Ex-Ax­o­vant crew at Arvelle ups Se­ries A haul, de­ploy­ing $200M-plus to com­mer­cial­ize epilep­sy drug in Eu­rope

One of the char­ac­ter­is­tic fea­tures of the sprawl­ing biotech group Vivek Ra­maswamy has built at Roivant is its abil­i­ty to whip up big-mon­ey fi­nanc­ing deals for its sub­sidiaries. Ax­o­vant was a prime ex­am­ple, rais­ing $315 mil­lion in an IPO — a mon­ster by 2015 and even to­day’s stan­dards — with an Alzheimer’s pitch be­fore a spec­tac­u­lar flop forced the com­pa­ny to re­plot its course di­rect­ly and piv­ot to gene ther­a­py.

Mark Alt­mey­er

But as the trans­for­ma­tion was tak­ing place, three of its top ex­ecs were keen to stay on the path of small mol­e­cule drugs tack­ling cen­tral ner­vous sys­tem dis­eases in the form of a new com­pa­ny. Arvelle Ther­a­peu­tics, the Switzer­land-based they found­ed, has re­tained a sim­i­lar abil­i­ty to at­tract siz­able in­vest­ments.

Arvelle dis­closed to­day that it’s bagged $207.8 mil­lion in an A round af­ter clos­ing the fi­nal tranche. The syn­di­cate fea­tures No­vaQue­st Cap­i­tal Man­age­ment, BRV Cap­i­tal Man­age­ment, LSP, H.I.G. Bio­Health Part­ners, An­dera Part­ners, F-Prime Cap­i­tal, KB In­vest­ments and mem­bers of man­age­ment.

The lat­est in­fu­sion reg­is­tered at $42.7 mil­lion, al­most a third of the ini­tial com­mit­ment of $133.3 mil­lion.

Then there was the $74.5 mil­lion raised pre­vi­ous­ly for “prod­uct fi­nanc­ing,” like­ly cen­tered around cenoba­mate, the foun­da­tion­al an­ti-seizure drug that Arvelle in-li­censed from South Ko­rea’s SK Bio­phar­ma­ceu­ti­cals for $100 mil­lion when it first launched.

What trig­gered the lat­est tranche was the EMA’s ac­cep­tance of the mar­ket­ing au­tho­riza­tion ap­pli­ca­tion for the volt­age-gat­ed sodi­um chan­nel block­er in late March — four months af­ter the FDA OK’d it as Xco­pri — the com­pa­ny said. The tar­get in­di­ca­tion is like­wise the ad­junc­tive treat­ment of fo­cal-on­set seizures in adults with epilep­sy.

“We be­lieve cenoba­mate has po­ten­tial as a new ther­a­peu­tic op­tion for pa­tients who con­tin­ue to have seizures de­spite the use of avail­able treat­ments,” Matthew Bullard at No­vaQue­st said in a state­ment.

One key sta­tis­tic SK has tout­ed is that 1 in 5 pa­tients tak­ing cenoba­mate in Phase III tri­als re­port­ed be­ing seizure-free. The com­pa­ny has re­tained mar­ket­ing rights around the world, in­clud­ing the US, Chi­na, Ko­rea and Japan.

With all its funds in place, Arvelle said it will con­tin­ue to ex­pand its op­er­a­tions across Eu­rope, “in­clud­ing key coun­try-by-coun­try hires in prepa­ra­tion of the Eu­ro­pean launch of cenoba­mate.”

Mark Alt­mey­er, the for­mer chief com­mer­cial of­fi­cer at Ax­o­vant, is Arvelle’s pres­i­dent and CEO.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.