Vivek Ra­maswamy bags $100M in risk cap­i­tal to back his lat­est PhI­II gam­ble at Der­ma­vant — while Urovant dives in­to gene ther­a­py

Vivek Ra­maswamy

Just a few days af­ter clos­ing on a $330 mil­lion deal with Glax­o­SmithK­line to reel in a Phase III-ready drug for the crowd­ed R&D field of pso­ri­a­sis and atopic der­mati­tis, Vivek Ra­maswamy’s Der­ma­vant inked a $100 mil­lion fi­nanc­ing deal to help pay for the next step in the clin­ic.

And that’s not all. The biotech fi­nancier al­so brought in an­oth­er key play­er for his Roivant um­brel­la or­ga­ni­za­tion, re­cruit­ing an in­vest­ment chair from NEA. And an­oth­er one of his com­pa­nies — Urovant — just in-li­censed a gene ther­a­py for over­ac­tive blad­ders.

Jack­ie Fouse

Der­ma­vant, helmed by ex-Cel­gene ex­ec Jack­ie Fouse, bagged $100 mil­lion in fi­nanc­ing from No­vaQue­st Cap­i­tal Man­age­ment “in ex­change for con­di­tion­al mile­stone pay­ments achieved by tap­inarof.”

The non­s­teroidal an­ti-in­flam­ma­to­ry top­i­cal cream— which ac­ti­vates the aryl hy­dro­car­bon re­cep­tor — hasn’t been a high-pro­file agent. But re­searchers have high­light­ed promis­ing da­ta to un­der­score its po­ten­tial.

No­vaQue­st fills a role that gets a lot of play but lit­tle at­ten­tion in the in­dus­try. Its port­fo­lio of com­pa­nies is filled with Big Phar­ma play­ers, like Pfiz­er and Sanofi, that can’t af­ford to fund every­thing they might like to try out in the clin­ic. In their case No­vaQue­st can put up the risk cap­i­tal where it sees a pay­back from struc­tured mile­stone pay­ments or roy­al­ties from an ap­proved prod­uct.

Frank Tor­ti

Now Frank Tor­ti can help over­see these in­vest­ment deals as the new “Vant In­vest­ment Chair,” charged with help­ing su­per­vise the grow­ing brood of biotechs un­der Ra­maswamy’s Roivant ban­ner. He’ll be op­er­at­ing along­side Genen­tech vet Myr­tle Pot­ter, the new “Vant Op­er­at­ing Chair.”

VCs will re­mem­ber that Tor­ti, who op­er­at­ed out of NEA’s Men­lo Park of­fice, had a port­fo­lio of com­pa­nies that in­clud­ed Der­mi­ra, Peplin and Ca­dence Phar­ma­ceu­ti­cals, bought out by Mallinck­rodt.

Urovant, mean­while, is be­ing giv­en a chance to test a once-and-done ther­a­py for over­ac­tive blad­der. Sep­a­rate­ly from the Der­ma­vant news and the lat­est hire, this oth­er Roivant com­pa­ny grabbed rights to hMaxi-K from Ion Chan­nel In­no­va­tions. The pro­gram has been through some ear­ly-stage tri­al work on safe­ty and ef­fi­ca­cy but still has a long ways to go be­fore any reg­u­la­to­ry sub­mis­sion.

Urovant is al­so in Phase III with vibegron, an in­ves­ti­ga­tion­al oral β3-adren­er­gic ag­o­nist be­ing stud­ied as a sec­ond-line treat­ment in adults with symp­toms of OAB.

“We are ea­ger to study the po­ten­tial of hMaxi-K as an al­ter­na­tive ther­a­py for OAB pa­tients who are not get­ting ad­e­quate re­lief from oth­er ther­a­pies,” said Kei­th A. Katkin, the CEO of Urovant. “Urovant al­so has ac­cess to gene ther­a­py ex­per­tise through the Roivant fam­i­ly of com­pa­nies.”

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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