As­traZeneca, Sam­sung quit race to de­vel­op Rit­ux­an copy­cat as ri­vals crowd out the mar­ket

Six years af­ter As­traZeneca teamed up with Sam­sung Bi­o­log­ics to de­vel­op a biosim­i­lar for Roche’s rit­ux­imab, they are throw­ing in the tow­el.

The part­ners have de­cid­ed to stop all R&D work on the pro­gram known as SAIT101, Ko­rea Bio­med­ical Re­view re­port­ed, cit­ing a quar­ter­ly re­port from Sam­sung. Archi­gen, a 50-50 joint ven­ture set up around the pro­gram, is set to be liq­ui­dat­ed.

As­traZeneca had wa­gered $70 mil­lion in cash back in 2014 to get it all start­ed, and topped up with an ex­tra $30 mil­lion two years lat­er. For Sam­sung, Ko­rea Bio­med cal­cu­la­tions sug­gest a to­tal in­vest­ment of $126 mil­lion.

Archi­gen was set up be­fore any biosim­i­lar for Rit­ux­an (MabThera in cer­tain coun­tries) — a megablock­buster pre­scribed for both can­cer and in­flam­ma­tion that brought Roche $6.54 bil­lion in rev­enue last year — ex­ist­ed. Sam­sung had hoped that com­bin­ing its con­tract man­u­fac­tur­ing skills and ca­pac­i­ty with As­traZeneca’s mar­ket­ing prowess would make a suc­cess­ful copy­cat in the US.

But the space has filled up in re­cent years.

Just in the past year Te­va/Cell­tri­on and Pfiz­er both scored FDA OKs for their knock­offs. Am­gen and Al­ler­gan are close on their heels, and while No­var­tis’ San­doz has pulled out of the US race, it re­mains a play­er in Eu­rope.

All that may ex­plain why, de­spite com­plet­ing a Phase III study for lym­phoma this Au­gust sug­gest­ing sim­i­lar ef­fects to Rit­ux­an, a Sam­sung spokesper­son told Ko­rea Bio­med “we con­clud­ed that the prod­uct lacks com­mer­cial vi­a­bil­i­ty af­ter dis­cussing with As­traZeneca.”

The Ko­re­an con­glom­er­ate has had bet­ter luck with Sam­sung Bioepis, a biosim­i­lars-fo­cused joint ven­ture it es­tab­lished with Bio­gen, get­ting five drugs cleared in Eu­rope and re­cent­ly fil­ing for a copy­cat of Lu­cen­tis in the US.

But don’t look for Bioepis to take over the de­vel­op­ment of SAIT101. As the orig­i­nal de­vel­op­er of Rit­ux­an, Bio­gen is still on the re­ceiv­ing end of a roy­al­ty stream from Roche. In fact, as ex­ecs ex­plained last year in a tri­al re­lat­ing to ac­count­ing fraud, the de­ci­sion to set up Sam­sung Bioepis in 2012 was ex­act­ly why they had abrupt­ly halt­ed the biosim­i­lar pro­gram — which had a Phase III al­ready un­der­way — un­til As­traZeneca came along. The stud­ies be­gan anew in June 2016.

Ex­ecs had ap­par­ent­ly made up their mind in that tri­al, not­ing: “Rit­ux­an busi­ness failed be­cause the prod­uct de­vel­op­ment was too late.”

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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