As­traZeneca joins Mer­ck, Bris­tol-My­ers in Chi­na's check­point race as reg­u­la­tors OK first PD-L1

As­traZeneca has made a stride to­ward re­al­iz­ing its am­bi­tions in Chi­na as reg­u­la­tors green­light Imfinzi as a treat­ment for non-small cell lung can­cer.

In par­tic­u­lar, the PD-L1 agent is fill­ing a void for im­munother­a­pies in Stage III un­re­sectable case, the com­pa­ny said, where the can­cer has not spread to the rest of the body. It is to be used, with cu­ra­tive in­tent, in pa­tients whose can­cer hasn’t pro­gressed fol­low­ing con­cur­rent plat­inum-based chemother­a­py and ra­di­a­tion ther­a­py.

Dave Fredrick­son

“This ap­proval il­lus­trates our long-stand­ing com­mit­ment to im­prov­ing health out­comes in Chi­na, where more than one-third of the world’s lung can­cer di­ag­noses and deaths oc­cur,” said Dave Fredrick­son, who heads As­traZeneca’s on­col­o­gy busi­ness unit, in a state­ment.

Imfinz’s ap­proval al­so marks the en­try of a PD-L1 in­hibitor to the coun­try, where PD-1 drugs have been pil­ing up. Bris­tol-My­ers Squibb scored the first-ever Chi­nese ap­proval for a check­point in­hibitor in June 2018, with Op­di­vo in­di­cat­ed for sec­ond-line treat­ment of NSCLC, and Mer­ck has been rack­ing up OKs for dif­fer­ent reg­i­mens in­volv­ing Keytru­da.

Then there are the do­mes­tic ri­vals, whose drugs are cur­rent­ly lim­it­ed to lym­phoma or melanoma but al­so have plans for a lu­cra­tive lung can­cer mar­ket. And they are ea­ger to com­pete on price.

Leon Wang

For As­traZeneca, this is just more rea­son to roll up its sleeves and get to ne­go­ti­at­ing with pay­ers. Its head of Chi­na, Leon Wang, has pre­vi­ous­ly told Bloomberg that he sees new treat­ments con­tribut­ing to 60% of all its Chi­na rev­enue with­in five years. To il­lus­trate that dri­ve, Wang of­fered the ex­am­ple of its first-gen EGFR-tar­get­ing lung can­cer Ires­sa, in which they won the drug sup­ply con­tract in by slash­ing the price more than 70%.

Quick ap­provals for third-gen EGFR TKI Tagris­so (which is now on the Na­tion­al Re­im­burse­ment Drug List), as well as the PARP in­hibitor Lyn­parza, helped — and now it’s time for Imfinzi to shine. No­tably, Roche’s PD-L1 Tecen­triq — which gained FDA ap­proval ear­li­er than Imfinzi — is not yet avail­able in Chi­na.

In the Phase III PA­CIF­IC tri­al, Imfinzi cut the risk of death by 32% and pro­longed pro­gres­sion-free sur­vival by 11.2 months ver­sus place­bo (me­di­an PFS 16.8 vs 5.6 months), when paired with chemo or ra­di­a­tion ther­a­py. At the three-year mark, 57% of pa­tients on the Imfinzi arm are still alive com­pared to 43.5% on place­bo, ac­cord­ing to a post hoc analy­sis pre­sent­ed at AS­CO.

Imfinzi sales have gone over the $1 bil­lion mark in the first three quar­ters of the year, grow­ing 182% com­pared to the same pe­ri­od last year.

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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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.”

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.

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.

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.)