UP­DAT­ED: 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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Elcin Barker Ergun, Menarini Group CEO

Amid Roche and Sanofi's oral SERD set­backs, Menar­i­ni gets speedy re­view at FDA

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.