Der­ma­vant en­gi­neers $160M deal to pay off Glax­o­SmithK­line mile­stones, gear up to launch pso­ri­a­sis cream

Der­ma­vant has nev­er been shy about its dreams to trans­form der­ma­tol­ogy with their top­i­cal cream. And the Roivant sub­sidiary has now found in­vestors just as en­thu­si­as­tic as they are.

Todd Za­vod­nick

Marathon As­set Man­age­ment, No­vaQue­st Cap­i­tal Man­age­ment and a third, un­named Boston-based in­vest­ment firm have agreed to shell out $160 mil­lion — if and on­ly if Der­ma­vant se­cures an ap­proval in plaque pso­ri­a­sis— in ex­change for a “sin­gle-dig­it per­cent­age rev­enue in­ter­est” of net tap­inarof sales, ac­cord­ing to the Roivant sub­sidiary. A big chunk of that mon­ey will go to Glax­o­SmithK­line as mile­stone pay­ments, while the rest will go to­ward com­mer­cial prepa­ra­tion.

The clock start­ed tick­ing days ago, when Der­ma­vant got the word out that it’s filed a BLA with the FDA for plaque pso­ri­a­sis.

The next step, said CEO Todd Za­vod­nick, will be to start a Phase III tri­al in atopic der­matits lat­er this year.

Orig­i­nal­ly de­vel­oped by GSK, tap­inarof was the cen­ter of a $330 mil­lion li­cens­ing deal back in 2018, when Der­ma­vant was still helmed by Cel­gene vet (and cur­rent Agios chief) Jack­ie Fouse. The biotech took over and steered the drug through two Phase III tri­als, pro­duc­ing the da­ta to po­si­tion it as a first-line al­ter­na­tive to steroids and a po­ten­tial add-on for ul­tra-ef­fec­tive but ex­pen­sive bi­o­log­ics.

“There’s been very lit­tle in­no­va­tion in the top­i­cal space,” Za­vod­nick pre­vi­ous­ly told End­points News, “so steroids have won the day … This is go­ing to trans­form derm.”

Not on­ly did tap­inarof eas­i­ly beat out place­bo on the pri­ma­ry end­point of clear or near­ly clear cas­es of pso­ri­a­sis, it al­so spurred con­sid­er­able gains on PASI-75 and PASI-90 — with around 20% of mod­er­ate to se­vere pa­tients achiev­ing 90% dis­ease clear­ance, which Za­vod­nick said is rare for top­i­cals.

The drug, an aryl hy­dro­car­bon re­cep­tor mod­u­lat­ing agent, is de­signed to be ap­plied once dai­ly.

Risk-shar­ing roy­al­ty deals — pop­u­lar­ized in re­cent years by Roy­al­ty Phar­ma — have been pop­ping up. No­vaQue­st, which has pre­vi­ous­ly backed Der­ma­vant, was re­cent­ly in­volved in a sim­i­lar arrange­ment with Tony Coles’ neu­ro play Cerev­el.

Man­ag­ing di­rec­tor Bri­an Axe high­light­ed the po­ten­tial to im­prove stan­dard of care for both pso­ri­a­sis and atopic der­mati­tis.

In ad­di­tion to buy­ing in­to tap­inarof sales, the anony­mous Boston group will of­fer a $40 mil­lion loan to Der­ma­vant for pay­ing off a pre­vi­ous cred­it fa­cil­i­ty as well as work­ing cap­i­tal.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

Viswa Colluru, Enveda Biosciences

A Re­cur­sion vet­er­an is map­ping plant life to chart a course to new ther­a­pies — and in­vestors like what they see

One of the earliest employees at AI biotech Recursion Pharmaceuticals is leading a new company, and he’s just closed a hefty Series A to get things moving.

Enveda Biosciences pulled in $51 million in the raise, the company announced Tuesday morning, with the goal of pushing some of its preclinical programs further along. Led by CEO Viswa Colluru, Enveda aims to research how machine learning can utilize natural biology to create new therapies for Wilson’s Disease, NASH and Parkinson’s disease, among others.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.