FDA re­jects Nabri­va a sec­ond time; Nabri­va pins it on trav­el re­stric­tions

A lit­tle over a year af­ter the FDA is­sued Nabri­va its first CRL for the an­tibi­ot­ic Con­tepo, the agency has is­sued an­oth­er.

By Nabri­va’s ac­count, the agency’s rea­son­ing hasn’t changed. They again cit­ed un­re­solved man­u­fac­tur­ing is­sues at the com­pa­ny’s CMO fa­cil­i­ties in Eu­rope and asked for no new clin­i­cal da­ta. The prob­lem, Nabri­va said, was that be­cause of trav­el re­stric­tions, the agency wasn’t able to do an on­site in­spec­tion of the fa­cil­i­ties to con­firm that the is­sues raised last year had been fixed.

Be­cause nei­ther com­pa­nies nor the FDA re­lease CRLs, it’s im­pos­si­ble to con­firm the claim, but it wouldn’t be the first time trav­el re­stric­tions have ap­peared to in­ter­fere with the re­view process. The agency warned in May that re­view times could be de­layed. And ear­li­er this month, No­var­tis an­nounced that the de­ci­sion date on its MS drug Arz­er­ra had been pushed from June to Sep­tem­ber. Though the com­pa­ny didn’t spec­i­fy rea­sons for the de­lay, one in­vestor at their Q1 call not­ed pos­si­ble out­stand­ing man­u­fac­tur­ing is­sues in Eu­rope that Covid-19 could have made dif­fi­cult to re­solve.

The re­jec­tion is a blow to a com­pa­ny that, like oth­er an­tibi­ot­ic mak­ers, has al­ready been ail­ing for some time. Al­though the Irish biotech reached $12 a share in 2017 off of pos­i­tive Phase III re­sults for the lead an­tibi­ot­ic and al­though that drug would soon be ap­proved, their shares tum­bled as oth­er suc­cess­ful an­tibi­ot­ic mak­ers filed for bank­rupt­cy and in­vestors be­gan to re­al­ize the grim fi­nan­cial log­ic of an­tibi­otics: To pre­vent re­sis­tance, you give new drugs on­ly as a last re­sort; a new drug, how­ev­er promis­ing, can be­come fa­tal­ly low-vol­ume.

The lat­est re­jec­tion cut shares by 15% pre-mar­ket, but it had al­ready en­tered pen­ny-stock ter­ri­to­ry.

The drug, known chem­i­cal­ly as fos­fomycin, has been avail­able in many coun­tries out­side the US since the ear­ly 1970s. Though of­ten giv­en oral­ly, Nabri­va had sub­mit­ted an in­tra­venous for­mu­la­tion for ap­proval in com­pli­cat­ed uri­nary tract in­fec­tions. The com­pa­ny ac­quired it from Za­vante in 2018 for 8.2 mil­lion shares — at the time worth around $25 mil­lion — and $100 mil­lion in mile­stones.

Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Covid-19 roundup: EU backs Os­i­vax's pur­suit of a uni­ver­sal vac­cine to fight Covid-19

The race to find a vaccine for the novel coronavirus continues to heat up, as the European Commission’s pilot R&D arm taps French biotech Osivax to head up its unique approach to the research.

Aiming to develop a universal jab for the flu and Covid-19, Osivax secured around $20 million in “blended financing” from the European Innovation Council. About $3 million comes from a Covid-19 “accelerator grant” and will go toward completing Osivax’s signature flu vaccine, dubbed OVX836 and currently in Phase IIa. The rest will be included as part of Osivax’s Series B funding, which aims to launch the Phase IIb portion of the study.

Adrian Gottschalk, Foghorn CEO

Mer­ck dan­gles up to $425 mil­lion to team with Flag­ship’s Foghorn Ther­a­peu­tics on drug­ging the shape of DNA

Two years after it first emerged from stealth mode, Flagship’s Foghorn Therapeutics has nabbed its first Big Pharma partner as Merck signs on to the biotech’s vision of drugging the very shape of DNA.

The deal, worth up to $425 million but with the upfront cash undisclosed, comes as Foghorn nears a pivot to a clinical stage biotech. The Cambridge-based company has added nearly 60 staffers from the 25 it had when it first emerged out of Flagship and, CEO Adrian Gottschalk said, they have finally refined the screening technology at the heart of the company, with plans to file their first IND towards the end of the year.

John Reed, Sanofi R&D chief (Endpoints News)

John Reed brings NK cells in­to Sanofi's CD38 ri­val­ry with J&J — and of­fers thumbs up for Kiadis' new fo­cus

Sanofi doesn’t just want to be a challenger to J&J’s dominant Darzalex multiple myeloma franchise. It’s looking to pioneer a new approach by pairing its own — newly approved — anti-CD38 drug with an NK cell therapy it’s just picked up.

The French pharma giant has teed up $19.7 million (€17.5 million) upfront and close to a billion dollars (€857.5 million) in milestones for a license to Kiadis Pharma’s preclinical K-NK004 program, which consists of NK cells that have been genetically engineered not to express CD38.

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GSK sets the stage for a toe-to-toe mar­ket show­down with Gilead­'s HIV cham­pi­on Tru­va­da

ViiV Healthcare and majority owner GlaxoSmithKline have cleared another important hurdle on a long-running quest to challenge Gilead’s dominance in preventative HIV treatments.

The final analysis of a new study shows the GSK subsidiary’s long-lasting injection, cabotegravir, proved 66% more effective in HIV prevention than Gilead’s breakthrough Truvada pill. And they now intend to carve away some of the blockbuster revenue that Gilead has enjoyed for years.

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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