From ze­ro to hero: En­do­cyte’s lit­tle deal a year ago spurred a come­back capped by $2.1B No­var­tis buy­out

A year ago, with its stock in the toi­let af­ter its lead drug flopped in Phase III, forc­ing a re­struc­tur­ing, new En­do­cyte CEO Mike Sher­man said every­thing you would ex­pect a biotech chief to say af­ter com­plet­ing a small li­cens­ing deal for a new lead drug. The $12 mil­lion up­front deal with ABX was trans­for­ma­tion­al, he boast­ed to re­porters. It was a block­buster head­ed to a multi­bil­lion dol­lar mar­ket. 

Mike Sher­man

Every­thing was great. (Yeah, sure.)

But Sher­man proved to skep­tics to­day that he was right to be op­ti­mistic about big things to come.

Thurs­day morn­ing No­var­tis stepped in and bought the com­pa­ny for $2.1 bil­lion just so it could get its hands on that drug. That’s a mod­est-sized bolt-on for the likes of No­var­tis, but it’s the kind of block­buster mon­ey that in­vestors in lit­tle biotechs dream of.

No­var­tis is buy­ing En­do­cyte $ECYT out for $24 a share, a 54% pre­mi­um over Wednes­day’s close. The price is 94% high­er than it was just be­fore their ABX deal closed last Sep­tem­ber.

The drug is Lu-PS­MA-617, a ra­dioiso­tope tar­get­ing prostate-spe­cif­ic mem­brane anti­gen, or PS­MA, com­mon­ly found in metasta­t­ic prostate can­cer. En­do­cyte hus­tled it straight in­to Phase III.

Liz Bar­rett

The seeds of this buy­out go back to just a few weeks af­ter En­do­cyte did its li­cens­ing deal. No­var­tis bought out France’s Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions in late Oc­to­ber, 2017, for $3.9 bil­lion. That ac­qui­si­tion gave the phar­ma gi­ant Lu­tathera and its plat­form tech on ra­dio­phar­ma­ceu­ti­cals. 

This new deal gives No­var­tis a late-stage as­set at an eco­nom­i­cal price for its new group, falling in­to its sweet spot of a $2 bil­lion to $5 bil­lion snap-on deal.

They’re buy­ing a drug that reg­is­tered a pro­gres­sion-free sur­vival rate of 7.6 months among PS­MA-pos­i­tive pa­tients, with one co­hort hit­ting an over­all sur­vival rate of 13.5 months — all sta­tis­ti­cal­ly sig­nif­i­cant. A few weeks ago an oblig­ing FDA OK’d ra­di­ograph­ic pro­gres­sion-free sur­vival as an al­ter­na­tive pri­ma­ry end­point to OS in the Phase III tri­al.

Liz Bar­rett, No­var­tis’ on­col­o­gy chief, did the hon­ors in herald­ing the deal.

To­day’s an­nounce­ment about the pro­posed ac­qui­si­tion of En­do­cyte builds on our grow­ing ca­pa­bil­i­ty in ra­dio­phar­ma­ceu­ti­cals, which is ex­pect­ed to be an in­creas­ing­ly im­por­tant treat­ment op­tion for pa­tients and a key growth dri­ver for our busi­ness. We are al­so ex­cit­ed about the op­por­tu­ni­ty to break in­to the prostate can­cer are­na with a near-term prod­uct that has the po­ten­tial to make a mean­ing­ful im­pact for pa­tients in great need of more op­tions.

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)

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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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.

Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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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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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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FDA ap­provals roundup: Zo­genix's Fin­tepla, Ul­tragenyx's Do­jolvi, and Genen­tech's Ph­es­go

A weekly update on new drug approvals and indications from the FDA:

New approvals

Fintepla gets the go-ahead for Dravet syndrome

Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.

The approval was based on findings from two clinical studies in 202 participants aged between 2 and 18 years, in which the change from baseline in frequency of convulsive seizures was measured. In both studies, children who received Fintepla had significantly greater reductions in the frequency of convulsive seizures, compared with those receiving placebo. The reductions were seen within 3-4 weeks of therapy initiation and remained generally consistent during the treatment periods of 14-15 weeks.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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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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