Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Fra­zier Health­care Part­ners’ Bhaskar Chaud­huri has been care­ful­ly and qui­et­ly groom­ing Ar­cutis Ther­a­peu­tics, a new der­ma­tol­ogy play he co-found­ed to de­liv­er top­i­cal for­mu­la­tions of well-known drugs. Now that the biotech is poised to en­ter Phase III, he’s be­ing joined by a mar­quee syn­di­cate for its $94.5 mil­lion Se­ries C.

John Smither

HBM Health­care In­vest­ments, Vi­vo Cap­i­tal, Black­Rock, Omega Funds, Piv­otal BioVen­tures, and Gold­man Sachs jumped on board, join­ing Bain Cap­i­tal Life Sci­ences, Or­biMed and RA Cap­i­tal Man­age­ment in back­ing Ar­cutis’ lead top­i­cal cream for plaque pso­ri­a­sis.

The ac­tive in­gre­di­ent in ARQ-151 is rof­lu­mi­last, a PDE4 in­hibitor that As­traZeneca mar­kets for chron­ic ob­struc­tive pul­monary dis­ease in oral form.

Ar­cutis’ li­cense cov­ers world­wide rights for its top­i­cal use and would ex­tend patent pro­tec­tion to 2035 and po­ten­tial­ly be­yond, CFO John Smither told End­points News.

“There’s been kind of this void for a long time for things like pso­ri­a­sis and atopic der­mati­tis, par­tic­u­lar­ly with pa­tients who have mild to mod­er­ate dis­ease as op­posed to mod­er­ate to se­vere,” he said.

The cur­rent treat­ment par­a­digm for these ail­ments span two ex­tremes, he added but leaves very lit­tle in be­tween. At one end of the spec­trum are ex­pen­sive bi­o­log­ics such as En­brel, Hu­mi­ra, Dupix­ent and even Ote­zla (the oral PDE4 drug that Bris­tol-My­ers Squibb re­cent­ly sold to Am­gen for $13.4 bil­lion); at the oth­er, there are dirt cheap gener­ic steroids, which come with their own short­com­ings in both ef­fi­ca­cy and side ef­fects.

Frank Watan­abe

West­lake Vil­lage, CA-based Ar­cutis re­cent­ly out­lined topline re­sults from a Phase IIb study, show­ing that ARQ-151 in­curred sig­nif­i­cant re­duc­tions in the signs of plaque pso­ri­a­sis as mea­sured by in­ves­ti­ga­tor glob­al as­sess­ment, or IGA. Af­ter six weeks of once-dai­ly treat­ment, 32.2% of the pa­tients on the 0.3% dose saw an IGA suc­cess, ver­sus 24.5% in the ARQ-151 0.15% group and 9.8% on ve­hi­cle (p=0.005). The biotech said the lat­ter is a po­ten­tial reg­is­tra­tional end­point for the up­com­ing piv­otal.

The plaque pso­ri­a­sis tri­al will read out in the first half of 2021, while Phase IIa topline da­ta in atopic der­mati­tis are ex­pect­ed lat­er this year.

Among the mil­lions of pa­tients suf­fer­ing from these in­flam­ma­to­ry dis­eases, Ar­cutis wants to carve out a seg­ment whose der­ma­tol­o­gists are al­ready in­clined to pre­scribe top­i­cal ther­a­pies. By Smither’s es­ti­mates, that could trans­late to 2 mil­lion pa­tients with pso­ri­a­sis and 1 mil­lion with atopic der­mati­tis.

“The bi­o­log­ics ac­count for some­thing like 80% of the to­tal mar­ket size of pso­ri­a­sis but it’s on­ly some­thing like 6% of the pa­tients,” Smither said. “We’re try­ing to solve a dif­fer­ent thing by ac­tu­al­ly treat­ing more pa­tients at a more cost-ef­fec­tive price” — a sweet spot where pa­tients won’t need physi­cian ap­proval to get re­im­burse­ment.

That strat­e­gy of find­ing a unique niche with­in crowd­ed class­es al­so ap­plies to its sec­ond pro­gram, a JAK1 in­hibitor that Ar­cutis li­censed from an un­named Chi­nese part­ner and plans to de­vel­op top­i­cal ap­pli­ca­tions for. The hope is that this method will avoid the well-pub­li­cized safe­ty is­sues plagu­ing the class.

With a C-suite full of bio­phar­ma vets skilled in com­mer­cial­iza­tion, Ar­cutis plans to even­tu­al­ly sup­ple­ment its cur­rent team of 24 with a rel­a­tive­ly mod­est sales­force — around 75 to 100 reps — to field its drugs.

That ef­fort will be di­rect­ly over­seen by CEO Frank Watan­abe, who was in­volved in the mar­ket­ing of En­brel dur­ing his tenure at Am­gen, as well as CCO Ken­neth Lock, who re­cent­ly joined from Gilead.

“We come from a phi­los­o­phy that com­pa­nies have to be built to go long,” Smither said. And they now have a lot more ma­te­r­i­al to work with.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.