Al­ler­gan en­lists Ex­i­cure in search of hair loss drugs with $25M up­front, dou­bling down on area dear to Ab­b­Vie

Af­ter Ab­b­Vie be­came a for­mi­da­ble play­er in med­ical aes­thet­ics overnight by swal­low­ing Al­ler­gan, the Botox mak­er is beef­ing up the pipeline with new R&D projects.

The lat­est deal brings in the gene ex­pres­sion ex­perts at Ex­i­cure, who is re­ceiv­ing $25 mil­lion up­front to dis­cov­er and de­vel­op two new treat­ments for hair loss dis­or­ders. Uti­liz­ing its spher­i­cal nu­cle­ic acid (SNA) tech­nol­o­gy, the biotech starts with an ar­ti­fi­cial nanos­phere as a scaf­fold, as­sem­bling sin­gle- and dou­ble-strand­ed nu­cle­ic acids on the sur­face to find mol­e­cules that could mod­u­late an­ti­sense or RNAi path­ways.

Should Al­ler­gan ex­er­cise its op­tion on the treat­ments, it will pay up to $362.5 mil­lion to­tal in mile­stones per pro­gram and take over clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion.

David Giljo­hann Ex­i­cure

“We are ex­cit­ed to com­bine our knowl­edge of nu­cle­ic acid ther­a­peu­tics with Al­ler­gan’s deep ex­per­tise in med­ical aes­thet­ics to de­vel­op and com­mer­cial­ize in­no­v­a­tive treat­ments for hair loss dis­or­ders.” Ex­i­cure CEO David Giljo­hann said in a state­ment. “This col­lab­o­ra­tion is an ex­cit­ing op­por­tu­ni­ty to ad­vance Ex­i­cure’s SNA tech­nol­o­gy in an im­por­tant new ther­a­peu­tic area.”

Al­ler­gan has pre­vi­ous­ly ob­tained a DP2 an­tag­o­nist from the buy­out of Kythera to com­bat male pat­tern bald­ness. But setip­iprant is now nowhere to be found on its web­site af­ter flunk­ing an ef­fi­ca­cy study in which pa­tients on the drug on­ly re­port­ed a 0.3 im­prove­ment on the 7-point sub­ject self-as­sess­ment score (SSA) over 0.2 on place­bo, with an abysmal p-val­ue of 0.9101.

In June the com­pa­ny placed a bet on a dif­fer­ent ap­proach by in­vest­ing in Stem­son, a cell ther­a­py play­er look­ing to gen­er­ate new hair fol­li­cles from in­duced pluripo­tent stem cells.

If they work out — and we won’t find out for a long time — these new ther­a­pies will have a heavy­weight com­mer­cial cham­pi­on in Ab­b­Vie, which has sig­naled strong in­ter­est in Al­ler­gan’s med­ical aes­thet­ics prod­ucts led by Botox.

Ear­li­er this week Ab­b­Vie sold $30 bil­lion of bonds to fi­nance the $63 bil­lion buy­out, up­sized from the $28 bil­lion ini­tial­ly planned. The Wall Street Jour­nal not­ed that the sale was the biggest of such type this year and the fourth biggest in­vest­ment-grade debt sale on record.

The phar­ma gi­ant end­ed up is­su­ing 10 dif­fer­ent bonds with ma­tu­ri­ties rang­ing from 1.5 years to 30 years. The yield on 10-year notes would re­port­ed­ly be 1.5 per­cent­age points about the com­pa­ra­ble US Trea­sury yield.

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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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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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.