6 months af­ter ar­riv­ing at Sanofi R&D, John Reed gam­bles $125M on De­nali’s RIPK1 work

Sanofi’s new R&D chief, John Reed, is on the march. 

New­ly ar­rived from Roche, Reed is hand­ing over $125 mil­lion in cash to part­ner with De­nali $DNLI on a RIPK1 ap­proach to tamp­ing down in­flam­ma­tion. And in the deal — which in­cludes more than a bil­lion dol­lars in mile­stones — the French phar­ma gi­ant is grab­bing sys­temic in­flam­ma­to­ry dis­eases while the De­nali team con­tin­ues to lead the charge on the blood-brain bar­ri­er and neu­ro dis­eases.

Alex Schuth

De­nali dived in­to RIP1 a lit­tle more than 2 years ago, buy­ing out In­cro and bag­ging one of their top drugs — which ini­tial­ly came out of Har­vard — for the pipeline. That ap­proach to in­flam­ma­tion, pro­vid­ed they could get it in­to the brain prop­er­ly, has po­ten­tial in ALS, mul­ti­ple scle­ro­sis and Alzheimer’s. And it’s pay­ing some quick div­i­dends af­ter a key play­er took care­ful no­tice of their work.

“John Reed was a cham­pi­on of this deal,” De­nali chief op­er­at­ing of­fi­cer Alex Schuth tells me, cit­ing some of the team play­ers around Reed who helped close the deal.

Reed is com­mit­ting his re­search group to the RIP1 tar­gets out­side the brain. Sanofi will take over the de­vel­op­ment work of DNL758 for tar­gets such as rheuma­toid arthri­tis and pso­ri­a­sis while fund­ing the Phase Ib/II costs for DNL747 for ALS, MS and oth­er con­di­tions — oth­er than Alzheimer’s, where De­nali re­tains re­spon­si­bil­i­ty for costs. Sanofi then will cov­er 70% of the costs in the piv­otal neu­ro work.

The com­pa­nies plan to share prof­its and loss­es in the US and Chi­na on 747, while Sanofi will pay roy­al­ties on 747 from the rest of the world and on all 758 sales. Sanofi al­so gets rights to pre­clin­i­cal RIPK1 in­hibitor mol­e­cules.

This is one of the first new deals to be struck by John Reed since he made the leap to Sanofi 6 months ago, with Elias Zer­houni on the way out. A deeply re­spect­ed sci­en­tist, Reed made lit­tle pub­lic progress while he was run­ning the show at pRED based in Basel.

Sanofi, mean­while, has earned a poor rep­u­ta­tion for in-house in­no­va­tion. But it has a great rep for col­lab­o­ra­tions, with a high-pro­file al­liance with Re­gen­eron that was re­cent­ly down­grad­ed at the gi­ant phar­ma com­pa­ny.

Steve Krognes

De­nali has man­aged to en­joy con­sid­er­able cred­i­bil­i­ty while walk­ing a mine field of risk. The ex­ec­u­tive team out of Genen­tech has some of the best re­sumes in the field, and their tar­get­ed, ge­net­ics-based ap­proach to CNS has won sig­nif­i­cant back­ing as they built the over­all staff to 175, with a new HQ un­der con­struc­tion right next to their cur­rent site in South San Fran­cis­co’s Oys­ter Point.

Steve Krognes, the CFO at De­nali, is hap­py to talk about the staffing (grow­ing), the new HQ (ready for move-in in March) and the mon­ey re­serves (sig­nif­i­cant). De­nali struck an­oth­er ma­jor col­lab­o­ra­tion with Take­da at the be­gin­ning of this year for Alzheimer’s and near that de­liv­ered $155 mil­lion in cash and an eq­ui­ty stake.

But he and Schuth are al­so a lit­tle low key about some of the timeta­bles and the ex­act chem­i­cal prop­er­ties that make these drugs best-in-class con­tenders.

We can find out more about that as da­ta are as­sem­bled.

They’re not alone in RIP1, by any means. Just a cou­ple of weeks ago Hal Bar­ron sin­gled out a mid-stage pro­gram at GSK, which he char­ac­ter­ized as a high-risk, high-re­ward drug that might need some work ahead of any piv­otal test.

Im­age: John Reed. 

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.