Cash-strapped No­van takes a hard knock as mol­lus­cum drug fiz­zles in late-stage tri­als

Tiny No­van is not just low on funds, its in­vestors are al­so scrap­ing the bar­rel for some con­fi­dence.

The Mor­risville, North Car­oli­na-based drug de­vel­op­er’s stock $NOVN plunged in­to pen­ny stock ter­ri­to­ry af­ter the com­pa­ny re­vealed two late-stage stud­ies test­ing its drug, SB206, failed in pa­tients with mol­lus­cum con­ta­gio­sum, a con­ta­gious skin in­fec­tion that af­fects about 2 mil­lion in the Unit­ed States.

G. Kel­ly Mar­tin

The top­i­cal an­tivi­ral gel is be­ing test­ed against a ve­hi­cle in two tri­als — with each en­rolling 340 sub­jects aged 6 months and old­er. The main goal for ei­ther study is the pro­por­tion of pa­tients with com­plete clear­ance of all treat­able mol­lus­cum le­sions at week 12. Large­ly af­fect­ing chil­dren, mol­lus­cum con­ta­gio­sum is char­ac­ter­ized by up to 100 le­gions — these are small, raised, and usu­al­ly white, pink, or flesh-col­ored with a dim­ple or pit in the cen­ter, and can be­come itchy, sore, red, and/or swollen.

The drug did not meet the pri­ma­ry end­point in ei­ther tri­al — B-SIM­PLE1 or B-SIM­PLE2.

Source: No­van, 2020

Click on the im­age to see the full-sized ver­sion

But some sta­tis­ti­cal wiz­ardry has con­vinced No­van oth­er­wise.

Source: No­van, 2020

Click on the im­age to see the full-sized ver­sion

No­van plans to use B-SIM­PLE2 as one of its con­fir­ma­to­ry tri­als for a mar­ket­ing ap­pli­ca­tion, pend­ing dis­cus­sions with the FDA. It al­so ex­pects to con­duct an­oth­er late-stage study (slat­ed to kick­off in April 2020) to sup­port the ex­ist­ing dataset, the com­pa­ny said, adding that its time­line for an NDA sub­mis­sion re­mains the sec­ond quar­ter of next year.

Paula Brown Stafford

The com­pa­ny’s stock was oblit­er­at­ed on Fri­day morn­ing. Shares cratered near­ly 73% to 85 cents.

The com­pa­ny’s pipeline, which in­cludes a range of oth­er der­ma­tol­ogy tar­gets, is en­gi­neered to har­ness the ther­a­peu­tic po­ten­tial of ni­tric ox­ide, a nat­u­ral­ly oc­cur­ring com­pound. When a threat is de­tect­ed by the body, white blood cells in the im­mune sys­tem en­gulf in­vad­ing pathogens by re­leas­ing a burst of ni­tric ox­ide to de­stroy the per­pe­tra­tor.

Fi­nan­cial­ly, No­van is in trou­ble. As of Sep­tem­ber 30, 2019, the com­pa­ny had around $22.5 mil­lion in cash — funds that should keep the lights on in­to the first quar­ter. But in or­der to keep de­vel­op­ing SB206 and sus­tain the com­pa­ny, man­age­ment is in search for a life­line — ex­plor­ing fi­nan­cial and strate­gic op­tions.

The No­van an­nounce­ment has so­lid­i­fied the po­si­tion of ri­val Ver­ri­ca $VR­CA, whose top­i­cal agent of can­tharidin is up for FDA ap­proval for pa­tients with mol­lus­cum con­ta­gio­sum by Ju­ly 13.

“(C)on­sid­er­ing the re­strict­ed cash on hand and the lack of con­vinc­ing com­pet­i­tive da­ta, we con­sid­er the sin­gu­lar threat to Ver­ri­ca’s VP-102 now es­sen­tial­ly elim­i­nat­ed,” Cowen’s  Ken Cac­cia­tore wrote in a note. “These re­sults are fur­ther con­fir­ma­tion that VP-102’s long term op­por­tu­ni­ty should be as­sured.”

Last month, No­van said its CEO and phar­ma vet­er­an Kel­ly Mar­tin — for­mer chief of Ma­lin Corp and Elan — is step­ping away in Feb­ru­ary. COO Paula Brown Stafford will take over the reins.

Mol­lus­cum con­ta­gio­sum

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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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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepreneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film “Fantastic Voyage,” the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his and his co-founders’ own accounts, along with some seed cash from friends and family.

Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.