Third time's the charm: Adamis nabs ap­proval of high-dose nalox­one in­jec­tion af­ter two CRLs

If at first you don’t suc­ceed, and at sec­ond you don’t suc­ceed, try, try again.

That’s been the un­of­fi­cial mantra for Adamis Phar­ma­ceu­ti­cals’ high dose nalox­one in­jec­tion, which re­ceived two CRLs in the span of a year be­tween the No­vem­bers of 2019 and 2020. But on Mon­day, word came through that the FDA ap­proved the drug on Adamis’ third at­tempt, giv­ing doc­tors an­oth­er tool to treat in­di­vid­u­als who over­dose on opi­oids.

The drug will be mar­ket­ed as Zimhi, and there’s no word yet on the price. An Adamis spokesper­son told End­points News via email that the drug will be priced by US WorldMeds which will set it “com­pet­i­tive­ly.”

“The high­er in­tra­mus­cu­lar dos­es of nalox­one in ZIMHI should re­sult in more rapid and high­er lev­els of nalox­one in the sys­temic cir­cu­la­tion, which in turn, should re­sult in more suc­cess­ful re­sus­ci­ta­tions,” said Jef­frey Galinkin, for­mer FDA ad­comm mem­ber and paid Adamis con­sul­tant, in a pre­pared state­ment. He added the drug will par­tic­u­lar­ly help the ris­ing num­ber of fen­tanyl-re­lat­ed over­dos­es.

In­vestors wel­comed the news for the small-cap play­er, send­ing Adamis shares $ADMP up 17% in ear­ly Mon­day trad­ing to $1.33 per share. The stock price has yet to re­cov­er from a Feb­ru­ary 2019 re­jec­tion, how­ev­er, when reg­u­la­tors shot down a pitch for an erec­tile dys­func­tion drug.

Nalox­one, gen­er­al­ly sold un­der the brand name Nar­can, has proven a key el­e­ment to try­ing to curb the opi­oid epi­dem­ic in the US, be­ing used by first re­spon­ders and emer­gency room doc­tors to im­me­di­ate­ly in­ter­vene dur­ing an over­dose. De­vel­oped by Adapt Phar­ma and now owned by Emer­gent BioSo­lu­tions, Nar­can is avail­able at a 40% dis­count to state and lo­cal gov­ern­ments and non-prof­it or­ga­ni­za­tions.

Adamis, mean­while, cen­ters its strat­e­gy on of­fer­ing low­er-cost al­ter­na­tives to drugs that are al­ready out there. Nar­can and oth­er nalox­one-based prod­ucts like Evzio gen­er­al­ly use less of the drug than Zimhi’s 5 mg/0.5 mL dose.

For Zimhi, the biotech ran in­to man­u­fac­tur­ing head­winds both times it re­ceived re­jec­tions, but the FDA has os­ten­si­bly been sat­is­fied with the com­pa­ny’s reme­dies. Pri­or to the sec­ond CRL, Adamis had en­tered in­to a dis­tri­b­u­tion agree­ment for the pro­gram that would have, pend­ing ap­proval, to­taled up to $26 mil­lion in up­front cash and mile­stone pay­ments. It’s un­clear whether that agree­ment will take ef­fect with Mon­day’s news.

Adamis’ main prod­uct is an ep­i­neph­rine in­jectable called Sym­jepi, which is used to treat al­ler­gic re­ac­tions and ana­phy­lac­tic shock sim­i­lar to My­lan’s block­buster EpiPen. Re­searchers for­mu­lat­ed a way to use the same de­liv­ery sys­tem for Zimhi as Sym­jepi, and the biotech is al­so de­vel­op­ing treat­ments for a range of res­pi­ra­to­ry dis­eases, such as Covid-19, in­fluen­za, asth­ma and COPD.

Pre­vi­ous­ly, the FDA had al­so ap­proved a gener­ic ver­sion of Nar­can nasal spray to be used by those with­out med­ical train­ing in April 2019.

This ar­ti­cle has been up­dat­ed to in­clude Zimhi pric­ing in­for­ma­tion and to clar­i­fy that Jef­frey Galinkin is a paid con­sul­tant for Adamis.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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