­ing for­ward on its plans to recre­ate Roche’s stal­wart can­cer drugs, an­nounc­ing pos­i­tive da­ta this morn­ing for its Rit­ux­an copy­cat called PF-05280586. Con­sid­er­ing Roche’s $RHH­BY re­cent back­lash to biosim­i­lar com­pe­ti­tion, it’s pos­si­ble that Pfiz­er will con­tin­ue to poke the rather liti­gious bear.

Like you’d want to see from a biosim­i­lar, PF-05280586’s tri­al met its pri­ma­ry end­point and showed equiv­a­lence in over­all re­sponse rate for pa­tients with CD20-pos­i­tive fol­lic­u­lar lym­phoma.

Am­rit Ray

“These re­sults re­in­force the po­ten­tial of our pro­posed rit­ux­imab biosim­i­lar in pro­vid­ing a safe and ef­fec­tive treat­ment op­tion for pa­tients,” said Pfiz­er’s R&D pres­i­dent Am­rit Ray in a state­ment.

Con­sid­er­ing its loss of patent pro­tec­tions for core brands like Lip­i­tor and Vi­a­gra, in­vest­ing in biosim­i­lars is a growth strat­e­gy for Pfiz­er. Biosim­i­lars, a pur­port­ed $10 bil­lion to $30 bil­lion glob­al mar­ket op­por­tu­ni­ty, is the com­pa­ny’s new tar­get.

Years ago, Pfiz­er got FDA ap­proval for In­flec­tra, its knock­off of J&J’s Rem­i­cade. Now it’s tak­ing on Roche’s can­cer port­fo­lio: Her­ceptin, Avastin, and Rit­ux­an. That’s large­ly due to the com­pa­ny’s 2015 ac­qui­si­tion of Hos­pi­ra, which was de­vel­op­ing biosim­i­lars for those drugs. US sales for these bi­o­log­ics was around $9.5 bil­lion in 2016. Since copy­cats are priced 20% un­der, some have spec­u­lat­ed that Pfiz­er is look­ing at a $7.5 bil­lion ad­dress­able mar­ket.

But as Pfiz­er puts the squeeze on Roche and J&J’s rev­enue, these drug­mak­ers are fight­ing back.

Roche launched a le­gal bat­tle against Pfiz­er for its Her­ceptin copy­cat, al­leg­ing Pfiz­er had in­fringed on 40 of Roche’s patents. The back­lash makes sense. Her­ceptin sales makes up a big chunk of the Roches’s to­tal rev­enue, bring­ing in about $2.5 bil­lion in sales last year (or 5% of to­tal rev­enue).

J&J, on the oth­er hand, has made deep cost cuts to Rem­i­cade to keep Pfiz­er’s ri­val biosim­i­lar at bay. Pfiz­er sued J&J al­leg­ing the com­pa­ny was us­ing “ex­clu­sion­ary con­tracts” that barred Pfiz­er from reach­ing most pa­tients. Pfiz­er got some good news on that bat­tle front ear­li­er this week, as a US ap­peals court up­held a rul­ing that in­val­i­dat­ed a key patent for Rem­i­cade.

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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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.

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

Bris­tol My­ers Squibb com­mits to $300 mil­lion to com­bat­ing racial in­equity

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.

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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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Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

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.