$7.5B in emer­gency con­gres­sion­al coro­n­avirus prep; Sick­le cell biotech sets terms for IPO

→ Mul­ti­ple out­lets, in­clud­ing the Wash­ing­ton Post, are re­port­ing that Con­gress is prepar­ing to ap­prove a $7.5 bil­lion emer­gency coro­n­avirus spend­ing pack­age. It’s not clear how much of that will go to drug and vac­cine de­vel­op­ment, al­though the orig­i­nal — and much small­er — White House fund­ing re­quest in­clud­ed $1 bil­lion for vac­cines.  The bill is re­port­ed­ly like­ly to be in­tro­duced to­day and pass the House lat­er this week, be­fore head­ing to the Sen­ate.

→ Imara, a ge­net­ic dis­or­der biotech work­ing on a drug for sick­le cell, has set the terms for its IPO, plan­ning to sell 4.5 mil­lion shares for $16 to $18 per share and a to­tal raise of $76 mil­lion. The com­pa­ny is one of sev­er­al hop­ing to treat sick­le cell by caus­ing the body to pro­duce fe­tal he­mo­glo­bin, which doesn’t sick­le even in pa­tients with the dis­ease. It’s an old idea that’s re­cent­ly gained trac­tion as oth­er ther­a­pies emerge for a dis­ease that went decades with­out any new treat­ments. Imara’s drug is in Phase II.

→ Al­ny­lam has re­ceived ap­proval to use its RNAi ther­a­py Givlaari in the Eu­ro­pean Union as a treat­ment for the ul­tra-rare con­di­tion acute he­pat­ic por­phyr­ia. GIVLAARI was ap­proved in the US in No­vem­ber, the sec­ond drug Al­ny­lam got past reg­u­la­tors af­ter spend­ing over a decade and a half de­vel­op­ing its RNA in­ter­fer­ence tech­nol­o­gy. Al­though it will as­sured­ly be cheap­er in the EU, the com­pa­ny is charg­ing $545,000 per year for the drug in the US.

→ A new biotech called Li­pidio Phar­ma­ceu­ti­cals has launched with a goal of tar­get­ing ill­ness­es re­lat­ed to ex­cess body weight, in­clud­ing NASH, Prad­er-Willi Syn­drome, and an­ti-psy­chot­ic drug in­duced weight gain. The com­pa­ny said they closed a Se­ries A, with in­vest­ments from the Foun­da­tion for Prad­er-Willi Re­search and “sev­er­al fam­i­ly of­fices and high net­worth in­di­vid­u­als,” but did not dis­close the amount raised. The com­pa­ny has sev­er­al for­mer Big Phar­ma ex­ecs on its board, in­clud­ing for­mer Pfiz­er head of glob­al R&D Nan­cy Hut­son.

→ Genen­tech‘s Es­bri­et, first ap­proved in the US in 2014 for id­io­path­ic pul­monary fi­bro­sis, has re­ceived FDA break­through sta­tus for un­clas­si­fi­able in­ter­sti­tial lung dis­ease. The des­ig­na­tion was based on a Phase II tri­al that sug­gest­ed Es­bri­et could slow the dis­ease, which has no ap­proved ther­a­pies. In­ter­sti­tial lung dis­ease is a clus­ter of over 200 rare pul­monary dis­eases. About 10% of pa­tients can’t be di­ag­nosed with one of the types and are des­ig­nat­ed as “un­clas­si­fied.”

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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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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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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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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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.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.