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.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.