Roche silent­ly whisks away its lead $1.7B Ser­agon drug in a Q1 foot­note

Rich Hey­man

Close to three years ago Roche’s Genen­tech team came in and bought out Ser­agon from Rich Hey­man for $725 mil­lion in cash and an­oth­er bil­lion dol­lars in mile­stones, herald­ing the po­ten­tial for se­lec­tive es­tro­gen re­cep­tor de­graders to “one day re­de­fine the stan­dard of care for hor­mone re­cep­tor-pos­i­tive breast can­cer.”

To­day, the phar­ma gi­ant qui­et­ly car­ried the lead drug from that deal out to the curb, not­ing in a foot­note on pro­gram ter­mi­na­tions that it was re­mov­ing the drug GDC-0810 (ARN-810, RG6046) from Phase II.

In re­sponse to a query, Roche says that 0810 is be­ing shelved now so the com­pa­ny can move for­ward with an­oth­er one of Ser­agon’s drugs in the same field that has bet­ter po­ten­tial — and they’re just as in­ter­est­ed in SERDs as ever. Their state­ment:

Genen­tech has de­cid­ed to halt fur­ther clin­i­cal de­vel­op­ment and on­go­ing stud­ies eval­u­at­ing GDC-0810 while we eval­u­ate our strate­gic op­tions for our Se­lec­tive Es­tro­gen Re­cep­tor De­graders (SERDs) pro­gram.
We have learned much about the SERD bi­ol­o­gy with tar­get­ing the es­tro­gen re­cep­tor. Based on cur­rent da­ta, GDC-0927, an­oth­er next-gen­er­a­tion oral SERD, ap­pears to have greater po­ten­tial than GDC-0810 to be a best-in-class SERD mol­e­cule. We have de­cid­ed to move for­ward with GDC-0927 in pa­tients with metasta­t­ic hor­mone re­cep­tor-pos­i­tive/HER2-neg­a­tive breast can­cer build­ing up­on what we have learned in the clin­ic with GDC-0810. In Q1 2015, we ini­ti­at­ed a Phase I dose-es­ca­la­tion tri­al to as­sess the safe­ty, tol­er­a­bil­i­ty, and phar­ma­co­ki­net­ics of GDC-0927 in pa­tients with metasta­t­ic hor­mone re­cep­tor-pos­i­tive/HER-neg­a­tive breast can­cer who have pro­gressed af­ter re­ceiv­ing cur­rent an­ti-hor­mon­al med­i­cines.
Genen­tech re­mains com­mit­ted to con­tin­u­ing to in­vest in SERD bi­ol­o­gy and nov­el SERD ther­a­pies. We be­lieve in­ves­ti­ga­tion­al next-gen­er­a­tion oral SERDs could one day re­de­fine the stan­dard of care for hor­mone re­cep­tor-pos­i­tive breast can­cer.

The re­ver­sal marks an un­usu­al set­back for Genen­tech and Roche, which rarely spend that kind of mon­ey on an ex­per­i­men­tal as­set. He­len Thomas, who was then writ­ing Heard on the Street for the Wall Street Jour­nal, found it “dis­con­cert­ing” at the time.

“Rarely in oth­er sec­tors,” she not­ed, “do com­pa­nies shell out vast sums for as­sets that could quite pos­si­bly amount to noth­ing.”

Ser­agon was what was left af­ter J&J came in and bought Aragon — Hey­man’s San Diego biotech cre­at­ed to pur­sue the in­sights of not­ed in­ves­ti­ga­tor Charles Sawyers — in one of its bil­lion-dol­lar buy­outs ($650 mil­lion in cash). Stan­dard ther­a­pies for breast and prostate can­cer are de­signed to block the ef­fect of the hor­mones, act­ing like “glue in the lock” of hor­mone re­cep­tors, then-Aragon CEO Hey­man told me back in 2010. But over time, pa­tients be­come treat­ment re­sis­tant and the ther­a­py can wind up fu­el­ing the can­cer. Hey­man called his lead ther­a­py for prostate can­cer “su­per glue. It tru­ly blocks the re­cep­tor in this re­sis­tant state.”

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

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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.

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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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[via AP Images]

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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]

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