Cel­gene joins the PD-1 check­point club, bag­ging BeiGene drug with $413M down and $1B on the ta­ble

Cel­gene is join­ing the fast grow­ing PD-1 club.

John Oyler, BeiGene

The big biotech $CELG has tak­en a lead po­si­tion in the sec­ond wave of PD-1 check­points in the clin­ic, bag­ging rights to BeiGene’s $BGNE can­di­date for sol­id tu­mors in a $1.4 bil­lion deal, with $263 mil­lion of that paid up­front in a li­cens­ing fee, $150 mil­lion for an eq­ui­ty stake and $980 mil­lion more in mile­stones.

It’s a rich deal for this stage of the game, aimed at the rich­est health­care mar­kets on the plan­et. Cel­gene gets the US and Eu­ro­pean mar­kets and every­thing else out­side of Asia, which the Chi­nese com­pa­ny is keep­ing for it­self, along with glob­al de­vel­op­ment rights on hema­to­log­i­cal ma­lig­nan­cies. Two years ago, Cel­gene paid As­traZeneca $450 mil­lion up front to part­ner on their PD-L1 for heme.

The move was an­nounced the same day as Mer­ck’s com­bi­na­tion stud­ies match­ing its PD-1 drug Keytru­da with Cel­gene’s Revlim­id and Po­m­a­lyst were put on hold by the FDA — a month af­ter in­ves­ti­ga­tors flagged a high­er rate of death in the check­point arm. This was one of the rare in­stances where a check­point was linked to a po­ten­tial­ly lethal safe­ty is­sue. So far, their abil­i­ty to spur an im­mune sys­tem at­tack on can­cer cells has been carv­ing out bil­lions in new rev­enue, with hun­dreds of com­bi­na­tion stud­ies un­der­way to match the im­muno-on­col­o­gy ap­proach with tar­get­ed ther­a­pies.

BeiGene, which is in late-stage stud­ies in Chi­na, is al­so get­ting Cel­gene’s com­mer­cial op­er­a­tions in the mas­sive Asian mar­ket, with ex­clu­sive rights to com­mer­cial­ize Revlim­id, Abrax­ane and Vi­daza. BeiGene al­so gets rights to Cel­gene’s C-122, a next-gen CelMOD cur­rent­ly in de­vel­op­ment for lym­phoma and he­pa­to­cel­lu­lar car­ci­no­ma. And BeiGene is com­mit­ted to beef­ing up its man­u­fac­tur­ing op­er­a­tions to sup­port the part­ner­ship in Asia.

The PD-(L)1 crew al­ready has 5 ther­a­pies on the US mar­ket. Mer­ck and Bris­tol-My­ers Squibb led the way, fol­lowed by Roche, Pfiz­er/Mer­ck KGaA and As­traZeneca. But they keep com­ing. Cel­gene’s check­point will start a piv­otal glob­al pro­gram next year, mak­ing it a dis­tinct­ly late en­try in the field.

While the ba­sic bi­ol­o­gy of the PD-1 drugs is well un­der­stood at this point, mak­ing the clin­i­cal risk rel­a­tive­ly mod­est, there have still been plen­ty of sur­pris­es as new pro­grams push ahead. Bris­tol-My­ers found that out with its mis­step in lung can­cer, which has cost the com­pa­ny dear­ly. There are some big de­bates go­ing on now on whether PD-1 is in­her­ent­ly more po­tent than PD-L1 in dis­man­tling a can­cer cell’s stealth mech­a­nism. That dis­cus­sion was sharp­ened af­ter Roche’s PD-L1 Tecen­triq failed a cru­cial late-stage study, but it’s nowhere close to be­ing re­solved.

For its part, BeiGene says that its PD-1 just might be bet­ter than the rest, point­ing to some added en­gi­neer­ing in the Fc re­gion of the an­ti­body. And Chi­na once again ben­e­fits from news that points to the boom­ing coun­try as a hot spot in drug de­vel­op­ment.

Cel­gene is bring­ing in the PD-1 as the com­pa­ny con­tin­ues one of the most am­bi­tious pipeline cam­paigns in the in­dus­try, beef­ing up its R&D group with a deal spree that has now con­tin­ued for years. For BeiGene, Cel­gene’s quest is their op­por­tu­ni­ty to part­ner up with one of the most ag­gres­sive biotechs in the busi­ness.

“This strate­gic part­ner­ship with Cel­gene is a trans­for­ma­tion­al event for BeiGene, tran­si­tion­ing us in­to a com­mer­cial-stage com­pa­ny and prepar­ing us well for the fu­ture po­ten­tial launch of our in­ter­nal­ly de­vel­oped com­pounds, some of which are al­ready in piv­otal tri­als in Chi­na,” said John Oyler, CEO and co-founder of BeiGene.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.