No­van’s shares in melt­down fol­low­ing "dis­cor­dant" PhI­II stud­ies of a new ac­ne drug

Nathan Stasko, No­van

Of­fi­cial­ly, No­van $NOVN put out some mixed da­ta from two Phase III stud­ies of their lead drug for ac­ne, with one suc­cess and one fail­ure. But even the pos­i­tive da­ta from one tri­al failed to stand out from the con­trol arm in a ma­jor way, putting this com­pa­ny un­der a cloud.

Its stock plunged 80% this morn­ing.

On the up side, in­ves­ti­ga­tors say that SB204 hit all three co-pri­ma­ry end­points for NI-AC302, with sig­nif­i­cant – though far from im­pres­sive – re­sults for re­duc­ing the num­ber of le­sions and ac­ne clear­ance. Here are the num­bers, for both stud­ies:

•The ab­solute change from base­line in the num­ber of non-in­flam­ma­to­ry le­sions in NI-AC301 was -15.4 for SB204 and -13.4 for ve­hi­cle (p=0.030), and in NI-AC302 was -14.9 for SB204 and -12.3 for ve­hi­cle (p=0.001).

•The ab­solute change from base­line in the num­ber of in­flam­ma­to­ry le­sions in NI-AC301 was -12.1 for SB204 and -11.1 for ve­hi­cle (p=0.114), and in NI-AC302 was -12.9 for SB204 and -10.6 for ve­hi­cle (p<0.001).

•The pro­por­tion of pa­tients with IGA suc­cess in NI-AC301 was 13.4% for SB204 and 13.8% for ve­hi­cle (p=0.866), and in NI-AC302 was 18.9% for SB204 and 14.3% for ve­hi­cle (p=0.032).

A to­tal of 2,639 pa­tients ages 9 and old­er with mod­er­ate to se­vere ac­ne were en­rolled across a to­tal of 110 sites in the Unit­ed States.

The sec­ondary end­points looked quite sim­i­lar, leav­ing Mor­risville, NC-based No­van count­ing its cash. There’s enough mon­ey on hand to make it through the end of the year, when it’s hop­ing to have some bet­ter da­ta from an up­com­ing read­out on an an­ti-fun­gal pro­gram.

No­van raised $45 mil­lion with its IPO last fall, ear­mark­ing the mon­ey for an NDA for this drug, which it billed as the first new chem­i­cal en­ti­ty to come along for ac­ne in 20 years. Those plans may well have to change now. The biotech end­ed the day yes­ter­day with a mar­ket cap of $298 mil­lion.

“While we are pleased with the re­sults of the NI-AC302 tri­al that met the reg­u­la­to­ry re­quire­ment for sta­tis­ti­cal­ly sig­nif­i­cant ef­fi­ca­cy of SB204, we are dis­ap­point­ed with the dis­cor­dant re­sults of NI-AC301. Our team has not yet re­ceived the full da­ta set and we in­tend to pro­vide an up­date on the SB204 pro­gram af­ter our com­plete analy­sis,” said Nathan Stasko, PhD, Pres­i­dent and CEO of No­van. “De­spite these dis­cor­dant re­sults, we be­lieve in the po­ten­tial of ni­tric ox­ide’s mul­ti­ple, well-doc­u­ment­ed mech­a­nisms of ac­tion and the da­ta we have re­cent­ly gen­er­at­ed for our SB206 an­ti-vi­ral and SB414 an­ti-in­flam­ma­to­ry prod­uct can­di­dates. We con­tin­ue to look for­ward to near term clin­i­cal re­sults from our SB208 an­ti-fun­gal pro­gram in the sec­ond quar­ter of 2017 and ad­vanc­ing our pipeline of in­no­v­a­tive ther­a­pies for pa­tients suf­fer­ing from skin dis­eases.”

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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CEO Marco Taglietti (Scynexis)

'N­ev­er been more ur­gent:' Scynex­is looks to tack­le su­per­bug cri­sis with late-stage read­out for an­ti­fun­gal hope­ful

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

A spot­light schiz­o­phre­nia drug in Neu­ro­crine's $2B Take­da deal flunks its first ma­jor test. But it's not giv­ing up yet

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.